MEDICAL DEVICE STERILIZATION Pacific BioLabs Inc. (510) 964-9000 [email protected].
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Transcript of MEDICAL DEVICE STERILIZATION Pacific BioLabs Inc. (510) 964-9000 [email protected].
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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
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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
Pacific BioLabs Inc.(510) 964-9000
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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
THANK YOU
Q & A
