AAMI TIR16775 2014
$162.84
AAMI/ISO TIR16775:2014 – Packaging for terminally sterilized medical devices – Guidance on the application of ISO 11607-1 and ISO 11607-2
| Published By | Publication Date | Number of Pages |
| AAMI | 2014 | 128 |
This technical report contains guidance on the application of ISO 11607-1:2006, Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems and packaging systems and ISO 11607-2:2006, Packaging for terminally sterilized medical device – Part 2: Validation requirements for forming, sealing, and assembly processes. Possible options for compliance with the requirements of Parts 1 and 2 will be addressed as special concerns that may require attention due to regional or local conditions, practices or regulations.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | ANSI/AAMI/ISO TIR16775:2014, Packaging for terminally sterilized medical devices — Guidance on the application of ISO 11607-1 and ISO 11607-2 |
| 3 | Title page |
| 4 | Copyright information |
| 5 | AAMI Technical Information Report ANSI Technical Report |
| 7 | Contents |
| 9 | Glossary of equivalent standards |
| 10 | Committee representation |
| 12 | Background of AAMI adoption of ISO/TS 16775:2014 |
| 13 | Foreword |
| 14 | Introduction |
| 15 | 1 Scope 2 Terms and definitions |
| 16 | 3 Guidance for health care facilities 3.1 Test methods 3.2 Guidance for conformance to ISO 11607-1 3.2.1 General guidance for materials, preformed sterile barrier systems and sterile barrier systems |
| 17 | 3.2.2 Design and development guidance for packaging systems (ISO 11607-1:2006, 6.1 and 6.2) 3.2.2.1 Selection criteria |
| 18 | 3.2.2.2 Selection considerations 3.2.2.3 Assembly considerations |
| 19 | 3.2.2.4 Labelling considerations 3.2.2.5 Regulatory considerations 3.2.2.6 Common choices for sterile barrier systems 3.2.2.6.1 General 3.2.2.6.2 Sealable pouches and reels (preformed sterile barrier systems) |
| 20 | 3.2.2.6.3 Sterilization wrap |
| 21 | 3.2.2.6.4 Reusable containers |
| 22 | 3.2.2.7 Protective packaging 3.2.3 Packaging system performance testing (ISO 11607-1:2006, 5.3, 5.4, 5.5, 6.3) |
| 23 | 3.2.4 Sterile barrier system stability evaluation (shelf life) (ISO 11607-1:2006, 6.4) 3.2.5 Documentation |
| 24 | 3.3 Guidance on conformance to ISO 11607-2, Validation requirements for forming, sealing and assembly processes 3.3.1 General 3.3.2 Method of validation 3.3.2.1 General 3.3.2.2 Drafting of validation plan |
| 25 | 3.3.2.3 Implementation of validation 3.3.2.4 Validation approval 3.3.2.5 Process control and routine monitoring |
| 26 | 3.3.2.6 Process/packaging changes and revalidation 3.3.2.7 Validation of the sealing process (pouch, reel or bag forming and sealing) of preformed sterile barrier systems 3.3.2.7.1 Installation Qualification |
| 27 | 3.3.2.7.2 Operational Qualification |
| 28 | 3.3.2.7.3 Performance Qualification 3.3.2.7.4 Self-sealing or taped pouches |
| 29 | 3.3.2.8 Validation of the wrapping process (folding and closing of sterilization wraps) 3.3.2.8.1 Installation Qualification 3.3.2.8.2 Operational Qualification 3.3.2.8.3 Performance Qualification |
| 30 | 3.3.2.9 Validation of the container process (filling and closing of re-usable containers) 3.3.2.9.1 Installation Qualification 3.3.2.9.2 Operational Qualification |
| 31 | 3.3.2.9.3 Performance Qualification |
| 32 | 3.4 Quality system 4 Guidance for industry 4.1 General guidance 4.1.1 Quality systems 4.1.2 Test methods |
| 33 | 4.1.3 Sampling 4.2 Design inputs 4.3 Selection and evaluation of materials 4.3.1 Guidance on sterilization requirements (ISO 11607-1:2006, 5.1.6 e) and 5.3) 4.3.2 Guidance on safety requirements (ISO 11607-1:2006, 5.1.5 and 5.1.6) 4.3.3 Guidance on barrier requirements (ISO 11607-1:2006, 5.1.4 and 5.1.6) 4.3.4 Guidance on visibility and appearance requirements 4.3.5 Guidance on physical property requirements (ISO 11607-1:2006, 5.1.6 c), 5.1.7 e), and 6.3.2) |
| 34 | 4.3.6 Guidance on heat sealability requirements [ISO 11607-1:2006, 5.1.6 d) and 5.1.8 c)] 4.3.7 Guidance on processing requirements (ISO 11607-1:2006, 5.1.2 to 5.1.9) 4.3.8 Guidance on printing requirements (ISO 11607-1:2006, 5.4) 4.3.9 Guidance on cleanliness and particulate requirements [ISO 11607-1:2006, 5.1.7d)] 4.3.10 Device-packaging system interaction 4.4 Sterile barrier system and protective packaging design (packaging system development) 4.4.1 Key elements in the design |
| 35 | 4.4.2 Steps in packaging system design 4.4.2.1 Design the sterile barrier system 4.4.2.2 Design the protective packaging 4.4.2.3 Prototype the packaging system 4.4.2.4 Labelling considerations for the packaging system design |
| 36 | 4.5 Packaging process feasibility evaluation 4.5.1 Sterile barrier system manufacturing process 4.5.2 Equipment Installation Qualification guidance 4.5.3 Prototype or trial runs 4.6 Sterile barrier system design feasibility evaluation 4.6.1 General considerations |
| 37 | 4.6.2 Sterile barrier system test method 4.6.3 Worst-case feasibility condition 4.6.4 Pass/fail status of packaging system |
| 38 | 4.7 Validation of sterile barrier system manufacturing process 4.7.1 Development of written process validation protocol 4.7.2 Performance of validation activities detailed in protocol 4.7.2.1 Installation Qualification (if not satisfied from previous IQ work) (ISO 11607-2:2006, 5.2) |
| 39 | 4.7.2.2 Operation Qualification (ISO 11607-2:2006, 5.3) 4.7.2.3 Performance Qualification (ISO 11607-2:2006, 5.4) 4.7.3 Assessment of validation results 4.7.4 Approval of process validation 4.7.5 Establishment of documented ongoing process control and monitoring 4.8 Packaging system design validation 4.8.1 General |
| 40 | 4.8.2 Validation protocol 4.8.3 Performing testing 4.8.4 Documenting validation results |
| 41 | 4.9 Revalidation |
| 42 | Annex A: Selection, evaluation and testing of packaging materials and sterile barrier systems — Guidance for industry and health care facilities A.1 General A.2 Compatibility with the sterilization process A.3 Safety considerations |
| 43 | A.4 Barrier guidance A.5 Visibility and appearance of the medical device A.6 Material physical property |
| 45 | A.7 Sterile barrier system integrity A.8 Seal strength and burst strength |
| 46 | A.9 Material processing guidance A.10 Printing guidance |
| 47 | A.11 Cleanliness and particulates A.12 Accelerated aging and environmental challenging |
| 49 | Annex B: Sterilization considerations — Guidance for industry and health care facilities B.1 Overview B.2 Ethylene oxide |
| 50 | B.3 Gamma irradiation |
| 51 | B.4 Electron beam sterilization (E-Beam) B.5 X-ray sterilization |
| 52 | B.6 Moist heat (steam) sterilization B.7 Sterilization using moist heat and non-porous packaging |
| 53 | B.8 Dry heat B.9 Peroxide sterilization |
| 54 | B.10 Ozone B.11 Chlorine dioxide (ClO2 or CD) |
| 56 | Annex C: Examples of wrapping methods — Guidance for health care facilities C.1 General C.2 Envelope method Figure C.1 — Envelope method steps 1 to 3 |
| 57 | Figure C.2 — Envelope method steps 4 to 6 Figure C.3 — Envelope method simultaneous double wrapping |
| 58 | Figure C.4 — Envelope method sequential double wrapping |
| 59 | C.3 Parallel packaging/square fold method wrapping Figure C.5 — Packaging/square fold method steps 1 to 3 Figure C.6 — Parallel wrapping steps 4 to 7 |
| 60 | Figure C.7 — Parallel wrapping steps 8 and 9 Figure C.8 — Square fold method simultaneous double wrapping |
| 61 | Figure C.9 — Square fold method sequential double wrapping |
| 62 | C.4 Pasteur or roll method Figure C.10 — Pasteur or roll method |
| 63 | Annex D: Validation plan documents — Guidance for health care facilities D.1 General Table D.1 — Number of process validations |
| 64 | D.2 Validation plan checklist: Heat Sealing Process Preformed Sterile Barrier Systems (PSBS: Pouches, Reels, etc.) |
| 68 | D.3 Validation plan checklist: wrapping process |
| 72 | D.4 Validation plan checklist: container process |
| 76 | D.5 Handling and distribution checklist: handling, distribution and storage |
| 79 | Annex E: Installation qualification documentation — Guidance for health care facilities E.1 Checklist installation qualification (IQ): heat sealing process |
| 82 | E.2 Checklist Installation Qualification (IQ): Wrapping Process |
| 83 | E.3 Checklist installation qualification (IQ): container process |
| 84 | Annex F: Operational qualification documentation — Guidance for health care facilities F.1 Checklist operational qualification (OQ): heat sealing process |
| 86 | F.2 Checklist operational qualification (OQ): wrapping process |
| 88 | F.3 Checklist operational qualification (OQ): container process |
| 90 | Annex G: Performance qualification documentation — Guidance for health care facilities G.1 Checklist performance qualification (PQ), sealing process |
| 92 | G.2 Checklist performance qualification (PQ), wrapping process |
| 94 | G.3 Checklist performance qualification (PQ), container process |
| 96 | Annex H: Addressing worst-case requirements — Guidance for industry and health care facilities H.1 Overview H.2 Worst-case configuration — Medical devices H.3 Worst-case — Sterile barrier system |
| 97 | H.4 Worst-case configuration — Sterile barrier system manufacturing process |
| 98 | Annex I: Generating a final packaging system validation protocol — Guidance for industry I.1 Plan objectives and background on protocol development I.2 Understanding the packaging system design configuration I.3 Grouping packaging systems for validation |
| 99 | I.4 Determining sample size for final packaging system validation I.5 Defining acceptance criteria I.6 Sterile barrier system preparation for testing I.7 Define the shipping environment |
| 100 | I.8 Defining shelf life |
| 101 | Annex J: Design inputs — Medical device attributes — Guidance for industry J.1 Introduction J.2 Product attributes |
| 102 | J.3 Medical device protection guidance J.4 Storage, distribution, and handling guidance |
| 103 | J.5 Manufacturing guidance J.6 Sterilization process guidance J.7 Marketing guidance |
| 104 | J.8 Budget guidance J.9 Customer guidance J.10 Regulatory guidance |
| 105 | Annex K: Risk analysis tools — Guidance for industry and health care facilities K.1 Applications K.2 Risk analysis tools |
| 107 | Annex L: Considerations for sampling plans — Guidance for health care facilities |
| 109 | Annex M: Stability testing (ISO 11607-1:2006, 6.4) — Guidance for industry |
| 110 | Annex N: Use of the Internet — Guidance for industry and health care facilities |
| 111 | Annex O: Test method validation — Guidance for industry |
| 112 | Annex P: Use of contract packagers — Guidance for industry and health care facilities P.1 General P.2 Functions performed by contract packagers P.3 Responsibilities |
| 113 | Annex Q: Guidance on establishing process parameters — Guidance for industry Q.1 General Q.2 EXAMPLE Forming and lidding a tray Q.2.1 FMEA (Failure modes and effects analysis) Table Q.1 — FMEA Example |
| 114 | Q.2.2 Design of Experiment (DOE) |
| 115 | Q.2.3 Heat seal curve analysis (Process range assessment) Figure Q.1 — Heat seal curve for optimum process parameters Q.2.4 Visual scoring method for heat seals |
| 117 | Q.2.5 Combining heat seal curve analysis and visual scoring Figure Q.2 — Seal strength and visual seal quality vs. temperature Q.2.6 Determination of process capability |
| 118 | Table Q.2 — CpK value example |
| 119 | Annex R: Investigation failure — Guidance for industry and health care facilities R.1 Evaluating failure R.2 Determining the source of the defect |
| 120 | R.3 Chemical vs. mechanical causes R.4 Other tools |
| 121 | R.5 Problem solving approach |
| 122 | Annex S: Packaging manufacturing process and packaging system design feasibility evaluation — Guidance for industry S.1 Feasibility evaluation for initial and full-scale packaging manufacturing process S.1.1 Projected volume S.1.2 Equipment/staff availability S.1.3 Capital guidance S.1.4 Total packaging system cost S.2 Packaging system design feasibility evaluation |
| 123 | S.2.1 Packaging system design feasibility evaluation S.2.2 Packaging system design feasibility plan S.2.3 Worst-case feasibility condition |
| 124 | S.2.4 Pass/fail status of packaging system |
| 125 | Bibliography |
