Usp 797 Clean Room Design

Usp 797 hazardous cleanroom design usp 800 while usp 797 previously established requirements for hazardous drug compounding usp chapter 800 sets forth new requirements.

Usp 797 clean room design.

Usp 797 clean room guidelines standards. Fs 209e iso m. 797 pharmaceutical compounding sterile preparations. The compounding facility must comply with clean room classifications as defined by the international organization for standardization iso in.

Pacific environmental technologies is a leading clean room manufacturer providing controlled environments for the aerospace pharmaceutical biomedical semiconductor and related industries. This requires a line of demarcation within the ante room separating the ante room into clean and dirty areas across which shoe covers must be donned with handwashing and further gowning on the clean side. Sterile compounding and room design by douglas theobald cfm health care organizations that compound sterile formulations are getting a head start on compliance with the usp 797 guidelines courtesy of the jcaho joint commission on accreditation of healthcare organizations. Large clean room facilities.

This article is not intended to be a design manual. Pharmacy personnel enter the dirty side of the ante room where they don their lab garb then cross to the clean side where they scrub prior to entering either lab. Portafab specializes in the turn key design and construction of modular clean rooms including applications specifically requiring usp 797 compliance. Iso classification of particulate matter in room air limits are in particles of 0 5 μm and larger per cubic meter current iso and cubic feet former federal standard no.

Usp 797 clean room design and construction by descco pharmacies that prepare compounding sterile preparations csps must follow standards created by the united states pharmacopeia usp chapter 797. To enable communication between the highly regulated labs and the broader work area of the pharmacy. 209e fs 209e class name particle count iso class u s. Instead think of it as a cliff notes to the rules of cleanroom design.

Our in house team of engineers architects and designers will provide assistance with the design and qualification process while our nationwide network. In order to fully grasp the requirements of usp 797 as well as ensure your compliance with them you must read the chapter. The basic configuration of the compounding rooms is this an ante room sandwiched between the usp 797 and usp 800 laboratories.