MEDICAL DEVICE STERILIZATION

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MEDICAL DEVICE STERILIZATION

• Pacific BioLabs Inc.
• [phone]
• info_at_PacificBioLabs.com

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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

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OUTLINE AFTERNOON SESSION

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

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GENERAL PRINCIPLES OF STERILIZATION AND VALIDATION

• Pacific BioLabs Inc.
• [phone]
• info_at_PacificBioLabs.com

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STERILIZATION METHODS

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

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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
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PRODUCT DESIGN CONSIDERATIONS

• Driven by performance requirement
• Is the material tolerant to radiation, heat,
  moisture, EO?
• Device shape
• Re-Sterilization

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STERILIZATION MARKET

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

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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

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HOW A MICROBIOLOGISTVIEWS BACTERIA
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HOW MANUFACTURING ANDQA VIEW BACTERIA
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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

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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

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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

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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

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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

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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

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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

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DOCUMENT! DOCUMENT! DOCUMENT!

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

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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)

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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

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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

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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

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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

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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

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VALIDATION PROTOCOL

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

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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

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THANK YOU

• Q A