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MEDICAL DEVICE STERILIZATION

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MEDICAL DEVICE STERILIZATION Pacific BioLabs Inc. (510) 964-9000 info_at_PacificBioLabs.com OUTLINE MORNING SESSION 8:30 Introduction 8:45 General Principles of ... – PowerPoint PPT presentation

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Title: MEDICAL DEVICE STERILIZATION


1
MEDICAL DEVICE STERILIZATION
  • Pacific BioLabs Inc.
  • (510) 964-9000
  • info_at_PacificBioLabs.com

2
OUTLINE MORNING SESSION
  • 830 Introduction
  • 845 General Principles of Sterilization
    Validation
  • 915 Contract Sterilizers and Testing
    Laboratories
  • 1015 Break
  • 1030 Radiation Sterilization Validation
  • 1145 Validating Heat Sterilization
  • 1230 Lunch

3
OUTLINE AFTERNOON SESSION
  • 130 Ethylene Oxide Sterilization Validation
  • 300 Break
  • 315 Monitoring Controlled Environments
  • 415 Class Exercise, Discussion, QA

4
GENERAL PRINCIPLES OF STERILIZATION AND VALIDATION
  • Pacific BioLabs Inc.
  • (510) 964-9000
  • info_at_PacificBioLabs.com

5
STERILIZATION METHODS
  • Moist Heat
  • Radiation (Gamma and E-beam)
  • Ethylene Oxide (EO)
  • Hydrogen Peroxide
  • Gas Plasma

6
STERILIZATION METHODS
Radiation Ethylene Oxide Moist Heat
Rapid No residues Good for convoluted shapes Compatibility with many materials Good for heat sensitive products Rapid No residues Economical
7
PRODUCT DESIGN CONSIDERATIONS
  • Driven by performance requirement
  • Is the material tolerant to radiation, heat,
    moisture, EO?
  • Device shape
  • Re-Sterilization

8
STERILIZATION MARKET
  • Ethylene Oxide (EO) 49
  • Gamma Radiation 44
  • E-beam Radiation 7

9
HOW DOES IT WORK?
  • Purpose
  • To kill bugs while keeping the devices functional
  • Chemical Alkylates proteins and DNA
  • Radiation DNA degraded by ionization
  • Heat Oxidizes and denatures enzymes

10
HOW A MICROBIOLOGISTVIEWS BACTERIA
11
HOW MANUFACTURING ANDQA VIEW BACTERIA
12
EO PROS CONS
  • Pros
  • Most materials compatible
  • Relatively low temperature process
  • Most packaging materials OK
  • Relatively low cost
  • Cons
  • Penetration sometimes difficult
  • Residuals
  • Batch process
  • Long process and release time

13
GAMMA PROS CONS
  • Pros
  • Well characterized parametric (fast) release
  • Penetrates well
  • Most materials OK
  • Cons
  • More expensive than EO
  • Not in-house process
  • PTFE and acetal difficult
  • Yellowing and embrittlement of some polymers

14
E-BEAM PROS CONS
  • Pros
  • Same as gamma except kinder to materials
  • Most easily scalable
  • Turnaround time BEST
  • Cons
  • Lower penetration and density limited
  • Not in house process for small companies
  • Some materials remain unsuitable

15
STEAM PROS CONS
  • Pros
  • More tolerant material available
  • More packaging choices
  • Relatively inexpensive
  • Often used in-house
  • Cons
  • Batch process
  • Few polymer-based devices work
  • Packaging aesthetics not great
  • Some maintenance costs

16
PACKAGING CONSIDERATIONS-RADIATION PROCESSES
  • Materials compatible with dose needed for
    sterilization without embrittlement or other
    physical problem over the life of the product
  • Must remain aesthetically acceptable.
  • Appearance
  • Feel
  • Odor

17
PACKAGING CONSIDERATIONS-MOIST HEAT PROCESSES
  • Must allow sterilant in and be breathable during
    cycle
  • Must remain aesthetically acceptable
  • Must allow efficient heat transfer
  • Seals must withstand temp, pressure, and moisture
    ranges during cycle

18
PACKAGING CONSIDERATIONS-EO PROCESSES
  • Must allow sterilant in and be breathable during
    cycle
  • Must remain aesthetically acceptable
  • Must allow gas elution during aeration
  • Seals must withstand temperature, pressure, and
    moisture ranges during cycle

19
DOCUMENT! DOCUMENT! DOCUMENT!
  • Decisions and rationale for selected
    sterilization process
  • Procedures, rationales, and results of
    post-exposure testing

20
WHY VALIDATE?
  • Quality System regulation Where the results of
    a process cannot be fully verified by subsequent
    inspection and test, the process shall be
    validated with a high degree of assurance and
    approved according to established procedures
  • 21 CFR 820.75 (a)

21
VALIDATION OBJECTIVES
  • Demonstrate that
  • The sterilization process will consistently
    achieve sterility
  • The sterilization process will not have an
    adverse impact on the device or its packaging

22
STERILITY
  • Definition
  • State of being free from viable organisms
  • In practice, no such absolute statement regarding
    the absence of microorganisms can be proven.
    Therefore a sterility assurance level (SAL) is
    used to define the objective in sterilization
    processing

23
LABELING AS STERILE
  • Testing for sterility vs. SAL
  • Sterility Assurance Level
  • Probability of a viable organism being present on
    a product unit after sterilization
  • FDA SAL 10-6 for invasive devices
  • FDA SAL 10-3 for non-invasive devices
  • EC SAL 10-6 for all

24
BASIC VALIDATION CONCEPTS
  • Rule of three is used to demonstrate
    reproducibility
  • Worst case challenge
  • Resistant organism
  • Most difficult device
  • Worst case conditions
  • High density of load
  • Low end of operating conditions

25
ASSESS IMPACT OF PROCESS
  • Test performance of product and package following
    sterilization
  • Package integrity and seal strength
  • Device meets products specifications for
    functionality
  • Assess residue dissipation

26
VALIDATION PROTOCOL
  • Purpose and objectives
  • Equipment
  • Tests to be performed and rationale
  • Detailed test methods
  • Acceptance criteria
  • Approvals
  • Effective date
  • Supporting documentation

27
VALIDATION REPORT
  • Documentation of
  • Assessments of equipment
  • Results of process testing
  • Deviations and rationale for determining impact
    on the validation study
  • Meeting of acceptance criteria
  • The establishment of processing parameters

28
THANK YOU
  • Q A
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