Section Draft Recommendation Evidence Impact/Notes 17.19(5) A licensee shall visually inspect the external Remove this requirement or clarify What is the portion of the PEC filters”? Ease of “external portion of PEC filters at least daily access to the visible portions of PEC filters varies based on manufacturer. Accessing filters on a daily basis is likely to cause unnecessary and unanticipated damage to filters that could be avoided if this were stricken from the requirements. If this becomes regulation, does this require written documentation of visual inspection? If so, how is this done? A leak would often not be visually recognized. Is there evidence of the value of this? Clarification requested on the extent of visual inspection. Knowing that even a pinhead sized hole in the filter can cause a leak to develop, the human eye is unable to easily distinguish the difference. To include this as a requirement rather provides no benefit or value. 17.20 (2) ISO 5 PEC shall include a pressure differential Strike the last sentence of this requirement, or change to It’s unclear how a 10% drop in pressure differential was read the PEC display a pressure differential gauge and/or a low flow device displaying the positive determined to be significant enough to shut down sterile “Should the minimum standard required by the manufacturer, pressure differential between the upstream and compounding operations within an ISO 5 PEC even if that 10% compounding in the PEC shall be suspended until downstream air flow in accordance with manufacturer drop results in a new pressure differential that is still above remediated.” specifications. The pressure shall be logged daily prior minimum requirements. to compounding. Should the PEC display a loss of pressure exceeding 10% of the last reading, compounding in the PEC shall be suspended until remediated. 17.20 (5) A pharmacy shall review differential pressure logs and Strike this requirement or modify language to require that USP <797> it agreeable that unexpected or egregious out of range the pharmacy respond and document any UNEXPECTED continuous monitoring device reports daily and shall results should be documented and responded to, there are out of range result document the review and response to any out of instances in which differential pressures may be out of range range pressure. that do not require response. Every time a door opens between labs, pressure differentials drop. The way this requirement is currently written, pharmacies would be required to keep a log of every time the pressure drops due to a door opening.
Section Draft Recommendation Evidence Impact/Notes 17.19(5) A licensee shall visually inspect the external portion of PEC filters at least daily Remove this requirement or clarify What is the “external portion of the PEC filters”? Ease of access to the visible portions of PEC filters varies based on manufacturer. Accessing filters on a daily basis is likely to cause unnecessary and unanticipated damage to filters that could be avoided if this were stricken from the requirements. If this becomes regulation, does this require written documentation of visual inspection? If so, how is this done? A leak would often not be visually recognized. Is there evidence of the value of this? Clarification requested on the extent of visual inspection. Knowing that even a pinhead sized hole in the filter can cause a leak to develop, the human eye is unable to easily distinguish the difference. To include this as a requirement rather provides no benefit or value. 17.20 (2) ISO 5 PEC shall include a pressure differential gauge and/or a low flow device displaying the positive pressure differential between the upstream and downstream air flow in accordance with manufacturer specifications. The pressure shall be logged daily prior to compounding. Should the PEC display a loss of pressure exceeding 10% of the last reading, compounding in the PEC shall be suspended until remediated. Strike the last sentence of this requirement, or change to read “Should the PEC display a pressure differential the minimum standard required by the manufacturer, compounding in the PEC shall be suspended until remediated.” It’s unclear how a 10% drop in pressure differential was determined to be significant enough to shut down sterile compounding operations within an ISO 5 PEC even if that 10% drop results in a new pressure differential that is still above minimum requirements. 17.20 (5) A pharmacy shall review differential pressure logs and continuous monitoring device reports daily and shall document the review and response to any out of range pressure. Strike this requirement or modify language to require that the pharmacy respond and document any UNEXPECTED out of range result USP <797> it agreeable that unexpected or egregious out of range results should be documented and responded to, there are instances in which differential pressures may be out of range that do not require response. Every time a door opens between labs, pressure differentials drop. The way this requirement is currently written, pharmacies would be required to keep a log of every time the pressure drops due to a door opening.