Bioburden Testing and Microorganism Characterisization: Enhanced Guidance for Low Sterilization Dose Products
In recent years, concerns have been raised regarding the lack of understanding of bioburden (both numbers and...
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2023 Spring AAMI Standards Week Update
In this podcast from Nelson Labs, business leaders who recently returned from the AAMI standards week meetings...
Removing rabbits from irritation testing: Current status of regulatory acceptance of ISO 10993-23
In recent years, significant changes have been made to the standards and practices surrounding biocompatibility testing, driven...
Skin Care Products Understanding Clinical Testing Options
Skin-care products have become an essential part of the cosmetic and personal-care industry. Whether you are dealing...
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...
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...