Pyrogen definition

Pyrogen means a substance or agent that tends to cause a rise in body temperature or fever.
Pyrogen means a substance that induces a febrile reaction in a patient.

Examples of Pyrogen in a sentence

  • Bacterial Endotoxin (Pyrogen) Testing – The USP Bacterial Endotoxin Test, or verified equivalent, shall be used to ensure compounded sterile products do not contain excessive endotoxins.

  • NOTE: Pyrogen free pipettes, micropipettor tips, test tubes, and other accessories are commercially available.

  • Additional speciation for infusion set: Single use, Sterile Non-Toxic Pyrogen free PVC material with inbuilt Air vent with bacteria barrier, fluid filter in the Drip chamber.

  • Baup, Ueber eine neue Pyrogen-Citronensäure, und über Benennung der Pyrogen- Säuren überhaupt.

  • Pyrogen: A substance that induces a febrile reaction in a patient.

  • Additionally the need for future inno- vations within BET that provide solutions to current challenges with modern pharmaceutical and biopharmaceutical products for the day-to-day testing should be in our focus.Enough reasons to attend this Endotoxin and Pyrogen Session at PharmaLab 2021.

  • See Section IX.C. Pyrogen on plastic containers can be generally removed by multiple WFI rinses.

  • Otherwise, we recommend that you assess material-mediated pyrogenicity using traditional biocompatibility extraction methods (e.g., 50 °C for 72 hours; 70 °C for 24 hours; or 121 °C for 1 hour per ISO 10993-12:2012), using a pyrogenicity test such as the one outlined in the USP 34 <151> Rabbit Pyrogen Test or 45 Historically, some have proposed the use of anticoagulant in a four hour canine in vivo thrombogenicity study to support regulatory submissions.

  • Pyrogen and Endotoxins Testing: Questions and Answers, at 4, and For the Submission of Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products, at 8.

  • The product bacterial endotoxin limits are based on FDA’s Guidance for Industry - Pyrogen and Endotoxins Testing: Questions and Answers (June 2012) and are verified using Limulus Amebocyte Lysate (LAL) testing Packaging and shelf- life validation tests were completed in compliance with ISO 11607-1:2009 Packaging for Terminally Sterilized Medical Devices.

Related to Pyrogen

  • Halogen means one of the chemical elements chlorine, bromine or iodine.

  • Catalyst means a substance whose presence enhances the reaction between chemical compounds.

  • Novartis shall have the meaning set forth in the Preamble.

  • nanomaterial means a natural, incidental or manufactured material containing particles in an unbound state or as an aggregate or as an agglomerate and where, for 50 % or more of the particles in the number size distribution, one or more external dimensions is in the size range 1-100 nm;

  • NPS means nominal pipe size.

  • Raptor means all birds of the orders Falconiformes and Strigiformes, commonly called falcons,

  • Elan means Elan Corp and its Affiliates.

  • Pyrolysis means the thermal degradation of a substance in the absence of any oxidising agent, which does not form part of the substance itself, to produce char and gas and/or liquid; and

  • Pyrophoric material means any liquid that ignites spontaneously in dry or moist air at or below 130° F (54.4° C) or solid, other than one classed as an explosive, which under normal conditions is liable to cause fires through friction, retained heat from manufacturing or processing, or which can be ignited readily and, when ignited, burns so vigorously and persistently as to create a serious transportation, handling, or disposal hazard. Included are spontaneously combustible and water-reactive materials.

  • Epinephrine auto-injector means a device for immediate self-administration or administration by another trained person of a measured dose of epinephrine to a person at risk of anaphylaxis.

  • Siemens means Siemens AG (Germany) and its Affiliates.

  • Bioassay means the determination of kinds, quantities or concentrations and, in some cases, the locations of radioactive material in the human body, whether by direct measurement, in vivo counting, or by analysis and evaluation of materials excreted or removed from the human body. For purposes of these rules, “radiobioassay” is an equivalent term.

  • API means the American Petroleum Institute.

  • BMS means the Company, all related companies, affiliates, subsidiaries, parents, successors, assigns and all organizations acquired by the foregoing.

  • DS Electric generation service that is provided at retail pursuant to the Applicable Legal Authorities under the Company’s retail electric tariffs and under any other agreements or arrangements between the Company and Customers, to any Customer that is not being served by an EGS. Default Allocation Assessment – shall have the meaning ascribed to it under the PJM Agreements. Delivery Period – The delivery period specified in an Appendix C Transaction Confirmation. Delivery Point – Means the applicable zone of the Company as designated by PJM. DS Customer(s) – Retail customers who are provided Default Service pursuant to the terms of this Agreement, the Applicable Legal Authorities and the Company’s retail tariffs.

  • APC means the Ambulatory Payment Classification system under 42 CFR 419.31 used by Medicare for grouping clinically and resource-similar procedures and services.

  • Aerosol coating product means a pressurized coating product containing pigments or resins that dispenses product ingredients by means of a propellant, and is packaged in a disposable can for hand-held application, or for use in specialized equipment for ground traffic/marking applications.

  • CTI means CTI Logistics Limited (ABN 69 008 778 925) and/or any Affiliate of CTI Logistics Limited as the case may be, which performs all or any of the Services.

  • Cannabidiol means a finished preparation containing, of its total cannabinoid content, at least 98 percent cannabidiol and not more than 0.90 percent tetrahydrocannabinol by volume that has been extracted from marijuana or synthesized in a laboratory.

  • SDS means safety data sheets;

  • Merck has the meaning set forth in the preamble.

  • Tetrahydrocannabinol means the natural or synthetic equivalents of the substances contained in the plant, or in the resinous extractives of, Cannabis sativa, or any synthetic substances, compounds, salts, or derivatives of the plant or chemicals and their isomers with similar chemical structure and pharmacological activity.

  • EMD means Earnest Money Deposit.

  • Manufacturing Technology means any and all patents, patent applications, Know-How, and all intellectual property rights associated therewith, and including all tangible embodiments thereof, that are necessary or useful for the manufacture of adeno- associated viruses, adeno-associated virus vectors, research or commercial reagents related thereto, Licensed Products, or other products, including manufacturing processes, technical information relating to the methods of manufacture, protocols, standard operating procedures, batch records, assays, formulations, quality control data, specifications, scale up, any and all improvements, modifications, and changes thereto, and any and all activities associated with such manufacture. Any and all chemistry, manufacturing, and controls (CMC), drug master files (DMFs), or similar materials provided to regulatory authorities and the information contained therein are deemed Manufacturing Technology.

  • SCI has the meaning set forth with respect thereto in the preamble. ---

  • ISIS means the department’s individualized services information system.