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Particulate Testing of Medical Devices

Pace Analytical Life Sciences (PLS) provides particulate analysis testing for the pharmaceutical, biopharmaceutical and medical device industries.

Particulate analysis, or particulate-particle testing, follows USP <788> testing methodologies. These methods include various procedures for counting, sizing and removing both viable and non-viable particulate contamination within the sample analyzed. We are experienced with a wide range of sample types from pharmaceutical solutions, parenterals, water for injection, ultra pure water solutions and from particulates on or in medical devices.

Our Process

Medical device particulate matter testing is done using a HIAC ROYCO liquid particle counting system offering a broad range of size analysis. The lab also employs light microscopy for visualization and confirmation of any particles detected. If needed, additional particle analysis and identification can be done on viable particles by culturing then utilizing our microbial identification systems for strain level information. Non-viable particles can be identified by a range of analytical chemistry techniques that may include ICP analysis or Mass Spectrometry.

We are FDA registered, DEA registered, cGMP compliant and ISO/IEC 17025 accredited.

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Scope of Services
Evaluation of Medical Devices

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