Read, Learn, Innovate: Pharmaceutical Engineering® Top 5 Online Articles in April 2021
Featured in this edition of the Pharmaceutical Engineering Online Reading Roundup are the most read online articles during April 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.
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
Breaking with Tradition: Laying the Foundation for Validation 4.0
A fundamental GMP requirement is that processes, systems, and methods used to produce medicines and treatments are validated, meaning their fitness for a purpose is demonstrated. If Industry 4.0 is to succeed in the pharma space as Pharma 4.0™, we need new paradigms for validation across the value chain that use new technologies to improve product quality and the safety of medicines and treatments for the patient. We must transition from our old ways of approaching compliance to embrace this new age of data-powered technology. This article lays the foundation for shifting our mindset and achieving Validation 4.0.
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.
