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...
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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,...
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...
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...
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...
ProDisinfectant Efficacy Testing Coupon/Carrier Method
Disinfectants must be qualified on the surfaces within a pharmacopeial manufacturing environment before their use in the...
Cleaning Validations for Newly Manufactured Medical Devices
The implementation of ISO 19227:2018, which addresses the cleanliness of orthopedic implants, has set a new standard...
Bioburden Alert and Action Levels – Low Hanging Fruit for a FDA Citation
Most standards regarding bioburden and environmental testing emphasize the importance of establishing alert and action levels. These...
Rapid Sterility Testing: A New Solution For Short Shelf Life Products
All drug products must undergo sterility testing to comply with Good Manufacturing Practices (GMP). Parenteral drug products,...