What is inside
- Document control, approvals and revision history
- 12 sections: scope, protection concept, air and pressure, leak tightness, VHP bio-decontamination, transfers, ergonomics, materials, monitoring, controls and data integrity, utilities, documentation
- 57 example requirements written to be testable, with [highlighted] fields to complete
- Priority (mandatory / desirable / optional), source and verification stage (DQ, FAT, SAT, IQ, OQ, PQ) for every requirement
- Appendices: referenced standards and a reach-point list for the ergonomic mock-up review
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Background reading
Guides that go with this template
How to write an isolator URS → Isolator FAT and SAT checklist → Hydrogen peroxide uptake in isolator filling →
Templates are provided for general guidance and must be adapted to your process, procedures and validation. They are not a substitute for qualification.