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Pharma Industry - Tetratex

Pharma Industry - Tetratex
2Pages

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A Guide to Filtration Compliance in Food & Pharmaceutical Processing TETRATEX CONTACT® - Specifically designed for food, beverage & pharmaceutical contact applications Donaldson Membranes understand that in food, beverage and pharmaceutical processing hygiene, quality and consumer protection are of utmost importance. Fabric filters are an intrinsic part of these manufacturing processes; whether a filter collecting the actual product being manufactured or a pure environmental emission control measure; quite simply fabric filters are plastics. To secure the high level of protection for human health and the interest of the consumer the appropriate governing bodies have set out specific legislative measures that need to be adhered to. ELIMINATING CONTAMINATION RISKS - Toxicity, global & specific migration 50% Ethanol Tenax Tetratex Contact provides complete confidence: global migration results are significantly below those of the threshold limit according to both the EU & FDA regulations, article 10/2011 Food and Plastics guidelines requires both reaction and degradation to be assessed for all product components. Threshold Limit Value To fulfil this requirement Donaldson Membranes worked rigorously with independent test houses to prove that each of our product formulations meets the correct specific migration level and inevitable toxicity test as required. As the graph shows the migration test results speak for themselves… Tetratex Contact® Polyester Tetratex Contact® Polyester Antistatic Tetratex Contact® Polyester Hydrophobic Tetratex Contact® Polypropylene Tetratex Contact® Tetratex Contact® Woven PTFE PPS DECLARATION OF COMPLIANCE A Declaration of Compliance should not be issued unless all the individual starting components have been tested for migration & toxicity levels according to the positive substances list. If not, a risk assessment cannot be completed. Tetratex Contact ePTFE membrane filter media can be supplied with a declaration of compliance according to EU regulation 10/2011 and on request in accordance to FDA CFR 21 § 177 and will also satisfy the auditing criteria of IS022000 and IFS Version 6, as filters are a key element of the processing operations. Tetratex Contact is believed to be the only EU & FDA compliant ePTFE membrane filter media currently ava

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AUDITING CRITERIA - EU 10/2011 + GMP Compliance To satisfy the auditing criteria and as stipulated by Article 3 of EU Framework Regulation 1935/2004, all parties involved in the manufacture of the filtration elements need to comply to Good Manufacturing Practice (GMP). Take the time to ask the right questions... Toxicity tests must be completed on both starting components and global migration. We have adopted the principles of HACCP to eliminate contamination within the manufacturing process, as a practice to ensure that… Control critical points are identified Risks are defined Corrective...

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Pharma Industry - Tetratex 2Pages

Catalog excerpts

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Pharma Industry - Tetratex
2Pages