Clean Room Certification Critical to Operations
By Ralph McBride, MBA, BS Pharm, RPh, BCSCP, HDDP, Pharmacy Surveyor
Certifying your pharmacy’s clean room meets USP <797> requirements is critical to ensuring the safe compounding of sterile preparations.
Beginning this month, we are presenting a series of articles on clean room certification requirements that often need further clarification. In this article, we take a look at the connection between specifications set forth in USP <797> and process guidelines established by the Controlled Environment Testing Association (CETA).
Together, these mutually interrelating requirements and procedures form the basis for clean room certification. USP <797> stipulates certification requirements and CETA’s “Certification Guide for Sterile Compounding Facilities” (CAG-0030-2006) details measurements and procedures to meet certification metrics.
For many compounding pharmacists, USP <797> is known as “the reference” because it details requirements specific to sterile preparations. Certifying your clean room is properly maintained helps ensure your pharmacy is following proper procedures to protect patients and staff.
However, while USP <797> provides minimally acceptable requirements for certification and testing of primary and secondary engineering controls that regulate the clean room environment, it does not provide the actual processes to assess each certification metric. This often causes confusion and can result in deficiencies during an accreditation survey when these assessments are not conducted according to guidance and time frames — or are not conducted at all.
USP <797> requires that certification procedures, like those outlined in CETA’s “Certification Guide for Sterile Compounding Facilities” (CAG-003-2006), be conducted by a qualified individual no less than every six months. These also must be conducted when equipment or the room is relocated or altered and when “major service” to the facility is performed.
Reviewing procedures outlined in the CETA guide with your pharmacy’s certification expert can help you better understand testing procedures for engineering controls and requirements for clean room certification.
Bottom line: Both USP <797> requirements and CETA testing guidelines are vital components of the clean room certification process and should be considered collectively when reviewing clean room operations. USP <797> provides an essential framework for clean room certification requirements. Additional details on processes to assess certification metrics are available in CETA’s “Certification Guide for Sterile Compounding Facilities” (CAG-003-2006).
Next month, our article will focus on the dynamic smoke study test.
For more information, please contact your Account Advisor, email customerservice@achc.org, or call (855) 937-2242, ext. 458.
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