Full Description

USP 797 requires compounding pharmacies to determine the risk level of the compounding done in their facilities and to perform the compounding in cleanrooms or other controlled environments as specified for the risk level. The documents in this Handbook will help users:Determine, design, and maintain the proper controlled environment for your application.Develop standard procedures for cleaning the controlled environment.Implement environmental sampling to monitor air quality regularly for viable and nonviable particles. Develop standard procedures for personnel gowning and gloving.
CONTENTSISO 14644-1 Classification of air cleanlinessISO 14644-2 Specifications for testing and monitoring to prove continued compliance with 14644-1ISO 14644-4 Design, construction and start-upISO 14644-5 OperationsISO 14644-7 Separative devices (clean air hoods, gloveboxes, isolators and minienvironments)IEST-RP-CC001HEPA and ULPA FiltersIEST-RP-CC002Unidirectional Flow Clean-Air DevicesIEST-RP-CC003Garment System Considerations for Cleanrooms and Other Controlled EnvironmentsIEST-RP-CC006Testing CleanroomsIEST-RP-CC007Testing ULPA FiltersIEST-RP-CC012Considerations in Cleanroom DesignIEST-RP-CC018Cleanroom Housekeeping - Operating and Monitoring ProceduresIEST-RP-CC020Substrates and Forms for Documentation in CleanroomsIEST-RP-CC023Microorganisms in CleanroomsIEST-RP-CC026Cleanroom OperationsIEST-RP-CC027Personnel in Cleanrooms

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