17.21(2) All ISO Classified areas shall maintain a Change “shall” to “should” or permit If this language were to become regulation, pharmacies relative humidity of 65% or less. planned excursions, such as those would be in violation every time they perform daily or experienced during daily and monthly monthly cleaning activities. Introducing a large volume cleaning activities, where the of cleaning agents often causes an increase in humidity introduction of a large volume of above 65% RH. liquid cleansers results in RH higher than 65%. (1) Primary and secondary Remove “altered” or define This language is too vague. What is considered altered? 17.22(1)(c) engineering controls shall be certified at least: (c) whenever the room is altered; and 17.22(6) A pharmacy shall verify the maximum Strike or provide guidance as a best CETA does not provide guidelines for this. number of compounding personnel practice recommendation Certification occurs based on the people, simultaneously capable of working in activities and conditions of the room at the time a buffer room or buffer space without of certification. In the past, when asked, CNBT disrupting ISO classification at least certifiers have stated they cannot provide a once per year. The verification maximum number of people to us because it procedures shall include non-viable depends on the materials and activities going on air, viable air, and surface sampling. in the room. It will be very difficult for pharmacies to comply with this regulation which requires the CNBT certifiers to perform verification of something that has no guidelines or defined standards. Section Draft Recommendation Evidence Impact/Notes
17.21(2) All ISO Classified areas shall maintain a relative humidity of 65% or less. Change “shall” to “should” or permit planned excursions, such as those experienced during daily and monthly cleaning activities, where the introduction of a large volume of liquid cleansers results in RH higher than 65%. If this language were to become regulation, pharmacies would be in violation every time they perform daily or monthly cleaning activities. Introducing a large volume of cleaning agents often causes an increase in humidity above 65% RH. 17.22(1)(c) (1) Primary and secondary engineering controls shall be certified at least: (c) whenever the room is altered; and Remove “altered” or define This language is too vague. What is considered altered? 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 non-viable 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 requires the CNBT certifiers to perform verification of something that has no guidelines or defined standards. Section Draft Recommendation Evidence Impact/Notes