Pace Analytical® Life Sciences (PLS) provides particulate matter testing (total particulate counts) for the pharmaceutical, biopharmaceutical and medical device industries.
Particulate analysis follows the guidance of USP general chapters <787>, <788>, and <789>. These methods include procedures for counting, by size range the particulate contamination within the sample analyzed. We are experienced with a wide range of sample types from pharmaceutical / biopharmaceutical products, purified water / water for injection, and particulates rinsed or extracted from medical devices / components either individually or deployed through an anatomical model Particulate matter testing is done using a HIAC ROYCO liquid particle counting system (Method 1, laser obscuration) offering a broad range of size analysis. The lab also employs light microscopy for visualization and confirmation of any particles detected (Method 2). We are FDA registered, DEA registered, cGMP compliant and ISO/IEC 17025 accredited.
We are FDA registered, DEA registered, cGMP compliant and ISO/IEC 17025 accredited.