TAKE CONTROL OF YOUR ENGINEERING CONTROL CERTIFICATION PROCESS by Jim Wagner Sterile compounding operations rely on Primary (Laminar Air Flow Workstations, Compounding Aseptic Isolators, and Biological Safety Cabinets) and Secondary Engineering Controls (Buffer and Ante areas) to provide appropriate environments for aseptic operations. Pharmacists invest heavily in this equipment and then invest again to ensure that the equipment is functioning properly. Highly trained, and well-equipped certification professionals provide the required documentation necessary for regulatory compliance. This testing process should ensure that the facility is not only operating as designed; it should confirm that the equipment is being used properly and is appropriate for the intended purpose. Unfortunately, the events that occurred at the New England Compounding Center (NECC) highlight the fact that certifiers are not always up to the task of properly certifying these facilities. The NECC engineering controls were certified, but those facilities were not tested according to the professional expectations referenced in USP Chapter <797>. Certification criterion is outlined in the Controlled Environment Testing Association (CETA) applications guide – CAG-003-2006 . What role this inappropriate certification played in the disaster that eventually killed at least 47 people is unclear. Owners and managers of sterile compounding operations have the ultimate responsibility to ensure properly their primary and secondary engineering controls are functioning properly and that their people are using them appropriately. USP <797> has made it easy to understand the minimum testing expectations. Those expectations are made clear in the statement “Certification procedures such as those outlined in “Certification Guide for Sterile Compounding Facilities” (CAG-003-2006) shall 16 Fall 2014 | IACPRx.org be performed by a qualified individual no less than every six months and whenever the device or room is relocated or altered or major service to the facility is performed.” Facility owners should insist that their certifier follow the CAG- 003 applications guide whenever they purchase certification services. This applications guide has been referenced in USP <797> since 2008. If your certifier has not referenced this document on their own by now, at a minimum, they should be asked to explain why. As a result of the NECC disaster, many states have increased their sterile compounding inspections. In some cases, states are finally inspecting sterile compounding operations for compliance with Chapter <797>. I have had many opportunities to perform sterile compounding facility gap analyses due to these stepped up inspections. Unfortunately, not many of the certification reports I reviewed satisfactorily documented compliance with minimum expectations. CETA has published a tool to assist pharmacists in evaluating whether or not their certifier provides adequate documentation. CAG-008-2010 is a matrix to walk you through appropriate documentation points in the certification report. It only covers the primary engineering controls, but reviewing this document should provide a good starting point for evaluating the quality of the reports you receive from your certifier. In addition to ensuring that you are receiving adequate documentation, you must verify that your certifier is qualified. There are two certifier accreditations that you should look for; National Sanitation Foundation (NSF) accreditation for certification of Biological Safety Cabinets and CETA National Board of Testing i ii
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