Posts Tagged ‘[Bio-Pharm]’
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 System Design Standards for Immersion Washers. Two Sani-Matic experts, Solo Yang, sales engineer and BPE contributing member, and Pete Barrie, senior product manager and BPE Systems Design committee member, provide a brief overview of ASME BPE, how standards…
Read MoreHow to Meet Pharmaceutical Equipment Components Requirements
Professionals in the bio-pharm industry understand meeting pharmaceutical equipment components requirements is a rigorous task. Close attention to the evolving FDA Current Good Manufacturing Practice (cGMP) regulations and American Society of Mechanical Engineers (ASME) Bioprocessing Equipment (BPE) standards is needed to be in compliance and ensure a hygienic process. “The BPE standards section for Process Components (SD-3)…
Read MorePharmaceutical 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 validation process pyramid is the FAT. From there the equipment is shipped to the customer site for the Site Acceptance Testing (SAT), then Commissioning, Installation/Operational…
Read MoreWhen to Upgrade Your CIP Skid
As food, beverage and pharmaceutical manufacturing processes change and operations grow, a CIP skid may require modifications to perform new tasks. Sani-Matic’s Tactical Solutions team specializes in finding the right CIP system solution for ever-evolving processes. Sani-Matic’s Tactical Solutions Manager Micah Muller and Tactical Solutions Engineer Chris Raulin, discussed the top reasons for updating a…
Read MoreSanitary Automation Controls: The Brains of Your Operation
Sanitary automation controls are at the heart, and brain, of repeatable and customizable cleaning solutions. Without automation, food and beverage processing equipment must be cleaned manually, which is time-consuming, labor intensive and non-repeatable. By automating a cleaning process to meet the requirements of each individual manufacturing process, operation engineers can be confident their process equipment and…
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