{"id":1137,"date":"2018-03-14T11:37:11","date_gmt":"2018-03-14T10:37:11","guid":{"rendered":"http:\/\/www.f-franceschetti.it\/?page_id=1137"},"modified":"2023-03-23T10:51:07","modified_gmt":"2023-03-23T09:51:07","slug":"medical-compounds-produced-in-a-white-room","status":"publish","type":"page","link":"https:\/\/www.marfran.com\/en\/innovation\/medical-compounds-produced-in-a-white-room\/","title":{"rendered":"Medical compounds produced in a clean room"},"content":{"rendered":"

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MEDICAL COMPOUNDS PRODUCED IN A CLEAN ROOM<\/h2>\n<\/div>\n<\/div><\/div><\/div><\/div><\/section>
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With our MARFRAN.MED<\/b> we supply the pharmaceutical <\/b>and medical industry<\/b>, producing in a controlled environment, in accordance with ISO 9001<\/b> and ISO 13485<\/b> and the ISO 14644<\/b> standard.
\nThe materials are basedon both styrenic block copolymers (TPE-SEBS) and polyolefins (TPO).<\/p>\n

The high quality of MARFRAN.MED allows to create products:
\n1. Highly flexible
\n2. With rubber-like appearance and feeling
\n3. PVC-free, phthalate-free, silicon-free and latex-free in the whole production chain
\n4. Highly transparent and easy to color
\n5. Recyclable
\n6. Sterilizable with gamma rays, EtO and steam (variable according to grades)<\/p>\n

We produce according to ISO 90001 and ISO 13485 standards (which regulate the production process of medical products) in a new clean room<\/b> specifically built, highly automatized and subjected to cleaning and management procedures.<\/p>\n

We have choosen the best technology<\/b> to provide our clients the best quality level: our compounds must undergo a strict selection process of the finale granule through an optic system.<\/p>\n

We select medical raw materials<\/strong> to create the MARFRAN.MED TPE compound, and we guarantee the reliability of both the formulation and the sources of raw materials.<\/p>\n

We also guarantee a two-year \u201cNotification of Change<\/b>\" in case a change in supplier, raw material or formulation is necessary due to extenuating circumstances.<\/p>\n

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Each family of compound underwent biocompatibility tests according to the following regulations.<\/p>\n

ISO 10993<\/b> (for biocompatibility, safety and implantability of medical devices), and more specifically:
\n\u2022 ISO 10993-4 Hemolysis
\n\u2022 ISO 10993-5 Cytotoxicity
\n\u2022 ISO 10993-10 Irritation and skin sensitization
\n\u2022 ISO 10993-11 Systemic toxicity<\/p>\n

USP Class VI<\/strong> (quality, pureness, strength and consistency standards of American pharmacopeia), and more specifically:
\n\u2022\u00a0Intracutaneous test
\n\u2022\u00a0Systemic injection test (Acute Systemic Toxicity)
\n\u2022\u00a0Implantation test<\/p>\n

We satisfy the highest requirements of Class VI because of the low level of toxicity<\/strong> of our compounds, thanks to our production environment with controlled contamination and the accurate selection of medical raw materials.<\/p>\n

The range of MARFRAN.MED<\/strong> products finds application in the production of items dedicated to the medical and pharmaceutical industry:
\ninfusion and transfusion lines, drainage bags, catheters, components for hemodialysis and urodynamic devices, devices for oxygen therapy, surgical instruments, tubes for peristaltic pumps, micro-balloons for catheters, breathing aids, individual protection masks, fittings, membranes elastics, dispensers, devices for pressure gauges, gaskets, products for orthopedics, containers for analyzes, valves\u2026 and many other items.<\/p>\n

Don’t hesitate to contact us to find out more about it!<\/strong><\/p>\n

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The MARFRAN.MED compounds can be processed<\/strong> through extrusion, co-extrusion, injection or bi-injection molding, blow-molding, micro-extrusion, and micro-molding processes.<\/p>\n

Our products range includes materials that can adhere<\/strong> to Polyolefine, and special grades that stick to polymers such as PC, ABS, SAN, and ASA.<\/p>\n

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R&D Department can work together with designers and technicians in order to develop customized compounds dedicated to specific applications.<\/p>\n<\/blockquote>\n

For more information about MARFRAN.MED please fill in the form below or write to: info@marfran.com<\/a><\/p>\n

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Contact us<\/h2>\r\n
If you are interested in our MARFRAN MED<\/div>\r\n <\/div>\r\n \r\n \r\n
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