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. CONTENTS ISO 14644-1 Classification of air cleanliness ISO 14644-2 Specifications for testing and monitoring to prove continued compliance with 14644-1 ISO 14644-4 Design, construction and start-up ISO 14644-5 Operations ISO 14644-7 Separative devices (clean air hoods, gloveboxes, isolators and minienvironments) IEST-RP-CC001 HEPA and ULPA Filters IEST-RP-CC002 Unidirectional Flow Clean-Air Devices IEST-RP-CC003 Garment System Considerations for Cleanrooms and Other Controlled Environments IEST-RP-CC006 Testing Cleanrooms IEST-RP-CC007 Testing ULPA Filters IEST-RP-CC012 Considerations in Cleanroom Design IEST-RP-CC018 Cleanroom Housekeeping - Operating and Monitoring Procedures IEST-RP-CC020 Substrates and Forms for Documentation in Cleanrooms IEST-RP-CC023 Microorganisms in Cleanrooms IEST-RP-CC026 Cleanroom Operations IEST-RP-CC027 Personnel in Cleanrooms