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Bioburden testing, either USP Bioburden or medical device microbiology following ISO 11737, is done to determine the total number of viable microorganisms, or total microbial count, in or on a medical device, container or component after completion of all of the in-process steps before final sterilization. At Pace Analytical Life Sciences product bioburden testing is done in strict compliance with USP, EP, JP, AOAC and BP guidelines. Bioburden testing is able to provide the initial starting point of data for all subsequent sterilization processes for your product. Effective and accurate bioburden testing as conducted at Pace Analytical Life Sciences can expedite your sterilization decision process. For medical devices with numerous parts this becomes especially important in the decision process regarding sterilization. Bioburden testing is not an added step but rather a key step in the process of determining the sterilization method. Bioburden testing answers the two key questions about your sample. How many viable organisms exist in my sample and what is the best sterilization process that can be used with my product to remove these contaminants? Pace Analytical Life Sciences’ staff is available for consultation about testing results and effective solutions based on the results of your bioburden testing results. Within the bioburden testing process answers are found for the evaluation of the manufacturing process, for evaluating test procedures, a direct indication of the antimicrobial qualities of the product along with setting recovery levels for various phases of the testing. At Pace Analytical Life Sciences, bioburden testing is accomplished using well qualified and trained personnel.

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 bioburden testing will be successfully executed.

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

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