Cutting costs in contamination control - Lyophilization Articles & Reports

Cutting costs in contamination control
30/09/2004
in-pharmatechnologist.com
One of the consequences of the new pharmaceutical legislation that came in last year is that companies involved in the manufacture of drugs have had to adapt their quality control processes. And these have not in all cases been made simpler.
For example, pharmaceutical manufacturers are now required to take larger, more time-consuming samples when it comes to measuring particles in the air of process and production units for contamination control.
Before the new regulations, one cubic foot was adequate for portable particle monitoring, but now one cubic meter is required per zone. This has had the effect of exponentially increasing the sampling time, from about a minute to more than half an hour, eating into operator time and hiking costs.
Now, Particle Measuring Systems has introduced a new product in its LASAIR range that it claims could cut back testing times and rein in increased labour costs.
The LASAIR II 550L uses a higher flow rate (50 litres per minute) than other samplers on the market, and can process one cubic metre of air in only 20 minutes ? saving 15 minutes? sampling time per zone - while still conforming to the European Union?s Good Manufacturing Practice (GMP) stipulations.
The LASAIR II?s software guides the user through the process of EU GMP sampling, then automatically generates a full final report.
Applications for the new system include the certification of clean rooms/zones to ISO standards, commissioning and troubleshooting aseptic filling lines, monitoring vial sterilisation, filling, freeze-drying and capping, and monitoring for presence of Colony-Forming Units (CFUs) in parenteral drug production, according to PMS.