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My presentation for MEDTEC China 2010
Citation preview
Sterilization requirements: Strategies
for Compliance
presented by John Beasley
Owner & Sr. Consultant MedTech Review
Topics
• General Requirements • Radiation Sterilization
– Impact to Subcontractors – Impact to Manufacturers
• EO Sterilization – Impact to Subcontractors – Impact to Manufacturers
• Summary
Introduction
• Presentation covers – Gap Analysis between
current version and previous version of standards
– Compliance information
– References
• Presentation does not cover – All differences – only
the most significant – The steps for
sterilization or validation of sterilization processes
Copyright laws prevent MedTech Review and MEDTEC China Conferences from providing copies of standards to
conference par;cipants.
Sterilization Processing by IR or EO
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)
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)
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)
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
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.
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
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.
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?
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.
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
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.
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
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
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.
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 – Auditing for safety
These items can be reviewed and covered during preven8ve
maintenance ac8vi8es and supplier audits.
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?
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.”
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.
Impact to Sterilization Contractor
• Each of the previous items must be audited in addition to – Personnel training – Dosimetery – Radiation cell refueling
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
Regarding China
• GB18280-2007 - Sterilization of health care products requirements for validation and routine control of radiation sterilization – idt ISO 11137:2006
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
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
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.
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
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
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
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
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.
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
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
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
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
Regarding China
• GB 18279-2000 ethylene oxide sterilization of medical equipment validation and routine control – idt ISO 11135:1994
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.
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.
Thank You
John Beasley Owner & Sr. Consultant MedTech Review, LLC
www.medtechreview.com Email: [email protected]
SKYPE: medtechreview