Entitled “USP 800 Brings New Regulations to Hospital Pharmacies”, the article is a comprehensive guide to designing clean room environments for sterile compounding and non-sterile compounding in accordance with the new USP 800 guidelines.
The full pharmacy design article can be found at http://www.hfmmagazine.com/articles/2526-handling-hazardous-drugs-in-health-care.
Below are some of the topics covered in this USP 800 article:
• History of USP 800
• Deadline for compliance with USP 800
• Relationship of USP 797 and USP 800
• Changes in guidelines on sterile compounding of hazardous drugs relative to previous guidelines in USP 797
• What does USP 800 mean when it refers to “hazardous drugs”
• Latest list of USP 800 hazardous drugs
• Frequency of review of list of USP 800 hazardous drugs
• Introducing new hazardous drugs in a USP 800 compliant facility
• Exceptions to list of USP 800 hazardous drugs
• Discussion of investigational drugs in USP 800 guideline
• Under what circumstances do hazardous drugs fall outside of USP 800 guidelines
• Discussion of “assessment of risk” in USP 800 guidelines
• Areas governed by USP 800
• How does USP 800 address storage of hazardous drugs
• How does USP 800 address compounding of hazardous drugs
• When is a negative pressure room required under USP 800
• How many air changes does USP 800 require
• What additional space does USP 800 require
• How does USP 800 address refrigeration of hazardous drugs
• Locations of refrigerated storage of hazardous drugs in USP 800
• Location of exhaust relative to refrigerator in USP 800
• Discussion of details of storage room shelving in USP 800
• Seismic considerations discussed in USP 800
• Discussion of which drugs go into the USP 800 storage room
• Storage of sterile and non-sterile hazardous drugs in USP 800
• Under what circumstances can sterile and non-sterile drugs be stored in the same room in USP 800
• Discussion of compounding vs. fixed formulations in USP 800
• Types of controls related to the compounding process in USP 800
• C-PEC in USP 800
• C-SEC in USP 800
• Closed-system, drug transfer device in USP 800
• When is an ISO-5 environment required in USP 800
• When is an ISO-7 environment required in USP 800
• When is a negative-pressure room required in USP 800
• USP 800 discussion of loss of power
• USP 800 discussion of emergency power
• Discussion of worker safety in USP 800
• Types of Biosafety Cabinets discussed in USP 800
• USP 800 eliminates available options that existed in USP 797
• USP 800 discussion of signage
• Location of spaces discussed in USP 800
• Receipt and unpacking of hazardous drugs as discussed in USP 800
• Water column measurements in USP 800
• What has to be externally vented in a USP 800 compliant pharmacy
• Air exchange rate requirements in USP 800
• USP 800 discussion of maintaining power to ventilation systems in a power outage
• Different USP 800 requirements for sterile compounding vs. non-sterile compounding
• Definition of non-sterile compounding in USP 800
• Definition of sterile compounding in USP 800
• Under what circumstances does USP 800 permit both sterile and nonsterile compounding in the same room
• Under what circumstances does USP 800 permit sterile compounding in a non-ISO space
• USP 800 discussion of segregated compounding area (C-SCA).
• USP 800 requirements for non-sterile compounding
• Carry-over of certain requirements from USP 797 in terms of cleanroom design in USP 800
• Discussion of USP 795, Pharmaceutical Compounding — Nonsterile Preparations, in USP 800
• Under what circumstances does USP 800 permit sterile and nonsterile compounding in the same room
• Relationship of storage and compounding spaces in USP 800
Author of this USP 800 article is William N. Bernstein, LEED AP, AIA, the president of Empire Projects, Inc. He can be reached at info@empireprojects.com.
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Empire Projects, Inc.on Blogger: http://empireprojects.blogspot.com/
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Empire Projects, Inc. on Facebook: https://www.facebook.com/empireprojectsusa/
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