Method 1 (from 11137-2) determines the lowest sterilization dose necessary for the determined bioburden population. Bioburden counts must be 1000 CFU or less. Furthermore, the validation is less expensive because fewer tests are necessary. The VDmax25 option (formerly TIR27, now in 11137: 2006) is convenient when a company wants several product lines sterilized at the same minimum dose, when product is expensive to make, or for companies with markets where a 25 kGy dose is the accepted standard. ANSI/AAMI/ISO 11137: 2006 Sterilization of health care products-Radiation and TIR33: 2005 Sterilization of health care products-Radiation-Substantiation of a selected sterilization dose-Method VDmax25 kGy as a sterilization dose-Method VDmax, provide are established methods for completing a validation process. When gamma irradiation is selected for product sterilization, the dose at which the product is irradiated must be established and validated in accordance with appropriate AAMI standards. These TIRs reflect common industry practices that evolve from an accumulated process knowledge base. Occasionally, the AAMI Standards board provides additional guidance to specific standards in the form of a Technical Information Report (TIR). The Association for the Advancement of Medical Instrumentation ( AAMI) generates numerous standards used by professionals in the medical device industry. Radiation Request Form Submittal Guidelines.Sterile Barrier Integrity and Seal Strength.

Dangerous Goods (UN DG) Package Testing.Method Development and Validation Services.Radiation Sterilization Validation Services.Sustainable EO В® Sterilization Services.

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