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Vol. 3, Issue 4, Part A (2018)

Microbial analysis of water system for veterinary vaccine manufacturing facility

Author(s): Hardik Mistry, Tejas Patel and Asha Patel
Abstract: Water is very widely used in the pharmaceutical, biopharmaceutical and biological industry for various purpose like as raw material, ingredient as a solvent in processing, formulation and manufacturing of the wide range of the finish products, as API and intermediates and analytical reagents. That’s why regulatory requirements over control of the quality of various types of the waters throughout the production, storage and distribution processes, including microbiological and chemical quality, are very stringent. Lack of monitoring over any of the parameters for the Potable, Purified or Water for Injection can leads to the loss of the costly drug product or drug substance.
Veterinary vaccines are considered as the sterile parenteral dosage form and water used for the various purposes in the veterinary vaccine manufacturing facility must have to comply with the regulatory requirements. So the aim of the present work is to bioburden testing and check the suitability of the different types of the water used for the various applications in vaccine manufacturing facility using the various techniques like MPN method, Plate count method, Filtration method and based on the results of the bioburden testing and identification of pathogens and conclusion to be done for the compliance and suitability of the water used for the manufacturing of the vaccines as sterile parenteral dosage form to have the claimed safety, integrity, strength, purity and quality.
Pages: 24-29  |  958 Views  16 Downloads
How to cite this article:
Hardik Mistry, Tejas Patel, Asha Patel. Microbial analysis of water system for veterinary vaccine manufacturing facility. Int J Vet Sci Anim Husbandry 2018;3(4):24-29.
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International Journal of Veterinary Sciences and Animal Husbandry