J065--Fume Hood Testing New

This shall include a comprehensive and detailed report at the conclusion of the inspections and testing noting any deficiencies and the corrective actions needed. The inspection and report shall include the following items: A. Test and certify one (1) LAFW in the IV room. (Rm #1647A) and one (1) LAFW in modular IV prep room tested as a Segregated Compounding Area (SCA). B. Test and certify two (2) supply High-Efficiency Particulate Air (HEPA) filters, located in (Rm #1647A and 1647) and two (2) HEPA filters located in SCA. C. Calculate and report supply air changes per hour in two (2) clean zones. 1) Rm. #1647A D. Rm. #1647 and SCA: Calculate and report pressure gradients at three (3) room locations. E. Classify three clean room zones. Perform non-viable environmental sampling (particle count sampling) in 3 clean room zones. F. Perform viable environmental sampling in two (2) LAFW and three (3) clean room zones. Four samples per room or Primary Engineering Control (PEC), two samples from 1647 pass through, twenty-two (22) total microbial samples. G. Provide control samples for viable environmental sampling (control plates). H. Perform non-viable environmental sampling (particle count classification) in two (2) LAFW. I. Perform dynamic smoke visualization tests in LAFW. Must work with site to have visual smoke testing video-recorded for site. J. Perform all tests, certifications and classifications according to USP-NF General Chapter 797 Pharmaceutical Compounding – Sterile Preparations and most current version of Controlled Environment Testing Association-CETA-Application Guide-003 (CETA-CAG-003). K. Work must be completed prior to 2PM.

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Heating, Ventilating, and Air Conditioning (HVAC), Instrumentation and Control for HVAC, HVAC Air Distribution, Ventilation Hoods, Fume Hoods, Central HVAC Equipment.