Read, Learn, Innovate: Pharmaceutical Engineering® Top 5 Online Articles in March 2021
Featured in this edition of the Pharmaceutical Engineering Online Reading Roundup are the most read online articles during March 2021. Learn more about understanding cleanliness classifications, steam sterilization, and more from what visitors to the PE Online site were reading last month.
Understanding Cleanliness Classifications for Life Science Facilities
The article discusses differences between the US Food and Drug Administration (FDA) environmental cleanliness requirements for sterile product manufacture and those of the European Medicines Agency EudraLex Volume 4, Annex 1.
Steam Sterilization Principles & Common Mistakes Using Autoclaves
This article presents how a good understanding of basic steam sterilization principles can help with avoiding most common mistakes made when using steam autoclaves.
GMP Implementation of Online Water Bioburden Analyzers
This article provides points to consider for OWBA implementation and a suggested framework for OWBA technology qualification, validation, and use to support in-process monitoring of a GMP water system.
Biopharmaceutical Manufacturing Process Validation and Quality Risk Management
Process validation today is a continual, risk-based, quality-focused exercise that encompasses the entire product life cycle. This article was a nominee for the Roger F. Sherwood Article of the Year
Design & Control of Pharma Water System to Minimize Microbiological Contamination
Water-borne microorganisms are ubiquitous and varied in their ability to survive and grow under different conditions. Therefore, an out-of-control water system can cause harm to the patient or adulterate pharmaceutical products. Purification of water is required to prevent interaction with drug substances or other ingredients in the product formulation. Water must also be microbiologically controlled and monitored.
