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AAMI/ISO TIR16775:2014 - Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2, 2014
- ANSI/AAMI/ISO TIR16775:2014, Packaging for terminally sterilized medical devices — Guidance on the application of ISO 11607-1 and ISO 11607-2
- Title page
- Copyright information
- AAMI Technical Information Report
- ANSI Technical Report
- Contents
- Glossary of equivalent standards
- Committee representation
- Background of AAMI adoption of ISO/TS 16775:2014
- Foreword
- Introduction
- 1 Scope
- 2 Terms and definitions
- 3 Guidance for health care facilities [Go to Page]
- 3.1 Test methods
- 3.2 Guidance for conformance to ISO 11607-1 [Go to Page]
- 3.2.1 General guidance for materials, preformed sterile barrier systems and sterile barrier systems
- 3.2.2 Design and development guidance for packaging systems (ISO 11607-1:2006, 6.1 and 6.2) [Go to Page]
- 3.2.2.1 Selection criteria
- 3.2.2.2 Selection considerations
- 3.2.2.3 Assembly considerations
- 3.2.2.4 Labelling considerations
- 3.2.2.5 Regulatory considerations
- 3.2.2.6 Common choices for sterile barrier systems [Go to Page]
- 3.2.2.6.1 General
- 3.2.2.6.2 Sealable pouches and reels (preformed sterile barrier systems)
- 3.2.2.6.3 Sterilization wrap
- 3.2.2.6.4 Reusable containers
- 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)
- 3.2.4 Sterile barrier system stability evaluation (shelf life) (ISO 11607-1:2006, 6.4)
- 3.2.5 Documentation
- 3.3 Guidance on conformance to ISO 11607-2, Validation requirements for forming, sealing and assembly processes [Go to Page]
- 3.3.1 General
- 3.3.2 Method of validation [Go to Page]
- 3.3.2.1 General
- 3.3.2.2 Drafting of validation plan
- 3.3.2.3 Implementation of validation
- 3.3.2.4 Validation approval
- 3.3.2.5 Process control and routine monitoring
- 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 [Go to Page]
- 3.3.2.7.1 Installation Qualification
- 3.3.2.7.2 Operational Qualification
- 3.3.2.7.3 Performance Qualification
- 3.3.2.7.4 Self-sealing or taped pouches
- 3.3.2.8 Validation of the wrapping process (folding and closing of sterilization wraps) [Go to Page]
- 3.3.2.8.1 Installation Qualification
- 3.3.2.8.2 Operational Qualification
- 3.3.2.8.3 Performance Qualification
- 3.3.2.9 Validation of the container process (filling and closing of re-usable containers) [Go to Page]
- 3.3.2.9.1 Installation Qualification
- 3.3.2.9.2 Operational Qualification
- 3.3.2.9.3 Performance Qualification
- 3.4 Quality system
- 4 Guidance for industry [Go to Page]
- 4.1 General guidance [Go to Page]
- 4.1.1 Quality systems
- 4.1.2 Test methods
- 4.1.3 Sampling
- 4.2 Design inputs
- 4.3 Selection and evaluation of materials [Go to Page]
- 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)
- 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) [Go to Page]
- 4.4.1 Key elements in the design
- 4.4.2 Steps in packaging system design [Go to Page]
- 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
- 4.5 Packaging process feasibility evaluation [Go to Page]
- 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 [Go to Page]
- 4.6.1 General considerations
- 4.6.2 Sterile barrier system test method
- 4.6.3 Worst-case feasibility condition
- 4.6.4 Pass/fail status of packaging system
- 4.7 Validation of sterile barrier system manufacturing process [Go to Page]
- 4.7.1 Development of written process validation protocol
- 4.7.2 Performance of validation activities detailed in protocol [Go to Page]
- 4.7.2.1 Installation Qualification (if not satisfied from previous IQ work) (ISO 11607-2:2006, 5.2)
- 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 [Go to Page]
- 4.8.1 General
- 4.8.2 Validation protocol
- 4.8.3 Performing testing
- 4.8.4 Documenting validation results
- 4.9 Revalidation
- Annex A: Selection, evaluation and testing of packaging materials and sterile barrier systems — Guidance for industry and health care facilities [Go to Page]
- A.1 General
- A.2 Compatibility with the sterilization process
- A.3 Safety considerations
- A.4 Barrier guidance
- A.5 Visibility and appearance of the medical device
- A.6 Material physical property
- A.7 Sterile barrier system integrity
- A.8 Seal strength and burst strength
- A.9 Material processing guidance
- A.10 Printing guidance
- A.11 Cleanliness and particulates
- A.12 Accelerated aging and environmental challenging
- Annex B: Sterilization considerations — Guidance for industry and health care facilities [Go to Page]
- B.1 Overview
- B.2 Ethylene oxide
- B.3 Gamma irradiation
- B.4 Electron beam sterilization (E-Beam)
- B.5 X-ray sterilization
- B.6 Moist heat (steam) sterilization
- B.7 Sterilization using moist heat and non-porous packaging
- B.8 Dry heat
- B.9 Peroxide sterilization
- B.10 Ozone
- B.11 Chlorine dioxide (ClO2 or CD)
- Annex C: Examples of wrapping methods — Guidance for health care facilities [Go to Page]
- C.1 General
- C.2 Envelope method [Go to Page]
- Figure C.1 — Envelope method steps 1 to 3
- Figure C.2 — Envelope method steps 4 to 6
- Figure C.3 — Envelope method simultaneous double wrapping
- Figure C.4 — Envelope method sequential double wrapping
- C.3 Parallel packaging/square fold method wrapping [Go to Page]
- Figure C.5 — Packaging/square fold method steps 1 to 3
- Figure C.6 — Parallel wrapping steps 4 to 7
- Figure C.7 — Parallel wrapping steps 8 and 9
- Figure C.8 — Square fold method simultaneous double wrapping
- Figure C.9 — Square fold method sequential double wrapping
- C.4 Pasteur or roll method [Go to Page]
- Figure C.10 — Pasteur or roll method
- Annex D: Validation plan documents — Guidance for health care facilities [Go to Page]
- D.1 General [Go to Page]
- Table D.1 — Number of process validations
- D.2 Validation plan checklist: Heat Sealing Process Preformed Sterile Barrier Systems (PSBS: Pouches, Reels, etc.)
- D.3 Validation plan checklist: wrapping process
- D.4 Validation plan checklist: container process
- D.5 Handling and distribution checklist: handling, distribution and storage
- Annex E: Installation qualification documentation — Guidance for health care facilities [Go to Page]
- E.1 Checklist installation qualification (IQ): heat sealing process
- E.2 Checklist Installation Qualification (IQ): Wrapping Process
- E.3 Checklist installation qualification (IQ): container process
- Annex F: Operational qualification documentation — Guidance for health care facilities [Go to Page]
- F.1 Checklist operational qualification (OQ): heat sealing process
- F.2 Checklist operational qualification (OQ): wrapping process
- F.3 Checklist operational qualification (OQ): container process
- Annex G: Performance qualification documentation — Guidance for health care facilities [Go to Page]
- G.1 Checklist performance qualification (PQ), sealing process
- G.2 Checklist performance qualification (PQ), wrapping process
- G.3 Checklist performance qualification (PQ), container process
- Annex H: Addressing worst-case requirements — Guidance for industry and health care facilities [Go to Page]
- H.1 Overview
- H.2 Worst-case configuration — Medical devices
- H.3 Worst-case — Sterile barrier system
- H.4 Worst-case configuration — Sterile barrier system manufacturing process
- Annex I: Generating a final packaging system validation protocol — Guidance for industry [Go to Page]
- I.1 Plan objectives and background on protocol development
- I.2 Understanding the packaging system design configuration
- I.3 Grouping packaging systems for validation
- 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
- I.8 Defining shelf life
- Annex J: Design inputs — Medical device attributes — Guidance for industry [Go to Page]
- J.1 Introduction
- J.2 Product attributes
- J.3 Medical device protection guidance
- J.4 Storage, distribution, and handling guidance
- J.5 Manufacturing guidance
- J.6 Sterilization process guidance
- J.7 Marketing guidance
- J.8 Budget guidance
- J.9 Customer guidance
- J.10 Regulatory guidance
- Annex K: Risk analysis tools — Guidance for industry and health care facilities [Go to Page]
- K.1 Applications
- K.2 Risk analysis tools
- Annex L: Considerations for sampling plans — Guidance for health care facilities
- Annex M: Stability testing (ISO 11607-1:2006, 6.4) — Guidance for industry
- Annex N: Use of the Internet — Guidance for industry and health care facilities
- Annex O: Test method validation — Guidance for industry
- Annex P: Use of contract packagers — Guidance for industry and health care facilities [Go to Page]
- P.1 General
- P.2 Functions performed by contract packagers
- P.3 Responsibilities
- Annex Q: Guidance on establishing process parameters — Guidance for industry [Go to Page]
- Q.1 General
- Q.2 EXAMPLE Forming and lidding a tray [Go to Page]
- Q.2.1 FMEA (Failure modes and effects analysis) [Go to Page]
- Table Q.1 — FMEA Example
- Q.2.2 Design of Experiment (DOE)
- Q.2.3 Heat seal curve analysis (Process range assessment) [Go to Page]
- Figure Q.1 — Heat seal curve for optimum process parameters
- Q.2.4 Visual scoring method for heat seals
- Q.2.5 Combining heat seal curve analysis and visual scoring [Go to Page]
- Figure Q.2 — Seal strength and visual seal quality vs. temperature
- Q.2.6 Determination of process capability [Go to Page]
- Table Q.2 — CpK value example
- Annex R: Investigation failure — Guidance for industry and health care facilities [Go to Page]
- R.1 Evaluating failure
- R.2 Determining the source of the defect
- R.3 Chemical vs. mechanical causes
- R.4 Other tools
- R.5 Problem solving approach
- Annex S: Packaging manufacturing process and packaging system design feasibility evaluation — Guidance for industry [Go to Page]
- S.1 Feasibility evaluation for initial and full-scale packaging manufacturing process [Go to Page]
- 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 [Go to Page]
- S.2.1 Packaging system design feasibility evaluation
- S.2.2 Packaging system design feasibility plan
- S.2.3 Worst-case feasibility condition
- S.2.4 Pass/fail status of packaging system
- Bibliography [Go to Page]