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Irradiation sterilization process control specification

Writer: Sterilization Time: 2020-10-22 Browse: 569 ℃

Irradiation sterilization process control specification.
Control of Irradiation sterilization to ensure the suitability and effectiveness of the documentation
2. Scope
Suitable for the control of our company's Irradiation sterilization products.
3. Responsibility
  • 3.1 R&D: Responsible for providing the sterilization method that the product materials can withstand and meet the set sterilization conditions.
  • 3.2 Operation department: Responsible for preparing products for sterilization
  • 3.3 Quality regulations: responsible for the audit of sterilization suppliers, sterilization verification; testing of product indicators before and after sterilization, and inspection of sterilization reports provided by the company
  • 3.4 Material management: After being responsible for the outer packaging, the product is released before the release (before and after sterilization), the transportation of the sterilized goods, and the sterilization agreement with the sterilization company.
4. Process
4.1 definition
4.1.1 Sterilization batch: a certain amount of products that meet the sterilization requirements under the same sterilization conditions in the same sterilizer
4.1.2 SAL=Sterility Assurance Level.Aseptic assurance level, indicating the probability of microbial survival of sterilized items.
4.1.3 Bioburden: The total number of microorganisms alive on a product and / or sterile barrier system
4.2 Sterilization supplier selection and evaluation
4.2.1 Quality management and production capacity assessment for suppliers (check supplier qualifications, on-site audits, etc.)
4.2.2 Project for evaluation of sterilization manufacturers
  • A)Confirm that the sterilization equipment is verified by installation and verified by operation
  • B)Confirm that the sterilization operator is professionally trained and holds a certificate of employment
  • C)Confirm the establishment of relevant documents of the quality system
  • D)The sterilization process should be confirmed and can provide a report that meets the requirements
  • E)When the sterilization company is replaced or the sterility is unqualified, the sterilization verification needs to be repeated.
4.3 Sterilization confirmation process
4.4 Sterilization confirmation
4.4.1 Product definition
Product definition includes the determination of packaging. At the same time, the product packaging or the loading mode of the product in the packaging shall be specified. If a sterilization dose is established for a product family, the product family needs to be defined
4.4.2 Process definition
Establish a maximum acceptable dose
Determine or carry out sterilization experiments based on some experimental data of packaging materials and product raw material suppliers to examine the maximum acceptable dose of the product
Establish sterilization dose
Establish a sterilization dose in accordance with ISO 11137-1. One of two methods should be used to establish a sterilization dose.
1)Obtain and use information on bioburden quantity and / or radiation resistance to establish sterilization doses。
2)Select and confirm 15kGy or 25kGy sterilization dose; when confirming 15kGy or 25kGy, provide evidence through dose experiments to prove that the selected sterilization dose can meet the specified sterility requirements
Take multi-batch VDmax25 as an example: (Please refer to ISO 11137-2 in other cases) Procedure for VDmax25 verification method-applicable to multiple production batches
Note: This method is only applicable to products with an average biological load of ≤1000

Five steps of sterilization confirmation

  • Step 1: Obtain product samples
Get at least 10 unit products from each of three independent production batches
  • Step 2: Determine the average bioburden
Determine the average bioburden of the product in accordance with ISO 11737-1; determine the average bioburden of the batch (arithmetic average of the bioburden per production batch) and the total average bioburden (the arithmetic average of the bioburden of all products)
a)If one or more batches average ≥ 2 × (total average bioburden), take the highest batch average
b)If the batch average of each batch is <2 × (total average bioburden), take the total average
When SIP = 1.0, if there is no average bioburden to be checked in Table, the most recent bioburden value in the table is greater than the calculated bioburden value.
When SIP <1.0, divide the average bioburden of SIP by SIP to get the bioburden of the complete product. If there is no calculated average bioburden in Table, use the most recent list of bioburden values greater than the calculated bioburden value in the table to find the SIP = 1.0VDmax25 value and the related reduction factor
  • Step 3: Determine VDmax25
Calculate SIP VDmax25 according to the average bioburden of the product in conjunction with Table, and according to the formula SIP VDmax25 = (SIP = 1.0VDmax25) + (SIP Dose Reduction Factor x log SIP)
  • Step 4: Complete the verification dose experiment
Irradiate 10 unit products with VDmax25, the required radiation dose is qualified, and the following conditions should be met
1) The highest dose applied to the unit product ≤ VDmax25 * (1.0 + 10%)
2) The arithmetic mean of the highest and lowest doses applied to the unit product is> 90% of VDmax25
Complete the sterility test of 10 units according to ISO11737-2
  • Step 5: Results judgment
1)If the number of positive tests for aseptic testing of 10 unit products is not more than 1.0, then 25kGy is confirmed as the sterilization dose, that is, the minimum absorbed dose required for daily irradiation processing is 25.0kGy
2)If the number of positive tests for the sterility test of 10 unit products is 2.0, then perform a dose verification experiment
3)If the number of positive tests for sterility test of 10 unit products is more than 2.0, the verification is invalid.

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