Read, Learn, Innovate: Popular Article in Pharmaceutical Engineering® during October
Featured in this edition of the Pharmaceutical Engineering® Online Reading Roundup are popular articles that visitors to the site were reading during October. Revisit articles on cleanliness classifications, steam sterilization, pharma water systems, and more.
Understanding Cleanliness Classifications for Life Science Facilities
This article discusses differences in modern classification systems: the 2004 US Food and Drug Administration (FDA) environmental cleanliness requirements for sterile product manufacture and the European Medicines Agency EudraLex Volume 4, Annex 1.
Steam Sterilization Principles
This article presents how a good understanding of basic steam sterilization principles can help with avoiding most common mistakes made when using steam autoclaves.
In Other Words: i.e., e.g., et al., etc.
Four Latin abbreviations are staples of scientific writing: i.e., e.g., etc., et al. Despite their ubiquity, however, their meanings and usage are often confused or misunderstood. How can this be—especially when the terms are used so frequently?
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.
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. Manufacturing processes for biopharmaceuticals must be designed to produce products that have consistent quality attributes.
