Pharmacy Clean Room Requirements

Understanding pharmacy cleanroom design requirements by james t.

Pharmacy clean room requirements.

Because compounding pharmacists handle hazardous drugs in usp 800 labs the room is designed to contain and remove chemical contamination. Basic clean room requirements designs for gmp clean rooms what is a clean room. Before entering the buffer area or the separate compounding area personnel must do the following. In reality however you can reach an iso 6 clean room with 1 recommendation is 2 airlock.

Some items like gloves hoods face masks bunny suits and shoe covers require safe and clean forward disposal after every session. Usp 797 guidelines outline minimal cleaning requirements and the following information is based on the typical class 7 room. Iso class 7 pharmacy cleanrooms are designed to minimize airborne contamination from contacting critical sites. Remove any garments that do not meet the local cleanroom 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. 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 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. Care must be taken to maintain the cleanliness of the room and pecs.

The requirements may differ based on the state board of pharmacy. Wagner and eric s. American cleanroom systems is knowledgeable about cleanroom requirements for usp797 usp 800 for compounding and filling rooms. Due to the differing state board of pharmacy regulations in each state american cleanroom systems only builds usp797 usp 800 cleanrooms in southern california.

Follow personnel cleaning and garbing procedures. 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. Table 3 on page 15 of the usp chapter requires that floors be cleaned daily.

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. Cleanroom dispensers and receptacle arrangements are essential for throughput and efficient workflow.