AAMI 13408 7 2012 RA 2018
$93.55
ANSI/AAMI/ISO 13408-7:2012/(R)2018 – Aseptic processing of health care products-Part 7: Alternative processes for medical devices and combination products
| Published By | Publication Date | Number of Pages |
| AAMI | 2012 | 36 |
Specifies the requirements for, and offers guidance on, processes, programs and procedures for procurement, development, validation, routine control of the manufacturing process and transport for aseptically processed cell based medical products (CBMP), especially tissue engineering products (TEP´s) whose biological properties have to be kept intact to maintain their efficacy as a medical device and/or medicinal product.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | ANSI/AAMI/ISO 13408-7:2012/(R)2018, Aseptic processing of health care products — Part 7: Alternative processes for atypical medical devices and combination products |
| 2 | Objectives and uses of AAMI standards and recommended practices |
| 3 | Title page |
| 4 | AAMI Standard Copyright information |
| 5 | Contents |
| 6 | Glossary of equivalent standards |
| 9 | Committee representation |
| 11 | Background of AAMI adoption of ISO 13408-7:2012 |
| 12 | Foreword |
| 13 | Introduction |
| 15 | 1 Scope 2 Normative references 3 Terms and definitions |
| 16 | 4 Quality system elements 5 Aseptic process definition 5.1 General 5.2 Risk management 5.2.1 General 5.2.2 Identification of microbiological contamination risks |
| 17 | 5.2.3 Assessment of contamination risks 5.2.4 Monitoring and detection of contamination 5.2.5 Prevention of contamination 5.2.6 Use of risk assessment during the development and initial qualification of the aseptic process prior to commercial production 5.2.7 Use of risk assessment for the aseptic process simulation for process validation of commercial production 6 Manufacturing environment 7 Equipment |
| 18 | 8 Personnel 9 Manufacture of the product 10 Process simulation 10.1 General 10.2 Media selection and growth support 10.3 Simulation procedures |
| 20 | 10.4 Incubation and inspection of process simulation units |
| 21 | 10.5 Initial performance qualification 10.5.1 General 10.5.2 Numbers to be filled 10.5.3 Acceptance criteria 10.6 Periodic performance requalification 10.6.1 Scheduling requirements 10.6.2 Numbers to be filled |
| 22 | 10.6.3 Acceptance criteria 10.7 Repeat of initial performance qualification 10.8 Documentation of process simulations 10.9 Disposition of filled product 11 Test for sterility 11.1 General 11.2 Investigation of positive units from tests for sterility |
| 23 | Annex A (informative) Risk assessment for aseptic processing — Quality risk management method A.1 General A.2 Background A.3 Risk priority number determination A.4 Risk assessment |
| 28 | A.5 Risk acceptance A.6 Risk reduction A.7 Verification of acceptability of overall residual risk A.8 Key process parameters |
| 29 | A.9 Process simulation design A.9.1 Process simulation of the initial aseptic process (manual method) A.9.2 Process simulation for the optimized aseptic process A.10 Acceptance criteria |
| 30 | Annex B (informative) Selection of a sample for testing for microbial contamination B.1 Actual product B.2 Surrogate product |
| 32 | Annex C (informative) Testing options for process simulation C.1 Testing option considerations |
| 33 | C.2 Test methods C.2.1 Direct contact of media with product C.2.1.1 General considerations C.2.1.2 Direct immersion method C.2.1.3 In situ direct contact of media with patient contact surfaces C.2.2 Elution/removal methods |
| 35 | Bibliography |
