Medical device sterilization
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MEDICAL DEVICE STERILIZATION. Pacific BioLabs Inc. (510) 964-9000 [email protected] 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

[email protected]


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

[email protected]


Sterilization methods

STERILIZATION METHODS

  • Moist Heat

  • Radiation (Gamma and E-beam)

  • Ethylene Oxide (EO)

  • Hydrogen Peroxide

  • Gas Plasma


Sterilization methods1

STERILIZATION METHODS


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 Radiation44%

  • E-beam Radiation7%


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


How a microbiologist views bacteria

HOW A MICROBIOLOGISTVIEWS BACTERIA


How manufacturing and qa view bacteria

HOW MANUFACTURING ANDQA VIEW BACTERIA


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


Thank you

THANK YOU

Q & A


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