1 / 28

MEDICAL DEVICE STERILIZATION

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

Download Presentation

MEDICAL DEVICE STERILIZATION

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript


  1. MEDICAL DEVICE STERILIZATION Pacific BioLabs Inc. (510) 964-9000 info@PacificBioLabs.com

  2. 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

  3. OUTLINE – AFTERNOON SESSION • 1:30 Ethylene Oxide Sterilization Validation • 3:00 Break • 3:15 Monitoring Controlled Environments • 4:15 Class Exercise, Discussion, Q&A

  4. GENERAL PRINCIPLES OF STERILIZATION AND VALIDATION Pacific BioLabs Inc. (510) 964-9000 info@PacificBioLabs.com

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

  6. STERILIZATION METHODS

  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

More Related