SubscribeHelps pharmaceutical manufacturers comply with regulations, reduce costs, and increase productivity
Biotest has recently introduced the APC M3, the first portable airborne particle counter to sample at a rate of 100 LPM (liters per minute). Measuring one cubic meter of air in only 10 minutes, the APC M3 is the world's fastest particle counter.
When sampling a cubic meter of air, conventional 1.0 CFM (28.3 LPM) units take more than 35 minutes; 50 LPM units take 20 minutes. The APC M3's higher flow rate reduces the time required to take samples by as much as 70%, thereby helping pharmaceutical manufacturers increase productivity and lower labor costs.
To identify particulate contamination, Pharmaceutical and Medical Device manufacturers are required to monitor one cubic meter (m3) of air in ISO Class 5 to ISO Class 7 environments.
Also, the EU GMP Annex 1 states, "For routine testing the total sample volume should not be less than 1 m3 for grade A and B areas and preferably also in grade C areas." Sampling with the APC M3 at the 100 LPM flow rate allows manufacturers to measure the required volume of air quickly & cost effectively.
August 2006