Monday, June 17, 2013

Clean Room & Aseptic Area, Air lock & Site Master File

1.What is Clean Room & Aseptic Area?

Clean Room

A room in which the concentration of airborne particles is controlled to meet specified airborne particulate cleanliness class. In addition, the concentration of microorganisms in the environment is monitored; is cleanliness class defined is also assigned a microbial level for air, surface, and personnel gear.

Aseptic Area

Any area in an aseptic process system for which airborne particulate and microorganism levels are controlled to specific levels appropriate to the activities conducted within that environment.

2.What is Air lock?

Airlock: An enclosed space with two or more doors, which is interposed between two or more rooms, e.g. of differing classes of cleanliness, for the purpose of controlling the airflow between those rooms when they need to be entered. An airlock is designed for use either by people or for goods and/or equipment. 

3.What Is Site Master File ?

Site Master File

Site Master File is prepared by the manufacturer and contains specific information about the quality assurance, the production and/ or quality control of pharmaceuticals manufacturing operations carried out at the named site and any closely integrated operations at adjacent and nearby buildings. If only part of a pharmaceuticals operation is carried out on the site. A site master file need only describe those operations that is analysis packaging etc.

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