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Management of Operations & Quality through Statistical Tools
Manufacturing tanks are various categories like Mixing tank, Holding tank,storage tank(WFI, Purified water).They are very sophisticated equipment having complex heating and cooling arrangement in jackets to maintain the temperature of vessel.Material of construction for tanks are SS316L and jackets are SS304. Water for Injection Storage tanks should be sterilized at regular intervals so as to …
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Sterilization “The act or process, physical or chemical, that destroys or eliminates all viable microbes including resistant bacterial spores from a fluid or a solid.” For Large volume parenterals products sterilization is ultimate steps which assure the manufacturer for complete removal or destroy of viable microbes, basis of successful sterilization cycle. Any sterilization cycle consist …
Filtration is backbone for the sterile drug manufacturing.Sterile products are difficult to prepare and consist of more sophistication than any other dosage form. The drug product which directly goes to systemic circulation (veins,blood vessels, intravenous) shall have no traces of particle size more than 0.2 micron, which can be performed by filtration technique. Filtration is …
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