Usp 797 Clean Room Specifications

It sets standards and lays out guidelines for any healthcare setting involved in csps.

Usp 797 clean room specifications. It describes a number of requirements including responsibilities of compounding personnel training environmental monitoring. Portafab specializes in the turn key design and construction of modular clean rooms including applications specifically requiring usp 797 compliance. The process is public health focused leveraging current science and technology and draws on the expertise of scientists and healthcare practitioners while providing. 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.

The use of. Iso 5 7 and 8 environments support primary engineering controls buffer rooms and ante rooms. 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. Revision bulletin 797.

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. 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. Sterile compounding cleanroom design components and procedure. Quality standards for csps of drugs and nutrients based on current scientific information and best sterile compounding practices.

Usp 797 clean room guidelines standards. 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. The door to the usp 797 swings out into the ante room to reduce entry of particulates into the clean room. After publication of the.

One or two chemical hoods depending on capacity for preparation of iv solutions parenteral nutrition tpn bags and the like. Usp chapter 797 cleanroom design requires that facilities pressurize non hazardous compounding and storage areas. 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. 7 usp 797 clean room guidelines you need to know usp chapter 797 describes the appropriate procedures and requirements for compounded sterile products csps.

Revised 797 on june 1 2019 usp received appeals on certain provisions of the chapter. Before you begin designing your cleanroom you need to understand the.