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USP 797 Compliance handbook

Complying with USP 797 Requirements for Cleanrooms and Other Controlled Environments

This Handbook contains ISO Standards and IEST Recommended Practices to assist clinical and pharmaceutical personnel as well as cleanroom design and operations professionals in implementing controlled environments that comply with the requirements of USP Chapter 797 “Pharmaceutical Compounding – Sterile Preparations” (USP 797).

Available in the IEST Bookstore
 














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