Medical Silicone & TPE Tubing

Transcription

1 Medical Silicone & TPE Tubing

2 Welcome to our Company! PENTASIL MED-TECH ENGINEERING designs, produces and supplies a great variety of flexible tubing and profiles made of Ultra Performance Silicones, TPEs and Specialty Polymers for medical and industrial use. Our Company uses highest quality Silicone Elastomers, Latex free, Thermoplastic & Specialty Polymers with long term tested chemical formulas, and offers in the world market products in conformity to International Standards i.e. ISO 9001:2008, ISO 13485:2012, Directives 93/42/ EEC, European Pharmacopoeia, United States Pharmacopoeia, FDA a.o. Our product portfolio is mainly adressed to markets with strict specifications and includes: ñ Silicone Tubing for Medical use with or without X-Ray opaque line Our Medical Silicone Tubing Portfolio is based on our Silopure (Platinum Cured), Siloplus (Peroxide Cured), Silopure X & Siloplus X (X-Ray detectable) & Siloflow (for peristaltic pumps) silicone elastomers. ñ TPE (Thermoplastic Elastomer) Tubing for Medical use Our TPE Tubing Portfolio is based on our Pentalene TPE/SEBS & SEPS and other Polymers. ñ Flexible Clear Thermoplastic Tubing for Medical use Our alternative Medical Thermoplastic Tubing Portfolio is based on our Pentavin & Pentavin/G (DEHP free) families of Thermoplastic Polymers. ñ Project Development Designing and Engineering of products and devices for medical use. ñ Sterilized Silicone & TPE Tubing (ready to use) in pouches for Medical use Our Sterile Silicone & TPE Tubing (ready to use) Portfolio is based on Accu-Ster Vaporized Hydrogen Peroxide Plasma sterilization method, developed by PentaSil. We guarantee top quality and no chemical residues in the product with respect to all our customers, employees and the enviroment. 2 PENTASIL MED-TECH ENGINEERING is certified to EN ISO 9001:2008, EN ISO 13485:2012, all of its products carry the CE mark (93/42/EEC) and is registered to IHK Limburg (Lahn).

3 Our Medical Tubing Portfolio at a glance SILOPURE MTi Silicone Tubing PLATINUM CURED FORMULAS see page 4 SILOPLUS MT Silicone Tubing SILORAY MTX X-Ray opaque coextruded Silicone Tubing SILOFLOW PP Peristaltic Pumps Silicone Tubing Multi Lumen/Multi Channel Silicone Tubing PEROXIDE CURED FORMULAS PEROXIDE CURED FORMULAS PEROXIDE CURED FORMULAS PLATINUM CURED and PEROXIDE CURED FORMULAS see page 5 see page 6 see page 7 see page 8 Sterile Silicone Tubing PENTALENE EPT Thermoplastic Elastomer (TPE) Tubing IN DOUBLE BAG POUCHES V-H2O2 PLASMA STERILIZED see page 9 PVC, SILICONE and LATEX FREE FORMULAS see page 10 3

4 SILOPURE MTi - PLATINUM CURED FORMULAS SILICONE TUBING FOR MEDICAL USE SILOPURE MTi - PLATINUM CURED FORMULAS Silopure Medical (Platinum Cured) New Generation Silicone (VMQ Quality Medical Grade, Non-Recycled) for UltraClear process None Shape Circular -45 C to +180 C Excellent heat stability, highly transparent, clear, odourless, tasteless, nontoxic, sterilizable (plasma, steam, EtO a.o.), unmeltable, highly elastic, non deformable, top mechanical properties, top clarity From I.D. O.D = 1,0 2,0 mm up to I.D. O.D = 12,5 19,0 mm (over 150 combinations). Other dimensions after request Suction (single use), liquid transportation & drainage in all human & veterinary surgical operations. Connection of all types medical equipment & devices Length/ Package Available Diameters Inner Ø Outer Ø m rolls (or other length on request) in PE transparent bags firmly sealed ΕΝ ISO 9001: 2008, EN ISO 13485:2012, ISO 10993, CE Mark Class Ι (MDD 93/42/EEC), USP VI (after agreement) , and over 150 combinations

5 SILOPLUS MT - PEROXIDE CURED FORMULAS SILICONE TUBING FOR MEDICAL USE SILOPLUS MT - PEROXIDE CURED FORMULAS Siloplus Medical (Peroxide Cured) Silicone (VMQ Quality Medical Grade, Non-Recycled) for UltraSafe process None Shape Circular -45 C to +180 C Excellent heat stability, transparent, odourless, tasteless, non-toxic, sterilizable (plasma, steam, EtO a.o.), unmeltable, highly elastic, non deformable, top mechanical properties, top safety From I.D. O.D = 1,0 2,0 mm up to I.D. O.D = 12,5 19,0 mm (over 150 combinations). Other dimensions after request Suction (single use), liquid transportation & drainage in all human & veterinary surgical operations. Connection of all types medical equipment & devices Length/ Package Available Diameters Inner Ø Outer Ø m rolls (or other length on request) in PE transparent bags firmly sealed ΕΝ ISO 9001: 2008, EN ISO 13485:2012, ISO 10993, CE Mark Class Ι (MDD 93/42/EEC), USP VI , and over 150 combinations

6 SILICONE TUBING WITH RADIO OPAQUE (X-RAY DETECTABLE) LINE FOR MEDICAL USE SILORAY MTX - PLATINUM CURED & PEROXIDE CURED FORMULAS SILORAY MTX - PLATINUM CURED & PEROXIDE CURED FORMULAS 6 RM PERFOand ANCE TOP SAFETY Tubing: Silopure Medical (Platinum Cured) & Siloplus Medical (Peroxide Cured) Silicone (VMQ Quality Medical Grade, Non-Recycled) Radio Opaque Line: Silopure X (Platinum Cured) & Siloplus X (Peroxide Cured) Silicone (VMQ Quality Medical Grade, Non-Recycled) Tubing: None Radio Opaque Line: Blue (green and yellow available) Shape Circular -45 C to +180 C X-Ray detectable coextruded (not glued) line. Excellent heat stability, transparent, odourless, tasteless, non-toxic, sterilizable (plasma, steam, EtO a.o.), unmeltable, highly elastic, non deformable, top mechanical properties, TOP SAFE From I.D. O.D = 3,0 5,0 mm up to I.D. O.D = 12,5 19,0 mm (over 150 combinations). Other dimensions after request Suction (single use), liquid transportation & drainage in all human & veterinary surgical operations. Connection of all types medical equipment & devices Length/ Package 25 m rolls (or other length on request) in PE transparent bags firmly sealed ΕΝ ISO 9001: 2008, EN ISO 13485:2012, ISO 10993, CE Mark Class Ι (MDD 93/42/EEC), USP VI (after agreement) Available Diameters Inner Ø Outer Ø ,5 19 and over 150 combinations

7 SILOFLOW PP - PEROXIDE CURED FORMULAS PERISTALTIC PUMPS SILICONE TUBING FOR MEDICAL USE SILOFLOW PP - PEROXIDE CURED FORMULAS Siloflow (Peroxide Cured) Silicone (VMQ Quality Medical Grade, Non-Recycled) Sterile Sterile (in pouches) or non sterile (in bags) delivered None Shape Circular -45 C to +180 C Instant rebound, laminar flow, top quality, highly elastic, top mechanical properties. From I.D. O.D = 2,0 4,0 mm up to I.D. O.D = 6,0 10,0 mm (and many other combinations). Other dimensions on request For peristaltic pumps. Liquid transportation & drainage in all human & veterinary surgical operations. Connection of all types pumping devices Length/ Package 0,40m (pouches). 25 m rolls (PE transparent bags firmly sealed). Other length on request ΕΝ ISO 9001: 2008, EN ISO 13485:2012, CE Mark Class Ι (MDD 93/42/EEC), ISO 10993, USP VI Standard Diameters Inner Ø Wall Thickness 2 1,0 3 1,0 3 1,5 4 1,0 4 1,5 5 1,5 6 1,5 6 2,0 and other after request also available in inches 7

8 SILOPURE MTim & SILOPLUS MTm - MULTI LUMEN/MULTI CHANNEL PLATINUM & PEROXIDE CURED FORMULAS MULTI LUMEN/MULTI CHANNEL SILICONE TUBING FOR MEDICAL USE SILOPURE MTim & SILOPLUS MTm - PLATINUM & PEROXIDE CURED FORMULAS 8 Silopure (Platinum Cured) & Siloplus (Peroxide Cured) Silicone (VMQ Quality Medical Grade, Non- Recycled) None Shape Circular, Rectangular Lumens up to 6-45 C to +180 C Excellent heat stability, transparent, odourless, tasteless, non-toxic, sterilizable (plasma, steam, EtO a.o.), unmeltable, highly elastic, non deformable, top mechanical properties From I.D. O.D = 1,0 2,0 mm up to I.D. O.D = 12,5 19,0 mm (over 150 combinations). Other dimensions after request Multi-purpose medical component Length / Package 25 m rolls (or other length on request) in PE transparent bags firmly sealed ΕΝ ISO 9001: 2008, EN ISO 13485:2012, DΥ8d/1348 (M.o.H.), CE Mark, Hellenic Drug Organization (Ε.Ο.F.) approval Class Ι (MDD 93/42/EEC) Available Diameters Inner diameter: from 1mm to 8mm Outer diameter: from 4mm to 10mm

9 STERILE V-H2O2 Standard Diameters Inner Ø Outer Ø Silopure Medical / Siloplus Medical Silicone Sterilization V-H2O2 Plasma none Pouch Double sealed - double bag Tyvek Pouch Constant properties from -45 C to +180 C No Latex containing! Excellent heat stability, transparent, odourless, tasteless, non-toxic, unmeltable, highly elastic, non deformable, top mechanical properties From I.D. O.D = 1,0 2,0 mm up to I.D. O.D = 11,0 16,0 mm (over 150 combinations). Other dimensions after request Liquid transportation & drainage in all human & veterinary surgical operations Length/ Package Standard lengths: 1.5, 2.0, 2.5 meters / Pouches in carton box (approx. 100 pcs) ΕΝ ISO 9001: 2008, EN ISO 13485:2012, ISO 10993, CE Mark Class Ιs (MDD 93/42/EEC) STERILIZED SILICONE TUBING IN POUCHES ACCU-STER STERILIZATION METHOD STERILIZED SILICONE TUBING IN POUCHES ACCU-STER STERILIZATION METHOD DEVELOPED BY PENTASIL and many combinations 9

10 PENTALENE - PVC, LATEX & SILICONE FREE FORMULAS TPE TUBING FOR MEDICAL USE PENTALENE - PVC, LATEX & SILICONE FREE FORMULAS 10 Available Diameters Inner Ø Outer Ø 100% Medical Grade Pentalene EPT Thermoplastic Elastomer None Shape Circular From -50 C to +125 C (unstressed material) Excellent heat stability, transparent, odourless, tasteless, non-toxic, sterilizable (plasma, steam, EtO a.o.), hardly meltable, high modulus, non deformable, top mechanical properties From I.D. O.D = 3,0 5,0 mm up to I.D. O.D = 16,0 20,0 mm (over 100 combinations). Other dimensions after request 5 8 Multi-purpose medical component and many other combinations Length/ Package 30 m rolls (or other length on request) in PE transparent bags firmly sealed ΕΝ ISO 9001: 2008, EN ISO 13485:2012, ISO 10993, CE Mark Class Ι (MDD 93/42/EEC), USP VI available 5 9

11 Why PENTASIL MED-TECH ENGINEERING Our Company designs, produces (under licence) and supplies medical products made of ultra performance elastomers. We focus our research on successful designing and engineering that meets individual customer s requirements. We, founders and owners of PENTASIL MED-TECH ENGINEERING, personally guarantee Top Quality, Reliability, Innovation and Customer Support. We value what we do and that is why we build strong working relationships with our customers. Direct service is always present and customer s satisfaction is among our top priorities. Through vertical and automatic production we achieve cost efficient operational excellence for our customers. Our vendors and co-workers are carefully selected in order to enhance customer s trust. PENTASIL MED-TECH ENGINEERING with full respect to customers exact needs sells successfully worldwide. Quality All our products are specially designed and engineered for our customers needs. Our company has as priority the intensive quality control. By providing technical solutions, by manufacturing innovative products and by being efficient and effective, our customers receive high quality products and services. All products are designed in Germany and manufactured in Europe according to the European and USA standards and recommendations. PENTASIL MED-TECH ENGINEERING has been approved by Lloyd s Register Quality Assurance to EN ISO 9001:2008 & EN ISO 13485:2012 Standards for the quality management system in designing, production and sales of elastomers and specialty polymers for Medical and Industrial use. Additional approval by Lloyd s Register Quality Assurance exists in compliance to the European Directive 93/42/ EEC. All our medical products are accompanied with the CE Mark (with Declaration of Conformity) acc.to 93/42/EEC. This data presented in this brochure - whether verbal, in writing or by way of trials - are in accordance with the present state of our knowledge. Our advise does not release the user from the obligation to check its validity and to test our products as to their suitability for the intended processes and uses and does not absolve the user from carefully checking all supplies immediately upon receipt. We reserve the right to alter product constants within the scope of technical progress or new developments. The information given in this brochure should be checked by preliminary trials because conditions during processing over which we have no control, especially where other companies materials are also been used. The information provided by us does not absolve the user from the obligation of investigating the possibility of infringement of third parties rights and, if necessary, clarifying the position. Recommendations for use do not constitute a warranty, either express or implied, of the fitness or suitability of the product for a particular purpose. Our products are sold in accordance with our General Conditions of Sales, Purchase and Delivery. 11

12 PENTASIL Med-Tech Engineering UG (haftungsbeschränkt) Falkenbacher Str Villmar Hessen Germany +49 (0) (0) info@pentasil.eu PentaSil 2017 all rights reserved