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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Terminal Sterilization traditionally means that the sterilization of the container
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Examples of Terminal Sterilization in a sentence

  • In the FEDERAL REGISTER of October 11, 1991 (56 FR 51354), theagency published a proposed rule entitled "Use of Aseptic Processing and Terminal Sterilization in the Preparation of Sterile Pharmaceuticals 1This guidance has been prepared by the Sterility Technical Committee of the Chemistry Manufacturing Controls Coordinating Committee of the Center for Drug Evaluation and Research (CDER), and the Center for Veterinary Medicine (CVM), at the Food and Drug Administration.

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

  • 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.

Related to Terminal Sterilization

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

  • Gasification means the substoichiometric oxidation or steam reformation of a substance to produce a gaseous mixture containing two or more of the following: (i) oxides of carbon; (ii) methane; and (iii) hydrogen;

  • Slug loading means any pollutant, including oxygen demanding pollutants, released in a discharge at a flow rate and/or pollutant concentration as to cause interference in the POTW.

  • Supply Point means the point of connection between the licensed network and your apparatus or equipment.

  • Manufacturing Site means the facilities where a Compound is Manufactured by or on behalf of a Party, as such Manufacturing Site may change from time to time in accordance with Section 8.7.