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MEDICAL DEVICE STERILIZATION. Pacific BioLabs Inc. (510) 964-9000 info@PacificBioLabs.com. OUTLINE – MORNING SESSION. 8:30 Introduction 8:45 General Principles of Sterilization & Validation 9:15 Contract Sterilizers and Testing Laboratories 10:15 Break

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MEDICAL DEVICE STERILIZATION


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medical device sterilization

MEDICAL DEVICE STERILIZATION

Pacific BioLabs Inc.

(510) 964-9000

info@PacificBioLabs.com

outline morning session
OUTLINE – MORNING SESSION
  • 8:30 Introduction
  • 8:45 General Principles of Sterilization & Validation
  • 9:15 Contract Sterilizers and Testing Laboratories
  • 10:15 Break
  • 10:30 Radiation Sterilization Validation
  • 11:45 Validating Heat Sterilization
  • 12:30 Lunch
outline afternoon session
OUTLINE – AFTERNOON SESSION
  • 1:30 Ethylene Oxide Sterilization Validation
  • 3:00 Break
  • 3:15 Monitoring Controlled Environments
  • 4:15 Class Exercise, Discussion, Q&A
general principles of sterilization and validation

GENERAL PRINCIPLES OF STERILIZATION AND VALIDATION

Pacific BioLabs Inc.

(510) 964-9000

info@PacificBioLabs.com

sterilization methods
STERILIZATION METHODS
  • Moist Heat
  • Radiation (Gamma and E-beam)
  • Ethylene Oxide (EO)
  • Hydrogen Peroxide
  • Gas Plasma
product design considerations
PRODUCT DESIGN CONSIDERATIONS
  • Driven by performance requirement
  • Is the material tolerant to radiation, heat, moisture, EO?
  • Device shape
  • Re-Sterilization
sterilization market
STERILIZATION MARKET
  • Ethylene Oxide (EO) 49%
  • Gamma Radiation 44%
  • E-beam Radiation 7%
how does it work
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
eo pros cons
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
gamma pros cons
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
e beam pros cons
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
steam pros cons
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
packaging considerations radiation processes
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
packaging considerations moist heat processes
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
packaging considerations eo processes
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
document document document
DOCUMENT! DOCUMENT! DOCUMENT!
  • Decisions and rationale for selected sterilization process
  • Procedures, rationales, and results of post-exposure testing
why validate
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)
validation objectives
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
sterility
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
labeling as sterile
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
basic validation concepts
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
assess impact of process
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
validation protocol
VALIDATION PROTOCOL
  • Purpose and objectives
  • Equipment
  • Tests to be performed and rationale
  • Detailed test methods
  • Acceptance criteria
  • Approvals
  • Effective date
  • Supporting documentation
validation report
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