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)
