Pace Analytical® Life Sciences (PLS) provides environmental monitoring (EM) testing services for the pharmaceutical, biopharmaceutical and medical device industries.
Clients contract us for facility monitoring services when commissioning new facilities, after facility remediation events, after planned shut downs, and during routine ongoing manufacturing. Environmental monitoring is performed to demonstrate that the systems used to control the microbiological quality of manufacturing environments are working as expected.
Excursions from established alert and action levels indicate the environmental systems may be drifting out of a state of control. Our service starts with client consultation to determine testing needs. We can perform testing to determine the viable population on surfaces, as well as the total particulates and viable particulates in air and compressed gasses. PLS has experienced and well-trained personnel who are available to execute the on-site sampling. PLS can also supply the necessary materials and instructions for the client to perform their own sampling and send the samples to PLS for incubation and enumeration.
Pace Analytical® Life Sciences provides clients with a comprehensive range of analytical services to support the validation of pharmaceutical facilities. Our analytical testing services provide support for the validation of purified water systems, clean steam systems, compressed gases and clean rooms. We can help our clients’ commission new facilities, perform on-going qualification services as well as decommission existing facilities.
All of this work is performed in strict compliance to cGMP requirements following USP, EP, JP, ISO or client specific requirements. We have extensive experience in purified water testing, clean steam testing, USP purified water system validation, DI water system validation, compressed gas testing and clean room testing.