eLibrary >
AAMI CR513:2024 Guidance on radiation validation and routine maintenance for single-use systems used for pharmaceutical and biopharmaceutical manufacturing >
Expand All
TOC Search:
AAMI CR513:2024 Guidance on radiation validation and routine maintenance for single-use systems used for pharmaceutical and biopharmaceutical manufacturing, 2024
- AAMI CR513:2024; Guidance on radiation sterilization validation and routine control of single-use systems used for pharmaceutical and biopharmaceutical manufacturing
- Title page
- AAMI Consensus Report
- Copyright information
- Contents
- Task Group representation
- 1 Purpose [Go to Page]
- 2 References and resources
- 3 Terms and definitions
- 4 Definition and maintenance of product families for dose establishment and dose auditing [Go to Page]
- 5 Selection and testing of product for establishing the sterilization dose [Go to Page]
- 6 Sterile claim
- 7 Transfer of dose between radiation types
- 8 Application of dose [Go to Page]
- 9 Risk assessment [Go to Page]
- 10 Guidance on release and independent verification for the user [Go to Page]
- 11 Regulatory aspects [Go to Page]
