ISO 11137-2:2012
Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
ISO 11137-2:2011 specifies methods of determining the minimum dose needed to achieve a specified requirement for sterility and methods to substantiate the use of 25 kGy or 15 kGy as the sterilization dose to achieve a sterility assurance level, SAL, of 10-6. ISO 11137-2:2011 also specifies methods of sterilization dose audit used to demonstrate the continued effectiveness of the sterilization dose.
ISO 11137-2:2011 defines product families for sterilization dose establishment and sterilization dose audit.
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1 Scope
2 Normative references
3 Terms, definitions and abbreviated terms
3.1 Terms and definitions
3.2 Abbreviated terms
4 Definition and maintenance of product families for dose setting, dose substantiation and sterilization dose auditing
4.1 General
4.2 Defining product families
4.3 Designation of product to represent a product family for performance of a verification dose experiment or sterilization dose audit
4.3.1 Product to represent a product family
4.3.2 Master product
4.3.3 Equivalent product
4.3.4 Simulated product
4.4 Maintaining product families
4.4.1 Periodic review
4.4.2 Modification to product and/or manufacturing process
4.4.3 Records
4.5 Effect of failure of establishment of sterilization dose or of a sterilization dose audit on a product family
5 Selection and testing of product for establishing the sterilization dose
5.1 Nature of product
5.2 Sample item portion (SIP)
5.3 Manner of sampling
5.4 Microbiological testing
5.5 Irradiation
6 Methods of dose establishment
7 Method 1: dose setting using bioburden information
7.1 Rationale
7.2 Procedure for Method 1 for product with an average bioburden greater than or equal to 1,0 for multiple production batches
7.2.1 General
7.2.2 Stage 1: Select SAL and obtain samples of product
7.2.3 Stage 2: Determine average bioburden
7.2.4 Stage 3: Obtain verification dose
7.2.5 Stage 4: Perform verification dose experiment
7.2.6 Stage 5: Interpretation of results
7.2.7 Stage 6: Establish sterilization dose
7.3 Procedure for Method 1 for product with an average bioburden greater than or equal to 1,0 for a single production batch
7.3.1 Rationale
7.3.2 General
7.3.3 Stage 1: Select SAL and obtain samples of product
7.3.4 Stage 2: Determine average bioburden
7.3.5 Stage 3: Obtain verification dose
7.3.6 Stage 4: Perform verification dose experiment
7.3.7 Stage 5: Interpretation of results
7.3.8 Stage 6: Establish sterilization dose
7.4 Procedure for Method 1 for product with an average bioburden in the range 0,1 to 0,9 for multiple or single production batches
8 Method 2: Dose setting using fraction positive information from incremental dosing to determine an extrapolation factor
8.1 Rationale
8.2 Procedure for Method 2A
8.2.1 General
8.2.2 Stage 1: Select SAL and obtain samples of product
8.2.3 Stage 2: Perform incremental dose experiment
8.2.3.1 General
8.2.3.2 A and FFP
8.2.3.3 D*
8.2.3.4 CD* batch
8.2.4 Stage 3: Perform verification dose experiment
8.2.5 Stage 4: Interpretation of results
8.2.6 Stage 5: Establish sterilization dose
8.3 Procedure for Method 2B
8.3.1 General
8.3.2 Stage 1: Select SAL and obtain samples of product
8.3.3 Stage 2: Perform incremental dose experiment
8.3.3.1 General
8.3.3.2 A and FFP
8.3.3.3 D*
8.3.3.4 CD* batch
8.3.4 Stage 3: Perform verification dose experiment
8.3.5 Stage 4: Interpretation of results
8.3.6 Stage 5: Establish sterilization dose
9 Method VDmax — Substantiation of 25 kGy or 15 kGy as the sterilization dose
9.1 Rationale
9.2 Procedure for Method VDmax25 for multiple production batches
9.2.1 General
9.2.2 Stage 1: Obtain samples of product
9.2.3 Stage 2: Determine average bioburden
9.2.4 Stage 3: Obtain VDmax25
9.2.5 Stage 4: Perform verification dose experiment
9.2.6 Stage 5: Interpretation of results
9.2.7 Confirmatory verification dose experiment
9.2.7.1 General
9.2.7.2 Stage 1: Obtain samples of product
9.2.7.3 Stage 2: Perform confirmatory verification dose experiment
9.2.7.4 Stage 3: Interpretation of results
9.3 Procedure for Method VDmax25 for a single production batch
9.3.1 Rationale
9.3.2 General
9.3.3 Stage 1: Obtain samples of product
9.3.4 Stage 2: Determine average bioburden
9.3.5 Stage 3: Obtain VDmax25
9.3.6 Stage 4: Perform verification dose experiment
9.3.7 Stage 5: Interpretation of results
9.3.8 Confirmatory verification dose experiment
9.3.8.1 General
9.3.8.2 Stage 1: Obtain samples of product
9.3.8.3 Stage 2: Perform confirmatory verification dose experiment
9.3.8.4 Stage 3: Interpretation of results
9.4 Procedure for Method VDmax15 for multiple production batches
9.4.1 General
9.4.2 Stage 1: Obtain samples of product
9.4.3 Stage 2: Determine average bioburden
9.4.4 Stage 3: Obtain VDmax15
9.4.5 Stage 4: Perform verification dose experiment
9.4.6 Stage 5: Interpretation of results
9.4.7 Confirmatory verification dose experiment
9.4.7.1 General
9.4.7.2 Stage 1: Obtain samples of product
9.4.7.3 Stage 2: Perform confirmatory verification dose experiment
9.4.7.4 Stage 3: Interpretation of results
9.5 Procedure for Method VDmax15 for a single production batch
9.5.1 Rationale
9.5.2 General
9.5.3 Stage 1: Obtain samples of product
9.5.4 Stage 2: Determine average bioburden
9.5.5 Stage 3: Obtain VDmax15
9.5.6 Stage 4: Perform verification dose experiment
9.5.7 Stage 5: Interpretation of results
9.5.8 Confirmatory verification dose experiment
9.5.8.1 General
9.5.8.2 Stage 1: Obtain samples of product
9.5.8.3 Stage 2: Perform confirmatory verification dose experiment
9.5.8.4 Stage 3: Interpretation of results
10 Sterilization dose audit
10.1 Purpose and frequency
10.2 Procedure for auditing a sterilization dose established using Method 1, Method 2A or Method 2B
10.2.1 General
10.2.2 Stage 1: Obtain samples of product
10.2.3 Stage 2: Determine average bioburden
10.2.4 Stage 3: Perform verification dose experiment
10.2.5 Stage 4: Interpretation of results
10.2.6 Augmentation of a sterilization dose established using Method 1, Method 2A or Method 2B
10.2.6.1 General
10.2.6.2 Stage 1: Analyse data from the failed sterilization dose audit
10.2.6.3 Stage 2: Determine extrapolation factor, E
10.2.6.4 Stage 3: Calculate adjusted dose (the dose to achieve an SAL value of 10–2)
10.2.6.5 Stage 4: Calculate augmented sterilization dose
10.3 Procedure for auditing a sterilization dose substantiated using Method VDmax25 or Method VDmax15
10.3.1 General
10.3.2 Stage 1: Obtain samples of product
10.3.3 Stage 2: Determine average bioburden
10.3.4 Stage 3: Perform verification dose experiment
10.3.5 Stage 4: Interpretation of results
10.3.6 Confirmatory sterilization dose audit
10.3.6.1 General
10.3.6.2 Stage 1: Obtain samples of product
10.3.6.3 Stage 2: Perform confirmatory verification dose experiment
10.3.6.4 Stage 3: Interpretation of results
10.3.7 Augmentation of a sterilization dose substantiated using Method VDmax25 or Method VDmax15
10.3.7.1 Method VDmax25
10.3.7.2 Method VDmax15
10.4 Failure of a sterilization dose audit
11 Worked examples
11.1 Worked examples for Method 1
11.2 Worked examples for Method 2
11.2.1 General
11.2.2 Worked example for Method 2A (SIP equal to 1,0)
11.2.2.1 Stage 1: Select SAL and obtain samples of product
11.2.2.2 Stage 2: Perform incremental dose experiment
Stage 3: Perform verification dose experiment
11.2.2.3 Stages 4 and 5: Interpretation of results and establishment of sterilization dose
11.2.3 Worked example for Method 2A (SIP less than 1,0)
11.2.3.1 Stage 1: Select SAL and obtain samples of product
11.2.3.2 Stage 2: Perform incremental dose experiment
11.2.3.3 Stage 3: Perform verification dose experiment
11.2.3.4 Stages 4 and 5: Interpretation of results and establishment of sterilization dose
11.2.4 Worked example for Method 2B
11.2.4.1 Stage 1: Select SAL and obtain samples of product
11.2.4.2 Stage 2: Perform incremental dose experiment
11.2.4.3 Stage 3: Perform verification dose experiment
11.2.4.4 Stages 4 and 5: Interpretation of results and establishment of sterilization dose
11.3 Worked examples for Method VDmax
11.4 Worked example of a sterilization dose audit for a dose established using Method 1, the findings from which necessitated augmentation of the sterilization dose
11.5 Worked example of a sterilization dose audit for a dose established using Method 2A, the findings from which necessitated augmentation of the sterilization dose
11.6 Worked example of a sterilization dose audit for a sterilization dose substantiated using Method VDmax25
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1 Scope
2 Normative references
3 Terms, definitions and abbreviated terms
3.1 Terms and definitions
3.2 Abbreviated terms
4 Definition and maintenance of product families for dose setting, dose substantiation and sterilization dose auditing
4.1 General
4.2 Defining product families
4.3 Designation of product to represent a product family for performance of a verification dose experiment or sterilization dose audit
4.3.1 Product to represent a product family
4.3.2 Master product
4.3.3 Equivalent product
4.3.4 Simulated product
4.4 Maintaining product families
4.4.1 Periodic review
4.4.2 Modification to product and/or manufacturing process
4.4.3 Records
4.5 Effect of failure of establishment of sterilization dose or of a sterilization dose audit on a product family
5 Selection and testing of product for establishing the sterilization dose
5.1 Nature of product
5.2 Sample item portion (SIP)
5.3 Manner of sampling
5.4 Microbiological testing
5.5 Irradiation
6 Methods of dose establishment
7 Method 1: dose setting using bioburden information
7.1 Rationale
7.2 Procedure for Method 1 for product with an average bioburden greater than or equal to 1,0 for multiple production batches
7.2.1 General
7.2.2 Stage 1: Select SAL and obtain samples of product
7.2.3 Stage 2: Determine average bioburden
7.2.4 Stage 3: Obtain verification dose
7.2.5 Stage 4: Perform verification dose experiment
7.2.6 Stage 5: Interpretation of results
7.2.7 Stage 6: Establish sterilization dose
7.3 Procedure for Method 1 for product with an average bioburden greater than or equal to 1,0 for a single production batch
7.3.1 Rationale
7.3.2 General
7.3.3 Stage 1: Select SAL and obtain samples of product
7.3.4 Stage 2: Determine average bioburden
7.3.5 Stage 3: Obtain verification dose
7.3.6 Stage 4: Perform verification dose experiment
7.3.7 Stage 5: Interpretation of results
7.3.8 Stage 6: Establish sterilization dose
7.4 Procedure for Method 1 for product with an average bioburden in the range 0,1 to 0,9 for multiple or single production batches
8 Method 2: Dose setting using fraction positive information from incremental dosing to determine an extrapolation factor
8.1 Rationale
8.2 Procedure for Method 2A
8.2.1 General
8.2.2 Stage 1: Select SAL and obtain samples of product
8.2.3 Stage 2: Perform incremental dose experiment
8.2.3.1 General
8.2.3.2 A and FFP
8.2.3.3 D*
8.2.3.4 CD* batch
8.2.4 Stage 3: Perform verification dose experiment
8.2.5 Stage 4: Interpretation of results
8.2.6 Stage 5: Establish sterilization dose
8.3 Procedure for Method 2B
8.3.1 General
8.3.2 Stage 1: Select SAL and obtain samples of product
8.3.3 Stage 2: Perform incremental dose experiment
8.3.3.1 General
8.3.3.2 A and FFP
8.3.3.3 D*
8.3.3.4 CD* batch
8.3.4 Stage 3: Perform verification dose experiment
8.3.5 Stage 4: Interpretation of results
8.3.6 Stage 5: Establish sterilization dose
9 Method VDmax — Substantiation of 25 kGy or 15 kGy as the sterilization dose
9.1 Rationale
9.2 Procedure for Method VDmax25 for multiple production batches
9.2.1 General
9.2.2 Stage 1: Obtain samples of product
9.2.3 Stage 2: Determine average bioburden
9.2.4 Stage 3: Obtain VDmax25
9.2.5 Stage 4: Perform verification dose experiment
9.2.6 Stage 5: Interpretation of results
9.2.7 Confirmatory verification dose experiment
9.2.7.1 General
9.2.7.2 Stage 1: Obtain samples of product
9.2.7.3 Stage 2: Perform confirmatory verification dose experiment
9.2.7.4 Stage 3: Interpretation of results
9.3 Procedure for Method VDmax25 for a single production batch
9.3.1 Rationale
9.3.2 General
9.3.3 Stage 1: Obtain samples of product
9.3.4 Stage 2: Determine average bioburden
9.3.5 Stage 3: Obtain VDmax25
9.3.6 Stage 4: Perform verification dose experiment
9.3.7 Stage 5: Interpretation of results
9.3.8 Confirmatory verification dose experiment
9.3.8.1 General
9.3.8.2 Stage 1: Obtain samples of product
9.3.8.3 Stage 2: Perform confirmatory verification dose experiment
9.3.8.4 Stage 3: Interpretation of results
9.4 Procedure for Method VDmax15 for multiple production batches
9.4.1 General
9.4.2 Stage 1: Obtain samples of product
9.4.3 Stage 2: Determine average bioburden
9.4.4 Stage 3: Obtain VDmax15
9.4.5 Stage 4: Perform verification dose experiment
9.4.6 Stage 5: Interpretation of results
9.4.7 Confirmatory verification dose experiment
9.4.7.1 General
9.4.7.2 Stage 1: Obtain samples of product
9.4.7.3 Stage 2: Perform confirmatory verification dose experiment
9.4.7.4 Stage 3: Interpretation of results
9.5 Procedure for Method VDmax15 for a single production batch
9.5.1 Rationale
9.5.2 General
9.5.3 Stage 1: Obtain samples of product
9.5.4 Stage 2: Determine average bioburden
9.5.5 Stage 3: Obtain VDmax15
9.5.6 Stage 4: Perform verification dose experiment
9.5.7 Stage 5: Interpretation of results
9.5.8 Confirmatory verification dose experiment
9.5.8.1 General
9.5.8.2 Stage 1: Obtain samples of product
9.5.8.3 Stage 2: Perform confirmatory verification dose experiment
9.5.8.4 Stage 3: Interpretation of results
10 Sterilization dose audit
10.1 Purpose and frequency
10.2 Procedure for auditing a sterilization dose established using Method 1, Method 2A or Method 2B
10.2.1 General
10.2.2 Stage 1: Obtain samples of product
10.2.3 Stage 2: Determine average bioburden
10.2.4 Stage 3: Perform verification dose experiment
10.2.5 Stage 4: Interpretation of results
10.2.6 Augmentation of a sterilization dose established using Method 1, Method 2A or Method 2B
10.2.6.1 General
10.2.6.2 Stage 1: Analyse data from the failed sterilization dose audit
10.2.6.3 Stage 2: Determine extrapolation factor, E
10.2.6.4 Stage 3: Calculate adjusted dose (the dose to achieve an SAL value of 10–2)
10.2.6.5 Stage 4: Calculate augmented sterilization dose
10.3 Procedure for auditing a sterilization dose substantiated using Method VDmax25 or Method VDmax15
10.3.1 General
10.3.2 Stage 1: Obtain samples of product
10.3.3 Stage 2: Determine average bioburden
10.3.4 Stage 3: Perform verification dose experiment
10.3.5 Stage 4: Interpretation of results
10.3.6 Confirmatory sterilization dose audit
10.3.6.1 General
10.3.6.2 Stage 1: Obtain samples of product
10.3.6.3 Stage 2: Perform confirmatory verification dose experiment
10.3.6.4 Stage 3: Interpretation of results
10.3.7 Augmentation of a sterilization dose substantiated using Method VDmax25 or Method VDmax15
10.3.7.1 Method VDmax25
10.3.7.2 Method VDmax15
10.4 Failure of a sterilization dose audit
11 Worked examples
11.1 Worked examples for Method 1
11.2 Worked examples for Method 2
11.2.1 General
11.2.2 Worked example for Method 2A (SIP equal to 1,0)
11.2.2.1 Stage 1: Select SAL and obtain samples of product
11.2.2.2 Stage 2: Perform incremental dose experiment
Stage 3: Perform verification dose experiment
11.2.2.3 Stages 4 and 5: Interpretation of results and establishment of sterilization dose
11.2.3 Worked example for Method 2A (SIP less than 1,0)
11.2.3.1 Stage 1: Select SAL and obtain samples of product
11.2.3.2 Stage 2: Perform incremental dose experiment
11.2.3.3 Stage 3: Perform verification dose experiment
11.2.3.4 Stages 4 and 5: Interpretation of results and establishment of sterilization dose
11.2.4 Worked example for Method 2B
11.2.4.1 Stage 1: Select SAL and obtain samples of product
11.2.4.2 Stage 2: Perform incremental dose experiment
11.2.4.3 Stage 3: Perform verification dose experiment
11.2.4.4 Stages 4 and 5: Interpretation of results and establishment of sterilization dose
11.3 Worked examples for Method VDmax
11.4 Worked example of a sterilization dose audit for a dose established using Method 1, the findings from which necessitated augmentation of the sterilization dose
11.5 Worked example of a sterilization dose audit for a dose established using Method 2A, the findings from which necessitated augmentation of the sterilization dose
11.6 Worked example of a sterilization dose audit for a sterilization dose substantiated using Method VDmax25