MD8 Airscan®

Monitoring ambient air in cleanrooms and controlled areas in the (c)GMP environment for viable microorganisms is a routine task in the pharmaceutical | biotechnology industry. As a rule, collection of data and subsequent analysis of the results permit trends to be recognized early and problems (OOS*) with bioburden levels exceeding the limits to be prevented.
* Out of specification

Active Air Monitoring in Cleanrooms and Controlled Areas

Active monitoring of viable airborne microorganisms is an important instrument for ensuring product quality and safety. Sampling of at least 1 m³ of air is required by regulation standards. In this procedure, care must be taken that turbulence is not caused by, for example, devices such as active air samplers
and that sampling is performed isokinetically.

The following areas need to be monitored using active sampling of airborne microorganisms:

In the pharmaceutical | biotechnology industry:

• Cleanrooms (grades A – D; ISO classes 5 – 9)
• Sterility testing isolators
• Filling lines
• Controlled areas, e. g. quality control (QC) laboratories
• Warehouses | raw materials depots
• Personnel airlocks and aseptic transfer chambers for materials

In the food and beverage industry:

• Manufacturing areas and production-related areas
• Quality control (QC) laboratories
• Warehouses | raw materials depots

Diagnostics | Medicine:

• Cleanroom or controlled area
• Filling lines
• Manufacturing areas and production-related areas
• Quality control (QC) laboratories
• Warehouses | raw materials depots

Quality Control

As Sartorius is a recognized supplier of products and services for the pharmaceutical industry, product quality and safety are its number one priorities. To meet stringent quality requirements, 100% final testing of the MD8 Airscan® is performed in manufacturing among the quality control checks carried out. In addition, every stainless steel sampling head is calibrated and adjusted after assembly.