Medical Device BioFilms Slimy Sticky Stubborn and Serious
Major advances in medical devices over the last few decades have significantly improved the quality of life...
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Evaluating Packaging Changes
Supply chain disruptions have made it imperative for businesses to rethink their supply chain management strategies. Incorporating...
Slimy Biofilms A Brief Overview
A biofilm is a community of microorganisms embedded in a slimy matrix that can attach to a...
Contamination Control for Pharmaceutical Products Real World Moist Heat Validation Pitfalls and Proper Verification of Sterility
Moist-heat sterilization is a commonly used and widely accepted process in pharmaceutical manufacturing. Given its critical role,...
Fundamentals of EBeam Sterilization
Since the 1950s, the irradiation of medical devices using electron beam (e-beam) sterilization has been a common...
Overcoming a Cytotoxicity Failure
Every medical device must demonstrate proven biocompatibility to protect users from potential biological risks associated with its...
Reprocessing Validations Flexible Endoscopes and AAMI ST91
The newly revised AAMI ST91:2021 standard provides comprehensive guidelines for the processing of flexible and semi-rigid endoscopes...
Virucidal Efficacy Testing for Submission to Regulatory Agencies
Virucidal efficacy testing is essential for determining the effectiveness of disinfectants or antiseptic products against viruses. This...
Big Changes to ISO 10993 What is happening to the main biocompatibility standard now?
In 2018, TC194, the ISO committee responsible for biocompatibility, released a new version of the 10993-1 standard....
Parenteral Drug Development Exploring the Potential Benefits of Terminal Sterilization
In this insightful webinar, originally presented at Pharmapack Europe 2022, S. Ross Tsakas, Pharmaceutical Segment Leader at...