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...
Archives: Courses
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...
Evaluating Packaging Changes
Supply chain disruptions have made it imperative for businesses to rethink their supply chain management strategies. Incorporating...
Pros Cons and Considerations of Using a Developmental Chamber During Ethylene Oxide Validation
A developmental chamber, typically smaller than a production chamber, is often utilized to perform studies that support...
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...
Biocompatibility Essentials
Biocompatibility is a crucial aspect of medical device design and manufacturing, ensuring that devices do not cause...
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....