If you work for a medical device or pharmaceutical company that is not using gamma irradiation to sterilize your products, this is something you may want to consider. Gamma rays, a […]

If you have a product that will be on the market, it is advised that you have proof that it is free from microbiological contaminants.  Antimicrobial preservatives are substances added […]

With one of the fastest areas of growth for plastics being the Medical Device Industry, there has been an increased demand for biocompatibility testing.  One aspect of evaluating whether a […]

Biocompatibility testing measures how compatible a device or material is with a biological system, and is needed to begin human trials of a medical device. Biocompatibility testing can provide an […]

Visit http://pacificbiolabs.com/learning_center/medical-device/reusable-device-validations/webinar/ to download a recorded version of the webinar or to view the slides from the presentation. This webinar presented an overview of FDA regulations regarding reusable medical device cleaning, disinfection, and […]

Why is an effective environmental monitoring program so important?In the end, whether you are manufacturing a medical device or a drug API, the safety of end users is at stake. […]

 What are Botulinum Toxins? Botulinum toxins are produced by the bacterium Clostridium botulinum and are perhaps the most poisonous natural toxins known.  Ingestion of the toxin results in rapid neurotoxicity, leading […]

Until recently, the only methods available to measure cytotoxicity were qualitative ones. These methods are subjective and rely on the skill of a microbiologist to identify malformed or lysed cells. […]

Why Is Microbial Testing Necessary? “How do we determine that our substance or preparation complies with an established specification for microbial quality?” This is what many manufacturers or producers of pharmaceuticals […]

*The following article is the Executive Summary from the booklet "Assessing Biocompatibility: A Guide for Medical Device Manufacturers" Purpose of Biocompatibility Testing Biocompatibility is, by definition, a measurement of how compatible a […]