Usp 797 Clean Room Specifications

The usp compounding guideline chapter 800 clarifies and expands upon the hazardous drug guidelines found in usp 797 usp 800 expands controls for the protection of workers and environments against hazardous drug compounds.

Usp 797 clean room specifications.

Portafab specializes in the turn key design and construction of modular clean rooms including applications specifically requiring usp 797 compliance. It sets standards and lays out guidelines for any healthcare setting involved in csps. The use of. After publication of the.

It describes a number of requirements including responsibilities of compounding personnel training environmental monitoring. Standards for compounding sterile preparations usp 797 helps to ensure patients receive quality preparations that are free from contaminants and are consistent in intended identity strength and potency. Microbiological evaluation of clean rooms and other controlled environments. Iso 5 7 and 8 environments support primary engineering controls buffer rooms and ante rooms.

Revised 797 on june 1 2019 usp received appeals on certain provisions of the chapter. The process is public health focused leveraging current science and technology and draws on the expertise of scientists and healthcare practitioners while providing. The door to the usp 797 swings out into the ante room to reduce entry of particulates into the clean room. One or two chemical hoods depending on capacity for preparation of iv solutions parenteral nutrition tpn bags and the like.

Revision bulletin 797. Clean room see. Before you begin designing your cleanroom you need to understand the. Developing usp general chapter 797 usp is a not for profit science driven organization that has an established process for convening independent experts in the development and maintenance of healthcare quality standards.

By the myriad of standards and references for cleanroom de sign and operation including usp chapter 797 require ments iso standard 14644 and institute for environmental sci ences and technology iest recommended practices rp. 7 usp 797 clean room guidelines you need to know usp chapter 797 describes the appropriate procedures and requirements for compounded sterile products csps. Our in house team of engineers architects and designers will provide assistance with the design and qualification process while our nationwide network. In contrast to usp 797 which only remedies sterile compounding activities usp 800 takes a 360 approach for processing hazardous drugs both sterile and nonsterile.

In accordance with the rules and procedures of the 2015 2020 council of experts usp is postponing the official date of pharmaceutical compounding sterile preparations 797. Sterile compounding cleanroom design components and procedure.