MEDICAL DEVICE STERILIZATION Pacific Bio. Labs Inc. (510) 964 -9000 info@Pacific. Bio. Labs. com
OUTLINE – MORNING SESSION n 8: 30 Introduction n 8: 45 General Principles of Sterilization & Validation n 9: 15 Contract Sterilizers and Testing Laboratories n 10: 15 Break n 10: 30 Radiation Sterilization Validation n 11: 45 Validating Heat Sterilization n 12: 30 Lunch 2
OUTLINE – AFTERNOON SESSION n 1: 30 Ethylene Oxide Sterilization Validation n 3: 00 Break n 3: 15 Monitoring Controlled Environments n 4: 15 Class Exercise, Discussion, Q&A 3
GENERAL PRINCIPLES OF STERILIZATION AND VALIDATION Pacific Bio. Labs Inc. (510) 964 -9000 info@Pacific. Bio. Labs. com
STERILIZATION METHODS n Moist Heat n Radiation (Gamma and E-beam) n Ethylene Oxide (EO) n Hydrogen Peroxide n Gas Plasma 5
STERILIZATION METHODS Radiation Ethylene Oxide Moist Heat § Rapid § Compatibility § Rapid § No residues with many § No residues § Good for materials § Economical convoluted shapes § Good for heat sensitive products 6
PRODUCT DESIGN CONSIDERATIONS n Driven by performance requirement n Is the material tolerant to radiation, heat, moisture, EO? n Device shape n Re-Sterilization 7
STERILIZATION MARKET n Ethylene Oxide (EO) 49% n Gamma Radiation 44% n E-beam Radiation 7% 8
HOW DOES IT WORK? n Purpose · To kill bugs while keeping the devices functional n Chemical – Alkylates proteins and DNA n Radiation – DNA degraded by ionization n Heat – Oxidizes and denatures enzymes 9
HOW A MICROBIOLOGIST VIEWS BACTERIA 10
HOW MANUFACTURING AND QA VIEW BACTERIA 11
EO PROS & CONS n Pros · · Most materials compatible Relatively low temperature process Most packaging materials OK Relatively low cost n Cons · · Penetration sometimes difficult Residuals Batch process Long process and release time 12
GAMMA PROS & CONS n Pros · Well characterized parametric (fast) release · Penetrates well · Most materials OK n Cons · · More expensive than EO Not in-house process PTFE and acetal difficult Yellowing and embrittlement of some polymers 13
E-BEAM PROS & CONS n Pros · Same as gamma except kinder to materials · Most easily scalable · Turnaround time BEST n Cons · Lower penetration and density limited · Not in house process for small companies · Some materials remain unsuitable 14
STEAM PROS & CONS n Pros · · More tolerant material available More packaging choices Relatively inexpensive Often used in-house n Cons · · Batch process Few polymer-based devices work Packaging aesthetics not great Some maintenance costs 15
PACKAGING CONSIDERATIONSRADIATION PROCESSES n Materials compatible with dose needed for sterilization without embrittlement or other physical problem over the life of the product n Must remain aesthetically acceptable. · Appearance · Feel · Odor 16
PACKAGING CONSIDERATIONSMOIST HEAT PROCESSES n Must allow sterilant in and be breathable during cycle n Must remain aesthetically acceptable n Must allow efficient heat transfer n Seals must withstand temp, pressure, and moisture ranges during cycle 17
PACKAGING CONSIDERATIONSEO PROCESSES n Must allow sterilant in and be breathable during cycle n Must remain aesthetically acceptable n Must allow gas elution during aeration n Seals must withstand temperature, pressure, and moisture ranges during cycle 18
DOCUMENT! n Decisions and rationale for selected sterilization process n Procedures, rationales, and results of postexposure testing 19
WHY VALIDATE? n 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) 20
VALIDATION OBJECTIVES n Demonstrate that: · The sterilization process will consistently achieve sterility · The sterilization process will not have an adverse impact on the device or its packaging 21
STERILITY n 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 22
LABELING AS STERILE n Testing for sterility vs. SAL n Sterility Assurance Level · Probability of a viable organism being present on a product unit after sterilization n FDA SAL 10 -6 for invasive devices n FDA SAL 10 -3 for non-invasive devices n EC SAL 10 -6 for all 23
BASIC VALIDATION CONCEPTS n Rule of three is used to demonstrate reproducibility n Worst case challenge · Resistant organism · Most difficult device n Worst case conditions · High density of load · Low end of operating conditions 24
ASSESS IMPACT OF PROCESS n Test performance of product and package following sterilization: · Package integrity and seal strength · Device meets products specifications for functionality n Assess residue dissipation 25
VALIDATION PROTOCOL n Purpose and objectives n Equipment n Tests to be performed and rationale n Detailed test methods n Acceptance criteria n Approvals n Effective date n Supporting documentation 26
VALIDATION REPORT n 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 27
THANK YOU Q&A
Скачать презентацию MEDICAL DEVICE STERILIZATION Pacific Bio Labs Inc 510
55b6549b4fd656e16555c83b7c911ecd.ppt