Pharmacy Clean Room Requirements

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.

Pharmacy clean room requirements. Usp 797 guidelines outline minimal cleaning requirements and the following information is based on the typical class 7 room. Understanding pharmacy cleanroom design requirements by james t. Cleanroom dispensers and receptacle arrangements are essential for throughput and efficient workflow. We are very satisfied with the service received from mecart from the engineering to delivery and complete installation of our cleanrooms.

What does usp say about cleanroom floors. 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. Table 3 on page 15 of the usp chapter requires that floors be cleaned daily. Usp 800 pharmacy design usp 800 design requirements prioritize staff safety.

Some items like gloves hoods face masks bunny suits and shoe covers require safe and clean forward disposal after every session. 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. The requirements may differ based on the state board of pharmacy. Basic clean room requirements designs for gmp clean rooms what is a clean room.

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. Because compounding pharmacists handle hazardous drugs in usp 800 labs the room is designed to contain and remove chemical contamination. Wagner and eric s.

American cleanroom systems is knowledgeable about cleanroom requirements for usp797 usp 800 for compounding and filling rooms. In reality however you can reach an iso 6 clean room with 1 recommendation is 2 airlock. Care must be taken to maintain the cleanliness of the room and pecs. 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.

Here are 7 usp 797 clean room guidelines that you and your staff must understand and follow. Remove any garments that do not meet the local cleanroom requirements.