Terminal Sterilization definition

Terminal Sterilization means the application of a lethal process (e.g., steam under pressure or autoclaving) to sealed containers for the purpose of achieving a predetermined sterility assurance level of usually less than 10−6, or a probability of less than one in one million of a non-sterile unit.
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Terminal Sterilization means the application of a lethal process (e.g. autoclaving) to sealed containers for the purpose of achieving sterility.
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Examples of Terminal Sterilization in a sentence

  • Craven, “Radiation and Ethylene Oxide Terminal Sterilization Experiences with Drug Eluting Stent Products,” AAPS PharmSciTech, December 2011, Vol.

  • Terminal Sterilization: The application of a lethal agent (e.g., heat) to sealed, finished drug products for the purpose of achieving a predetermined sterility assurance level (SAL) of usually less than 10-6 (i.e., a probability of a non-sterile unit of greater than one in a million).

  • Task Estimated Effort (hours) Estimated Duration (months) End Date Composition and Coatability [*] 3 20 May 2012 Terminal Sterilization Evaluation [*] 2 27 May 2012 Drying Study [*] 4 20 Jul 2012 Total elapsed time estimated: 4 months Total hours estimated: [*] hours Total direct costs: ~ $40,000 In all other respects, the terms and conditions of the Agreement remain in full force and effect.

  • As used in this document, the process of actively reducing the microbial burden on flight hardware so that the hardware is nearly free (consistent with the appropriate specifications) of all living microorganisms.A.16 Terminal Sterilization.

  • The MAH committed to add a Terminal Sterilization step in the current manufacturing process for the product.

  • As used in this document, the process of actively reducing the microbial burden on flight hardware so that the hardware is nearly free (consistent with the appropriate specifications)of all living microorganisms.A.16 Terminal Sterilization.

  • Whether the 505(b)(2) Pathway Is Necessary for Regadenoson Products That Differ From Lexiscan With Respect to the Plastic Prefilled Syringe and Whether Human Factors Studies, Extractable and Leachable Studies, and Terminal Sterilization Are Necessary Your second requested action has two parts.

  • If the pharmaceutical product has been found to deviate from the bioburden acceptance criteria, the decision on product release should be made upon reviewing the outcomes of actions taken in accordance with Section 13.4.Annex‌‌ The information contained in this Annex is provided as a supplement to the Guidance on the Manufacture of Sterile Pharmaceutical products by Terminal Sterilization.

  • Use of Terminal Sterilization Process Lastly, you request that FDA require that a “follow-on version of Lexiscan that differs from the RLD with respect to the plastic prefilled syringe packaging presentation .

  • The purpose of these notices is to give interested persons an opportunity to participate in the rule making prior to the adoption of the final rulesDEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration 21 CFR Parts 211, 314, and 514[Docket No. 91N-0074]RIN 0905 AD45Use of Aseptic Processing and Terminal Sterilization in the Preparation of Sterile Pharmaceuticals for Human and Veterinary Use;Extension of Comment Perioda g e n c y : Food and Drug Administration.

Related to Terminal Sterilization

  • Sterilization means the procedure that kills all microorganisms, including their spores.

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