Is it time to Re-Evaluate your Design History File for Reusable Device Validations
Standards for reprocessing have become a top priority for regulatory bodies worldwide. The active work around reusable...
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Guidance on Combining Biocompatibility and Cleaning Validation Testing
Testing all biocompatibility endpoints for reusable medical devices both at first-time use and after multiple reprocessing cycles...
The Biocomp Trail A Challenging hike towards Animal Free Testing
The main purpose of ISO 10993-1 is to emphasize a risk-based approach for evaluating the biocompatibility of...
Appropriate uses for Product Sterility Testing When is Sterility testing appropriate
Sterility testing is often the first test that comes to mind when determining if something is “sterile.”...
EPA Regulatory and Testing Guidelines for Residual Efficacy
With the recent implementation of the EPA guidance for residual efficacy claims on antimicrobial products, there is...
Release and Stability Testing Requirements for Parenteral Drug Products
Parenteral products, which include sterile drugs, solutions, emulsions, and suspensions, are distinct from other pharmaceutical dosage forms...
Introduction to Evaluating Persistent or Residual Antimicrobial Efficacy of Topically Applied Products
Topically applied antimicrobial products are vital tools in limiting the spread of microorganisms and diseases. These products...
The Impact of Radiation Sterilization Modalities on Flexible Sterile Barrier Packaging
Selecting the appropriate sterilization technology for your product and organization involves numerous factors. In this informative webinar,...
Understanding Container Closure Integrity Test Failures
Does a container closure integrity test (CCIT) failure always indicate a defective closure? This webinar aims to...
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...