CLEANROOM COMPLIANCE EVALUATIONS AND TESTING
ASAP provides Pharmacy Cleanroom Evaluations for USP <797> & <800>. These evaluations will provide you with the information that you will need to determine the state of compliance with the current USP Standards of your facility. ASAP's Cleanroom Testing is more than just providing you the results of testing, ASAP provides detailed easy to understand reporting that will show the overall compliance of your cleanroom and ISO Class 5 equipment. ASAP's reporting has passed inspections by local State Board of Pharmacies, FDA Inspections for 503B Outsourcing Facilities and Joint Commission Inspections.
ASAP Cleanroom Tests Performed at each certification:
- Viable Sampling - Testing performed to CETA CAG-009 and USP <797> (ASAP Personnel will determine the appropriate locations to be sampled by visually observing your facility and its workflow as well as sampling in the recommended locations as per USP <797>)
- Non-Viable Sampling - Testing performed to CETA CAG-003, USP <797> and ISO 14644-1:2015
- Airflow and Differential Pressure - Testing performed to CETA CAG-003 and USP <797> (ASAP will measure and record all the supply airflow entering through the HEPA Filtration to determine if the required amount of Air Changes per Hour have been achieved. Additionally ASAP measures the pressure readings for all the ISO Classified Areas and any rooms or areas connected to the ISO Classified Cleanrooms)
- ISO Class 5 Compounding Equipment (BSC, LAFW, RABS (CACI & CAI)) - ASAP performs many rigorous tests to your equipment used for compounding CSPs. All testing is performed to the Manufacturer's recommendations for Airflow, Pressure (CAI & CACI), and HEPA Filter Leak Testing. For all RABS and HEPA Filtered Equipment used for compounding Airflow visualization testing is also provided to ensure that there is a sufficient amount of airflow to sweep particles away from the DCA (USP <797>). ASAP recommends having the airflow visualization testing recorded to be used for training new personnel.
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