Usp 797 Clean Room Guidelines Standards

Recommended usp 797 cleaning disinfecting decontaminating for sterile compounding.

Usp 797 clean room guidelines standards. In june 2019 the united states pharmacopeia usp released several new and revised pharmacy compounding standards. 209e fs 209e class name particle count iso class u s. Over the course of 2018 the henderson engineers team of experts has evaluated nearly a hundred facilities across the country to prepare their pharmacies for this deadline. Fs 209e iso m.

Usp 797 cleaning disinfecting guidelines. Achieving pharmacy flow with usp 797 and usp 800 standards october 10 2019 pharmacies and compounding laboratories are a hot topic in the health care world as the us pharmacopeial convention s usp revised guidelines necessitate new pharmacy design to meet usp 797 and usp 800 compliance. Iso classification of particulate matter in room air limits are in particles of 0 5 μm and larger per cubic meter current iso and cubic feet former federal standard no. Some items like gloves hoods face masks bunny suits and shoe covers require safe and clean forward disposal after every session.

Usp 797 standards require consideration for proper gowning and personal protective equipment ppe. This includes floors hoods and countertops. Adopt usp 797 facility engineering clean room guidelines. The requirements may differ based on the state board of pharmacy.

Standards for prescribing preparation. 797 pharmaceutical compounding sterile preparations. Minimum standard for pharmacies in hospitals. Practices28 31 32 and a discussion guide on usp chapter 797 17 and has recognized usp chapter 797 as a relevant practice standard in the ashp guidelines.

Portafab specializes in the turn key design and construction of modular clean rooms including applications specifically requiring usp 797 compliance. The entire compounding environment which includes the clean rooms and ante rooms must be disinfected on a regular basis. The revisions to usp 797 and new usp 800 standards will go into effect december 1 2019. During this time we ve discovered the only way to make these projects successful is to not just to understand the content of.

In the interim the currently official version of 797 last revised in 2008 including the section. Specifically usp published revisions to general chapter 797 pharmaceutical compounding and sterile preparations and published a new general chapter 800 hazardous drugs handling in healthcare settings. The opportunity to request further review by an appointed panel and usp has received three 3 such requests on 797. Our in house team of engineers architects and designers will provide assistance with the design and qualification process while our nationwide network.

Usp 797 clean room guidelines standards. Our recommendations are based on a class 7 buffer zone however facilities with class 5. 33 other professional organizations also provide guidance on specific aspects of compounding.