Golden Rules for Aseptic BioPharmaceutical Manufacturing Facility Design

Aseptic BioPharmaceutical Manufacturing Facility

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!

  1. All equipment should be designed to be completely self-drainable
  2. Low points and dead-legs should be avoided
  3. Automatic valves should be fail-closed where ever possible
  4. Any process that line that is cleaned (CIP’d) and steamed (SIP’d) should employ only diaphram valves
  5. Process lines should have NLT (not less than) 1% slope where possible
  6. Pressurized vessels should have a local pressure indicator
  7. Filters should be sanitizable inline
  8. Transfer lines to a vessel should be designed to be independently CIP’d from the vessel

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