Sterilization Validation report
Model:XXXXX
Sterilization condition:Gravity steam,134℃for10minutes
Test parts:XXX3,XXX2and XXX3
Prepared by:________________Audited by:________________ Title:RA Engineer Title:Management reprentative
1.General information
Report No.:XXX FDA-01
Sponsor:XXX Limited.
Add:XXXXXXXXXX,China.
Study personal:XXXX
Test objective:To Validate the sterilization efficacy of XXX when procesd in a hospital steam gravity cycles:273℉（134℃）for ten(10)minutes exposure.
Test sample:XXX3,XXX1XXX2,XXX2,e table1
Test Lab:XXXLimited
Date:Test samples were sterilized on Nov.12,2019.the result was received on Nov.16,2019 Microbiol
ogical
testing laboratory：XXX LTD(Registration ID:CNAS XXX)
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.
4)ANSI/AAMI TIR12:2010Designing,testing,and labeling reusable medical devices for reprocessing in
health care facilities:A guide for device manufacturers.
5)AAMI/ISO14937:2009Sterilization of health care products–General requirements for
characterization of a sterilizing agent and the development,validation and routine control of a
鲜为人知是什么意思
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.
7)ANSI/AAMI ST79:2010&A1:2010&A2:2011(Consolidated Text)Comprehensive guide to steam东方快车翻译
sterilization and sterility assurance in health care facilities.
8)Reprocessing Medical Devices in Health Care Settings:Validation Methods and Labeling Guidance for意大利语在线翻译器
Industry and Food and Drug Administration Staff.March17,2015
9)Ur manual.
2.Introduction责任心
negro的复数This report details the methods ud in determining the sterilization validation of the samples when procesd in a gravity steam sterilization cycle of134℃for10mins exposure.A method of steam sterili
zation was utilized in order to achieve a sterility assurance level(SAL)of1.0×10-6using the biological indicator(BI) overkill method.The SAL was achieved by placing a minimum of1.0×106spores of Geobacillus stearothermophilus and processing at one-half the excepted full cycle exposure time.Following exposure, BI’s were nt to XXX LTD for incubation.A total of three testing cycles were performed.
3.JUSTIFICATION
The overkill method was lected to verify the sterilization efficacy of the devices per AAMI/ISO guidelines. In this method,validation was accomplished by demonstrating that a minimum of10×106highly resistant Geobacillus stearothermophilus spores were killed in a half-cycle(6-log reduction).A full cycle would therefore result in a12-log reduction of spores and produce a10-6SAL,which reflects a one-in-a-million chance of a non-sterile item.The study provides the sterilization efficacy data for the product.
4.EQUIPMENT AND MATERIALS
1)XXXs:XXX3,XXX2and XXX3
2)Lubricant:Mineral Oil bad spray,NSK PANA SPRAY oil:LOT:XXXX
tiger mother
英文信件结尾3)Sterilizer:Midmark XX ULTRACLAVE：Equipment No：XXXX
4)Sterilization pouches：XXX,5.25"x10",LOT#XXXXX
5)Test organism(BI):Geobacillus stearothermophilus ATCC7953biological indicator(BI)spore
strips.Spore strips:LOT#MPXXXXX
6)Steam integrators(CI):SPSMedical STEAMPlusTM Class5Integrators:LOT#XXXXX
5Sterilization
5.1Gravity Steam Half-cycle description
Temperature:134℃（273℉）;Exposure Time:5mins.
5.2Validation of spores
The biological indicators lected for testing were chon for u bad on the listed population,D-value, and actual test data from a compliant AAMI/ISO resistometer.
5.3Procedure
1)The sterilizer was preconditioned by running a warm up cycle to verify functionality.
2)Three ts ofXXX:each t include one piece of air motor,one piece of XXX1,one piece of XXX2.
See bill of materials of Table1.
what the hell
3)Each t of device was cleaned and lubricated according to the method recommended in ur manual.
4)Each t of inoculated device was placed in a parate steam sterilization pouch along with one(1)BI
spore strip and one CI.See Figure1.
5)The pouches were aled and numbered for traceability.
生于忧患 死于安乐翻译6)Using a pouch divider for positioning,the pouched devices were placed on the bottom shelf above the
drain of a fully loaded chamber and procesd in the gravity steam cycle stated in Section5.1.
7)Following cycle completion,the printout of program cycle was verified.
8)Removed the procesd pouched devices from the sterilizer after completed the sterilization.Opened the
pouches.Took out the CI and the device,the BI will be remained in the pouch and the pouch will be realed.
9)The CI’s were obrved for steam penetration.
10)Repeated steps2)through9)two more times for a total of three half-cycles.
11)One unprocesd BI spore strip was prepared as positive control for XXX.Immediately nt the positive
BI and the above sterilized BI’s to XXX LTD for BI test.Separately incubated the BI’s and one non-BI tube of culture media(as negative control)at56℃for48h.
12)Results were recorded,e table2.
6.0Results
6.1All biological indicator test samples were negative for growth following the incubation period.
6.2The positive control were positive for growth
6.3The negative control were negative for growth
6.4The integrators demonstrated steam penetration.
7.0Conclusion
Performance testing has validated that the recommended cycle parameters are able to achieve a10-6SAL when sterilizing the XXX in the following gravity sterilization cycle:Temperature--134℃（273℉),Exposure time--10minutes.翻译在线发音
Table1Bill of materials
Accessories name Part No.:Lot number Quantities per half-cycle Photo
XXX3XXX3C0911013PCS
XXX1XXX1C0911013PCS
XXX2XXX2C0911013PCS
Note:Each t for sterilization include one XXX3,one XXX2and one XXX3.
Figure1
Table2Biological indicator test result
(Details refer to test report of XXX LTD(Report No.:XXXX))
Sample ID Results Cycle#1LP-01N
LP-02N
LP-03N Cycle#2LP-04N
LP-05N
LP-06N Cycle#3LP-07N
LP-08N
