October 2001
Perspectives

Particle Measuring Systems develops new pharmaceutical application for aerosol particle counter

Pill bottleParticle Measuring Systems' particle counting systems are used to detect contaminants in aerosols, liquids, gas streams and vacuum processing environments. Working with customers in the pharmaceutical industry, PMS has successfully adapted its Lasair product and the launch of Lasair II® represents a significant advance in real-time measurement of defect-causing particles in pharmaceutical cleanroom environments.

Pharmaceutical companies are required by regulatory bodies to certify that the cleanroom where the drugs are manufactured meets a specified standard of performance on a regular basis. The portable Lasair II is used during drug manufacture either as an instrument to prove compliance to cleanroom standards or to detect faulty filters or unsatisfactory process performance.

The specification, design, testing and release of Lasair II have been carried out to PMS's internal ISO9001 quality standard and the product comes with a validation manual. PMS is the only company to offer this feature for particle counters. The manual specifies the detailed design of the instrument's hardware and software, documents all the hardware and software testing and, finally, lists a series of tests which the customers perform themselves. This is a valuable tool for integrating new equipment into a highly regulated industry, saving the customer thousands of dollars in internal validation.

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