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  • Validacion Refrigeradores

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    Andres Riascos Enriquez
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    Validacion refrigeradores

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    7 views4 pages

    Validacion Refrigeradores

    Uploaded by

    Andres Riascos Enriquez

    Copyright:

    © All Rights Reserved
    Download as PDF or read online from Scribd
    Flag for inappropriate content
    of 4
    Phillip A. Cloud f the tree types of devices — Utensil nsiruments, and equipment =the refrgerator-freezr falls under the definition of equipment ‘Therefore, it must be validated. ‘rss have no contol specifications and no measurements. OFen, such devices replace what an operator would do by hand. ‘They include ste plates, tir rods, and spatulas, Vensils do not need tobe validated, Glassware used to measure a volume is ceritied by the vendor. lasers take physical measurements and display their values bat have no control ‘ot analytical function. Such devies include stopwatces, timers, and thermometers Instrments donot need to be validated, but Validating a Refrigerator-Freezer In QC laboratories, rofigorator- {roezers are used to store in- process product samples for ‘ongoing quality control studies. As equipment, they must be validated. Philip A Cloud is validation special 1 Geneva Pharmaceuticals, 2635 Mivay Bis, Broomfield, CO 80038-0446, (303) 428-45, fox (303) 438-459, email pacloud@prodigy.net, Ts artcl is adaptad wit person from te author's boots, Pharmecesical Buipment Validation: The ‘imate Qualification Gudsbook and How to Develop and Manage Quaifcaton Protocols for FDA Compliance (ierpharm Press, Buflo Grove, 1, 1988 ana 1999, respectively). they do require inital and ongoing calibration programs. Egeinment performs a process to produce a resalt, producing an environment or performing an action on something. Whether simple device or a collection of ‘components, equipment must be validated, This article explains how to validate a refiigeratr-feezér tha is used for storing ‘in-process product samples. The materials are environmentally controlled at 2-8 °C in the reftigerator, ‘The Validation Protocol Following ae the major elements of a validation protocol fora refrigerator freezer. “The protocol example canbe used as a GMP ‘compliance guide, bu it shoud be tailored ‘to meet individual company equirement, ‘The equipment validation method

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