{"id":1755,"date":"2024-06-26T11:29:42","date_gmt":"2024-06-26T09:29:42","guid":{"rendered":"https:\/\/fm-medientechnik-test.de\/?page_id=1755"},"modified":"2024-10-08T08:38:31","modified_gmt":"2024-10-08T06:38:31","slug":"elements-for-pharma","status":"publish","type":"page","link":"https:\/\/sinbran.de\/en\/products\/elements-for-pharma\/","title":{"rendered":"Elements for pharma"},"content":{"rendered":"

Pharmaceuticals<\/h1>\n

SINBRAN\u00ae<\/sup> filter elements for industrial applications in the pharmaceutical industry<\/strong><\/p>\n

SINBRAN\u00ae<\/sup> Pharma filter elements are precisely designed to meet the demanding requirements of the pharmaceutical industry. We are the only filter manufacturer able to produce USP Class VI-compliant filter elements with antistatic properties.
\nDuring the packaging process, these are subjected to a germ-reducing treatment.<\/p>\n<\/div>

<\/i><\/i><\/span>REQUIREMENTS FOR PHARMACEUTICAL CONTACT MATERIALS<\/span><\/a><\/h4><\/div>
SINBRAN\u00ae <\/sup> In the pharmaceutical industry, materials that come into contact with pharmaceutical products must comply with strict regulations:
\n1. Authorisation of the materials used for pharmaceutical contact.
\n2. Manufacture in accordance with the “Good Manufacturing Practice” (GMP) guidelines, as required by EU Regulation 2023\/2006 and FDA Regulation 21CFR177.XXXX.<\/p>\n

SINBRAN\u00ae <\/sup> filter elements are made exclusively from materials that have been classified as safe in accordance with these regulations. No auxiliary materials such as adhesives, solvents or casting compounds are used during the manufacturing process. Production is carried out in full compliance with the requirements of EU 2023\/2006.<\/div><\/div><\/div>

<\/i><\/i><\/span>OPTIMISED MATERIAL SELECTION<\/span><\/a><\/h4><\/div>
SINBRAN\u00ae<\/sup> filter elements are made exclusively from polyethylene, PTFE, stainless steel and pharmaceutically approved silicone seals.<\/p>\n

SINBRAN\u00ae<\/sup> filter elements and their components are manufactured using precise thermal and mechanical processes that exclude the use of foreign materials such as lubricants, oils, adhesives, casting compounds or solvents. This guarantees that pharmaceutical products are not contaminated in any way.<\/p>\n

The porous sintered body consists of firmly fused particles that prevent particles from being released from the filter element. The ePTFE membrane is robustly bonded to the sintered surface and ensures efficient dust separation, thus preventing contamination of the filter element.<\/p>\n

The stainless steel of the flange reinforcements is chemically inert to the product.<\/p>\n

The seals are made of silicone that is approved for pharmaceutical use.<\/div><\/div><\/div>

<\/i><\/i><\/span>COMPLIANCE WITH GOOD MANUFACTURING PRACTICE (GMP)<\/span><\/a><\/h4><\/div>
\n

EU Regulation 2023\/2006 ensures that “Good Manufacturing Practice” guarantees that products meet the required quality standards and do not endanger human health or change the pharmaceutical product in an unauthorised manner.<\/p>\n

To ensure this, the regulation defines specific requirements and measures. SINBRAN\u00ae<\/sup> Pharma elements are manufactured and packaged according to these standards.<\/p>\n

SINBRAN\u00ae<\/sup> Pharma filter elements are free of unintentional contamination. Sterilisation is possible depending on the selected process. Please contact us.<\/p>\n<\/div><\/div><\/div>

<\/i><\/i><\/span>CONFORMITY AND SAFETY<\/span><\/a><\/h4><\/div>
The conformity of the materials used is ensured by their listing in the relevant regulations. In addition, the materials are subject to regular migration tests by independent testing institutes to ensure their suitability. Production is fully compliant with GMP guidelines.<\/p>\n

Detailed specifications for the intended use are available from Sinbran GmbH. The overall suitability of SINBRAN\u00ae<\/sup> Pharma filter elements is confirmed by corresponding declarations of conformity.<\/p>\n

Certificate of Conformity for USP Tests<\/strong>
\nSINBRAN\u00ae<\/sup> PHARMA filter elements are manufactured exclusively at our plant in Germany. Various studies are carried out to determine the biocompatibility of this product in accordance with USP <87> and USP <88>.<\/p>\n

The cytotoxicity study shows that no cytotoxic substances are released. In the acute systemic toxicity study, no significant systemic reactions occur. The toxicity study shows no significant deviations. The implantation test shows that the macroscopic reaction of the test item does not significantly differ from the USP negative control.<\/p>\n

The results of these tests confirmed that the SINBRAN\u00ae<\/sup> PHARMA filter element type “P” meets the strict requirements of USP Class VI.<\/div><\/div><\/div>

<\/i><\/i><\/span>MATERIAL COMPOSITION<\/span><\/a><\/h4><\/div>
\n

SINBRAN\u00ae<\/sup> Pharma filter elements are made exclusively of polyethylene, expanded polytetrafluoroethylene (ePTFE), silicone seals and, if necessary, stainless steel. For antistatic applications, carbon black is embedded in the polyethylene.<\/p>\n

Polyethylene:<\/strong> Listed in the EU Union list 10\/2011 under Ref. No. 125 and recognised by the FDA in 21CFR177.1520.
\nPTFE:<\/strong> Listed in the EU Union list 10\/2011 under Ref. No. 281 and recognised by the FDA in 21CFR177.1550.
\nSilicone:<\/strong> Evaluated in the BfR database under Recommendation 150 “XV. Silicone” and recognised by the FDA in 21CFR177.2600.
\nStainless steel:<\/strong> Generally recognised as a suitable material for pharmaceutical contact.<\/p>\n<\/div><\/div><\/div>

<\/i><\/i><\/span>OVERVIEW OF ADVANTAGES<\/span><\/a><\/h4><\/div>
\n

1. Excellent filtration properties:<\/strong><\/p>\n

    \n
  • The micro-fine structure of the membrane ensures separation efficiency of >99.9%.<\/li>\n
  • The ePTFE surface minimises product adhesion thanks to its anti-adhesive properties.<\/li>\n
  • The smooth surface allows product residues to be quickly removed.<\/li>\n<\/ul>\n

    2. Minimal pressure loss:<\/strong><\/p>\n

      \n
    • Enables double the throughput at the same load.<\/li>\n<\/ul>\n

      3. Conforming materials:<\/strong><\/p>\n

        \n
      • Use of only polyethylene, ePTFE, stainless steel and silicone seals.<\/li>\n<\/ul>\n

        4. Manufactured according to GMP:<\/strong><\/p>\n

          \n
        • The highest level of care in production.<\/li>\n<\/ul>\n

          5. Available declarations of conformity:<\/strong><\/p>\n

            \n
          • A declaration of conformity confirms suitability for use in the pharmaceutical industry.<\/li>\n<\/ul>\n

            Discover the advantages of SINBRAN\u00ae<\/sup> Pharma filter elements for your pharmaceutical applications and ensure the highest quality and reliability.<\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":4,"featured_media":0,"parent":1849,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"100-width.php","meta":{"footnotes":""},"class_list":["post-1755","page","type-page","status-publish","hentry"],"yoast_head":"\nSINBRAN\u00ae filter modules for pharmaceuticals<\/title>\n<meta name=\"description\" content=\"High-quality SINBRAN\u00ae pharma modules for maximum purity and safety in the pharmaceutical industry. 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