ANSI AAMI ISO TIR15843-2000 pdf download Sterilization of health care products- Radiation sterilization- Product families and sampling plans for verification dose experiments and sterilization dose audits, and frequency of sterilization dose audits
In the performance of a sterilization dose audit in accordance with Method 1 or 2 of ISO 11137, augmentation of the sterilization dose as an interim measure is permitted. However, the procedures for augmentation of the sterllization dose when using these alternative sampling plans have not yet been developed. In the event of failure of the sterilization dose audit when using the alternative sampling plans, the sterilization dose shall be reestablished.
5.3 Selection and testing of product
5.3.1 Selection
5.3.1.1 Method of selection The method of selecting product units for testing shall be in accordance with ISO 11137:1995, B.3.1.
5.3.1.2 Sample item portion (SIP)
5.3.1.2.1 Whenever practicable, an entire product unit should be used ftor testing, but it is recognized that this is not always possible. In such situations, a selected portion of a product unit (sample item portion, SIP), which is convenient to handle during testing, may be substituted. The SIP should be as large a portion of the product unit as is possible to manipulate readily in the laboratory. SIP can be calculated on the basis of length, mass, volume, or surface area of the product unit to be tested, as appropriate.
5.3.1.2.2 The SIP shall represent validly the microbial challenge presented to the sterilization process and the diverse elements of complex product units. The distribution of viable microorganisms on the product unit shall be considered and, if it can be demonstrated that these microorganisms are evenly distributed, the SIP may be selected from any single location on the product unit. In the absence of such a demonstration, the SIP shall be constituted from several portions of a product unit selected at random.
5.3.1.2.3. Twenty SIPs should be prepared and a test of sterility performed in accordance with ISo 11737-2. At least 17 of these tests shall be positive. If this criteria is not achieved, a larger SIP is required. NOTE- The occurrence of 17 positives out of 20 tests of sterility indicates that there is an average of 2 cfwSIP. If the entire product unit is tested, no minimum number of positives is specified for noniradiated samples.
5.3.1.2.4 If a product unit or SIP cannot be tested in available laboratory glassware, it may be divided into two or more containers and these containers scored together as one unit. If in the performance of a test of sterility one container yields a positive result, the entire unit is considered positive.
5.3.1.2.5 If the product unit has a label claim of sterility of the fluid path only, testing of the fluid path should be considered as the entire product unit (ie., SIP = 1.0). .
5.3.1.2.6 The preparation and packaging of an SIP shall be conducted under conditions chosen to minimize alterations in the bioburden. Environmentally contolled conditions should be used for preparation of SIPs. Packaging materials and conditions should be equivalent to those used for the finished product.
5.3.1.2.7 Packaging shall be capable of withstanding the radiation doses to be delivered. Packaging for products, or portions thereof, for iradiation shall be chosen in order to minimize contamination during post-irradiation handling.