ANSI AAMI 11138-4 pdf free download – Biological indicators for dry heat sterilization processes

ANSI AAMI 11138-4 pdf free download.Sterilization of health care products—Biological indicators—Part 4: Biological indicators for dry heat sterilization processes.
6 Suspension The requirements of ISO 1 1 1 38-1 apply. 7 Carrier and primary packaging 7.1 The suitability of the carrier and primary packaging materials for biological indicators for use in dry heat sterilization processes shall be demonstrated in accordance with the requirements of ISO 11 1 38-1:201 7, 5.2 and Annex B. 7.2 The exposure conditions to determine compliance shall be the following: a) minimum exposure temperature: greater than or equal to 5 °C above the manufacturer’s stated maximum temperature; b) sterilizing agent: dry heat in ambient air; c) maximum exposure temperature: as stated by the manufacturer; if not stated by the manufacturer, the maximum exposure temperature shall be greater than or equal to 1 80 °C; d) exposure time: greater than or equal to 30 min. NOTE These conditions have been selected to represent a realistic challenge to the carrier while remaining within the practical limits of a dry heat sterilization process. 8 Inoculated carriers and biological indicators The requirements of ISO 1 1 1 38-1 apply. 9 Population and resistance 9.1 The manufacturer shall state the resistance characteristics according to ISO 11 1 38-1:201 7, 6.4. 9.2 The viable count shall be stated with increments less than or equal to 0,1 × 1 0 n per unit (e.g. per ml of suspension, per inoculated carrier or per biological indicator). 9.3 For inoculated carriers and biological indicators, the viable count shall be greater than or equal to 1,0 × 1 0 6 . 9.4 The resistance shall be expressed as the D value in minute at 1 60 °C. The D value of each batch/lot of biological indicators or inoculated carriers shall be stated in minutes to one decimal place at 160 °C. 9.5 Suspensions, inoculated carriers or biological indicators containing Bacillus atrophaeus spores shall have a D 1 60 value of not less than 2,0 min when tested according to the conditions in Annex A. Other microorganisms shall have D values supporting the application. The z value of the test organisms in the suspension, on the inoculated carrier or in the biological indicator shall be determined at not less than three temperatures, in the range of 1 50 °C to 180 °C. These data shall be used to calculate the z value, which shall be greater than or equal to 20 °C (see Annex B). 9.6 The resistance characteristics specified in this document and any other document shall be defined using the specific critical variables associated with the referenced sterilization process. 9.7 D values are determined according to methods given in ISO 11 1 38-1 :201 7, Annexes C and D. 9.8 Determination of D value and survival-kill response characteristics require the use of a resistometer applying the reference resistometer process parameters (see Annex A). NOTE The values stated above would fit a dry heat sterilizer with forced air distribution, running a cycle of 160 °C with a holding time of 2 h. 9.9 The survival-kill window should be calculated using the formulae in ISO 1 1 1 38-1 :201 7, Annex E. NOTE This information can be of value to the user when comparing different batches from the same manufacturer. EXAMPLE Using the formulae in ISO 1 1 1 38-1 :201 7, Annex E, with the minimum population and minimum D value requirements specified in this document, the survival-kill response characteristics are — at 160 °C: survival time greater than or equal to 8 min and kill time less than or equal to 20 min.ANSI AAMI 11138-4 pdf download.