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Sterilization Standards Update: Strategies for Compliance

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My presentation for MEDTEC China 2010

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Sterilization Standards Update: Strategies for Compliance

  1. 1. Sterilization requirements: Strategies for Compliance presented by John Beasley Owner & Sr. Consultant MedTech Review
  2. 2. Topics •  General Requirements •  Radiation Sterilization –  Impact to Subcontractors –  Impact to Manufacturers •  EO Sterilization –  Impact to Subcontractors –  Impact to Manufacturers •  Summary
  3. 3. Introduction •  Presentation covers •  Presentation does not –  Gap Analysis between cover current version and –  All differences – only previous version of the most significant standards –  The steps for –  Compliance sterilization or information validation of –  References sterilization processes Copyright  laws  prevent  MedTech  Review  and  MEDTEC  China   Conferences  from  providing  copies  of  standards  to   conference  par;cipants.  
  4. 4. Sterilization Processing by IR or EO
  5. 5. General Requirements •  Aligned somewhat with the requirements of ISO 13485:2003 –  Document and Record Retention •  Procedures for development, validation, routine control and release (ISO 13485:2003, Clause 4) –  Management Responsibility •  Authority, responsibility, including contractors (ISO 13485:2003, Clause 5)
  6. 6. General Requirements –  Product Realization •  Procedures for purchasing, identification and traceability, and calibration are required (ISO 13485:2003, Clause 7) –  Measurement and Improvement •  Controls for non-conforming material and corrective actions (ISO 13485:2003, Clause 8)
  7. 7. Sterilization by Radiation •  ISO 11137:2006 –  Part 1 •  Requirements for development, validation, and routine control of a sterilization process for medical devices (approved 15 April 2006) –  Part 2 •  Establishing the sterilization dose (approved 15 April 2006) –  Part 3 •  Guidance on dosimetric aspects (approved 15 April 2006)
  8. 8. Sterilization by Radiation •  ISO 11137:2006 is now mandatory and fully implemented in the EU (as of April 2009) –  The following standards are now OBSOLETE •  EN 552 •  ISO 11137:1995 •  AAMI TIR 27:2001 •  ISO/TIR 13409:1996 •  TIR 15844:1998
  9. 9. Certification •  Contract sterilization companies who carry out irradiation processing can include EN ISO 11137-1:2006 within the scope of their ISO 13485 registration. •  EN ISO 11137 Parts 2 and 3 cannot be included.
  10. 10. ISO 11137:2006 – Main Changes •  Clause 3 – Definitions –  Processing category •  Group of different products that can be sterilized together, based on –  Composition –  Density –  Dose requirements
  11. 11. ISO 11137:2006 – Main Changes –  Product family •  Group of different products that can be given the same sterilization dose based on the nature of the –  Raw materials –  Components –  Manufacturing processes –  Equipment –  Environment –  Location It  would  be  helpful  for  the  manufacturer  to  develop  a  process  map  or   decision  tree  to  consistently  address  the  requirements  and  document  the   ra8onale  for  groupings.  
  12. 12. ISO 11137:2006 – Main Changes •  Clause 5 – Sterilizing Agent Characterization –  New requirements for environmental considerations Are  there  environmental  impacts  such  as  discharges  into  the  air  or  water   that  may  adversely  impact  the  environment?    How  are  these  controlled?  
  13. 13. ISO 11137:2006 – Main Changes •  Clause 6 – Process and Equipment Characterization –  Requirements have been expanded – irradiator and its method of operation shall be specified. Can  be  addressed  under  vendor  contract  /  purchasing  control  /  internal  control   procedures  such  as  process  control,  equipment  valida8on  and  equipment  change   control.  
  14. 14. ISO 11137:2006 – Main Changes •  Clause 7 – Product Definition –  New requirements emphasize control of product AND packaging AND control of bioburden –  New requirements – defining product families in establishing dose and dose audit based on •  Bioburden •  Representative product •  Master product •  Equivalent product •  Simulated product Product  families  must  be  established  with  documented  criteria,  maintained  (i.e.,   reviewed)  and  risks  in  using  product  families  must  be  addressed    
  15. 15. ISO 11137:2006 – Main Changes •  Clause 8 – Process Definitions –  Incorporates Method 1, Method 2 and Vdmax Method (15 and 25) –  New Means for dose transference SOPs  need  to  include  requirements  for  establishment  of  max  dose  and  steriliza8on   dose;  manufacturers  need  to  document  the  appropriate  method  used  and  process   for  valida8on.  
  16. 16. ISO 11137:2006 – Main Changes •  Clause 9 – Validation –  IQ / OQ / PQ requirements have been expanded –  Dose mapping (both container and product) –  Process specifications established directly from validation; requirements detailed –  Defined sample sizes required
  17. 17. ISO 11137:2006 – Main Changes •  Clause 12 – Maintaining process effectiveness –  Standard defines a more flexible approach for maintaining effectiveness of process •  Bioburden specifications (number and type) –  1 month, 3 month, each batch •  Dose audits – frequency; rationale •  Failure Investigation and actions
  18. 18. Impact to Sterilization Contractor •  Requirements for environmental considerations “The  poten8al  effect  on  the  environment  of  the  opera8on  of  the  radia8on  steriliza8on   process  shall  be  assessed  and  measures  to  protect  the  environment  shall  be  iden8fied.     This  assessment,  including  poten8al  impact  (if  any)  shall  be  documented  and   measures  for  control  (if  iden8fied),  shall  be  specified  and  implemented.  
  19. 19. Impact to Sterilization Contractor •  Think about all of the possible environmental impacts that might occur in the event of a failure of the radiation control system. –  Maintenance of the source material and its storage (pool water levels, alarms, testing) –  Control of access to the cell –  Care and maintenance of the source racks/ carriers –  Control room alarms These  items  can  be  reviewed  and   covered  during  preven8ve   –  Auditing for safety maintenance  ac8vi8es  and  supplier   audits.  
  20. 20. Impact to Sterilization Contractor •  Process interruptions –  What happens when there is an interruption in the exposure? –  What is the impact of stopping and restarting the cycle and the timing? How are under-dosing and overdosing prevented? –  What is the additional exposure to the product resulting from the travel time of the source material rising up and lowering down, possibly multiple times? –  Is there a risk of product or package degradation caused by the changes in temperature while in the cell due to the interruptions?
  21. 21. Impact to Sterilization Contractor •  Partial containers – dose mapping “If  par8ally-­‐filled  irradia8on  containers  are  to  be  used,  the  effect  of  par8al  filling  on   dose  distribu8on  within  irradia8on  containers  or  in  other  irradia8on  containers   present,  shall  be  determined  and  recorded.    When  a  carrier  is  not  completely  full,   the  density  of  the  load  becomes  inconsistent,  and  therefore  the  delivered  dose  can   vary.  By  properly  mapping  par8al  carrier  loads,  equivalent  dose  distribu8on  can  be   assured.”  
  22. 22. Impact to Sterilization Contractor •  Procedures for review and product release •  11.1 – Any specific periodic tests, calibrations, maintenance tasks and necessary re-qualifications need to be documented. •  11.2 – Procedures for review of records and product release from sterilization need to be written. When  a  steriliza8on  process  is  found  to  not  meet  specifica8ons,  taking  into   account  the  uncertainty  of  the  measurement  system(s),  then  the  product  shall  be   handled  as  nonconforming.  
  23. 23. Impact to Sterilization Contractor •  Each of the previous items must be audited in addition to –  Personnel training –  Dosimetery –  Radiation cell refueling
  24. 24. Impact to Manufacturer •  VDMax 25 –  Bioburden testing unchanged (<1000 CFU per device); verification does set to 10-1; sterility testing on 10 units •  VDMax 15 –  Bioburden control limits extremely low (<1.5 CFU per device) •  ISO 15843 – Dose audit frequency –  Quarterly -> Semi-annually -> Annually
  25. 25. Regarding China •  GB18280-2007 - Sterilization of health care products requirements for validation and routine control of radiation sterilization –  idt ISO 11137:2006
  26. 26. Sterilization by EO •  ISO 11135-1:2007 –  Requirements for development, validation, and routine control of a sterilization process for medical devices (approved 01 May 2007) •  ISO 11135-2:2008 –  Guidance on the application of ISO 11135-1:2007
  27. 27. Sterilization by EO •  ISO 11135 is now mandatory and fully implemented in the EU (as of May 2010) –  The following standards are now OBSOLETE •  EN 550:1994 •  ISO 11135:1994
  28. 28. Certification •  Contract sterilization companies who carry out EO processing can include EN ISO 11135-1:2007 within the scope of their ISO 13485 registration. •  EN ISO 11135-2:2008 cannot be included.
  29. 29. Sterilization by EO •  Cycle Development –  Several methods for cycle development offered in Annex –  Use of developmental chambers as well as production chambers for process development expanded –  Chamber and process equivalency –  Clarification of microbiological and physical PQ provided
  30. 30. Sterilization by EO •  Main Changes –  Clause 5 – Sterilizing Agent Characterization •  New requirements for microbicidal effectiveness if EO outside range of widely recognized compositions or if novel diluents are to be used •  Effects of EO on the product to be documented •  Environmental considerations
  31. 31. Sterilization by EO –  Clause 6 – Process and Equipment Characterization •  Generally relates to the requirements of the contractor; responsibility lies with the manufacturer to ensure contractor sterilizer complies with these specific requirements •  Process Characterization is a result of the OQ •  Equipment Characterization is a result of the IQ
  32. 32. Sterilization by EO –  Clause 7 – Product Definition •  Product and packaging must meet the specified requirements for safety, quality, and performance following the sterilization process at the most challenging process parameters –  Useful Standards •  ISO 10993 (relevant parts) for biological safety and EO residuals following exposure •  AAMI TIR 28:2001; Product Adoption and Process Equivalency for EO Sterilization
  33. 33. Sterilization by EO •  ISO 11737-1:2006 specifies requirements and provides guidance for the enumeration and microbial characterization of the population of viable micro- organisms on or in a medical device, component, raw material or package. •  ISO 17664:2004 specifies the information to be provided by the medical device manufacturer on the processing of medical devices claimed to be resterilizable, and medical devices intended to be sterilized by the processor. •  ISO 11607-1:2006 specifies the requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems and packaging systems that are intended to maintain sterility of terminally sterilized medical devices until the point of use.
  34. 34. Sterilization by EO –  Clause 8 – Process Definition •  Process parameters clearly defined •  Appropriateness of BI and process challenge device to be defined and documented to demonstrate and support SAL
  35. 35. Sterilization by EO –  Clause 9 – Validation •  The number of sensors in PQ (temperature, humidity, BIs) in the load is based on product load volume as opposed to usable chamber volume. •  The number of sensors in IQ/OQ is based on chamber volume. –  Clause 10 – Routine Monitoring and Control •  New requirements for additional levels of reviews when parametric release is to be used
  36. 36. Sterilization by EO –  Clause 11 – Product Release •  Conventional release and parametric release are more harmonized –  Clause 12 – Maintaining Process Effectiveness •  Justification for requalification requirements / intervals of requalification
  37. 37. Sterilization by EO –  Requalification Review to include •  Verify appropriateness of BIs •  Verify loading patterns remain unchanged •  Verify no changes to design, materials, load configuration or manufacturing process •  Verify no change in bioburden or characterization has occurred •  Verify temperature distribution and chamber operation remain unchanged •  Review of sterilization process history demonstrates repeatability •  Review of preventive maintenance programs demonstrate no change to sterilizing equipment Recommended  reduce  microbial  performance  qualifica;on  studies  are  performed   at  least  every  two  years  to  verify  the  documented  paperwork  review  has  captured   any  changes  in  the  product  or  steriliza;on  review  
  38. 38. Regarding China •  GB 18279-2000 ethylene oxide sterilization of medical equipment validation and routine control –  idt ISO 11135:1994
  39. 39. Summary •  While techniques of sterilizing medical devices have not changed much over the past 25 years, the levels at which sterilization processes are monitored and controlled have changed significantly.
  40. 40. Summary •  Sterilization Validation is DYNAMIC –  ISO 14937:2009 specifies the elements of a Quality Management System which are necessary to assure the appropriate characterization of the sterilizing agent, development, validation and routine monitoring and control of a sterilization process. •  It provides a standardized procedure for validating new sterilization technologies.
  41. 41. Thank You John Beasley Owner & Sr. Consultant MedTech Review, LLC www.medtechreview.com Email: john@medtechreview.com SKYPE: medtechreview

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