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1. March 3-5, 2009 www.healthpack.net European Packaging Regulations What to expect from a notified body audit of your packaging Dr. Ralf Walther TÜV Süd Product…
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  • 1. March 3-5, 2009 www.healthpack.net European Packaging Regulations What to expect from a notified body audit of your packaging Dr. Ralf Walther TÜV Süd Product Service GmbH
  • 2. European Packaging Regulations - R. Walther Content 1. Short introduction of TÜV Süd Product Service 2. The European Medical Device Directive 3. Harmonized Standards and their role in the European medical device regulation 4. Typical observations during audits and design dossier review 5. Final remarks
  • 3. European Packaging Regulations - R. Walther 3 The Company TÜV Süd Technical service provider More than 13.000 employees More than 600 sites worldwide turnover 2007: 1.269 Mio. Euro Main offices: Munich, Danvers, Singapore successful in the market since more than 140 years
  • 4. TÜV Süd Product Service GmbH - is a subsidiary of TÜV Süd - is the Notified Body with the majority of class III certificates for Medical Devices - has branch offices in many European countries, North America and Asia
  • 5. European Packaging Regulations - R. Walther The European Medical Device Directive Correct title: Council Directive 93/42/EEC of 14 June 1993 concerning medical devices • Annex I defines the requirements for products and packages. • They are very general in the description of the requirements and address safety aspects to be met including – Design – Manufacturing – Transport – Storage – Prevention of infections – Labelling
  • 6. European Packaging Regulations - R. Walther The European Medical Device Directive Anx. I, 8.4. Devices delivered in a sterile state must have been manufactured and sterilized by an appropriate, validated method
  • 7. European Packaging Regulations - R. Walther Harmonized Standards • Article 5 of the MDD makes reference to the Harmonized Standards. • Presumption of conformity in case the standard is followed. • They are published in the Official Journal of the European Community.
  • 8. European Packaging Regulations - R. Walther Harmonized Standard • The European foreword of a harmonized standard gives or may give additional information on the use the standard • Annex ZA references the sections of the standard to the Essential Requirements of the MDD that will be fulfilled
  • 9. European Packaging Regulations - R. Walther Reference EN ISO 11607-2 and MDD 4.1 1, 2 4.2, 4.3, 4.4 3, 4, 5, 6 5.1 to 5.7 7.1, 7.5, 7.6, 8.1, 8.5 6.1 8.5 6.3 8.6 7 1, 2, 6, 8.5, 8.6 8.1, 8.2 7.1, 7.5, 7.6, 8.1
  • 10. European Packaging Regulations - R. Walther Harmonized Standards • The use of standards – including harmonized standards – is voluntary! • In case you decide not to refer to the standards you have to demonstrate that the same level of safety is achieved by your solution • In case you claim compliance with a harmonized standard you have to comply with all requirements (not only to those referenced in Annex ZA)
  • 11. European Packaging Regulations - R. Walther Notified Bodies and Packaging Assessment • There are several Notified Bodies and they may not necessarily use the same interpretations. Harmonization may be expected but is still not very likely • Within one Notified Body you may also expect differences in interpretation between auditors • Beside audits experts also review design dossiers including packaging
  • 12. European Packaging Regulations - R. Walther General comment Auditors expectations: • Risk analysis shall be available • Is not a requirement specific for packaging • Is based on a requirement of ISO 13485 sect. 7.1 (…shall establish documented requirements for risk management throughout product realization)
  • 13. European Packaging Regulations - R. Walther Parts 1 and 2: 4.2 Sampling • Requirement: Sampling plans based on statistically valid rational • Observation: No information provided • Comment: Typical applications for big lots, small lots or infrequent process (e.g. closure of preformed sterile barrier system e.g. pouches or rolls) usually require different approaches
  • 14. European Packaging Regulations - R. Walther Parts 1 and 2 4.3 Test Method Validation • Requirement: Methods shall be validated • Observation: No validation preformed or no data provided. Historical data used for demonstration of performance • Comment : Test methods described in standards or not described in standards may need a different extend in validation. In house testing is acceptable.
  • 15. European Packaging Regulations - R. Walther Parts 1 and 2 4.3 Test Method Validation Requirement: Rational for selection of method Observation: No data provided Comment : --
  • 16. European Packaging Regulations - R. Walther Parts 1 and 2 4.3 Test Method Validation • Requirement: Assessment of method for repeatability and reproducibility • Observation: In depth knowledge of test method not always obvious, e.g. interpretation of underlying data not clear, no information about software used. • Comment: --
  • 17. European Packaging Regulations - R. Walther Seal strength testing paper – paper pouch
  • 18. European Packaging Regulations - R. Walther Seal strength testing paper – paper pouch
  • 19. European Packaging Regulations - R. Walther Seal strength testing paper – film pouch
  • 20. European Packaging Regulations - R. Walther Seal strength testing paper – film pouches
  • 21. European Packaging Regulations - R. Walther Parts 1 and 2 4.3 Test Method Validation • Requirement: Sensitivity for integrity test • Observation: Not performed or no data provided • Comment: --
  • 22. European Packaging Regulations - R. Walther Parts 1and 2 4.3 Test Method Validation • Requirement: Conditioning of samples • Observation: No conditioning of samples, no rational for not performing conditioning • Comment: Not all tests / materials may require conditioning, provide short rational if not applicable
  • 23. European Packaging Regulations - R. Walther Part 1 5.1.4 General Requirements • Requirement: Consideration of tests, e.g. bioburden • Observation: No bioburden testing for packaging materials • Comment: Regular testing depends on product and/or sterilization method
  • 24. European Packaging Regulations - R. Walther Part 1 5.2 Microbial Barrier • Requirement: Porous material shall provide an adequate barrier to microorganisms • Observation: No data provided • Comment: No generally accepted test method; supplier of material shall certify microbial barrier property
  • 25. European Packaging Regulations - R. Walther Part 1 5.3 Compatibility with the sterilization process • Requirement: Material must be compatible with sterilization process (microbial barrier, biocompatibility) • Observation: No or insufficient data provided • Comment: Usually this information is provided by the supplier of the packaging materials
  • 26. European Packaging Regulations - R. Walther Part 1 6.3 Packaging system performance testing • Requirement: Use sterilized products/packages, preferable standardized methods • Observation: No or insufficient data provided • Comment: It is recommendable to use AAMI TIR 22 for guidance
  • 27. European Packaging Regulations - R. Walther Part 1 6.4 Stability testing • Requirement: Accelerated aging and real time shelf life shall begin simultaneously • Observation: Not followed • Comment: May be difficult to achieve. It is essential that samples for real time shelf life cover possible influences of the packaging and the sterilization process
  • 28. European Packaging Regulations - R. Walther Part 2 5.1.4 General • Requirement: Development is not a part of validation • Comment: Clear separation recommended to make sure that the criteria are met within planned scope of the protocol
  • 29. European Packaging Regulations - R. Walther Part 2 5.1 General • Requirement: Validation using data of existing products • Observation: Insufficient rational provide (esp. in design dossiers) • Comment: Usually only IQ and / or OQ data may be used
  • 30. European Packaging Regulations - R. Walther Part 2 5.2 Installation Qualification • Requirement: Definition of critical parameters • Observation: Risk management is not used for identification of critical parameters • Comment: Risk management not always properly integrated into validation and CAPA
  • 31. European Packaging Regulations - R. Walther Part 2 5.2 Installation Qualification • Requirements: Calibration of sensors and gauges before and after validation • Observation: No calibration before and after validation • Comment: Acceptance of single calibration of test equipment possible, rational required
  • 32. European Packaging Regulations - R. Walther Part 2 5.2 Installation Qualification • Requirement: Software validation • Observation: Incomplete or difficult to trace back • Comment: Includes as a minimum the controller of the packaging machine; software of test instrument(s) if applicable
  • 33. European Packaging Regulations - R. Walther Part 2 5.3 Operational Qualification • Requirement: All anticipated conditions for manufacturing • Observation: It is not precisely described and assessed if such investigations are performed; data are insufficient to demonstrate compliance • Comment: It is recommended to address this in protocol and report
  • 34. European Packaging Regulations - R. Walther Part 2 5.3 Operational Qualification • Requirement: Selection of worst case conditions = upper and lower limits for process parameters and their combination(s) • Observation: -- • Comment: Identification of worst case conditions should / could be referenced to process analysis in order to understand process inputs; description for selection of parameters helpful
  • 35. European Packaging Regulations - R. Walther Part 2 5.4 Performance Qualification • Requirement: Process repeatability and reproducibility • Observation: No criteria defined or no justification given for acceptance criteria • Comment: --
  • 36. European Packaging Regulations - R. Walther Part 2 5.4 Performance Qualification • Requirement: 3 production runs with adequate sampling; duration should account for process variables • Observation: No explanation given for selection of conditions used • Comment: What is defined to be “a run”? Which variations have to be considered (e.g. materials, brakes, clearance of process disturbance, personnel change?) See also 4.2 for statistics!
  • 37. European Packaging Regulations - R. Walther Part 2 5. 4 Performance Qualification • Requirement: The process shall be under control and capable • Observation: No statistical data provided that demonstrate a capable process
  • 38. European Packaging Regulations - R. Walther Part 2 5.7 Performance Qualification • Comment: Definition of process capability index or other process performance figure that demonstrates compliance. The index or figure shall be related to anticipated risks for the patient in case of non compliance.
  • 39. European Packaging Regulations - R. Walther Part 2 5.7 Changes and Revalidation • Comment: – Rational for extent of revalidation required. – Assessment of impact of change on validated process – Planning of validation measures incl. acceptance criteria, performance and final evaluation of change
  • 40. European Packaging Regulations - R. Walther Part 2 Use of preformed sterile barrier • Process: Use of preformed sterile barriers e.g. use of pouches that are only closed at the bottom seal (usually non peelable) or rolls • Comment: Confirmation by supplier that requirements of ISO 11607 part 1 and 2 are met (should include process validation)
  • 41. European Packaging Regulations - R. Walther Part 2 Purchasing Control • Process: Interface between manufacturer of the device and supplier of packaging material(s) • Comment: – Purchasing control required – Certificate for compliance with ISO 13485 strongly recommended
  • 42. European Packaging Regulations - R. Walther Packaging in Design Dossiers The following should be mandatory 1. Package material specifications 2. Specification of the packaging system (sterile barrier + protective packaging) 3. Process validation for manufacturing of the sterile barrier 4. Stability data, at least plan + initial data 5. Validation plan and report for final pack
  • 43. European Packaging Regulations - R. Walther Additional Guidance Document • Guidance document for validation of sealing process published by „Deutsche Gesellschaft für Sterilgutversorgung“, ZLG and TÜV Rheinland GmbH (version 1 dated July 2008). • Only available in German language. • Is supposed to support hospitals but also may be used by other organizations using this type of process. • The authors do not guarantee completeness of implementation of the ISO 11607-2.
  • 44. European Packaging Regulations - R. Walther Further reading For general information about the European approach and web links: • See AAMI TIR 22:2007 Annex A.3
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