text:
In-Depth Validation of Closed-Vial Technology
Patrick Baleriaux, Anne Glibert, Benoit Verjans
BioPharm International, BioPharm International-09-01-2012, Volume 25, Issue 9
The authors describe a validation master plan for closed-vial filling technology.
Continuous improvement in the development of technologies for aseptic filling of injectable products has led to innovative solutions. The main driver for innovation is that a small deviation from GMP may trigger product contamination leading to septic shock and even death for the patient. For example, analysis of an outbreak database has shown that, among 1537 patients contaminated by parenteral products, the mortality rate reached 15%. Of those contaminations, 20% were due to deviations during pharmaceutical drug manufacturing, showing that improvement of injectable processing operations is worth investigating (1).
The rate of contamination has been strongly reduced during the past 50 years thanks to major innovations targeting both the container and the filling technologies. Among the major changes observed during this period were:
Emergence of the vial as the standard primary packaging, replacing the ampul. This change resulted in a significant decrease in breakage, a reduction in risk of contamination through small cracks, and elimination of glass particle generation when the ampul is opened.
Development of prefilled syringes and cartridges to ease drug administration by healthcare practitioners or patients.
Adoption of new materials such as cyclo-olefin co-polymer (COC) and cyclo-olefin polymer (COP) that increase resistance to damage and eliminate glass particles.
Creation of a physical barrier between the operator and the filling area. Initially, barriers were simple walls, but now can be isolators that prevent the operator from coming in direct contact with the product, the container, and the product contact parts.
Use of extensive in-process control (IPC) and process analytical technology (PAT) to perform on-line checks and to monitor the process itself. On top of the classical weight check, new checks such as continuous environmental monitoring, equipment performance monitoring, automatic particle inspection, and leak detection are now frequently used to reject defective containers and batches.
Crystal closed-vial technology aims to further address the quality issue for the patient and also to simplify the aseptic filling process (2, 3). The concept of crystal closed-vial technology consists of three different steps:
The vial is molded and directly assembled with its stopper in a ISO5 clean room, leading to a clean and closed vial.
The vial is then sterilized by gamma irradiation, leading to a clean, sterile, ready-to-fill vial.
During the filling process, a needle punctures the stopper and dispenses the liquid, followed by immediate laser resealing of the stopper to restore closure integrity and capping by snap fit. These three operations are performed in an ISO5 environment.
Although the goal is still to fill a vial with the pharmaceutical drug under aseptic conditions, closed-vial technology allows for some differences. Three main advantages include:
Increased safety for the patient: the vial remains closed during the process, significantly reducing the risk of a contaminant entering the vial compared with other containers remaining fully open, resulting in a two-log reduction of contamination risk due to exposure (4).
Simplification of the filling process: the vial is delivered clean and sterile, allowing the pharmaceutical manufacturer to eliminate the preparation of the container components (i.e., washing, siliconization, and depyrogenization for classical glass vials).
Easier handling for healthcare professionals: the handling, the opening, the piercing of the stopper, and collection of the product are facilitated compared with glass vials, because of the special shape of the stopper without a recess area. Out of 246 hospital professionals, 87% preferred closed-vial containers versus 6% who preferred glass-vial containers, according to a survey of practitioners and nurses conducted in Europe and the US (5).
Eliminating some process technologies requires the introduction of other solutions, such as:
Use of COC and thermoplastic elastomer (TPE) as container material for the vial body and for the stopper, respectively
Filling with a special needle piercing the stopper
Laser resealing of the piercing trace to restore closure integrity
Capping by snap fit of high-density polyethylene caps.
Making such changes raises several questions from the pharmaceutical industry regarding their acceptance by regulatory authorities. To ensure that the technology is suitable for aseptic filing of injectables, a series of tests should be performed regarding container materials and characteristics, container manufacturing process, and filling process.
This article describes the major changes that have been introduced, the validation processes, and their results. These data have been used by GSK Biologicals to support the approval for Europe of Synflorix, a vaccine against pneumococcal infection, using the closed vial for a Type II variation of the previous approval of the same product in other containers. It is clear that product stability data are mandatory to obtain regulatory product approval, but providing a complete set of supporting data can help the applicant to set up a complete and consistent file for submission to the authorities.
OVERVIEW OF THE VALIDATION MASTER PLAN
As described above, several modifications have been introduced compared with the classical glass-vial technology. To ensure that these modifications meet regulatory requirements and expectations, they have been tested according to the US and European pharmacopeas and to the guidelines published by the International Conference on Harmonization (ICH), and compiled in the validation master plan.
The tests performed are listed in Table I. They can be split into four parts: the container–closure materials, the behavior of the container closure in various conditions, the specific filling operations, and the overall process.
Table I: Overview of the tests performed in the validation master plan.
One crucial aspect of the container–closure is that the container has to be treated by gamma-irradiation to ensure its overall sterility, and not only asepsis. Gamma-irradiation may have physico-chemical effects on the materials. Therefore, to be robust, validation must be performed using worst-case conditions regarding the irradiation dose. To that end, a dose-mapping experiment on the densest pallet (1-mL vials) showed that to ensure a minimum of 25 kGray at the coldest point, the hottest point can receive up to 46 kGray. Therefore, the decision was made to irradiate all the test material at minimum 50 kGray.
VALIDATION OF THE CONTAINER MATERIALS
Different chapters of the pharmacopeia are applicable to closed-vial materials, as indicated in Table I. Of course, these tests must be conducted only on materials in direct contact with the pharmaceutical drug (i.e., the TPE stopper and the COC vial body).
The toxicity test described in USP <87> Biological Reactivity Tests, In Vitro has been conducted on both vial body and stopper materials. Extract of materials are subjected to the elution test in which L-929 cells are incubated for 48 hours with media used to extract materials. This test was repeated on three batches of each material and did not show any sign of reactivity.
The toxicity test described in USP <88> Biological Reactivity Tests, In Vivo is directly linked to the USP Class VI classification. It combines systemic injection, intracutaneous injection, and intramuscular implantation tests with extracted materials or strips of materials. Based on the results obtained, the material can be classified from Class I up to Class VI. According to the application, a certain level of classification is mandatory (e.g., USP Class VI is mandatory for permanent implantation such as prosthesis). For injectable containers, Class IV is acceptable. Nevertheless, as most of container materials meet the most stringent conditions (i.e., class VI), this one became a recommended standard. To perform a complete range of tests, the products must be extracted with four different solutions: 0.9% sodium chloride, 1:20 alcohol solution in sodium chloride, 0.9% polyethylene glycol 400, and vegetable oil. For both vial body and stopper materials and with all extraction solutions, the test was performed on three different batches and no toxicity was recorded, showing that USP Class VI requirements are met.
Other tests were performed regarding material physico-chemical properties. The US Pharmacopeia requires a series of tests on polymers in USP General Chapter <661>. These tests are limited to nonvolatile residues, residues on ignition, heavy metals, and buffer capacity. Some polymers such as polyethylene require specific tests but these are not applicable to COC. In the European Pharmacopoeia, chapter EP 3.1.3 Polyolefines, is dedicated to polyolefin. Although COC does not fall in that category, because the definition of polyolefin is limited to "polyethylene or co-polymer of ethylene with less than 25% of another organic compound," it was still decided to conduct that series of tests on COC. The vial body passed all these tests.
Concerning the tests to be conducted on the elastomeric closure, because USP <381> Elastomeric Closures for Injections contains the in vitro and in vivo tests described here as well as other tests harmonized with those described in EP 3.2.9 Rubber Closures for Containers, EP 3.2.9 for single-dose container was selected. This chapter describes mixing chemical tests on elastomeric closure extracts and mechanical tests such as fragmentation and penetrability on the whole stopper. The TPE stopper successfully passed all these tests for single-use container.
VALIDATION OF THE CONTAINER CLOSURE
Among the expectations regarding behavior of a container closure, some of them come from pharmacopeias or ICH guidelines while others are based on glass-vial standards. The list of the relevant tests and expected behaviors are indicated in Table I. Nevertheless, before starting validation of the container closure, it is crucial to ensure that it is appropriate to use the vial after gamma-irradiation. Gamma irradiation generates significant ozone. Because the vial is closed, the ozone cannot exit from the vial, and therefore, its disappearance results mainly from its natural degradation in oxygen. To ensure that degradation is sufficient to return to acceptable conditions, remaining concentration was calculated on the basis of ozone half-life (6). As half-life in atmospheric conditions is less than an hour, the ozone level would return back to normal concentration within 10 hours. In practice, such delay is much shorter than the delivery time from the irradiation site to the filling site, so there is no concern with ozone content.
Particle presence
According to both the US and the European pharmacopeias, the particle content inside a small volume injection container should not exceed 6000 for particles > 10 µm and 600 for particles > 25 µm (if the light obscuration particle count method is used). The method recommends careful withdrawal of the water for injection (WFI) content of several vials (to exceed 25 mL of test solution) and to pool it into a clean container. Usually, the stopper is carefully withdrawn to perform the WFI collection. In case of the closed vial, the stopper withdrawal being not feasible, the collection is performed by means of a syringe equipped with a 23 G needle piercing the stopper (which means that the particles generated during piercing of the stopper for product collection are included in the results). Particles generated by the movement of the syringe plunger are neutralized by a blank value of syringe movement.
Table II: Particles generated by complete process (from vial manufacturing up to product collection) in 2 mL crystal vials.
The results from a typical test, summarized in Table II, show that the particle content is much lower than the acceptable limits. In addition, these data are roughly two times lower than the particle content in glass vials measured according to the same procedure. This test is performed routinely to monitor the level of particle presence in vial batches.
Container–closure integrity
Container–closure integrity was assessed on vials that were pierced, filled, and laser resealed but not capped. The objective was to assess in one test the integrity at the junction between the stopper and the vial body and also the quality of the laser resealing. The dye ingress challenge test was used for validation and also for regular performance of batch release tests.
The selected dye test was based on EP 3.2.9 under the denomination "self-sealing test." The normal procedure consists of immersing vials in methylene blue solution and challenging them with a –27 kPa vacuum for 10 minutes, followed by a return to atmospheric pressure for 30 minutes. To be more challenging, three successive cycles were applied, each of them consisting of a vacuum of –30 kPa for 30 minutes, followed by an overpressure of +15 kPa for 30 minutes. The results showed the absence of dye ingress.
Microbiological tests have been conducted as well. Tests based on immersion in solution with Brevundimonas Diminuta and Proteus Mirabilis bacteria showed no contamination of vials filled with Tryptic Soy Broth and laser resealed.
Endotoxin contamination
It is crucial to ensure that the endotoxin contamination of vials is acceptable because no depyrogenization process takes place in the overall vial manufacturing and filling process. To ensure that the level of endotoxin is acceptable, both the raw material pellets and the vials are tested for endotoxin presence with an acceptable limit of 0.25 EU/mL. The method used was the Limulus Amebocyte Lysate (LAL) test using Endosafe equipment from Charles River. All batches tested until now showed low level of endotoxin on raw materials (1 g extracted with 2 mL of WFI, 0.05–0.10 EU/mL for 5 batches of raw materials) and the level inside the vial was always below the detection limit (<0.05 EU/mL UI for all vial batches). If endotoxin levels appears to be systematically low thanks to a robust process to avoid contamination, the level of control may be reduced in the future following a risk analysis.
Bioburden
Because the vials are sterilized by gamma-irradiation, the bioburden should be assessed to ensure that the irradiation dose is in line with ISO-11137 requirements. Because both vial body and stopper are molded at a temperature in the range of 200 °C and directly assembled in ISO5, the bioburden should be very low. Currently, all the samples tested (10 vials from each tested batch) showed absence of bioburden. This test should be performed either each batch or every three months according to ISO-11137 guidelines.
Gas permeability
Compared with glass, polymer materials have a significantly higher permeability to gas. COC material, used for the vial body, has been selected on basis of its well-recognized gas barrier properties. Nevertheless, gas permeability has to be assessed to ensure that products will not be subject to significant changes. In particular, water vapor transmission rate (WVTR) and oxygen exchange must be carefully checked. WVTR can lead to loss of water from liquid product, resulting in change of product concentration. Oxygen ingress can lead to oxidation of oxygen-sensitive products.
Table III: Water vapor transmission rate from 2-mL vials filled with 1.2 mL water-for-injection. RH is relative humidity.
To measure WVTR, 2-mL vials filled with 1.2 mL of WFI were stored in various ICH conditions. According to the ICH Q1A (R2) guideline, semipermeable containers should be stored in the following conditions to meet the class III and IV conditions (i.e., hot conditions): –20 °C for frozen products, 2–8 °C (normal conditions) and 25 °C ± 2 °C / 60% ± 5% relative humidity (RH, accelerated conditions) for refrigerated products, 3 °C ± 2 °C / 35% ± 5% RH (normal conditions) and 40 °C ± 2 °C / not more than 25% RH (accelerated conditions) for products kept at room temperature. According to ICH, a loss of 5% water within a period of three months in accelerated conditions is the acceptable limit. If that limit is exceeded, investigations should be conducted to assess the effect on the product.
Table III illustrates the loss of water in various storage conditions. In both accelerated conditions, water loss was significantly below the limit. Similar experiments are on-going with other vial formats and identical conclusions can be drawn. This supports the initial expectation that COC has excellent barrier properties for water vapor.
It is less obvious how to measure oxygen permeation due to ambient oxygen. Therefore, a specific test was set up to characterize the vial behavior regarding permeation to oxygen. The vial was packed with a bag of FeO crystals, validated regarding absence of loss of crystals outside the pack, inside a sealed aluminum pouch to serve as an oxygen scavenger. Such an assembly will first deplete the oxygen around the vial, bringing the oxygen concentration inside the pouch in the range of 0.1% within 24 h. In a second phase, the oxygen will leak out of the vial because of the concentration differential. When exiting the vial, the oxygen is captured by the scavenger, keeping the external concentration permanently low. Figure 1 shows the different kinetics observed according to storage temperature, leading to residual oxygen concentration in the vial of less than 3% in two months.
Figure 1: Speed of oxygen depletion in 2-mL closed vials when incubated with an oxygen scavenger in aluminum pouch. Oxygen concentration was measured using a Microx TX3 fiber optic oxygen transmitter (Presens), connected to a needle-type oxygen microsensor. Vials were incubated at 25 °C (blue line) and 40 °C (red line).
A useful application of that permeation to oxygen is the opportunity to prepare oxygen-depleted vials in advance after ensuring sufficient preincubation time. When filling oxygen-depleted vials by piercing with the noncoring needle through the stopper, no significant oxygen increase was observed in the vial, maintaining the initial oxygen concentration without nitrogen flush. For example, a test made with 2 mL oxygen depleted vials (pre-incubated for four months) showed that before and after filling, the concentration remained around 0.5% oxygen. After filling, the vials were kept under aluminum pouch protection with an oxygen scavenger for six months. The oxygen concentration inside the vials continued to decrease down to 0.1%. Although it requires an additional secondary packaging, closed vials are able to decrease the level of oxygen to significantly lower levels than classical procedures applied to glass vials, showing significant benefit for oxygen-sensitive products.
Vial shelf-life
To define the shelf-life of vials, irradiated vials were stored for up to five years. On a regular basis, vials were tested for appearance, container closure, particle content, sterility, and laser reseal ability. Until now, four years of shelf-life have been validated for the 2-mL vials.
Extractables
Extractables studies are becoming more and more mandatory. The purpose of the extractables studies is to identify all compounds that could leach out of both the vial body and the stopper, while leachable studies aim to identify all compounds that actually leach to the solution. Therefore, the detection of an extractable does not mean that this compound will be present as a leachable when long-term studies are conducted with pharmaceutical drugs, but it is worth specifically tracking such a chemical compound when the possibility of it being present exists. To perform appropriate extractable studies, four factors must be taken into account:
maximization of contact surface for extraction
use of aggressive solvents at high temperature
optimization of extraction time to ensure that all material has been extracted
use of wide range of detection methods to ensure that no significant material remains undetected.
For each of these key success factors, a method has been set up to ensure optimal extraction.
Based on extractable results, a list of 13 potential compounds categorized as potential leachables was established and these compounds were followed during compatibility studies.
Compatibility studies
Beside drug stability studies, the behavior of the vial itself must be assessed because its performance may vary according to the solution filled inside. Some products can be aggressive to the materials used for the container, leading to significant leachables, while others can degrade components material. Before final testing with pharmaceutical drugs, preliminary supporting data can be collected with some of the classical solvents/excipients. The characteristics assessed during long-term compatibility studies are visual aspect, maintenance of closure integrity, particle generation, and leachables.
The first three tests were conducted in the presence of WFI but additional simulants were selected for leachable studies. These simulants were WFI, 10% ethanol, phosphate buffered saline, 0.9% NaCl, and 0.5% 2-phenoxyethanol. Vials of 2 mL were filled with 1.2 mL of simulant and stored 50% right-side-up and 50% upside-down. The last results corresponded to two years of incubation at 30°C ± 2°C / 35% ± 5% relative humidity and showed that the visual aspect of the vial was not altered, the closure integrity was maintained, and the particle profile did not change significantly. Regarding the leachables, a one-year assessment was conducted to notice possible differences. Because no major differences were seen after one year, two of them, WFI and 10% ethanol were selected for long-term studies (five years). The leachable results showed the presence of two compounds, acetic acid and formic acid, exceeding 5 ppm. Low leachable quantities of t-butanol and acetone were detected in concentrations exceeding 0.2 ppm and all other products, including nine of the extractables recommended for follow-up, were either not detectable or at trace level. It is important to note that these four most abundant compounds in solution belong to the Class III solvent category according to the ICH Q3C guidelines. In these guidelines, the acceptable daily administration dose for Class III solvents is fixed at 50 mg, equivalent to more than 40,000 ppm in a vial filled with 1.2 mL. In addition, the full leachable profile was reviewed by a toxicology expert who did not report any toxicity concern.
Low temperature storage
Many of the new pharmaceutical drugs belong to the biological class. These products are often sensitive to heat and show lack of stability even at 2–8 ° C (for example, recombinant viruses and cell therapies). One option is to store them frozen at –20 °C, at –70 to –80 °C or even in liquid nitrogen (in vapor or submerged inside, i.e., at –196°C).
Some issues are reported with glass vials when stored at very low temperature, such as small cracks —ranging up to complete breakage—and loss of closure integrity caused by differential retraction of the stopper regarding the glass vial neck. Loss of integrity can lead to contamination risk, loss of sublimated water, or severe acidification when stored in dry ice.
To assess the suitability of the vial for low temperature storage, WFI-filled vials were stored as long as one year at –20°C, –80°C, or inside liquid nitrogen. The outcome is that none have shown any visual defect, loss of closure integrity, or loss of water.
To confirm the vial integrity at very low temperature, vials were filled with 100% oxygen and laser-resealed before being immersed in liquid nitrogen. Some unsealed vials were equipped with a small catheter in the stopper as positive samples. After 11 days of storage in these conditions, the oxygen content remained at 100% in resealed vials, whereas it decreased to about 60% in positive vials. This result showed that nitrogen did not enter the resealed vials, thus demonstrating the maintenance of the tightness of the closure.
These tests demonstrate that the closed vial, because of its resistant COC and effective closure assembly, is suitable for long-term storage in extreme conditions of low temperature.
Resistance to breakage
COC is known to be resistant to damage, and resistance to breakage was assessed in two different conditions: by drop test, to assess risk of cracks due to shock, and by freeze-thawing to assess resistance to the expansion of frozen liquids.
To quantify resistance to shock and to compare it with that of glass vials, a drop test procedure from different fixed heights to a concrete floor was set up. The percentage of intact and nonleaking vials was recorded for each height. The results showed that for the two tested sizes (1-mL and 10-mL vials), the closed vial is significantly more resistant than the equivalent glass vial (2R and 10R vials). For example, for the 10 mL vial size, 50% of glass vials are broken when falling from table height (75 cm) whereas closed vials can stand up to above 2 meters before seeing the first damage (see Figure 2).
Figure 2: Damage to 10-mL closed vials (blue line) and 10R glass vials (red line) when dropped from different heights. Vials were dropped once from each height, starting from the lowest, until damaged or broken.
To assess resistance to product expansion, a freezing-thawing test at –80 °C was conducted with vials filled with 15% mannitol, which is known to expand significantly during freeze-thawing. This test was performed according to a test reported by Jiang et al. who recorded glass vial breakage when frozen with this solution inside (7). Jian et al. observed that glass vial breakage depends on the filled volume and on the vial size. Jian et al. recorded 100% breakage for 20-mL glass vials and 50–60% breakage with 5- and 10-mL glass vials when filled at half of nominal volume. When this test has been performed according to the same procedure, no broken closed vial was observed with 5-, 10- and 20-mL size. The test was also performed with closed vial filled at full nominal volume and again, no breakage was reported.
This test showed that not only is COC resistant to shocks but that it is also able to tolerate significant product dilatation without damage.
VALIDATION OF THE EQUIPMENT
The main changes in equipment compared with classical filling technologies are the needle piercing of the stopper and the laser resealing of the piercing trace.
Needle piercing
Regarding the validation of the needle, the three main aspects assessed were the venting of the overpressure created inside the vial during filling, the level of particle generation during piercing, and the ability of the needle to support thousands of piercing.
Venting of the overpressure was validated by using a manometer connected to the inside of the vial. It showed that the pressure increased during filling in the range of 0.1–0.2 bar according to filling speed and vial size, then returned back to normal atmospheric pressure within 0.2 to 0.4 seconds. This measure correlates well with the observation that a short delay is necessary before needle withdrawal to avoid drop generation due to filling tube expansion, especially if silicone tubing is used.
Results of the particulate analysis showed that the needle generates very limited amount of particles during the piercing process. This result was obtained because of the noncoring pencil point design of the needle.
Moreover, the evolution of the particle generation inside the vial along a 5000-vial filling campaign using the same needle, did not show any increasing trend that could have been induced by the needle wear. Being observed with a microscope, the needle did not show any difference in shape, cutting edge or surface quality.
Laser resealing
The laser needs to be validated on several aspects. First, the absorption coefficient of the stopper material must be characterized; second, the impact on material should be assessed; third, the effectiveness of the resealing should be validated and last, the absence of effect of the laser on the product should be verified.
The TPE characteristics should ensure absorption of the laser beam energy by the stopper in such a way that the needle trace is resealed to a sufficient depth without burning the surface of the stopper. Simultaneously, almost all the laser beam energy must be absorbed in the stopper thickness to avoid the laser beam passing through the stopper and hitting the filled product. The right absorption rate is obtained because of a colorant master batch mixed with the stopper material. The range of colorant percentage in stopper composition is precisely defined to obtain absorption of at least 97% of the laser energy over the thickness of the stopper, according to a Beer-Lambert curve.
The potential effect of the laser shot on the stopper material was assessed by near-infrared spectrometry of the stopper surface before and after a laser shot. The profiles are identical between the two records, showing that there is no detectable change of stopper composition.
The laser power to be selected for an effective laser resealing was validated with physical challenge tests on the closure integrity of the resealed stoppers: dye test on vials resealed at different laser powers and bubble test looking for leakage from over-pressurized vials. It was shown that the stoppers that were not resealed only exhibit a small percentage of failure at the dye test while stoppers resealed with enough energy do not fail. Another way to assess the effectiveness of the resealing is to cut the resealed stopper perpendicularly to the trace. The resealing depth ranged from 0.4 mm to 1.0 mm when using a 6 mm diameter 12W laser beam. To assess the resistance of the weld, overpressure was produced inside the vials through their bottom side and leakage was assessed by bubble generation at the piercing trace. Resealed vials started leaking from 140 kPa to 200 kPa whereas a range from 30 kPa to 150 kPa was observed for the nonresealed vials.
To ensure that the product was securely stored when laser resealed, the effect of a laser shot on the temperature was measured at different location of a 2-mL vial and results are illustrated in Table IV.
Table IV: Temperature change recorded at various position of the vial when a 4 mm laser shot is applied.
The results, achieved using a 4 mm diameter laser and reproduced with a 6 mm diameter laser, showed that the product was fully secured inside the vial because no temperature change could be detected following laser resealing of the stopper.
ROBUSTNESS OF THE CONCEPT
To challenge the new concept, media fills had to be run. The first media fills were performed with equipment in an assembly workshop. These conditions were challenging for several reasons including:
The sanitization by wiping was performed with doors opened in an unclassified environment.
The vials were loaded under laminar airflow protection but surrounded by the unclassified environment.
Tryptic Soy Broth (TSB) bulk was connected through the Gamma-SART connector from an unclassified environment to the ISO5 environment (8).
The bottom of the line enclosure was directly opened to the unclassified environment.
Despite these adverse conditions, none of the 26,313 TSB filled vials were contaminated during media fill. Contamination was assessed after vials were incubated for 14 d, during 7 of which they were stored upside-down. Since installation of that equipment in an ISO8 clean room, more than 88,000 additional vials have been filled with TSB without any contamination.
Developing a new technology for filling injectable products requires an in-depth validation plan to ensure that such technology meets all regulatory requirements and provides the necessary features to protect and conserve the product. This article has shown that the closed-vial technology satisfies all requirements according to regulatory authorities. This article describes a useful structure of investigation to follow to prove suitability for drug approval when developing a new container (or of a new part of container).
These data have been well received by the European authorities to support approval of Synflorix, a vaccine from GSK Biologicals against pneumococcal infections that has been approved in all European countries.
Aseptic Technologies receives grants from the Region Wallonne and from the Agence Wallone à l'Exportation (AWEX). Technology has been licensed by Medical Instill Technologies.
Benoît Verjans, PhD*, is chief commercial officer, Anne Glibert is in quality control, and Patrick Baleriaux is chief executive officer, all at Aseptic Technologies, Gembloux, Belgium. *To whom correspondence should be addressed, Benoit.verjans@aseptictech.com.
1. R.P. Vonberg and P. Gastmeier P, J. Hosp. Infect. 65, 15–23 (2007).
2. B. Verjans, J. Thilly, and C. Vandecasserie, C., Aseptic Processing, supplement to Pharm. Tech. 29, S24–S29 (2005).
3. J. Thilly, D. Conrad, and C. Vandecasserie, Pharmaceutical Engineering 26, 66–74 (2006).
4. B. Verjans and C. Reed, BioPharm Int. 25 (3), 46–58 (2012).
5. B. Verjans, Pharm. Tech. Eur. 24 (6) 49–55 (2012).
6. "Ozone," http://en.wikipedia.org/wiki/ozone, accessed Aug. 2012.
7. Jiang et al., PDA J. Pharm. Sc. Technol. 61, 441–451 (2007).
8. B. Verjans et al., Pharm. Tech. 31 (4), 184–195 (2007).
Vaccine Development and ManufacturingManufacturingDownstream ProcessingBioPharm International-09-01-2012


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Obama Goes to Copenhagen
I thought the country elected a president last November. I guess was wrong. It appears we elected an Űbermayor of Chicago.
Mr. Obama is going to Copenhagen this week to pitch his home town Chicago as the site for the 2016 Summer Olympics. This is the first time in history that an American president has been Pitchman-in-Chief before the International Olympic Committee.
Meanwhile, Mr. Obama insists he's too busy to expedite consideration of Gen. McChristal's recommendation for more troops in Afghanistan, has his health care program to occupy his time, along with three recently discovered "homegrown" terrorist plots to ponder and the Iranian nuclear threat. Oh, yeah, North Korea keeps popping up on the radar too. Maybe we should add Multitasker-in-chief to Obama's many titles.
I still like "Teleprompter Reader-in-Chief" (TRiC) the best. We've been TRiCed since February, and I believe we will continue to be TRiCed for as long as Mr. O occupies the Oval Office.
BTW, I've heard on the news that Chicagoans are split 50/50 on whether they want the Olympics there at all. For all the hoopla and promises of an economic surge, history suggests that most Olympic Games venues absorb a net loss in connection with the Games.
Labels: Chicago, Obama, Olympics
President Pantywaist?
Once again, more valuable insight into what Mr. Obama is doing to the United States is available from abroad than from our domestic "news" organizations, whose credibility is now approximately on the same level as whale poop in the view of many if not most Americans.
Here's Gerald Warner, writing in the UK's Telegraph:
Thanks to President Pantywaist's supine policies, the former satellite states can see that they are fast returning to their former status. The American umbrella cannot be relied upon on a rainy day. They have been here before. Poles remember how a leftist US president sold them out to Russia at Tehran and Yalta. The former Czechoslovakia was betrayed twice: in 1938 and 1945.
If the word is out that America is in retreat, it will soon find it has no friends. The satellites will pragmatically accept their restored subordination, without openly acknowledging it, and co-operate with their dangerous neighbour, ushering in a new generation of Finlandisation.
Barack Obama is selling out America and, by extension, the entire West. This is a catastrophe for America and the wider world.
I wish I'd said that.
When words like "President Pantywaist" appear in the public discourse taking place in the staunchest friend that the US has in the world, it can't be good.
Labels: defense, Great Britain, media bias, Obama
Obama Worship in Burlington Township
As usual, I'm late to the party, but sometimes it's more fun to let details come out before commenting. Everyone who has electricity and doesn't depend on MSNBC for news has by now seen at least a portion of the creepy video of second graders at B. Bernice Young Elementary School in Burlington Township, NJ literally singing praises to President O.
Incredibly, the principal of the school has said she approves and would do it all again. Also, I heard on Fox News this morning that the superintendent of schools Burlington Twp. not only thinks the activity was appropriate, but has attacked whoever posted the video on Youtube for invasion of privacy. (The link is to a secondary source, but my attempt at this writing to access the Burlington Twp. schools website was unsuccessful--it is unclear whether the site is down because of traffic or the message was purposely tossed down the memory hole.)
As Michelle Malkin notes in her take on the incident (which I urge you to read), the person who originally posted the video, one Charisse Carney-Nunes, is a longtime admirer of Barack Obama and author of the children's book, "I Am Barack Obama." It appears that Ms. Carney-Nunes might have been present at the school when the video was made in February 2009. Be that as it may, according to Ms. Malkin, Ms. Carney-Nunes has removed the video from her Youtube account as of sometime in the morning of 24 September.
I have no problem with teaching kids about famous black Americans, nor am I concerned about teaching kids to respect the office of President of the United States. What bothers me about this video is the emphasis on Mr. Obama as the source of everything good and pure. The emphasis on him personally as a sitting President is what I find so disturbing, as well as the obvious political propaganda, e.g., "He said we must be fair today, equal work means equal pay." This crosses over into the realm of building a personality cult and political indoctrination, and that is absolutely contrary to the American tradition.
I saw a video bite this morning in which a mom whose child attends the school said she had no problem with the event, parroting school officials who said it was merely a recognition of Black History month and Presidents Day. I wonder what her reaction would have been if the name of Barack Hussein Obama were replaced by George Walker Bush?
The sad thing is, nothing is likely to happen to either the principal or the superintendent in future elections because the township, according to Fox News, voted almost 3 to 1 for Obama in 2008. So I guess we have a little San Francisco clone in New Jersey--no wonder a plurality of adults in New Jersey would move out of the state if they could.
Labels: Education, Obama, Personality Cult, Political correctness, politics, schools, Youtube
Obama's UN Speech
I only heard snippets, but Obama just might be the most anti-American president in history. Carter was the first one.
Labels: Obama, United Nations
Ol' Jimmeh
Former President Jimmy Carter--always good for a laugh.
If he weren't a former president, Mr. Carter would be annoying--sort of like a tomato seed that gets stuck between your teeth. But because he is a former president, he rises to a grander scale and becomes a national embarrassment.
Labels: Democrats, politics, race card, racism
Obama and Ahmadinejad
There was a little flurry of Iran news during the week past as on Monday Mr. Ahmadinejad announced that Iran considers the nuclear issue closed and rejects any halt to [uranium] enrichment. Then on Wednesday Iran presented "a package of proposals to diplomats representing the five permanent members of the U.N. Security Council and Germany" outlining the subjects on which Iran would be willing to negotiate with the civilized world.
Ahmadinejad clearly (and rightly, in my opinion) believes that neither the United States nor anyone else is willing to take whatever steps might be necessary to prevent Iran from developing nuclear weapons and the delivery systems necessary to make them an imminent threat to their neighbors and even some European countries.
The Europeans have been negotiating with Iran for what seems like at least a decade, without any results except more negotiations. The IAEA, the UN's nuclear proliferation watchdog, has been doing just that--watching as Iran developed the capability to enrich uranium to weapons-grade concentrations of U-235. Russia and China, both of which possess vetoes in the UN Security Council, have repeatedly refused to consider any but the lightest sanctions on Iran for violating UNSC resolutions regarding nuclear proliferation, and indeed Russia has even assisted Iran's efforts. So have many European companies, shipping dual-use materials to Iran that Iran has used in building its uranium enrichment industry.
President Obama either does not recognize the threat that Iran poses to its neighbors, recognizes it but does not believe it is either immediate or serious, or recognizes it but doesn't care. The administration has repeatedly said that it wants to negotiate with Iran about its nuclear ambitions, and is apparently still willing to negotiate even though Ahmadinejad has clearly stated that nuclear development is a non-negotiable issue. I believe this is whistling past the graveyard, except that in this case, the goblins are real and dangerous.
In an opinion piece (registration and/or subscription probably required) that appeared in the September 10 issue of the Wall Street Journal, former Senators Daniel R. Coats and Charles S. Robb and retired general Charles Wald stated that Iran will be able to produce a nuclear bomb using enriched uranium within a year, and urged Mr. Obama to begin gearing up for military action against Iran in case diplomacy failed to ameliorate the threat. They believe (as do I, FWIW) that without a credible military threat to back up diplomacy, Iran will continue on its merry way to developing the capability to, among other things, "wipe Israel off the map." If Mr. Obama thinks things are difficult now, wait until that happens.
In From The Cold blog has posted an analysis, which I commend to you.
# posted by ExRat @ 3:03 PM
Obama's Health Care Speech
Angry. Glittering generalities. Gratuitous jabs at Republicans. How ya gonna do it? Kennedy nostalgia.
"We don't want to run the banks."
"We don't want to run the auto industry."
"If you pass the stimulus bill the unemployment rate will not exceed 8%."
"If you want to know what I'm about, look at the people I surround myself with." (OK, that's a paraphrase, or not, but it's essentially what he said. In any event, the old adage about you're known by the company you keep still applies.)
I don't believe a f***ing word this guy says.
If this bill passes, by 2016 we'll have a single payer health system in this country, and it'll look a lot like the UK and Canada systems. I'm 63, and under Obamacare I don't expect to make it much past 75, if I'm fortunate enough to get that far.
Labels: Canada, Health Care, Obama, UK
World-Class Cuban Health Care
Kim Priestap at Wizbang has a post today about Cuban health care--you know, that world-class free health care that Michael Moore drooled all over himself about in his movie, "Sicko"?
Turns out Cuba isn't the medical Eden that Moore made it out to be (Surprise, surprise!-Ed). Priestap links to this site, which has text and photos that purportedly show the real state of Cuba's free health care paradise. Caution! The photos at this site are very graphic and unpleasant. Do not follow the link unless you have a strong stomach.
I have no idea what's true, but I can tell you I don't believe Mr. Moore for so much as a nanosecond.
Query: Is this what our kids and grandkids can expect in 50 years under Obama's version of single-payer health care?
Labels: Cuba, Health Care, Michael Moore
Lots of to-do lately about the checkered past of Van Jones, the Prez's Green Jobs czar. First he admitted to being a communist, then he called Repubs a**holes, then he railed against white polluters and white environmentalists for directing the poison to minority neighborhoods. In the last couple of days it came out that he signed the 'truther" petition asking for an investigation whether the attacks of September 11, 1991 were an "inside job." (All of the above facts appear in the Wikipedia article on Mr. Jones, which bears a disclaimer that the neutrality of the article is disputed, so you might not see what I saw if you visit that page.)
Now Jones has issued one of those "politician special" non-apology apologies--you know, the kind where he says "I'm sorry if I offended anyone" without admitting doing anything wrong. He also says he does not now and never did agree with the truthers' claims. Query: why, then, did he sign the petition? Mr. Jones' office has issued a statement to the effect that he didn't review the document carefully before signing. I call bushwa--whether he read it or not, he certainly knew its tenor and purpose at the time. Was he lying then or is he lying now?
I for one do not accept so-called "apologies" that are really insults in disguise; i.e., "I'm right and you're wrong but if you're too stupid to see that then I didn't mean to hurt your feelings while trying to educate you." I further believe that the statements Mr. Jones made before becoming a part of the Obama administration more truly demonstrate his real thinking than the measured, massaged and vetted comments that he makes now. Accordingly, I believe Mr. Jones is a racist, radical communist who wants to overturn the capitalist system that the United States has done so well by these last 220 years and replace it with something he calls the "Green Collar Economy" that pretty much has the government running everything. I don't want a guy like that advising any president.
Assuming the facts are true (and some undoubtedly are, as they appear in video clips available on YouTube in which you can see and hear Jones speak), then either the Obama administration did a really crappy job of vetting this guy before bringing him aboard, or they knew about all of this stuff and made a conscious decision that it didn't matter. Either way, in my view it doesn't reflect well on the Obama administration.
You're judged by the company you keep, Mr. President. Better keep that in mind.
Labels: Czars, Economy, Environmentalism, Obama, politics, weasel words

redpajama_set_name: RedPajamaCommonCrawl


text:
keilah Summary and Overview
Bible Dictionaries at a Glance
keilah in Easton's Bible Dictionary
citadel, a city in the lowlands of Judah (Josh. 15:44). David rescued it from the attack of the Philistines (1 Sam. 23:1-8); but the inhabitants proving unfaithful to him, in that they sought to deliver him up to Saul (13), he and his men "departed from Keilah, and went whithersoever they could go." They fled to the hill Hareth, about 3 miles to the east, and thence through Hebron to Ziph (q.v.). "And David was in the wilderness of Ziph, in a wood" (1 Sam. 23:15). Here Jonathan sought him out, "and strengthened his hand in God." This was the last interview between David and Jonathan (23:16-18). It is the modern Khurbet Kila. Others identify it with Khuweilfeh, between Beit Jibrin (Eleutheropolis) and Beersheba, mentioned in the Amarna tablets.
keilah in Smith's Bible Dictionary
(fortress), a city of the Shefelah, or lowland district of Judah. #Jos 15:44| Its main interest consists in its connection with David. #1Sa 23:7-13| It is represented by Kila, a site with ruins, on the lower road from Beit Jibria to Hebron.
keilah in Schaff's Bible Dictionary
KEI'LAH (fortress), a city in the lowland of Judah, near the Philistine frontier. Josh 15:44. When captured and plundered by a Philistine invasion David came to its rescue, but the inhabitants treacherously plotted with Saul for his betrayal. 1 Sam 23:1-13. After the Captivity its rulers aided in restoring the walls of Jerusalem. Neh 3:17-18; now Kila, 7 miles east of Beit Jibrin.
keilah in Fausset's Bible Dictionary
("fortress".) In the shephelah or lower hills of Judah (Joshua 15:44), hence the phrase "go down to Keilah." David in dependence on Jehovah's promise, notwithstanding his men's protest on the ground of their weakness, rescued it from the Philistines (1 Samuel 23); here Abiathar joined him with the ephod, having escaped from the massacre of priests at Nehemiah The proximity of Hareth, where David was, accounts for his helping it though he did not help other towns when robbed by the Philistines. frontHARETH.) Saul too looked to God, as if His providence had "delivered" David to him by David's entering a town with "gates and bars," Saul's hope was presumption, for God would never be the minister to gratuitous and murderous malice. David again consulted God in sincere faith, whether the men of Keilah would betray him. Like the Antitype, David was being betrayed by the ungrateful men whom he came to save. The grain abounding character of the Judaeau lowland accords with the Philistines robbing the "threshing floors" of Keilah. Its strength, as a key to the hill country of Judah, is implied in the "armies" of the Philistines, and in Saul's calling "all the people together to go down to Keilah." All "the inhabitants of Keilah" probably did not join in the treachery against David, only the Baalites, Hebrew: Baali for "men" of Keilah (Joshua 15:11-12), i.e. the Canaanite portion, votaries of Baal, to whom David's devotion to Jehovah and the presence of the sacred ephod with the priest Abiathar were an offense. Psalm 31:6; Psalm 31:8; Psalm 31:21 alludes, with the undesignedness which characterizes genuineness, to this: "I have hated them that regard lying vanities (idols as Baal), but I trust in Jehovah." "Thou hast known my soul in adversities" (David's phrase in the independent history, 2 Samuel 4:9). "Thou hast not shut me up into the hand of the enemy, Thou hast set my feet in a large room .... Blessed be Jehovah, for He hath shown me His marvelous kindness in a strong city," the very description of Keilah. In Nehemiah 3:17-18 Hashabiah is "ruler of the half part (pelek ) of Keilah" and Bavai ruler of the other half part. Pelek means a "breast," a "round hill", or mamelon ; applied to Jerusalem composed of two swelling hills with the Tyropeon valley passing between. Each half had its military ruler. El Khuweilifeh on the edge of the great plain, the road between Gaza and Hebron, answers probably to the double stronghold Keilah. It consists of two tells or round hills, with a valley between.
keilah in Easton's
keilah in Fausset's
keilah in ISBE's
keilah in Naves's
keilah in Schaff's
keilah in Smith's
keilah in Bible Dictionaries
© Naves Topical Bible


text:
Hillary Clinton Takes Your Questions
Hillary Clinton is the first female major-party nominee for president in this country's history. So, on the eve of the election, what do young women—conservative and liberal—want to ask her? And will her answers affect your vote?
One of two things will happen on the night of November 8, 2016. Either Hillary Clinton will be elected the first female president in U.S. history—or she will become the first woman in 227 years to come thisclose to the Oval Office. In the latest surveys, the majority of young women were rooting for Door Number One, preferring Clinton two to one in a head-to-head race against GOP nominee Donald J. Trump, according to the latest New York Times/CBS News poll. You may or may not be among them, but regardless of outcome, women have impacted this race.
GOP candidate Carly Fiorina (profiled by Glamour early this year) stood her own among a field of men. The Green Party's Jill Stein is making her second run for president (her first, in 2012, got a record number of votes for a woman in a general election). You're making history too: An unprecedented 51 million young women are eligible to vote in 2016. And you have questions for the barrier-breaking nominee—lots of questions.
As part of Glamour's ongoing 51 Million Voices campaign, we asked female Democrats, Independents, and Republicans to submit their top queries, then sent them to Clinton. Perhaps surprisingly—debate moderators, take note!—women asked less about topics that typically dominate the news, like Clinton's email server, and more about the issues that affect your everyday lives: your paycheck, your family, your safety. (We've reached out to Trump for an interview too.)
Will Clinton's answers sway you? Read, consider, register to vote right here, and—whatever your decision—vote.
1. I was a big Bernie supporter because I felt he was genuine; you could tell he believed he could make things better. I don't really feel that from you. What are your motives for wanting this job? —Cristie Andrews, 27, graphic designer, Los Angeles
Cristie, I really appreciate your question. It tells me I haven't done as good a job as I've hoped of conveying who I am and what I care about. Thanks for the opportunity to tell you a little more about me. I've worked on a lot of issues during my career, and I have a lot of detailed plans for many things I want to accomplish as president. But the one issue that has always mattered the most to me is children.
While I was a law student, I spent a year at the Yale Child Study Center, observing clinical sessions and learning about child development. Then I started working with the medical staff at the Yale New Haven Hospital on child abuse—a problem that hospitals were only beginning to acknowledge. I helped draft the legal procedures that the hospital would rely on when a child came in that the staff suspected was being abused.
Those experiences got me hooked. So when I graduated law school, I went to work for the Children's Defense Fund, representing the legal rights of kids. I went door-to-door in Massachusetts, meeting children who couldn't go to school because of their disabilities—because they were blind, or in wheelchairs, or had learning disabilities, and their local schools had no way to serve them. Because of these kids, and many others across the country, we urged Congress to change the law—and they did, and the right of all children to be educated in public schools, regardless of their disabilities, was established.
I worked with teenagers being housed (wrongly) in adult jails in South Carolina, went undercover in Alabama to expose school segregation, and helped start a program in Arkansas that taught parents in places without affordable preschool how to be their children's first teachers.
This is a real calling for me. I believe every child deserves good schools, good health care, safe homes and communities, clean air and water. I believe every little girl and boy deserves to be loved and respected and given every chance to develop their talents and pursue their dreams. And I believe the most important measure of a society is how we treat our kids—and I do mean all our kids.
I'm running for president for a lot of reasons. I believe I could do a lot of good for women, workers, veterans, immigrants, seniors, students. But my first priority will always be serving children. That has been the work of my life. That's my motivation.
ANDREWS REACTS: "I wish her response didn't include her past résumé—I know about all her great work for children. I wanted to hear more about why in this present moment she wants this job so badly. But I will still vote for her because I admire some of Hillary's policies and I don't like Trump."
2. I'm a University of Southern California student, where last year 30 percent of female undergraduates said they had experienced some form of sexual assault or misconduct since attending the university. What will you do to make sure everyone can pursue their education without compromising their safety? —Emma Peplow, 20, student, Los Angeles
Across the country, roughly one in five women reports being sexually assaulted while in college. And we can only imagine how many women and men choose not to come forward. The stories I've heard from survivors and their families are absolutely heartbreaking. I'm so proud of the advocates and survivors who have helped shine a light on this issue. Their efforts have sparked the beginnings of good work across our country. But we still have significant work to do.
First, we need to make sure every campus offers survivors the physical and emotional support they need, no matter their gender, sexual orientation, ethnicity, or race. Those services should be confidential, comprehensive, and coordinated.
Second, we need to ensure a fair process for all. Too often, the process of addressing a sexual assault on campus is confusing and convoluted. We need to make the process fairer and more transparent for all involved, and we need to make sure complaints are taken seriously.
Lastly, we need to step up our prevention efforts—and start them earlier. We should increase education programs that cover issues like consent and bystander intervention, not just in college but in high school.
This is a serious issue and it deserves our attention—not next month, not in years to come, but immediately. It's not enough to simply condemn campus sexual assault. We need to end it.
PEPLOW REACTS: "I'm very impressed. So many times survivors of sexual assault feel afraid to come forward because of the system in place, and I appreciate that she both recognized the flaws in our current system and detailed ways to effect change in the future. I will definitely take her answer into account at the polls."
3. I would love to see the next president work across the aisle and get more accomplished than the gridlock that President Obama has had to deal with over the past eight years. Would you consider nominating a Republican for a leadership position in your administration? If so, who? —Colleen Nelson, 38, attorney, Denver
Colleen, I definitely share your goal! If I'm elected president, I want to get as much done as I possibly can. And you're right—working across the aisle is key.
Now, I don't want to get ahead of myself—I have to win this election first. But I will say this: There are several Republicans I admire a great deal and have worked well with as senator and secretary of state. So yes: if I win the presidency, I certainly will consider Republicans for leadership roles.
I'm not just going to be a president for Democrats. I'm going to be a president for Republicans, Independents—all Americans. I take that really seriously and will seize every opportunity to bring people together across party lines.
NELSON REACTS: "Clinton made me feel heard, even though she declined to name a Republican she would consider for a leadership position—I can understand why she may be hesitant to do so. I'm planning to vote for her in November."
4. The tensions around police violence remain high. What steps do you plan to take to end police abuse of power in the lives of black and brown people in this country? —Kenya Fairley, 40, victims-and-family advocate, New York City
Kenya, this is something on the minds of many Americans right now, as it should be. The spate of police-involved shootings across the country, and the murders of police officers in Dallas and Baton Rouge, have laid bare serious challenges in our nation. We need to face them and fix them.
I've been clear in my belief that killing police officers is a terrible crime. That's why our laws treat the murders of police so seriously—because they represent the rule of law itself. If you take aim at that, you take aim at all of us. I've also insisted on facing the facts. There's something profoundly wrong when people of color are far more likely to be stopped and searched by police, charged with crimes, convicted, and sentenced to longer prison terms than white people who do the exact same thing. We can't ignore that. We have to make it right. But that can only happen if we build trust and take action together.
That's why I believe one of our most important challenges is rebuilding the bonds of trust between our law enforcement officers and communities. I believe we're all safer when everyone has respect for the law and everyone is respected by the law. That's why I've pledged $1 billion for police training on implicit bias, and I want to make broad investments in state-of-the-art training on a broad range of issues, including de-escalation and officer safety. I'll fight to end racial profiling by law enforcement and make body cameras available to every police department in America. And I'll bring law enforcement and communities together to develop national guidelines on the use of force.
This has to be an ongoing process, because these problems won't be fixed in a day. I'm going to stick with it for as long as it takes. I've spent so many hours sitting with mothers who have lost children—hours spent looking at photos of birthday parties, proms, and high school graduations…hearing stories about their son's favorite basketball team, or their daughter's love of music, or any of a million other things that mothers treasure about their kids. These conversations have changed me. They keep me going every day.
And I hope you and all Americans who care about justice and safety for all will join me. This is going to take all of us looking into our hearts and asking hard questions about whose lives and futures we value, and how we can each be a force for justice and peace in our communities.
FAIRLEY REACTS: "I'm disappointed. My question was specifically about the flagrant abuse of power by law enforcement, and she conflated that with the issue of police officers being murdered—her answer is disrespectful to black and brown Americans who have to live in fear. Police training means nothing without accountability. I will vote for Mrs. Clinton, but I will be watching to see how her thinking and her policies evolve."
5. When you were secretary of state, at times it didn't seem to me as if you would take every measure necessary to make all military employees absolutely safe while serving abroad. What would you do to gain the trust of military members like me? And what action by ISIS would cause you to resort to declaring war? —Erika Seagle, 35, Air Force Reserve flight nurse and nurse practitioner, Destin, Fla.
If I become your next commander in chief, nothing will be more important to me than the lives, safety, and well-being of our men and women in uniform. I believe our president has a sacred responsibility to send troops into battle only as a last resort. I believe the decision whether, when, where, and how to deploy troops is the most important decision a president can make.
I've visited troops in theaters of war; I've visited wounded warriors at military hospitals; I've sat with the parents and spouses of those wounded or killed in battle. I remember one trip to Afghanistan when I was a senator. An American soldier I met there said something to me I'll never forget: "Welcome to the forgotten front lines in the war against terrorism." I never want any of our troops to think that their country has forgotten them—or the fight they're waging on our behalf. And that commitment extends to our veterans, who put their lives on the line for our country. We need to do our part and make sure they get the benefits and respect they've earned when they come home.
Saying this isn't enough. I know that. You don't earn someone's trust through your words—you earn it through your actions. So here's what I can say: I hear you. I take your concerns very seriously. I never want members of our military to doubt for one minute that their commander in chief values their lives and safety. As president, I'll oversee the military with all the skill and experience in me—and I'll rely on our generals, admirals, and other top officials, because their skill and experience are enormous assets to our nation. I'll question my assumptions. I'll seek out criticism. I'll never forget the lessons of the war in Iraq—our military deserves well thought-out strategies, not half-baked plans.
And at the end of my term in office, I'll consider myself a success if members of our military like you say that I earned your trust. You may not agree with every decision I make in office. But I hope you'll trust that I made them with you and your families in mind, and that I did my best.
SEAGLE REACTS: "She missed the mark for me. It's clear she holds the military in high regard, but I feel my question about ISIS was completely ignored. I'm not sure that I trust her just yet—as she stated, this will take time. I'm still undecided about how I'll vote."
6. As a software engineer, I believe the tech industry is one of the most powerful industries in the world, but the creators of technology tend to be from the most homogeneous groups. How do you intend to work with companies to ensure that they are hiring diverse employees? —Kaya Thomas, 21, student and software engineer, Hanover, N.H.
Kaya, congratulations on embarking on such an exciting career path! You raise a really important point. The technology industry is too homogenous. There aren't many women or people of color. And that's a real problem. It's a problem for all the talented people out there who would love to work in this field but don't see a way in. And it's a problem for everyone else, because America needs all the talented technologists, computer scientists, and engineers we can get. These are the industries of the future. When they're effectively closed off to a lot of people, that makes our entire economy less competitive.
We've got to get back to that fundamental principle: In America, you should be able to go as far as your hard work and talent take you—no matter what you look like or where you come from.
This is a challenge across our entire economy. People of color face disproportionately high barriers to become entrepreneurs. African Americans and Latinos struggle to locate start-up capital; white men have a much easier time getting help. And the unemployment rate for African American teenagers is almost double that of white teenagers—which means a lot of young people are having a hard time participating in our economy right from the start.
So yes, we need to diversify tech. More broadly, we need to make sure all people can get a good education and a good job, no matter what field they're in. I have plans for improving K–12 education and making higher education affordable for people at every income level. And my jobs plan includes major investments in communities that have seen too little opportunity and too few jobs for too many years. There are a lot of communities across our country that have been overlooked for a long time and need an economic boost, and we ought to deliver it.
I also think a big piece of the puzzle is people like you—young women entering the tech industry and saying, "I belong here, and I hope more people feel like they belong here too." I've been the only woman in the room more times than I can count. It wasn't always easy. Sometimes it was a great relief to have another woman there. Representation matters. And if you don't believe that, my exhibit A is the U.S. Foreign Service. Our diplomatic corps includes Americans from all backgrounds, because when we send our people out into the world to represent the United States, we want the world to know, this is what the United States looks like: people of all races and faiths and genders, working together. Our diversity makes us stronger.
So keep sharing your story. And look for opportunities to mentor young people from different backgrounds. You're on an exciting path—make sure to bring some great people along with you.
THOMAS REACTS: "I really appreciated hearing her say that white men have a much easier time getting help. That matter-of-fact statement is not something I'd expect from any politician. She sees how multifaceted the issue is. And she has my vote in November."
7. Choice is a major issue for me. But the biggest attacks on women's reproductive rights recently have happened at the state level. How will you ensure states do not continue to strip away a woman's right to have an abortion? —Tiffany Ullian, 38, entrepreneur, Chicago
You're absolutely right, Tiffany. In just the first three months of 2016, more than 400 abortion restrictions were introduced by states. That's in addition to attempts by the U.S. Congress to defund Planned Parenthood at the federal level. This fight is taking place locally and nationally. So we've got to step up our advocacy for women's health and autonomy.
There's good news, too. This summer, the Supreme Court struck down the Texas law that forced abortion providers across the state to close their doors. It was a huge victory for women in Texas, and for the millions of Americans who believe women should be free to make our own health decisions.
Our work is far from over. The stakes in this election couldn't be higher. Donald Trump has pledged to defund Planned Parenthood. He would appoint Supreme Court justices who will overturn Roe v. Wade. He also said women should be punished for having abortions [Editors note: Trump later amended his statement to say that, if abortion became illegal, doctors performing the procedure should be punished.] Of course, we shouldn't be surprised—this is a man who calls women he dislikes "fat pigs."
So first, we need to make sure he doesn't get anywhere near the Oval Office. Then we can roll up our sleeves and really get to work.
UNITED STATES - JULY 28: Democratic presidential nominee Hillary Clinton, and her daughter, Chelsea, appear on stage at the Wells Fargo Center in Philadelphia, Pa., on the final night of the Democratic National Convention, July 28, 2016. (Photo By Tom Williams/CQ Roll Call)CQ-Roll Call,Inc.
As president, I'll defend Roe v. Wade and safe, legal abortion. I'll proudly stand with Planned Parenthood—just like I have for my entire life, as First Lady, senator, and secretary of state. I'll fight to make sure patients and staff can walk into health centers without facing harassment or violence. We'll work to repeal laws like the Hyde Amendment that make it nearly impossible for low-income women—disproportionately women of color—to exercise their full reproductive rights. Together, we'll build on the progress we've made to bring down rates of unintended pregnancy and teen pregnancy. We'll do that by investing in what actually works: accurate sex education and effective, affordable birth control.
Here's the bottom line. Issues of reproductive health and access to abortion are women's issues. They're also family issues, economic issues, and constitutional issues. They should matter to every American.
ULLIAN REACTS: "I feel her answers did not get into the meat of how she will do this on a state level—the very fragile ground where women's reproductive choices have been stripped away now. But I was pleased to see her weaving reproductive health into the larger context of family and economic issues. Birth control has helped women move closer to economic equity. This is just one example of how reproductive choice is part of a larger framework. I am confident that Clinton's tenacious resolve will protect a woman's right to choose, and I'm voting for her this November."
8. What are your plans to ensure that Generation Xers and those who retire after us are able to receive the Social Security benefits we currently pay into but are forecast to receive only a portion of? —Tiffany Lassek, 41, social worker, Omaha
You've put your finger on a serious problem. Social Security is a sacred promise to every American: After decades of hard work, you'll be able to retire with dignity. But forecasts indicate that many Americans will get back less from Social Security than they've put in through their labor. That's not right. We've got to make some changes, starting right now. Many Republicans want to cut benefits and/or privatize Social Security—which is a polite way of saying, "Gamble seniors' retirement security on the stock market." That's the wrong approach.
I want to take the opposite path. I fought against privatizing Social Security when I was a senator. Instead of cutting benefits, I'll ask the wealthiest Americans to contribute more, so we can strengthen Social Security for the long term. I also want to fix some problems that have lingered for too long—like making sure people who leave the workforce to become caretakers for family members aren't penalized. Those years of caretaking should count toward their Social Security benefits, too.
Social Security represents America at its best. It's humane. It's compassionate. And it works because we all do our part. Now we've got to come together and make smart, principled reforms to ensure that Social Security is strong for your generation and those that follow.
LASSEK REACTS: "I don't feel that having the wealthy pay more is a realistic or sustainable solution—I believe there is widespread wasteful government spending that should be redirected to Social Security to ensure the American citizens are protected. But I'm glad that Clinton is actively thinking of strategies to address this problem and I still plan to vote for her."
9. I quit my job after I had my baby because 12 weeks' maternity leave wasn't enough, since my son was in the NICU for a week and I had breastfeeding issues. How would you change our country's maternity/paternity policies? —Heather Hogsette, 31, stay-at-home mom, Las Vegas
Heather, I'm so sorry you had to choose between keeping your job and taking care of your newborn. No parent should face that choice. I remember being pregnant with Chelsea and having to write my law firm's maternity policy—they didn't have one because no woman on staff had ever returned to work after having a baby. That was then. But this is 2016. More mothers work than ever before—and more fathers stay home for at least some time with their children. But the United States is still the only developed nation in the world without paid leave. We need to do better.
Over the years, I've had a lot of wonderful people work for me—in Arkansas, the White House, the Senate, the State Department. And I've worked very hard to create an office culture that supported working parents. Your little one is sick? Go home, and don't worry about work; we'll handle it. New baby? Savor those early weeks, and we'll be here when you get back. (And in the meantime, send pictures!) Aging parent needs you? Let's figure it out together. I believe in flexible scheduling, telework, part-time assignments that really are part-time, not full-time in disguise. And I believe in employees and staff coming together and supporting each other, in work and in life.
But you know what? Whether or not you can be there for your family shouldn't depend on the personal beliefs—or the whims—of your boss. It's too important for that. We need a national policy.
As you may know, I've made paid parental leave a centerpiece of my campaign. I'll fight to pass 12 weeks of paid family leave, so no one will have to lose a paycheck—or worse, lose their job—to take care of their child, spouse, or parent. This is the right thing to do, plain and simple. And it's good for our economy in the long run. We should be making it easier for people to work and raise a family. Otherwise, we'll end up pushing a lot of hardworking, talented people out of the workforce. That makes no sense.
Paid family leave is important at every stage of life—but, Heather, you know firsthand that those early days and weeks with a newborn are especially precious. Infants need an enormous amount of care. They also need to bond with their parents—moms and dads. The same goes for children who join families later in life through adoption or foster care. Those families need time to get to know one another, too.
If we care about families, we should enact policies that support families. I believe this really deeply, and I'll fight hard for families as president.
HOGSETTE REACTS: "I appreciate her passion for this issue, but I felt a little frustrated that she focused only on a 12-week leave. We need longer parental leave. I don't want to say who I'm voting for, but I think all elected officials, regardless of party, should have consideration for working parents and the sacrifices they make."
10. A key issue for me is immigration: I feel that we first need to take care of our own citizens who are suffering, particularly our veterans, before we can take in more legal immigrants. How would your policies keep our country safe and prevent our nation from overextending financially? —Maleah D., 42, attorney, Birmingham, Ala.
I hear this question from a lot of people, Maleah. You're right—we do need to do a better job of taking care of Americans, especially our veterans and other vulnerable people, like children. And I understand why you would think that allowing more immigrants to enter the country would mean fewer dollars going to services for American citizens. But it's not that simple. Our country was built by immigrants—and still today, immigrants contribute billions to our economy every year. They start businesses. They create jobs. They pay taxes. And that money goes to services for veterans—as well as our military, public schools, national parks, and countless other government programs. Plus, as I'm sure you realize, a lot of veterans are immigrants. There are people from different countries serving in our armed forces right now. So I believe we should see immigrants as part of the solution to the challenges we all face. Now, your question was about legal immigrants, not undocumented ones. But even then, my answer would largely be the same. There's no question we have some serious problems with our immigration system. We need comprehensive reform—because as President Obama often says, we are a nation of immigrants and a nation of laws, and we need to defend both. But let's not forget how many undocumented immigrants contribute to our country, too. If tomorrow all the undocumented immigrants were rounded up and expelled from America (something Donald Trump has said he will do), it wouldn't just be cruel and scary for a lot of kids—it would be an economic disaster. And that would hurt all of us, including a lot of veterans.
One last point: I've spent a good portion of my career fighting for health care for all. I believe the Affordable Care Act was a major breakthrough, and I have a plan for how to build upon it and make sure quality, affordable health care is available for all Americans. I also have a plan for strengthening and reforming the V.A., so our veterans can get the health care they deserve. I hope everyone who cares about this issue will look at my plans and then look at my opponent's. The differences are clear. I'm the only candidate in this race with serious strategies to fix these problems.
MALEAH D. REACTS: "Mrs. Clinton said, 'Let's not forget how many undocumented immigrants contribute to our country.' But she didn't explain how their contributions outweigh the costs to the American taxpayer. I don't particularly like any candidate."
11. While women are starting businesses at impressive numbers, too many female small-business owners are getting tripped up with regulations, like those contained within the Affordable Care Act, that can hinder their growth. What relief can you offer these women who get stuck in the "missing middle"? —Crystal Arredondo, 39, retirement planning specialist, Dallas
I'm a big supporter of small businesses, which are a huge engine of growth for our economy. And at a time when women are creating more small businesses than ever before, I want to make sure our government is doing everything it can to encourage women entrepreneurs.
You ask about the Affordable Care Act. As you may know, businesses with fewer than 50 employers are exempt from the ACA rules. Beyond that, I have a plan to expand tax relief for small businesses, to make it easier for them to afford health care for their employees. So that should go a long way toward helping small businesses struggling with providing benefits to their workers.
And I'm really excited about my plan to help women entrepreneurs get access to start-up capital. Women tend to start businesses with about half the capital that white men have when they start businesses. The same goes for African Americans and Latinos. There's just so much less support for starting a business if you're not a white man. This is a major opportunity gap! So my plan includes working with banks and foundations to match capital and funding for promising small businesses.
I want to create more business incubators across the country, and expand training, mentoring, and certificate programs, to reach 50,000 entrepreneurs in underserved communities. And I think our schools should start encouraging entrepreneurial training as early as high school. Our young people have so many great ideas—let's give them the skills they need to see them through.
I've said I want to be the "small-business president," because I think this is so vital to our economy. So if you have additional ideas for how we can better help women entrepreneurs, I want to hear from you.
ARREDONDO REACTS: "I appreciate Secretary Clinton's commitment to small businesses. She is right that they are a driving force in our economy. She is also correct that too many women entrepreneurs lack the resources they need to start or grow their businesses. Her ideas certainly have merit and value for new entrepreneurs, but different challenges remain for those businesses who have graduated to mid-tier status. It will be important for the next president to understand nuances such as these and be able to stimulate and encourage entrepreneurism in all business stages, sizes, and sectors."
12. My generation has become so disenfranchised with politicians. Many of the things they say they're going to do never happen. If elected, how will you do all the things you say you will? —Kathryn Morris, 35, executive assistant, Oklahoma City
Here's the truth, Kathryn. Any time a politician promises that they'll definitely get something done, 100 percent guaranteed, they're not being honest—not with you and maybe not with themselves. In Washington, the days when bills get passed easily and smoothly are rare. Most of the time, it's a whole lot of debating and strategizing and persuading and negotiating. And progress can come a lot slower than any of us wants. That's just how our democracy works.
I know how hard it is—boy, do I know. And I try very hard not to make promises I can't keep. I've told voters what I believe, what I stand for, what I'll work hard to accomplish as president. I've come up with detailed plans because I don't believe in winging it—not when it comes to something as important as your health or your kid's education or your parent's retirement. I'm prepared. I'm tested. I'm ready. And if I win this election, I'll fight incredibly hard for the American people. I believe we'll win important battles. But will we lose some, too? Likely, yes.
I realize that may be discouraging. But I urge you to push through that discouragement and stick with these fights, because they matter and they're never resolved in a day. That's how progress happens—because we refuse to give up. If we pass an important bill, let's focus on the next one. If we lose a vote, let's figure out why and get back out there and keep fighting.
I can't promise that we'll win every fight.
I can promise that I'll never stop fighting for you.
MORRIS REACTS: "I liked her promise to never stop fighting. It made me believe Hillary really will fight the good fight; she will stand up for us. But as a voter—and I feel I speak for many—we are fed up with the mudslinging in this campaign. In the end, I am still undecided. However, I will vote. It's my right and my privilege. If I don't vote, I lose my voice."
Topicshillary clinton51millionelection 2016


We believe including a non-cognitive skills education (along with STEM and other cognitive subjects) can support students to achieve greater academic and personal success. But our belief in the potential of non-cognitive skills doesn't come from wishful thinking. There are an increasing number of studies that point to successful academic and life outcomes for school students who learn specific non-cognitive skills. There are literally dozens of researched benefits that flow from learning and mastering non-cognitive skills. Here, we've detailed just some of the key benefits of developing non-cognitive habits and skills.
Work by Dr. Carol Dweck at Stanford University has shown that teaching students about fixed and growth mindsets, then introducing techniques to apply a growth mindset to problems, can lead to improved self-confidence and self-belief in the face of new challenges. Fixed mindset thinking affects all of us at times, but by learning to recognize and adjust our thinking, anyone can become more confident in taking on new challenges. You can learn more about growth mindsets here.
Another key benefit that stems from learning growth mindsets is an improved ability to bounce back from failure or set back. One of the key reasons for this, is that viewing a challenge from a growth mindset allows a student to see failure in a whole new light. Rather than failure being bad, or a negative outcome, it is simply seen as a stepping stone to future success. Learning to accept failure as a necessary part of the process to learning and mastering anything can become a freeing experience for students, allowing them to push the boundaries of their existing skill level more confidently, as they no longer fear failing, and have a stronger sense of self-esteem and self-confidence. You can learn more about accepting failure here.
Closely related to the concept of growth mindsets is persistence. Persistence (as we call it) has been researched and championed most publicly by Angela Duckworth from the University of Pennsylvania under the name 'Grit'. Duckworth defines grit as 'perseverance and passion for long-term goals' – a skill that seems obviously beneficial to anyone who wants to achieve a long-term goal of any kind. In her book, 'Grit: The Power of Passion and Perseverance', Duckworth outlines not only the specific benefits of grit, but the ways in which this skill can be increased. Some of the techniques to build higher levels of persistence link closely to other well researched non-cognitive skills such as Dweck's growth mindsets, Mihalyi Csikszentmihalyi's concept of flow, and Anders Ericsson's work on deliberate practice. Learn more about persistence and grit here.
There is a huge amount of research that points to the benefits of mindfulness practices. Just one of these is the ability to build the brain's ability to focus for longer periods of time on a single task. Closely related of course, is the ability for the brain to not be as easily distracted. Improved focus is highly beneficial in helping students to improve academic and non-academic outcomes in school and beyond. Mindfulness practice allows students to notice when they lose focus or are distracted, teaching how to move past a distraction and bring attention back to the task at hand. Mindfulness is often considered to be another name for meditation, but meditation is simply one form of mindfulness training. Find out more about mindfulness here.
Mindfulness practice, along with other non-cognitive habits and skills such as developing positive attitudes, building self-control, learning to accept failure and forming healthy habits all contribute to helping students to lower their levels of anxiety and in some cases even prevent the symptoms of depression. Each of these skills helps students to recognise and manage their emotions as a means of helping them stay calm and as a result, can help them function at their best. For more on mindfulness, click here.
Research has consistently shown that there are a number of interventions that can be made to help anyone improve their levels of optimism and happiness (or wellbeing). Scholars such as Martin Seligman and Shaun Achor have demonstrated a variety of techniques that can support improvement in optimism and happiness, leading to a host of benefits. Happiness it seems improves performance in practically every way you can imagine. You can find out more about happiness and optimism here.
One of the key drivers of non-cognitive skills is the ability to improve self-control. The importance of self-control cannot be overstated. Longitudinal studies such as the now famous Dunedin Study and, the work of self-control researchers such as Walter Mischel, have shown that not only can self-control be improved through the application of specific techniques, but the lifelong benefits to those with high levels of self-control are significant. One such benefit is a lower likelihood of addiction or problems with alcohol or drugs, and (perhaps relatedly) a lower instance of committing a crime. It seems that self control also leads to health improvements across the board, including lower levels of stress and anxiety, lower levels of obesity and even a longer life. You can learn about the other benefits of self-control here.
Skill development in areas such as empathy, communication and building a sense of community all contribute to helping students develop stronger relationships, as do seemingly internally focused strengths such as self-awareness and self-confidence. Habits such as being curious and self-control further enhance relationships while also helping to expand the diversity of relationships students develop. In broad terms, these skills are often discussed under the banner of Social Emotional Learning (SEL). The Grant Study, a Harvard Medical School's 75 year-old longitudinal study run in tandem with The Glueck Study, has shown the importance of relationships in helping people to lead happy and healthy lives, while many studies focusing on the impact of SEL point to significant academic and life outcomes as a result of learning social emotional skills. Strong relationships have perhaps a far more significant impact than we might have imagined; not just on happiness either, but success and income. Discover more about empathy here, and social emotional learning here.
We all know that one of the best ways to succeed at anything is to practice. But how do you ensure your practice is effective at pushing you closer to success and not simply using up your time? The answer is a concept expertise researcher Anders Ericsson calls Deliberate Practice. We call it perfect practice, but the method is the same. There are ways that practice can be structured to ensure ongoing improvement in any area. Unfortunately, most of us don't practice in this way, so we don't get all the benefits of practice that we could. You can discover the basics of perfect or deliberate practice here.
It's perhaps no surprise, when reviewing the list of benefits above, that students with strong non-cognitive skills might also succeed in cognitive tests and assignments. Traits such as self-belief in the face of new challenges, persistence and the ability to bounce back from failure all seem obvious to achieving academic success. Even factors like relationships with others and self-control are firmly on our radars as student traits that seem to correlate well with positive academic outcomes. What appears less obvious however is how we teach these skills, or even whether we can. Research in all these areas (and more) suggests not only that teaching non-cognitive skills is possible, but it also outlines the specific methods by which to do it. This is the foundation for teaching the skills, habits and techniques introduced via Passion Arena.
Watch the video below to see why we think it's critical to be teaching non-cognitive skills at this time.
Interested to know more about specific non-cognitive skills?
Here's a small sample of some of our favourite books that dive into more detail about some of the specific non-cognitive skills and habits we cover. Enjoy!


This song is written in G Mixolydian mode. The printed key signature of C major is used to denote an altered form of the G major scale.
Baby's good to me you know, she's happy as can be, you know she said so.


text:
Pelosi proposes even partisan split in latest 1/6 commission proposal
House Speaker Nancy Pelosi is now proposing a new structure for a commission to study to the January 6 attack on the Capitol that would give Democrats and Republicans an equal number of commissioners, a source familiar with the draft told CBS News.
Pelosi informed her leadership team of the new proposal Monday evening, the source said, though a spokesperson for Minority Leader Kevin McCarthy confirmed again on Wednesday that Republicans have not yet received it.
"Neither the Republican Leader nor his staff have been provided Speaker Pelosi's latest proposal, but hopefully the speaker has addressed our basic concerns of equal representation and subpoena authority," the spokesperson said.
Pelosi told Democratic colleagues Friday she had extended a new offer to Republicans after months of stalemate between congressional leaders on the issue.
"On this 100th day, we are determined to seek the truth of January 6th. To do so, we must have a January 6th Commission. To that end, we have once again sent a proposal for such a Commission to the Republicans, modeled after the 9/11 Commission," she wrote in a letter to colleagues marking the 100th day since the attack.
The speaker's previous offer to Republicans, extended in February, would have allowed Democrats to appoint seven commissioners and Republicans, four. Pelosi, McCarthy, Senate Majority Leader Chuck Schumer and Senate Minority Leader Mitch McConnell would each have appointed two people to the commission. President Biden would have appointed three members, including the chair.
Either the chairperson or a majority of members on the commission would have the authority to issue subpoenas, giving control of the process to Democrats.
Pelosi's initial offer also contained several references to domestic terrorism and instructed the commissioners to study "influencing factors that contributed to the domestic terrorist attack on the Capitol and how technology, including online platforms, financing, and malign foreign influence campaigns may have factored into the motivation, organization, and execution of the domestic terrorist attack on the Capitol and other targeted violence and domestic terrorism relevant to such attack."
Republican leaders objected to both the proposed makeup of the group, and the proposed focus of the commission's investigation.
McCarthy and McConnell have insisted from the outset that the commission be equally split between members appointed by Democrats and Republicans, citing the makeup of the 9/11 commission, which studied the September 11, 2001 terrorist attacks.
"It both helped the effectiveness of the investigation itself and helped give the whole country confidence in its work and recommendations," McConnell said on the Senate floor in February. "This time, Speaker Pelosi started by proposing a commission that would be partisan by design."
He also said if the panel looks beyond Capitol security itself, then it should also be examining "the full scope of the political violence problem in this country."
"Rioting and political violence are abhorrent and unacceptable no matter what cause the mob is advancing. These are not forms of political speech," he said. "We cannot have artificial cherry-picking of which terrible behavior does and does not deserve scrutiny."