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The Medical Device Group at Pace Analytical Life Sciences offers comprehensive analytical support to help medical device manufacturers establish the functionality and safety of their product through our physical medical device testing services. With a focus on the client, our lab has earned a reputation for delivering high quality data on time. The physical testing services that we provide the medical device industry enable them to better select materials, evaluate the effect of material degradation, aid them in the evaluation of vendor changes and provide quality control on incoming raw materials.

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Drug Device Combination Products

The demand for sophisticated drug-delivery devices and combination products continues to drive novel product development and innovation within the medical device industry. At Pace Analytical, we understand that the convergence of drugs/biologics and devices bring exciting new opportunities, business, and a host of new challenges and regulations. Pace Analytical Life Sciences has the experience and expertise to embrace these opportunities and manage the challenges associated with drug device combination products.

Physical and Chemical Information for Biological Risk Analysis

Pace Analytical Life Sciences provides material characterization testing to support our medical device clients by assisting in establishing biocompatibility of a medical device by identifying and quantifying the chemical constituents of the materials.

Microbiology for Medical Devices

Pace Analytical Life Sciences is a full-service contract analytical testing laboratory providing microbiology testing services to the pharmaceutical and medical device industries. PLS has expertise in testing many dosage forms, including: transdermal delivery systems, aerosols, creams/ointments, tablets and capsules, medical devices and device/drug combination products.

Particulate Matter Testing

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.

Facility Validation Support

Our analytical testing services provide support for the validation of purified water systems, clean steam systems, compressed gases and clean rooms. We can help our clients commission new facilities, perform ongoing qualification services, as well as decommission existing facilities.

Environmental Monitoring

Environmental monitoring covers a range of areas requiring microbiological testing to detect changing trends of microbial counts and micro-flora growth within the manufacturing environments.

Ethylene Oxide Residual Testing

Many medical devices require some form of terminal sterilization and often ethylene oxide is chosen because it is effective and does not adversely affect many of the materials used to make medical devices. The use of ethylene oxide as a sterilant obligates companies to demonstrate that ethylene oxide (ETO) and its common degradants ethylene chlorohydrin (ECH) and ethylene glycol (EG) are removed from the product and packaging.

Medical Devices Endotoxin Testing

Pace Analytical Life Sciences (PLS) provides endotoxin testing for the pharmaceutical, biopharmaceutical and medical device industries. This test is also known as the Limulus Amebocyte Lysate, or LAL, test.

Medical Devices Physical Testing

The Medical Device Group at Pace Analytical Life Sciences (PLS) offers comprehensive analytical support to help medical device manufacturers establish the functionality and safety of their product through our physical testing services. With a focus on the client, our lab has earned a reputation for delivering high quality data on time.

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