AAMI CR513 2024
$80.17
AAMI CR513:2024 Guidance on radiation validation and routine maintenance for single-use systems used for pharmaceutical and biopharmaceutical manufacturing
| Published By | Publication Date | Number of Pages |
| AAMI | 2024 |
This consensus report provides guidance on simplified approaches for validation and routine control of single-use systems used for pharmaceutical and biopharmaceutical manufacturing sterilized by radiation.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | AAMI CR513:2024; Guidance on radiation sterilization validation and routine control of single-use systems used for pharmaceutical and biopharmaceutical manufacturing |
| 3 | Title page |
| 4 | AAMI Consensus Report |
| 5 | Copyright information Contents |
| 6 | Task Group representation |
| 9 | 1 Purpose 1.1 Scope 2 References and resources |
| 10 | 3 Terms and definitions 4 Definition and maintenance of product families for dose establishment and dose auditing 4.1 Representative product 4.1.1 Master product |
| 11 | 4.1.2 Equivalent product 4.1.3 Simulated product 5 Selection and testing of product for establishing the sterilization dose 5.1 Selection of product to be tested 5.2 Sample item portion (SIP) |
| 12 | 6 Sterile claim 7 Transfer of dose between radiation types 8 Application of dose 8.1 Application of verification dose to SUSs 8.2 Application of sterilization dose to SUSs |
| 13 | 9 Risk assessment 9.1 Risk assessment for SAL 9.2 Risk assessment for simplification of SUSs for testing 10 Guidance on release and independent verification for the user 10.1 SUS release information |
| 14 | 10.2 SUS user information 11 Regulatory aspects |
