Posts Tagged ‘[Bio-Pharm]’
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] design standards have been in place for CIP systems for quite some time, The American Society of Mechanical Engineers Bioprocessing Equipment Committee (ASME BPE) recognized the FDA’s…
Read MoreCIP 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 results are achieved when the CIP system design is considered during the preliminary stages of the facility’s entire process design. “Pharmaceutical manufacturers must perform frequent…
Read MoreWhat is CIP Cleaning?
CIP cleaning, also referred to as Clean-In-Place cleaning, is a procedure of cleaning interior product contact surfaces such as process pipes, vessels and equipment, without disassembly. Typical food and beverage applications cleaned using an automated CIP system are product transfer lines, processing tanks, homogenizers, mixers, blenders and fillers. In contrast, Cleaning-Out-of-Place (COP) is a method used when…
Read MoreShaking Hands & Making Recipes – Ensure Proper Cleaning and Sanitation from your System with Start-Up Services
Following the purchase and installation of a Sani-Matic cleaning and sanitation system, the company’s Start-up Services give customers confidence that their system will operate as it was designed to. Many customers see great value in the company’s flexibility and ability to provide solutions to a sometimes complex and customized start-up procedure, according to John Leach, technical services…
Read MoreThe 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, which involves testing procedures conducted at the Sani-Matic facility that directly engage the customers. During several days of rigorous testing, systems are put through the…
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