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...
Archives: Courses
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....
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...
DHF and Design Control
In this episode, host Brandon Miller is joined by Jessica Schafersman, a Biomedical Engineer, Project Management Professional,...
What is Irritation and Sensitization
In this episode, host Brandon Miller is joined by Dr. Matthew Jorgensen and Audrey Turley to delve...
Outsourcing and Staff Augmentation
In this episode, host Brandon Miller is joined by Erica Porcelli, CEO of Regulatory Compliance Associates (RCA),...
The 3Rs of EO Sterilization – Sustaining the Continued Safe Use of EO
Ethylene Oxide (EO) sterilization technology is crucial for enabling critical medical products and devices to safely reach...
Lessons from the Lab
This eBook, created in partnership with Medical Products Outsourcing Magazine, addresses common challenges and best practices for...
Current Regulatory Acceptance of Alternative Testing for Biocompatibility
The release of ISO 10993-1 in 2018 marked a significant shift in the biocompatibility evaluation of medical...
FDA Regulation of Hand Sanitizers – What Testing Should be conducted to Markt a new Hand Sanitizer?
All hand sanitizers, whether used by consumers or healthcare professionals, are considered over-the-counter (OTC) drugs regulated by...
What is ISO13485
In this episode, host Brandon Miller is joined by Jordan Elder, Director of Regulatory Affairs at Regulatory...
Disinfectant Efficacy Testing for Submission to the US Environmental Protection Agency
When developing a disinfectant or sanitizer (herein referred to as disinfectant) for use on environmental surfaces, the...
Tools of the Trade Ways to make EO Processing more Efficient
Ethylene Oxide (EO) sterilization is one of the most complex sterilization methods commonly used, with numerous approaches...