Microbial Limits Testing

Pace Analytical Life Sciences (PLS) operates a 40,000 square foot state of the art contract analytical laboratory that provides microbial limits testing, or MLT testing, for the pharmaceutical, biopharmaceutical and medical device industries following USP <61>, <62> or EP2.6.12 requirements. 

Microbial limits testing provides microbial enumeration of raw materials and non sterile products used in pharmaceutical manufacturing. This testing requires the experience and qualified personnel that Pace Analytical Life Sciences employs. Key to this testing is the initial preparatory test to determine inhibitory effects of the product on the recovery of the microbial limits test organisms.  At a minimum five organisms are used covering 3 different bacteria, a fungus and a yeast.  Once preparatory testing is completed routine testing can proceed.  The routine screening not only looks for bacteria, yeast and molds but other objectionable organisms.  Experience counts when problems arise and PLS personnel have the expertise to proceed in these cases.  In 2009 the microbial limits test was harmonized to cover USP, EP and JP methodologies.  PLS has extensive experience in harmonized microbial limits testing on a wide range of product types.  We can also provide helpful consultation with clients about any phase of microbial limits testing.

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 microbial limits testing will be successfully executed. 

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