Evaluating the biocompatibility of reusable medical devices during their whole life cycle
In the past, the primary focus for reusable medical devices was on validating reprocessing efficacy with regard...
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The Production Process and Qualification of a Pharmaceutical Film
What is required to qualify primary packaging materials for Large Volume Parenterals (LVPs)? What factors should be...
Challenges and Considerations for Complex LVP Drug Products
Addressing the toxicological risks associated with patient exposure to leachables requires a strategy tailored to the unique...
An introduction to large volume parenterals (LVPs) as a pharmaceutical dosage form
Pharmaceutical dosage forms are primarily distinguished by their route of administration, with secondary differentiation based on other...
Decontamination, Sterile Processing, and Performance Testing of Personal Protective Equipment (PPE)
During the COVID-19 pandemic, the demand for personal protective equipment (PPE), especially medical face masks and respirators,...
MDR with Brexit_ How the Combination is Impacting the European Medical Device Industry
With the COVID-19 crisis, the implementation of the Medical Device Regulations (MDR) was delayed by one year....
Requirements and Impact of the New Guideline – ISO 10993-23: Tests for Irritation
The landscape of biocompatibility testing for medical devices is evolving with the recent shift of irritation assessment...
Biocompatibility for Medical Devices 101 – Prepare for Clinical Trial
This is a crash course overview of medical device biocompatibility, designed to provide a comprehensive understanding of...
Container Closure Integrity and Stability Testing for Rigid Containers
Setting up a stability test plan for vial products can be a daunting task with many variables...
Validating, Optimizing and Monitoring EO Sterilization Processes – Part 2
Establishing an Ethylene Oxide (EO) sterilization process involves navigating a complex path, as multiple factors influence the...