Usp 797 Clean Room Specifications

After publication of the.

Usp 797 clean room specifications.

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. Clean room see. 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.

One or two chemical hoods depending on capacity for preparation of iv solutions parenteral nutrition tpn bags and the like. 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. Our in house team of engineers architects and designers will provide assistance with the design and qualification process while our nationwide network. Sterile compounding cleanroom design components and procedure.

Portafab specializes in the turn key design and construction of modular clean rooms including applications specifically requiring usp 797 compliance. Iso 5 7 and 8 environments support primary engineering controls buffer rooms and ante rooms. Usp 797 clean room guidelines standards. The door to the usp 797 swings out into the ante room to reduce entry of particulates into the clean room.

Revision bulletin 797. The use of. It sets standards and lays out guidelines for any healthcare setting involved in csps. Revised 797 on june 1 2019 usp received appeals on certain provisions of the chapter.

It describes a number of requirements including responsibilities of compounding personnel training environmental monitoring. Before you begin designing your cleanroom you need to understand the. Quality standards for csps of drugs and nutrients based on current scientific information and best sterile compounding practices. Microbiological evaluation of clean rooms and other controlled environments.

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. 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.