Following the test procedures implemented by USP <797/800> in CETA CAG-003-2006, our CETA National Board of Testing (CNBT) accredited technicians provide the expertise needed to keep you compliant and up to date on the latest standards from USP <797/800>. Each aspect of the cleanroom must work together to reach optimal performance; understanding them is imperative to compliance.
The Primary Engineering Control (PEC) is instrumental in sterile compounding facilities and is your first line of defense to prevent contamination of your sterile preparations. The BioSafety Cabinets (BSCs), Laminar Air Flow Workstations (LAFW) and Isolators provide your product with a particle free environment when operated properly. Our accredited technicians have years of instruction for the proper testing of all types of PECs. We can even provide education to those unfamiliar with their operation, demonstrating good technique and visualizing where “first air” is present inside every PEC. This is crucial to protecting the critical site from contamination.
The Secondary Engineering Control (SEC) is the continually working cleanroom. Understanding the dynamic operation is important to keeping your cleanroom clean and compliant. HEPA filter integrity testing, airflow measuring and pressure gradient analyzation are the foundation of a cleanroom, but only the beginning of compliance. Where there might be failure or shortcoming, we can provide the consultation necessary to achieve total compliance. A compliant cleanroom should give you “state of control” providing reliable operation. Performing ISO 14644 non-viable particle counting and viable(microbial) surface/air sampling is an important part of USP<797/800>. We can evaluate your facility and recommend a comprehensive microbial testing plan; this helps prove how well your cleanroom is functioning and if adjustments need to be made to your process, work flow or equipment. All microbial sampling is sent to an ISO 17025 accredited lab for analyzation.
It’s important that you have an experienced certification firm that can perform all the tests required by CETA CAG-003-2006 and CETA CAG-002-2006 and can also provide solutions to resolve issues that surface during testing. We understand cleanroom technology and have the experience behind us to demonstrate compliance and keep your sterile compounding pharmacy operational.