Confirm sterilization process
Writer: Sterilization Time: 2020-10-23 Browse: 696 ℃
gamma irradiation sterilization validation
Confirm sterilization process (completed by sterilization supplier)
1) IQ；
2) OQ；
3) PQ
The main thing in this part is to determine the distribution of the dose field and thus the sterilization process.
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Distribution diagram of dosimeters distributed in a network in an irradiation container
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Maximum and minimum doses
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Location of maximum and minimum doses
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Irradiation device
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Product packing mode
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Number of dose field distribution or source arrangement
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Review and approval of sterilization confirmation
The Quality Law Department summarizes the entire sterilization confirmation process, forms a sterilization confirmation report, and determines the general sterilization process parameters with the sterilization supplier.
Routine sterilization control
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1. Sterilize according to sterilization process parameters and loading methods confirmed by sterilization
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2. Daily sterilization and packing operations in accordance with SOP. If there is a change in the sterilization and packing method, the impact of the evaluation by the quality and regulations department on the effectiveness of sterilization
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3. Procurement should form a sterilization entrustment agreement with the sterilization supplier, specifying the sterilization requirements and quality responsibility in the agreement
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4. The production department is responsible for sorting the list of sterilized products, and filling out the “External Sterilization Order”, transporting or delivering the sterilized products to the sterilizing supplier, and the sterilizing supplier sterilizes according to the sterilization protocol.
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5. The sterilization supplier returns to the company after completing the sterilization process and dose testing, and issues an "Irradiation Certificate"
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6. The quality regulation department is responsible for inspecting the sterilized products.
Maintenance of sterilization effectiveness
Determine the continued effectiveness of sterilization doses through bioburden monitoring, dose audits, and maintenance of product families, and confirm the continued effectiveness of irradiation processing by maintaining irradiation conditions
1. Product bioburden monitoring
When the average bioburden of the product is greater than or equal to 1.5, the maximum time interval for bioburden detection is 3 months
When the average bioburden of the product is less than 1.5,
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a) Use method 2 (see GB 18280.2) to establish a sterilization dose
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b) 25kGy is selected as the sterilization dose, and the maximum time interval for bioburden detection is 3 months
When the average bioburden of the product is less than 1.5, and according to a) use method 1 (see GB 18280.2) to establish the sterilization dose, or b) select 15kGy as the sterilization dose, the maximum time interval for bioburden detection is 1 month.
If the batch interval is greater than 1 month, each product batch should be tested for bioburden, if applicable
If the results of the bioburden experiment exceed the specified limits, investigate according to the method of ISO 11737-1. If the results of the investigation show that the results of the bioburden experiment are real, take action and immediately perform a sterilization dose review
2. Sterilization dose confirmation
After the sterilization dose is established, in the continuous production phase of the product, the Quality and Law Department shall organize representative products to be dosed every 3 months for a dose audit. The frequency reduction can be as low as half a year, but at least once a year. In the discontinuous production stage of the product, the quality regulations department is responsible for completing the dose audit before producing the formal product. The dose audit shall complete the bioburden test, dose test and sterility test in accordance with the requirements of ISO 11137-2. If the dose audit is successful, the sterilization dose will continue to be effective
3. Product family retention
The quality regulations department shall review the product family every year to ensure that the product family and the products representing the product family are continuously effective. During the production process, products that have changed production conditions and production processes and new products should be tested for initial pollution to ensure the continued effectiveness of the representative product
4. Maintenance of irradiation conditions
When the irradiation conditions of the sterilization supplier change, the quality regulations department will conduct dose distribution experiments or reconfirm or replace the irradiation mechanism according to the results of the impact.
Reconfirmation of sterilization process
In the following cases, the quality regulations department needs to assess the impact and document it, and reconfirm it if necessary
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1)When the irradiation mechanism changes, it is necessary to confirm the irradiation mechanism and the irradiation processing.
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2)When the representative product changes and the dose audit fails to re-establish the sterilization dose, the radiation dose confirmation is required
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3)When irradiation conditions change, irradiation processing confirmation is required
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4)Change in sterilizer or product family
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5)Product design, production process, packaging material, production material, production process, loading mode changed
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6)Increase in initial contaminated bacteria or changes in microbial properties
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7)The product has been routinely sterilized.
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8)Clinical adverse events due to product sterilization caused by products entering the market
Nonconforming Product Control
Failure during sterilization process (including sterilization verification process) and testing, in accordance with the "Defective Product Control Procedure".
At present, In addition to the very mature and industrialized application of cable materials, relatively mature nuclear technology applications include: heat shrinkable materials, foaming materials, polytetrafluoroethylene ultrafine powder, hydrogel wound dressing, fiber irradiation grafting modification, medical polymers, etc., and also in the aspects of chitosan, wood plastic materials, battery separator, biomedical functional film and so on. A major breakthrough.
