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Meeting Regulatory Requirements for Vent Filtration on Water For Injection (WFI) Tanks

Pall Life Sciences - Laboratory, Food, Beverage

Meeting Regulatory Requirements for Vent Filtration on Water For Injection (WFI) Tanks

23 Dec 2015

Water systems for the production, storage and distribution of purified water or WFI remain critical points in pharmaceutical production plants. A key concern of regulatory authorities is the installed vent filter on high purity water-holding tanks. This document provides Pall’s technical recommendations to meet current regulatory requirements and to ensure sterile protection of the tank utilizing Emflon® HTPFR or PFR vent filters, built-in drainage utilizing Pall Advanta™ liquid and gas filter housings, prevention of condensate utilizing Pall Advanta housing trace heaters and reliable water intrusion testing utilizing the Palltronic® AquaWIT filter integrity test system.

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FiltrationFiltration and microfiltration are used to separate solids, particulates or large molecules from fluids (liquid or gases) in order to purify the filtrate. Explore a range of filter formats, including filter paper, plates and membranes for your separation needs. While larger particulates may be separated by gravity filtration, smaller particulates may require additional force for timely separation. Microfiltration equipment includes vacuum filters, as well as positive pressure, crossflow and centrifugal filtration devices. Find the best filtration products in our peer-reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.Water PurificationThere are a number of water purification methods available to remove contamination from laboratory water. These systems include demineralization, reverse osmosis, filtration and ultrafiltration. A combination of methods is sometimes necessary to achieve purified water suitable for use in experiments.RegulatoryPharmaceutical regulations impact on all areas of drug development, manufacture and control and supply. Services are provided from the early stages of drug development and clinical trials through to dossier submission, approval and marketing. Regulatory also includes submission of analytical studies from the pharmaceutical product and safety. Bioprocessing / FermentationBioprocessing is the use of biological materials to perform commercial, scientific or medical research processes. Biological materials used include cells, enzymes and organisms. Usually bioprocessing requires a batch or continuous bioreactor such as a fermentor or cell culture system. The advantages of using a reactor include high productivity, easy configuration, adjustable values and automation.PharmaceuticalsPharmaceuticals are medicinal drugs used in healthcare to diagnose, prevent, cure and treat illnesses. Pharmaceuticals that are excreted after use appear in wastewater and can have detrimental effects on the environment.ManufacturingManufacturing is the production of merchandise for use or sale using labor and machines, tools, chemical and biological processing, or formulation.Water Content AnalysisWater content analysis is crucial for determining the moisture levels in food, pharmaceuticals, chemicals, and other materials. Accurate measurement ensures product quality and shelf-life. Explore water content analysis tools in our peer-reviewed product directory; compare products, check reviews, and get pricing directly from manufacturers.Pure WaterPure water is processed to remove significant level of contaminants and is suitable for use in many laboratory applications.Ultrafiltration

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