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RADIATION STERILIZATION VALIDATION

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Fast moving electrons, more penetrating than alpha, stopped by ... Bacteriostasis and fungistasis test. Sterility test. Summary Report. 12. METHOD 1 (cont. ... – PowerPoint PPT presentation

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Title: RADIATION STERILIZATION VALIDATION


1
RADIATION STERILIZATION VALIDATION
  • Pacific BioLabs Inc.
  • (510) 964-9000
  • info_at_PacificBioLabs.com

2
TYPES OF RADIATION
  • Alpha
  • 2 protons and 2 neutrons, positively charged,
    stopped by a sheet of paper
  • Beta
  • Fast moving electrons, more penetrating than
    alpha, stopped by book or human tissue
  • Gamma
  • Very penetrating electromagnetic radiation, pass
    through human body, stopped by concrete wall
  • X-Ray
  • Form of electromagnetic radiation produced by
    artificial means

3
STERILIZATION PROCESS VALIDATION
  • Product qualification
  • Installation qualification
  • Process qualification
  • Administrative procedure to review and approve
    documentation
  • Maintenance of validation

4
PRODUCT QUALIFICATION
  • Effect of radiation on product materials and
    packaging
  • Quality, safety and performance of the product
    throughout its shelf life
  • Testing may include
  • Strength
  • Clarity and color
  • Biocompatibility
  • Package integrity

5
RADIATION EFFECTS ON MATERIALS
  • Brittle
  • Color
  • Odor
  • Stiffness
  • Softens
  • Toxicity
  • Chemical inertness
  • Melt temperature

6
INSTALLATION QUALIFICATION
  • Equipment documentation
  • Equipment testing
  • Equipment calibration
  • Irradiator dose mapping

7
PROCESS QUALIFICATION
  • Determination of product loading pattern
  • Product dose mapping

8
ROUTINE PROCESS CONTROL
  • Process specification
  • Product handling
  • Routine preventive maintenance
  • Product irradiation
  • Process documentation
  • Sterilization acceptance

9
RADIATION VALIDATION APPROACHES
  • Sterilization dose is selected using the
    bioburden information
  • AAMI Method 1 and 2
  • Appropriateness of 15-30 kGy can be substantiated
  • VDmax Method

10
DOSE DETERMINATION METHODS
  • ANSI/AAMI/ISO 11137-2 -2006
  • Method 1 - dose is determined based on product
    bioburden
  • Method 2 - dosed is determined by incremental
    dose experiments
  • VDmax Method substantiation of 15 and 25 kGy
    dose
  • AAMI TIR332005
  • VDmax Method substantiation of 15 - 35 kGy dose

11
ANSI/AAMI/ISO 11137-22006 METHOD 1
  • Protocol
  • Bioburden Validation
  • Bioburden
  • Verification Dose Calculation
  • Verification Dose Experiment
  • Irradiation
  • Bacteriostasis and fungistasis test
  • Sterility test
  • Summary Report

12
METHOD 1 (cont.)
  • Bioburden Validation
  • 3 to 5 units
  • Exhaustive recovery or inoculated product
  • Calculate correction factor for recovery
    efficiency
  • Bioburden Test
  • 10 units from 3 different batches that have gone
    through every step of production except
    sterilization

13
METHOD 1 (cont.)
  • Verification Dose Calculation
  • Determine the individual batch and overall
    average bioburden
  • If any single batch average is more than twice
    the overall average that particular batch average
    is used
  • Use extraction efficiency factor to calculate the
    theoretical bioburden
  • Set the verification dose (kGy) using an SAL of
    10-2 on Table 5

14
METHOD 1 (cont.)
  • Verification Dose Experiment
  • Product irradiation of 100 units at the
    verification dose 10
  • Sterility test of 100 units using SCDM incubating
    at 28-32ºC for 14 days
  • Interpretation
  • lt2 non-sterile validation passed and can
    release product at 10-6 kGy
  • gt3 non-sterile validation failed

15
METHOD 1 AUDIT
  • Must be conducted every quarter for continued
    release of product
  • Bioburden 10 non-sterile products
  • Review of environmental controls
  • Sterility test of 100 units sterilized at 10-2
  • Interpretation
  • lt2 non-sterile passed
  • 3 or 4 non-sterile dose should be augmented
  • 5 or 6 non-sterile w/ bioburden increase -
    augment
  • 5 or 6 non-sterile w/out bioburden increase
    -revalidate
  • 7 or more non-sterile - revalidate

16
AAMI TIR332005 VDMAX METHOD
  • Sterilization of health care products Radiation
    sterilization Substantiation of 15-35 kGy as a
    sterilization dose Method VDmax
  • Bioburden must be lt1,000 CFU/device

17
AAMI/ISO TIR No. 158441998
  • Sterilization of health care products
    Radiation sterilization- Selection of a
    sterilization dose for a single production batch
  • Very similar to Method 1
  • Bioburden of 10 devices instead of 30

18
VDMAX METHOD (cont.)
  • Protocol
  • Bioburden Validation
  • Bioburden
  • Verification Dose (VDmax) Calculation
  • Verification Dose Experiment
  • Irradiation
  • Bacteriostasis and fungistasis test
  • Sterility test
  • Summary Report

19
VDMAX METHOD (cont.)
  • Verification Dose Experiment
  • Product irradiation of 10 units at the
    verification dose 10
  • Sterility test of 10 units using SCDM incubating
    at 28-32ºC for 14 days
  • Interpretation
  • lt1 non-sterile validation passed and can
    release product at selected kGy
  • gt2 non-sterile confirmatory test
  • gt3 non-sterile validation failed

20
VDMAX METHOD (cont.)
  • Confirmatory Verification Dose Experiment
  • 10 devices irradiated at confirmatory dose
  • Confirmatory dose verification dose
  • All sterile selected dose (kGy) substantiated
  • gt1 non-sterile validation failed

21
VDMAX METHOD AUDIT
  • Must be conducted every quarter for continued
    release of product
  • Bioburden 10 non-sterile products
  • Review of environmental controls
  • Sterility test of 10 units sterilized at
    verification dose
  • Interpretation
  • lt1 non-sterile passed
  • 2 non-sterile confirmatory test
  • gt3, lt6 non-sterile augment dose and revalidate
  • 7 or more non-sterile - revalidate

22
SINGLE PRODUCTION BATCH VDMAX
  • Selected dose (kGy) can be validated as a
    sterilization dose for a single batch
  • Method is limited to a single production batch
    and no provisions are given for audits or
    augmentation
  • Testing difference bioburden of 10 devices
    instead of 30

23
SAMPLE ITEM PORTION (SIP)
  • Defined portion of health care product that is
    tested
  • Should be as large a portion of product that is
    convenient to handle during testing
  • Adequacy must be demonstrated
  • Bioburden present in gt85 of samples, or
  • Sterility testing of 20 units must result in 17
    positives
  • Verification Dose SIP1 kGy (log SIP x
    reduction factor)

24
PRODUCT FAMILIES ANDFREQUENCY OF AUDITS
  • ANSI/AAMI/ISO TIR 158432000
  • Sterilization of health care products- Radiation
    sterilization - Product families, sampling plans
    for verification dose experiments and
    sterilization dose audits, and frequency of
    sterilization dose audits

25
PRODUCT FAMILIES
  • Documented criteria for establishing a product
    family
  • Raw materials
  • Components
  • Product design
  • Manufacturing process, equipment, environment,
    location

26
A FAMILY OF PRODUCTS SHALL BE REPRESENTED BY
  • The master product
  • An equivalent product
  • A simulated product
  • Selection must be based on
  • and type of organism
  • Size of product and number of components
  • Complexity of product
  • Degree of manufacturing automation
  • Manufacturing environment

27
SAMPLE SIZES
  • TIR 15843 offers provision for reducing the
    sample size for verification dose experiments and
    dose audits
  • Example Method 1
  • 52 units instead of 100 ? 0() OK
  • 70 units instead of 100 ? 1() OK

28
FREQUENCY OF AUDITSCONDITIONS FOR REDUCTION
  • From a 3-month to 6-month
  • 4 successful consecutive quarterly audits
  • Bioburden characterization
  • Controlled manufacturing environment
  • From a 6-month to 12-month
  • 2 successful consecutive biannual audits
  • Bioburden characterization
  • Controlled manufacturing environment

29
REFERENCES
  • ANSI/AAMI/ISO TIR 158432000, Sterilization of
    health care products-Radiation sterilization-Produ
    ct families and sampling plans for verification
    dose experiments and sterilization dose audits,
    and frequency of sterilization dose audits
  • AAMI TIR 302005, Sterilization of health care
    products-Radiation - Substantiation of a selected
    sterilization dose-Method VDmax
  • ANSI/AAMI/ISO 11737-1- 2006, Sterilization of
    health care products-Microbiological
    methods-Part1 Determination of the population of
    microorganisms on products
  • AAMI/ISO 11737-2 -1998, Sterilization of medical
    devices-Microbiological methods-Part 2 Tests of
    sterility performed in the validation of a
    sterilization process

30
REFERENCES (cont.)
  • AAMI/ISO TIR No. 158441998, Sterilization of
    health care products-Radiation sterilization-Selec
    tion of a sterilization dose for a single
    production batch
  • AAMI TIR No. 17 1997, Radiation
    Sterilization-Material Qualification
  • ANSI/AAMI/ISO 11137-12006, Sterilization of
    health care products-Radiation-Part 1
    Requirements for development, validation, and
    routine control of a sterilization process for
    medical devices
  • ANSI/AAMI/ISO 11137-22006, Sterilization of
    health care products-Radiation-Part 2
    Establishing the sterilization dosE

31
THANK YOU
  • Q A
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