Pace Analytical Life Sciences (PLS) provides environmental monitoring (EM) testing services for the pharmaceutical, biopharmaceutical and medical device industries following USP <797> requirements.
Environmental monitoring covers a range of areas requiring microbiological testing to detect changing trends of microbial counts and micro-flora growth within the manufacturing environments. In aseptic manufacturing the most challenging part of the process is producing a sterile product. Our services at PLS cover sampling and testing in any controlled manufacturing environment from process water systems to compressed air and gas systems for pharmaceutical and medical devices.
Our environmental monitoring services follow all USP and FDA testing standards. Our service starts with an extensive consultation with each client. This includes review of blueprints to site visits and evaluations. Our personnel utilize risk assessment tools to determine the most appropriate methods for environmental monitoring. Once an environmental monitoring protocol is set, PLS’s experienced personnel are available to execute the on-site sampling with their own equipment and supplies and can provide training to the client’s workers for conducting the ongoing periodic routine testing required. Alternately, PLS can supply the necessary materials and instructions for the client to perform their own samplings and send the samples for environmental monitoring to PLS.
PLS has specific experience in air sampling, surface sampling, surface swab testing and the testing of viable or non-viable particulates. We routinely perform rodac testing, settling plate testing and air sampling for microbes.
We are FDA registered, DEA registered, cGMP compliant and ISO/IEC 17025 accredited.