bacterial and fungal) in all classified areas according to the full environmental monitoring sampling map. If the filter in a PEC that is a BSC fails, the environmental monitoring should be limited to the PEC. If a facility ceiling filter fails, the environmental monitoring should be limited to the area likely to be affected by a single failed filter. An appropriate sampling plan for various scenarios should be developed in advance of a filter failure event this – should be based on a risk assessment developed after consultation with design engineer, certifier, microbiologist or industry hygienist. The Failed Filter Plan should be a section of the Business Continuity Plan. 17.19 (5) Sterile Compounding Facility; HEPA filters -A licensee shall visually inspect the external portion of PEC filters at least daily. Pharmacy staff is not easily able to inspect the PEC filters easily. HEPA filters are checked routinely during re-certification. If you have proper alarms set on your PEC, it will alert you if not working properly. 17.21 Sterile Compounding Facility; Temperature and Humidity Monitoring (2) a minimum humidity is not defined. Suggestion: USP1066 Physical Environment General Information states ideal conditions are 30-50% humidity. (3) and (4) could be combined 17.22 2 (h) Sterile Compounding Facility; Certification of Classified Areas 2 The certification testing be completed in its entirety within a 72-hour time. Certification testing includes: (h) temperature and humidity Pharmacies should check temperature and humidity daily to ensure that it is comfortable for staff wearing PPE. The range of temperature and humidity should be set at a range depending on the amount of garb being worn by staff. Staff in the Buffer room should maintain cool without risk of sweating in PPE. 17.22 Sterile Compounding Facility: Certification of Classified Areas. (3) In the event a primary or secondary engineering control requires major repair or major servicing, a pharmacy shall stop compounding and may not resume compounding until: a) the repair or service is complete b) the affected engineering control has been certified c) environmental monitoring results in the affected engineering control within USP <797> action levels are obtained. -It would be helpful to registrants if this were qualified further. For example, in the case of a failed PEC, advice that parallels 17:28 Environmental Monitoring: Remediation of Above Action Level Environmental Results would be appropriate. Monitoring in an ISO Classified Area
bacterial and fungal) in all classified areas according to the full environmental monitoring sampling map. If the filter in a PEC that is a BSC fails, the environmental monitoring should be limited to the PEC. If a facility ceiling filter fails, the environmental monitoring should be limited to the area likely to be affected by a single failed filter. An appropriate sampling plan for various scenarios should be developed in advance of a filter failure event – this should be based on a risk assessment developed after consultation with design engineer, certifier, microbiologist or industry hygienist. The Failed Filter Plan should be a section of the Business Continuity Plan. 17.19 (5) Sterile Compounding Facility; HEPA filters -A licensee shall visually inspect the external portion of PEC filters at least daily. Pharmacy staff is not easily able to inspect the PEC filters easily. HEPA filters are checked routinely during re-certification. If you have proper alarms set on your PEC, it will alert you if not working properly. 17.21 Sterile Compounding Facility; Temperature and Humidity Monitoring (2) a minimum humidity is not defined. Suggestion: USP1066 Physical Environment General Information states ideal conditions are 30-50% humidity. (3) and (4) could be combined 17.22 2 (h) Sterile Compounding Facility; Certification of Classified Areas 2 The certification testing be completed in its entirety within a 72-hour time. Certification testing includes: (h) temperature and humidity Pharmacies should check temperature and humidity daily to ensure that it is comfortable for staff wearing PPE. The range of temperature and humidity should be set at a range depending on the amount of garb being worn by staff. Staff in the Buffer room should maintain cool without risk of sweating in PPE. 17.22 Sterile Compounding Facility: Certification of Classified Areas. (3) In the event a primary or secondary engineering control requires major repair or major servicing, a pharmacy shall stop compounding and may not resume compounding until: a) the repair or service is complete b) the affected engineering control has been certified c) environmental monitoring results in the affected engineering control within USP <797> action levels are obtained. -It would be helpful to registrants if this were qualified further. For example, in the case of a failed PEC, advice that parallels 17:28 Environmental Monitoring: Remediation of Above Action Level Environmental Monitoring Results in an ISO Classified Area would be appropriate.
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