17.13(18) An ISO classified area constructed or renovated after January 1, 2017 may not contain overhangs or ledges. Change date to reflect a future date, suggesting 18 months post publication. Change verbiage to “An ISO classified area constructed or renovated after Month Day, Year shall be constructed to minimize dust-collecting unnecessary overhangs or ledges or Make this a best practice recommendation Adjust to “Best Practice”. One 4’ hood provides much more dust collecting “ledge” area than a 0.25” ledge around a door in the clean room. Pass-throughs need to have a wide enough deck/ base for material to be set down onto it during transfer between rooms. Walls between the anteroom and the adjacent space and between the anteroom and buffer room(s) would need be 24" + thick to remove all "dust collecting overhangs". Section Draft Recommendation Evidence Impact/Notes 17.13(23) Beginning January 1, 2018, sprinkler heads in all ISO classified areas shall be specifically designed for clean rooms and installed in such a manner to withstand weight-bearing loads on the ceiling Simplify to “sprinkler heads in all ISO classified areas shall be specifically designed for clean rooms”. Clarify: what is the importance of having the sprinkler heads being load-bearing? This will be very confusing and difficult to construct and adhere to.
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
17.22(2) The certification testing shall be completed in its entirety within a 24 hour time period. Certification testing includes: airflow and velocity test; airflow smoke pattern test; room pressurization test; air flow displacement test, as applicable; HEPA filter leak test; induction leak and back streaming test; airborne non-viable particle counting, conducted under dynamic operating conditions; and Temperature and humidity test. Remove “airflow smoke pattern test” or make this a best practice recommendation. CETA There is no evidence showing that this requirement is necessary and is an optional test within the CETA requirements. Section Draft Recommendation Evidence Impact/Notes