Pharmacy Clean Room Requirements

Usp 797 guidelines outline minimal cleaning requirements and the following information is based on the typical class 7 room.

Pharmacy clean room requirements.

American cleanroom systems is knowledgeable about cleanroom requirements for usp797 usp 800 for compounding and filling rooms. Follow personnel cleaning and garbing procedures. Usp 800 pharmacy design usp 800 design requirements prioritize staff safety. Because compounding pharmacists handle hazardous drugs in usp 800 labs the room is designed to contain and remove chemical contamination.

Iso class 7 pharmacy cleanrooms are designed to minimize airborne contamination from contacting critical sites. Table 3 on page 15 of the usp chapter requires that floors be cleaned daily. Understanding pharmacy cleanroom design requirements by james t. What does usp say about cleanroom floors.

Kastango rph mba fashp before you begin designing your cleanroom you need to understand the performance parameters that measure hepa filters cleanroom classification air changes and pressurization. Wagner and eric s. Iso 6 cleanroom class 1 000 in theory for an entire room to reach iso 6 air cleanliness you need to enter the cleanroom via an iso 8 ante room then go through an iso 7 to finally get into the iso 6 as shown in the image. The requirements may differ based on the state board of pharmacy.

In reality however you can reach an iso 6 clean room with 1 recommendation is 2 airlock. Due to the differing state board of pharmacy regulations in each state american cleanroom systems only builds usp797 usp 800 cleanrooms in southern california. To contain harsh drugs and contaminants in the lab the usp 800 door swings into the room. Basic clean room requirements designs for gmp clean rooms what is a clean room.

Care must be taken to maintain the cleanliness of the room and pecs. Here are 7 usp 797 clean room guidelines that you and your staff must understand and follow. Before entering the buffer area or the separate compounding area personnel must do the following. Cleanroom dispensers and receptacle arrangements are essential for throughput and efficient workflow.

A clean room gmp cleanroom in my mind are a combination of engineering design fabrication finish and operational controls control strategy that are required to convert a normal room to a clean room. The chapter states that floors in the buffer or clean area ante area and segregated compounding area are cleaned by mopping with a cleaning and disinfecting agent once daily at a time when no aseptic operations are in progress.