Validation protocol for radiation.docx

1、Validation protocol for radiationCOMPANY NAME: - PRODUCT NAME: - .Table of Contents 1.PROTOCOL APPROVAL SHEET:-The Validation Protocol shall be Prepared, Reviewed and Approved by the concerned personnel. It shall be signed and dated as shown below.Prepared by:NAMEDESIGNATIONSIGNATUREDATEAssistant ma

2、nager- QA(validation)Checked by:NAMEDESIGNATIONSIGNATUREDATEGM-ProductionGM- Q.CApproved by:NAMEDESIGNATIONSIGNATUREDATEGM-Quality assurance2.REVISION HISTORY:-REVISIONREVISION DATEREASON FOR REVISION/CHANGE REQUESTREVISED BY0111/06/2010Original release3.OBJECTIVE:To determine that radiation sterili

3、sation process consistently performs as intended by running the system on its intended schedules and recording all relevant information and data and test results must demonstrate that the process meets pre-determined specifications under normal conditions, and where appropriate worst case conditions

4、.4.SCOPE:- The scope of validation protocol is to provide sterilization validation strategies of radiation of medical device. This document will show two approaches for reducing or eliminating bioburden on medical devices. This will also show test method, sampling method and acceptance criteria used

5、 in validating radiation sterilisation of medical devices.5.RESPONSIBILITY:-PERSONRESPONSIBILITYValidation teamPreparation of protocolOrganization of validation activityCollecting the samples and sending to QCReview and interpretation of final resultsPreparation of reportQuality controlReview of pro

6、tocol and reportAnalyzing the test samplesReporting and interpretation of resultsProductionReview of protocol and reportConducting the validation activity as per the protocolQuality assurance managerReview and approve the validation protocol6.STANDARDS FOR REGULATORY REQUIREMENT:-ISO 11137:2006 Ster

7、ilization of health care productsRadiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devicesISO 11137:2006 Sterilization of health care productsRadiation Part 2: Establishing the sterilizationISO 11137:2006 Sterilization of health car

8、e productsRadiation Part 3: Guidance on dosimetric aspects doseISO 11737-1, Sterilization of medical devices Microbiological methods Part 1: Determination of a population of microorganisms on productsISO 11737-2, Sterilization of medical devices Microbiological methods Part 2: Tests of sterility per

9、formed in the validation of a sterilization processISO 10993-1:2002 Biological evaluation of medical devices Part 1: Evaluation and testing7.LIST OF SOPs:-SOP for e-beam sterilization processSOP for gamma sterilization processSOP for environmental monitoringSOP for sampling procedureSOP for testing

10、methodSOP for material handling including biological indicator8.PREREQUISITE:-The following requisite must be fulfilled before the radiation sterilization process validation. Equipment Qualification:-Equipment associated with radiation sterilization process must be qualified prior to process qualifi

11、cation. Calibration: - All process sensing, controlling, indicating, and recording devices on the sterilizer or independent systems associated with sterilizer must be calibrated and recoded. Calibration program must be documented and detailed procedure of calibration frequency for all the instrument

12、s should be identified.Product and packaging material evaluation: -As per AAMI TIR 17 product and packaging material must be evaluated for tensile strength, impact strength, and shear strength and packaging integrity.Product grouping:-For efficient and cost-effective validation performance, similar

13、devices can be grouped into families. Product families for radiation processes should be selected based on bioburden.Family of products must be of similar design and materials of construction, and similar bioburden levels, but can be of different sizes.Selection of family representative:-Each family

14、 of products will contain a number of devices. From these devices, the representative challenge product is selected. The selected device will be the most difficult device to sterilize in the family group and will be used in verification dose experiments. Family representative should be selected base

15、d on following criteria:-number of microorganismstypes of microorganismssize of productnumber of componentscomplexity of productdegree of automation during manufacture (manually assembledproducts will generally have higher bioburden levels) manufacturing environment9.PROCESS AND VALIDATION APPROACH:

16、-E-beam Sterilisation Process: -The product is qualified for e-beam sterilisation for product and packaging integrity, strength and product characteristics. The product is loaded on conveyor belt according to pre-established loading pattern, considering the number of tote, tote loading and packaging

17、 load wrapping for shipment. Electrons are generated by electron accelerators. Accelerator is machine which contain five components such as,Electron gunHigh voltage fieldVacuum tubeElectromagnetScam horn Accelerator uses electrical energy to generate free electrons, accelerate them to high speed and

18、 then direct them through accelerator, at material passing on a conveyor.Gamma Sterilisation Process: -The sterilisation process by Gamma Radiation involves exposing the product to radioactive source which emits irradiation. Gamma Radiation kills microorganisms by attacking the DNA molecule. Both di

19、rect and indirect mechanisms are instrumental in the disruption of the DNA bond, which results in the prevention of cellular division and, consequently, the propagation of life.Gamma rays have low dose rate but high penetration power up to 50 cm. There are two types of sterilisation process by Gamma

20、 Radiation,1.CONTINUOUS PROCESS: - works with an automated conveyance system moving product through the maze.2.BATCH PROCESS: - works by loading a set number of carriers and positioning in irradiation chamber.E-beam sterilisation process and parameters: -Sterilisation process steps process parameter

21、s to be considerProductBioburden levelProduct compatibility Product characteristics (density, geometry)Product family/ groupingElectrons pass through product loadElectron generated by electron acceleratorsProduct loading on conveyor beltGamma sterilisation process and parameters: -Product loading in

22、 radiation chamberProductSterilisation process steps Process parameters to be consider GAMMA RADIATION Validation of radiation sterilization:-Radiation sterilisation validation can be done by following steps.1)Process qualification2)Product and packaging qualification3)Administrative procedure to re

23、view and approve documentation4)Maintenance of validation1)Process qualification: -vDetermination of product loading pattern: Loading pattern must be specified including number of totes, tote loading, packaging, load wrapping for shipment, minimum sterilisation dose for the particular loading patter

24、n and location of dosimeters.vBio-burden determination: Bioburden is the population of viable microorganisms on a raw material, a component of a finished device. The assessment of the bioburden includes the number of microorganisms with their identities. Dose setting and product grouping is based on

25、 bioburden level. Obtain samples randomly from three different batches of routine production processes.Bioburden evaluation must be performedPerform bioburden determination by extracting each device individually and filtering the extract through a sterile bacterial retentive filter.Perform bioburden

26、 recovery validation (An additional nonsterile samples are required for this.)Determine the average bioburden per device for each lot, as well as the overall batch average bioburdenCalculate the overall average bioburden. If a spike (a single value at least 2 X the overall average) occurs, the spike

27、 value may be used rather than the average for the dose selection.vDetermine the Verification Dose:-Dose verification can be done by method 1, method 2 or VDmax method. Refer to the appendix 1 for description of this method. If any single batch average is 2 times greater than the overall bioburden a

28、verage, use it to determine the verification dose. If not, use the overall average. Randomly select packaged devices from a single batch of products. These can be selected from any of the batches used for bioburden or from a fourth batch recently manufactured in a similar manner.Sterility testing mu

29、st be performed on the sterilised samples. Bacteriostasis and fungistasis testing must be performed on this product.vEvaluation of sterility test results:-The verification dose is acceptable if two (2) or less samples show growth. If more than two (2) samples show growth, the verification test is re

30、jected. An investigation shall be performed to evaluate if the failure could be due to incorrect handling of product, incorrect performance of the test, or incorrect dosing. If so determined, the verification dose experiment can be repeated.vSterilisation dose selection: -If the verification dose is

31、 found acceptable, then a sterilization dose is determined. vProduct dose mapping: Dose mapping of product in an established loading pattern should be conducted to determine the minimum and maximum dose zones and dose uniformity.Prepare each product samples and place in final packaging.Send the samples for product functionality, package and shipping evaluation. The effect of shipping and handling on the package shall be evaluated using a p