Usp 797 Clean Room Specifications

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

Usp 797 clean room specifications.

Microbiological evaluation of clean rooms and other controlled environments. The process is public health focused leveraging current science and technology and draws on the expertise of scientists and healthcare practitioners while providing. Sterile compounding cleanroom design components and procedure. Before you begin designing your cleanroom you need to understand the.

Our in house team of engineers architects and designers will provide assistance with the design and qualification process while our nationwide network. Iso 5 7 and 8 environments support primary engineering controls buffer rooms and ante rooms. 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. Portafab specializes in the turn key design and construction of modular clean rooms including applications specifically requiring usp 797 compliance.

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. It describes a number of requirements including responsibilities of compounding personnel training environmental monitoring. Revision bulletin 797. After publication of the.

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. It sets standards and lays out guidelines for any healthcare setting involved in csps. Clean room see. 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 chapter 797 cleanroom design requires that facilities pressurize non hazardous compounding and storage areas. Usp 797 clean room guidelines standards. The use of. Quality standards for csps of drugs and nutrients based on current scientific information and best sterile compounding practices.

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