Five Must-Knows About ASME BPE System Design Standards for Immersion Washers
Guidance to meet pharmaceutical manufacturing regulatory standards is everchanging, as is highlighted in the recent 2019 ASME BPE
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Pharmaceutical Factory Acceptance Test: The Foundation of Your Cleaning Validation Process
The Pharmaceutical Factory Acceptance Test (FAT) is the foundation of your validation process. Conceptually, one can see the validation process as a pyramid. And at the very base of the
GMP Washers: Sani-Matic’s Top 10 Things You Need to Know About the New ASME BPE Cabinet Washer Standards
Over the last decade, the FDA has strongly encouraged pharmaceutical manufacturing facilities to standardize and replace manual washing with automated GMP washers capable of generating repeatable results. While cGMP [1]
CIP System Design Considerations for Cleaning Pharmaceutical Equipment
Pharmaceutical manufacturing process equipment such as bioreactors, fermenters and process piping are generally cleaned using a strategic CIP system design that meets ASME-BPE standards. The most efficient, effective and hygienic
The Gift of Time: Robust Documentation Means Validation Process Savings
Robust documentation, or turnover packages, helps customers realize great time and money savings in their critical cleaning and validation process. It starts with a well-organized Factory Acceptance Test, or FAT,
Cleaning Validation is Anything but ‘Off the Rack’
Designing a washer rack to clean pharmaceutical components—and make the cleaning validation process easier—requires a blend of science and art. Because a validatable cleaning process is so important, customers frequently
Achieve Cleaning Validation with Well-Designed CIP Systems
Pharmaceutical manufacturing processes using bioreactors and fermenters require a detailed plan to achieve cleaning validation. Read how Chris McNulty, Sani-Matic’s Director of Pharmaceutical/Biotech Sales, outlines the key considerations for successfully