Technical Standard

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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-CC001HEPA and ULPA Filters
• IEST-RP-CC002Unidirectional Flow Clean-Air Devices
• IEST-RP-CC003Garment System Considerations for Cleanrooms and Other Controlled Environments
• IEST-RP-CC006Testing Cleanrooms
• IEST-RP-CC007Testing ULPA Filters
• IEST-RP-CC012Considerations in Cleanroom Design
• IEST-RP-CC018Cleanroom Housekeeping – Operating and Monitoring Procedures
• IEST-RP-CC020Substrates and Forms for Documentation in Cleanrooms
• IEST-RP-CC023Microorganisms in Cleanrooms
• IEST-RP-CC026Cleanroom Operations
• IEST-RP-CC027Personnel in Cleanrooms

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