Particle Measuring
Systems develops new pharmaceutical application for aerosol particle counter
Particle
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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