A Stepwise Approach to Deal with In Vitro Cytotoxicity Failures
Manufacturers are required to perform a biological evaluation of any medical device as outlined in ISO 10993-1....
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Cytotoxicity Failure What Now
Cytotoxicity testing is a critical endpoint for all medical devices that come into contact with patients or...
Testing of Packaging Systems for Large-Volume Parenteral Drugs: Extractables Study Design and Challenges
Flexible bag systems for large volume parenterals (LVPs) are subject to stringent regulatory oversight for extractables and...
Establishing Maximum Acceptable Dose for Medical Devices in Radiation Sterilization
Medical device manufacturers using ionizing radiation (gamma, electron beam, or X-ray) for sterilization purposes must establish the...
The Necessity of Extractable and Leachable Qualifications for Lyophilized Drug Products: Some Fallacies Addressed
Lyophilized drug products, also known as freeze-dried pharmaceuticals, require specialized containers and administration devices to ensure their...
Good Identification Practices For Organic Extractables & Leachables Via Mass Spectrometry
Ensuring the safety and efficacy of pharmaceutical products requires the accurate identification of organic extractables and leachables....
Establishing Bioburden Alert and Action Levels
In the realm of bioburden, sterilization, and environmental testing, national and international standards play a crucial role...
Gamma: the heart of radiation sterilization past, present and future
The COVID-19 pandemic of 2020 highlighted the pivotal role of the medical device supply chain in delivering...
Animal Testing
Traditionally, animals have been used as test subjects during drug development studies to reliably detect the toxic...
Challenges in Design Development – Why Design Control Makes Sense
The journey from a novel idea for a new medical product to its commercial realization involves significant...