Read, Learn, Innovate: Pharmaceutical Engineering® Top 5 Online Articles in February 2021
Featured in this edition of the Pharmaceutical Engineering® Online Reading Roundup are the most read online articles during February 2021. Learn more about cleaning classifications, steam sterilization, biopharma process validation and more for what visitors to the Pharmaceutical Engineering® 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
Cleaning Validation Considerations for Automated Washing Systems
What is cleaning validation and where does it fall in the life cycle validation scheme? How can an automated washing system be validated? This article provides insights that may help answer these questions.
Bowtie Analysis and Barrier-Based Risk Management
Every business has legal, economical, and ethical objectives that range from mandatory safety to commercial goals to corporate citizenship. Businesses undertake a certain amount of risk to achieve these objectives. The balance between risk and reward is an ongoing challenge regardless of the activities involved. The bowtie technique can be used to visualize, assess, and manage risk.
