Hello good people of the world! Today’s post covers some of the “golden rules” on aseptic biopharmaceutical manufacturing facility design. Please add yours in the comments below!
- All equipment should be designed to be completely self-drainable
- Low points and dead-legs should be avoided
- Automatic valves should be fail-closed where ever possible
- Any process that line that is cleaned (CIP’d) and steamed (SIP’d) should employ only diaphram valves
- Process lines should have NLT (not less than) 1% slope where possible
- Pressurized vessels should have a local pressure indicator
- Filters should be sanitizable inline
- Transfer lines to a vessel should be designed to be independently CIP’d from the vessel
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Mike Williamson Validation 