Usp 800 Cleanroom Design

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Usp 800 cleanroom design.

Usp 800 context for implementation published 11 26 2019 compendial applicability of usp 800 published 11 18 2019 usp 800. Parallel designs provide the proper ante room requirements via cascading air systems. Usp 800 is a regulatory chapter issued by the united state pharmacopoeia. Usp 800 clean room usp 800 hazardous drugs clean room design and construction by descco the united states pharmacopeial convention usp chapter 800 provides standards for handling hazardous drugs to promote patient safety worker safety and environmental protection.

It covers crucial standards and design requirements for the safe handling of hazardous drugs in pharmaceutical and healthcare environments. Mecart is a north american turnkey design build cleanroom manufacturer with over 45 years of experience building world class cleanrooms. Whisperflow laminar flow hood meets iso 5 primary engineering control requirement of usp 797. When you work with cleanroom design llc you are guaranteed the most state of the art technology and the highest quality of specialized engineering for your cleanroom project.

Pac s usp 797 and 800 cleanrooms provide cross functional structures with parallel rooms that share entrances and gowning spaces. The usp compounding expert committee is responsible for the development of general chapter 800. Cleanroom suite with usp 795 usp 797 usp 800 compounding areas. To contain harsh drugs and contaminants in the lab the usp 800 door swings into the room.

The current design of common commercial hvac systems are mostly inadequate for maintaining usp 800 s required acph engineering and iso clean air standards. By transporting non sterile hazardous drugs through sterile spaces the pharmacy increases the risk of cross contamination. Usp 800 design requirements prioritize staff safety. Because compounding pharmacists handle hazardous drugs in usp 800 labs the room is designed to contain and remove chemical contamination.

Usp 800 allows this but only for drugs that will be used for sterile compounding. Review their work plan and past meeting summaries. This fails to consider the non sterile hazardous drugs which will need to be stored in a separate negative pressure storage room.