Section Draft Recommendation Evidence Impact/Notes 17.22(3) In the event a primary or secondary engineering Clarification requested: Change to “shall” “should” control requires major repair or major servicing, a It can take up to 7 days before the viable results of pharmacy shall stop compounding and may not the environmental monitoring are available. Many resume compounding until: organizations would not be able to function for a the repair or service is complete; full week without operating clean rooms. the affected engineering control has been If a facility followed the repair with an intensive certified; and cleaning and disinfecting of the area and an Environmental monitoring results in environmental testing, is it necessary to wait the 7 the affected engineering control within days before compounding can resume? The re-test USP <797> action levels are obtained. could immediately confirm that the HEPA filters and PECs are working properly and the particle counts are within range for the room ISO classification(s). In the event of an unscheduled down time, it could take many days before it is possible to arrange for a testing company to arrive on site. This delay could push out the ability to use the clean room to up to 2 weeks. In the event that one of the ISO 5 SEC needed to be repaired, would the entire room need 17.22(6) A pharmacy shall verify the maximum number of Strike or provide guidance as a best practice CETA does not provide guidelines for this. Certification to be shut down or can compounding continue in recommendation compounding personnel simultaneously capable of occurs based on the people, activities and conditions other ISO 5 SECs? working in a buffer room or buffer space without of the room at the time of certification. In the past, disrupting ISO classification at least once per year. when asked, CNBT certifiers have stated they cannot The verification procedures shall include provide a maximum number of people to us because it viable air, air, and surface sampling. depends on the materials and activities going on in the room. It will be very difficult for pharmacies to comply with this regulation, which required cooperation of the CNBT certifiers.
Section Draft Recommendation Evidence Impact/Notes 17.22(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: the repair or service is complete; the affected engineering control has been certified; and Environmental monitoring results in the affected engineering control within USP <797> action levels are obtained. Change “shall” to “should” Clarification requested: It can take up to 7 days before the viable results of the environmental monitoring are available. Many organizations would not be able to function for a full week without operating clean rooms. If a facility followed the repair with an intensive cleaning and disinfecting of the area and an environmental testing, is it necessary to wait the 7 days before compounding can resume? The re-test could immediately confirm that the HEPA filters and PECs are working properly and the particle counts are within range for the room ISO classification(s). In the event of an unscheduled down time, it could take many days before it is possible to arrange for a testing company to arrive on site. This delay could push out the ability to use the clean room to up to 2 weeks. In the event that one of the ISO 5 SEC needed to be repaired, would the entire room need to be shut down or can compounding continue in other ISO 5 SECs? 17.22(6) A pharmacy shall verify the maximum number of compounding personnel simultaneously capable of working in a buffer room or buffer space without disrupting ISO classification at least once per year. The verification procedures shall include air, viable air, and surface sampling. Strike or provide guidance as a best practice recommendation CETA does not provide guidelines for this. Certification occurs based on the people, activities and conditions of the room at the time of certification. In the past, when asked, CNBT certifiers have stated they cannot provide a maximum number of people to us because it depends on the materials and activities going on in the room. It will be very difficult for pharmacies to comply with this regulation, which required cooperation of the CNBT certifiers.