Usp 797 Clean Room Specifications

7 usp 797 clean room guidelines you need to know usp chapter 797 describes the appropriate procedures and requirements for compounded sterile products csps.

Usp 797 clean room specifications.

Revised 797 on june 1 2019 usp received appeals on certain provisions of the chapter. 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. Clean room see. 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.

Usp chapter 797 cleanroom design requires that facilities pressurize non hazardous compounding and storage areas. Quality standards for csps of drugs and nutrients based on current scientific information and best sterile compounding practices. It sets standards and lays out guidelines for any healthcare setting involved in csps. 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. 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. The use of. The door to the usp 797 swings out into the ante room to reduce entry of particulates into the clean room.

Iso 5 7 and 8 environments support primary engineering controls buffer rooms and ante rooms. The process is public health focused leveraging current science and technology and draws on the expertise of scientists and healthcare practitioners while providing. It describes a number of requirements including responsibilities of compounding personnel training environmental monitoring. 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. After publication of the. 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.

Portafab specializes in the turn key design and construction of modular clean rooms including applications specifically requiring usp 797 compliance. Sterile compounding cleanroom design components and procedure.