Particulate Analysis

Pace Analytical Life Sciences (PLS) operates a 40,000 square foot state of the art contract analytical laboratory that provides particulate analysis testing for the pharmaceutical, biopharmaceutical and medical device industries.

Particulate analysis, or particulate-particle testing, at Pace Analytical Life Sciences 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.  Particle analysis experience at Pace covers 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.

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.  All of these capabilities for particulate analysis exist at Pace in our Oakdale MN laboratory.

Pace Analytical Life Sciences brings years of experience performing all types of analytical testing on many drug substances, drug products and medical devices.  We bring the highest level of quality and attention to detail to our clients to assure that their particulate analysis testing will be successfully executed. 

We are FDA registered, DEA registered, cGMP compliant, and ISO/IEC 17025:2005 accredited.