Sterilization Validation Protocol
Device name: XXXX
Model: XXXX
Sterilization condition: Gravity steam, 134℃for 10 minutes
鹅肉怎么做好吃Test parts: XXXX
Prepared by: ________________ Audited by: ________________ Title: RA Engineer Title: Management reprentative
1.General information
Protocol No.: XXXX-01
Sponsor: XXXX Limited.
Add: XXXX China.
Test personal :XXX
Test objective: To Validate the sterilization efficacy of XXXX when procesd in a hospital steam gravity cycles: 273℉（134℃）for ten (10) minutes exposure.
Test sample: XXXX, e table 1.
Test Lab:XXXX Limited
11到19的平方
Microbiological
Testing laboratory：XXXX LTD (Registration ID: CNASXXXX)
Reference:
1)Pflug, IJ, and Holcomb, RG, “Principles of the Thermal Destruction of Microorganisms” in Disinfection,
Sterilization and Prervation, (SS Block, ed). Lea & Febiger, Philadelphia, 4th edition, 1991.
2)United States Pharmacopeia. Current Edition.
3)ANSI/AAMI ST55:2013, Table top steam sterilizers.惠龙儿
4)ANSI/AAMI TIR12:2010 Designing, testing, and labeling reusable medical devices for reprocessing in
health care facilities: A guide for device manufacturers.
5)AAMI/ISO 14937:2009 Sterilization of health care products –General requirements for
characterization of a sterilizing agent and the development, validation and routine control of a
sterilization process for medical devices.
6)ANSI/AAMI ST81: 2004 (R2010) Sterilization of medical devices –Information to be provided by
the manufacturer for the processing of resterilizable medical devices.散粉的作用
7)ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 (Consolidated Text) Comprehensive guide to steam丑比头
sterilization and sterility assurance in health care facilities.
8)Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for
Industry and Food and Drug Administration Staff. March 17, 2015
阿胶图片高清图片9)XXXX instructions: Ur manual.
2. Introduction
This protocol details the methods to be ud in determining the sterilization cycle of XXXX when procesd in a gravity steam sterilization cycle of 273℉（134℃）for ten (10) minutes exposure. A m
ethod of steam sterilization was utilized in order to achieve a sterility assurance level (SAL) of 1.0×10-6 using the biological indicator (BI) overkill method. The SAL was achieved by placing a minimum of 1.0×106 spores of Geobacillus stearothermophilus and processing at one-half the excepted full cycle exposure time. Following exposure, BI will be nt to external certification body (XXXX LTD) for incubation.
A total of three (3) testing cycles will be performed.
3. JUSTIFICATION
The overkill method was lected to verify the sterilization efficacy of the devices per AAMI/ISO guidelines. In this method , validation is accomplished by demonstrating that a minimum of 10×106 highly resistant Geobacillus stearothermophilus spores will be killed in a half-cycle (6-log reduction). A full cycle would therefore result in a 12-log reduction of spores and produce a 10-6 SAL, which reflects a one-in-a-million chance of a non-sterile item. The study provide the sterilization efficacy data for the product.
4. EQUIPMENT AND MATERIALS
1)XXXXs: XXXX
2)Lubricant: Mineral Oil bad spray
3)Sterilizer: Table top steam sterilizer
4)Sterilization pouches
5)Test organism(BI): Geobacillus stearothermophilus ATCC 7953 biological indicator (BI) spore
strips.松昌中学
6)Steam integrators (CI): Class 5 Integrators
5 Sterilization
5.1 Gravity Steam Half-cycle description
Temperature : 134℃（273℉）; Exposure Time: 5mins.
5.2 Validation of spore
The biological indicators lected for testing will be chon for u bad on the listed population, D-value,
and actual test data from a compliant AAMI/ISO resistometer.
5.3 Procedure
1)Precondition the sterilizer by running a warm up cycle to verify functionality.
2)Obtain three XXXXs. See bill of materials of Table 1.
3)Cleaning and lubricating the device according to the method recommended in ur manual.
4)Place each inoculated device in a parated steam sterilization pouch along with one (1) BI spore strip
and one CI . See Figure 1.
5)Seal and number the pouches.
6)Using a pouch divider for positioning, place the pouched devices on the bottom shelf above the drain of
a fully loaded chamber and process in the gravity steam cycle stated in Section 5.1.
7)Following cycle completion, verify the printout of program cycle.
8)After finishing the sterilization, remove the procesd pouched devices from the sterilizer. Take out the
CI and the device, the BI will be remained in the pouch and the pouch will be realed.
9)Obrve CI for steam penetration.减肥狠招三天瘦十斤
10)Repeated steps 2) through 9) two more times for a total of three half-cycles.
11)One unprocesd BI spore strip were prepared as positive control. After finishing the three half-cycle,
Immediately nd the positive BI and the above sterilized BI’s to XXXX LTD for BI test. Separately
incubate the BI’s and one non-BI tube of culture media (as negative control) at 56℃for 48h.
12)Results will be recorded and issued in the final report.
6.0 Acceptance criteria:
●All biological indicator test samples shall be negative for growth following the incubation period.
●The positive controls shall be positive for growth.
●The negative controls shall be negative for growth.
●The integrator shall demonstrate steam penetration.
7.0 Maintenance of equipment
The sterilizer is maintained as per written procedures.
8.0 Final Report
The test report shall include but not limited: name and address of test institution, name of test personnel, start and end time, description of the test sample, test methods, obrvations, as well as the results of other necessary information, etc.
Table 1 Bill of materials
Figure 1
Note: BI: Biological indicator; CI: Steam integrators
The package will be numbered on front by HP-XX (XX means rial number of sterilization).
