Dialyzers. Medical Technologies GmbH Pirna. a member of Serumwerk Bernburg AG

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1 Dialyzers Medical Technologies GmbH Pirna a member of Serumwerk Bernburg AG

The Serumwerk Bernburg group Serumwerk Bernburg AG The company Serumwerk Bernburg was founded in 1954 and

During this time, the firm grew into a company that is famous throughout the world as a producer and

based on natural biopolymers (dextran, gelatin, hydroxyethyl starch).

2 The Serumwerk Bernburg group Serumwerk Bernburg AG The company Serumwerk Bernburg was founded in 1954 and privatized into a joint stock company in During this time, the firm grew into a company that is famous throughout the world as a producer and supplier of medicines for human and veterinary use with the focus on colloidal volume replacement agents based on natural biopolymers (dextran, gelatin, hydroxyethyl starch). The Serumwerk Bernburg group manufactures at the German sites in Bernburg und Pirna: application infusion accessories, bicarbonate cartridges and dialyzers) Synthesis products (HES and other polyglucanes)

... is based on tradition and innovation Medical Technologies GmbH MTP Medical Techologies GmbH develops and produces high-qualitiy medical devices for hemodialysis.

For over 100 years, the traditional site Pirna in Saxony has been producing artificial silk and cellulose fibres for technical, textile and also medical areas of application.

3 ... is based on tradition and innovation Medical Technologies GmbH MTP Medical Techologies GmbH develops and produces high-qualitiy medical devices for hemodialysis. The core competence of the company is the dialyzer product series VitaPES, within which the innovative, effective, and clinically approved hollow fibre membrane Purema is applied. For over 100 years, the traditional site Pirna in Saxony has been producing artificial silk and cellulose fibres for technical, textile and also medical areas of application. Materials and products for dialysis have been developed and manufactured here. Pirna is located both near Dresden and the attractive Elbe Sandstone Mountains. MPT Medical Technologies GmbH was re-founded in 2007 as a 100 per cent subsidiary of the Serumwerk Bernburg AG. Drawing from the long-standing knowhow in the area of dialyzer development and production, a modern manufacturing plant was built, and its operation was started within a short period of time. Only one year after the re-foundation of the company, the first VitaPES dialyzers with the required European product certification rolled off the production line. All manufacturing steps of VitaPES dialyzers including all its components are conducted under the highest quality criteria in Germany and Switzerland. By now VitaPES dialyzers are clinically applied worldwide every day. Offering a complete lineup of high-quality disposables for dialysis in numerous countries directly or via local distributor organizations, Serumwerk Bernburg performs as a compentent and strong marketing partner to MTP Medical Technologies GmbH. The certification of MTP Medical Technologies GmbH is based on a systematic quality management according to ISO The MTP product lineup is continually improved and extended through high internal qualitiy standards as well as a fast and precise implementation of customer requirements.

The characteristics of VitaPES dialyzers are a good tolerance, high clearances across a wide range of molecules and an effortless handling.

4 VitaPES is engineered to fulfill the complex requirements Outstanding tolerance and clearance profile The outstanding features of VitaPES dialyzers, approved in clinical practice, are the result of the development of innovative manufacturing technologies, of an optimized product design and of a complex qualitiy assurance system. The characteristics of VitaPES dialyzers are a good tolerance, high clearances across a wide range of molecules and an effortless handling. The highly effective and at the same time gentle and eco-friendly sterilization by electron beam results in maximum product safety without any impairments on the potential, biocompatibility and tolerance of the Purema membrane. Highly reliable dialysis dose and quality combined with perfect biocompatibility are important prerequisites to avoid immunologic abnormalities which might cause an increased risk for ESRD patients. High qualitiy dialysis may thus contribute to: Broad product range for individual therapy The product lineup of VitaPES dialyzers with membrane surfaces from 1.3 to more than 2 m² in low flux, mid flux and high flux range allow for a individualized and efficient treatment of patients suffering from chronic renal failure. This enables the nephrologist to bring the dialysis therapy into line with the patients' needs. Purema is a registered trademark of Membrana GmbH, Wuppertal, Germany.

of today s end-stage renal disease treatment.

membrane surface structure Based on breakthrough process innovation, the

distribution than conventional synthetic dialysis membranes. Th

the nanoscopic structure of the inner membrane surface with integrated active

stability over the duration of therapy due to minimum immunologic influence and

The Purema membrane's high performance is enhanced by an optimum membrane flow

Plasma- Clearance ß2M (ml/ min) 100 50 0 Albumin loss (g/4h) 3,0 2,0 1,0 0 - HD

5 of today s end-stage renal disease treatment. Innovative high-performance membrane Core piece of VitaPES LF and VitaPES HF is the fully synthetic Purema membrane. red = hydrophobic domains green = hydrophilic domains blue = active centre membrane surface structure Based on breakthrough process innovation, the unprecedented performance properties of Purema have been achieved through the patented pore forming technology S.E.T. (Sieving Enhancing Technology). S.E.T. forms a membrane structure with a more uniform pore size and improved pore distribution than conventional synthetic dialysis membranes. Thus, S.E.T. clearly improves the separation profile of the membrane.the nanoscopic structure of the inner membrane surface with integrated active centres (see figure) produces an excellent bio-tolerance and high performance stability over the duration of therapy due to minimum immunologic influence and protein absorption. The Purema membrane's high performance is enhanced by an optimum membrane flow distribution based on P.E.T. (Performance Enhancing Technology). Plasma- Clearance ß2M (ml/ min) Albumin loss (g/4h) 3,0 2,0 1,0 0 - HD Polysulfone - HDF Polyamix - HDF By means of the unique membrane structure based on Sieving Enhancing Technologie (S.E.T.), dialyzers comprising Purema HF membrane achieve an excellent clearance profile across a wide molecular range with a minimum albumin loss at the same time. Clearance rates as they are achieved here in conventional hemodialysis (HD) can only compare to the more complex hemodiafiltration (HDF) when working with conventional high flux membranes [1]. [1] DH Krieter et al. Artif Organs 2008, 32: : Matching Efficacy of Online Hemodiafiltration in Simple Hemodialysis Mode

6 Kopenhagen Hamburg Rostock Hannover Berlin Warschau Amsterdam Brüssel Düsseldorf Bernburg Leipzig Frankfurt Dresden Pirna Prag 100 km 200 km 300 km 400 km 500 km 600 km Paris Nürnberg Stuttgart München Wien Bern Budapest Sales Germany: Serumwerk Bernburg Vertriebs GmbH Hallesche Landstraße 105 b Bernburg Tel.: Fax: info@serum-werk.de Sales International: Serumwerk Bernburg AG Hallesche Landstraße 105 b Bernburg Tel.: Fax: info@serumwerk.de

Berlin 3 Bautzen Leipzig Dresden Wilsdruff 72 Heidenau mtp Pirna Chemnitz 7 72 Prag You may reach us by the

A4 from Chemnitz, from western direction via A14 from Leipzig, or from northern direction via A13 from

Then follow the main road B172 towards Dresden and turn right after approx.

By train You may reach us via Dresden central station and onwards by S-Bahn transit S1 or S2 towards Schöna.

By plane Scheduled flights arrive at Dresden airport, which is located in the north of Dresden, approx.

7 Berlin 3 Bautzen Leipzig Dresden Wilsdruff 72 Heidenau mtp Pirna Chemnitz 7 72 Prag You may reach us by the following means of transport: By car Take the autobahn towards Dresden (from southern direction via autobahn A4 from Chemnitz, from western direction via A14 from Leipzig, or from northern direction via A13 from Berlin), change to A17 at the junction Dresden-West towards Prague and leave the autobahn at the exit Pirna. Then follow the main road B172 towards Dresden and turn right after approx. 500 meters into the industrial park Kunstseidenstraße. Follow the signs to MTP Medical Technologies GmbH. By train You may reach us via Dresden central station and onwards by S-Bahn transit S1 or S2 towards Schöna. These lines operate via Pirna every 30 minutes between 4:00 am and 1:00 am (please, check for further information). If you inform us about your arrival at Pirna train station, we will be glad to meet you there. By plane Scheduled flights arrive at Dresden airport, which is located in the north of Dresden, approx. 25 km from Pirna. You may board the S2 to Pirna directly at the airport. At the airport you will find agencies of all conventional car rentals. You may also arrive at one of the Berlin airports (approx. 200 km from Pirna) and continue your journey to Pirna by car or train from Berlin.

8 MTP Medical Technologies Gesellschaft mbh Kunstseidenstraße Pirna Germany Tel.: Fax: info@mtp-pirna.de /4

10 Dialysator/ Dialyzer VitaPES L P MTP Medical Technologies GmbH Kunstseidenstraße 4, Pirna, Germany Phone , Fax info@mtp-pirna.de, In vitro performance Ultrafiltrationskoeffizient (ml/h/mmhg) Ultrafiltration coefficient (ml/h/mmhg) Clearance: Q B 200 ml/min VitaPES VitaPES VitaPES VitaPES L 0 2 Harnstoff/ Urea Kreatinin/ Creatinine Phosphat/ Phosphate Vitamin B 12 / Vitamin B Clearance: Q B 300 ml/min Harnstoff/ Urea Kreatinin/ Creatinine Phosphat/ Phosphate Vitamin B 12 / Vitamin B Clearance: Q B 400 ml/min Harnstoff/ Urea Kreatinin/ Creatinine Phosphat/ Phosphate Vitamin B 12 / Vitamin B Massentransferkoeffizient/ Mass transfer coefficient KoA (Harnstoff/ urea) * Technische Angaben/ Technical information Membranfläche (m²) Membrane Surface Area (m 2 ) Wandstärke/ Innendurchmesser (µm) Wall thickness / Internal diameter (µm) 1,5 1,7 1,9 2,1 35/200 Füllvolumen (ml)/ Priming volume (ml) Membran/ Membrane PUREMA Polyethersulfone Gehäusematerial/ Vergussmaterial Housing material/ Potting compound Polycarbonate/ Polyurethane Sterilisation/ Sterilization Electron Beam St. pro Karton/ Palette Units per box/ pallet 30/960 Art.-Nr./ Art.-No. REF In-vitro Leistungsdaten entspr. EN (UF- Koeffizient: Humanblut, Clearance: Q D =500 ml/min, Q F =0) In vitro performance according to EN (UF coefficient: human blood, Clearance: Q D =500 ml/min, Q F =0) PUREMA is a trademark of Membrana GmbH, Wuppertal, Germany. *KoA berechnet aus Clearance bei Q B =300 ml/min, Q D =500 ml/min *KoA calculated from clearance at Q B =300 ml/min, Q D =500 ml/min Best.-Nr./ Order No /1 0483

11 Balanced Flux Dialysator Balanced Flux Dialyzer

12 MTP Medical Technologies GmbH Kunstseidenstraße 4, Pirna, Germany Phone , Fax Balanced Flux Dialysator / Balanced Flux Dialyzer In vitro performance Ultrafiltrationskoeffizient (ml/h/mmhg) Ultrafiltration coefficient (ml/h/mmhg) Clearance: Q B 200 ml/min VitaPES 140 BF VitaPES 160 BF VitaPES 180 BF VitaPES 200 BF Harnstoff / Urea Kreatinin / Creatinine Phosphat / Phosphate Vitamin B 12 / Vitamin B Clearance: Q B 300 ml/min Harnstoff / Urea Kreatinin / Creatinine Phosphat / Phosphate Vitamin B 12 / Vitamin B Clearance: Q B 400 ml/min Harnstoff / Urea Kreatinin / Creatinine Phosphat / Phosphate Vitamin B 12 / Vitamin B Massentransferkoeffizient / Mass transfer coefficient KoA (Harnstoff / Urea) * Technische Angaben / Technical information Oberfläche (m 2 ) / Surface (m 2 ) Wandstärke/ Innendurchmesser (µm) Wall thickness / Internal diameter (µm) 35/200 Füllvolumen (ml) / Priming volume (ml) Membran / Membrane Gehäusematerial/ Vergussmaterial Housing material / Potting compound Sterilisation / Sterilization St. pro Karton/ Palette Units per box / pallet Polyethersulfone Polycarbonate/ Polyurethane Elektronenstrahl / Electron Beam 30/ / / / 960 Art.-Nr. / Art.-No Best.-Nr./ Order No In vitro Leistungsdaten entspr. EN 1283 (UF-Koeffizient: Humanblut, T=37 C, ISO 8637, Clearance: Q D = 500 ml/min, Q F = 0) In vitro performance data according to EN 1283 (UF coefficient: human blood, T=37 C, ISO 8637, clearance: Q D = 500 ml/min, Q F = 0) * KoA berechnet aus Clearance bei Q B =300 ml/min, Q D =500 ml/min KoA calculated from clearance at Q B =300 ml/min, Q D =500 ml/min /

13 High Flux Dialysator High Flux Dialyzer

14 High Flux Dialysator / High Flux Dialyzer MTP Medical Technologies GmbH Kunstseidenstraße 4, Pirna, Germany Phone , Fax info@mtp-pirna.de, In vitro performance Ultrafiltrationskoeffizient (ml/h/mmhg) Ultrafiltration coefficient (ml/h/mmhg) Clearance: Q B 200 ml/min VitaPES 150 HF VitaPES 170 HF VitaPES 190 HF VitaPES 210 HF Harnstoff / Urea Kreatinin / Creatinine Phosphat / Phosphate Vitamin B 12 / Vitamin B Inulin / Inulin Clearance: Q B 300 ml/min Harnstoff / Urea Kreatinin / Creatinine Phosphat / Phosphate Vitamin B / Vitamin B Inulin / Inulin Clearance: Q B 400 ml/min Harnstoff / Urea Kreatinin / Creatinine Phosphat / Phosphate Vitamin B / Vitamin B Inulin / Inulin Massentransferkoeffizient / Mass transfer coefficient KoA (Harnstoff / Urea) * Siebkoeffizient / Sieving coefficient Inulin / Inulin 1 ß2-microglobulin / ß2-microglobulin 0.8 Albumin / Albumin <0.01 Technische Angaben / Technical information Oberfläche (m 2 ) / Surface (m 2 ) Wandstärke/ Innendurchmesser (µm) Wall thickness / Internal diameter (µm) 30 / 200 Füllvolumen (ml) / Priming volume (ml) Membran / Membrane PUREMA Polyethersulfone Gehäusematerial/ Vergussmaterial Housing material / Potting compound Polycarbonate / Polyurethane Sterilisation / Sterilization Elektronenstrahl / Electron Beam St. pro Karton/ Palette Units per box / pallet 30 / / / / 960 Art.-Nr. / Art.-No Best.-Nr./ Order No In vitro Leistungsdaten entspr. EN 1283 (UF-Koeffizient: Humanblut, T=37 C, ISO 8637, Clearance: Q D = 500 ml/min, Q F = 0, Siebkoeffizient: Q B = 300 ml/min, Q F = 60 ml/min) In vitro performance and according to EN 1283 (UF coefficient: human blood, T=37 C, ISO 8637, clearance: Q D = 500 ml/min, Q F = 0, sieving coefficient: Q B = 300 ml/min, Q F = 60 ml/min) PUREMA is a trademark of Membrana GmbH, Wuppertal, Germany. * KoA berechnet aus Clearance bei Q B =300 ml/min, Q D =500 ml/min KoA calculated from clearance at Q B =300 ml/min, Q D =500 ml/min /

16 Dialysator/ Hämodiafilter HDF Dialyzer/ Hemodiafilter HDF P P G K 4, 017 6, G F ,. -. I H 25 / ( / ) ( / ) 300 /, F 75 / / 289 / 280 / / / /, F 100 / / 361 / 344 / / / 194 / ( / ) * 1295 / / ( ²)/ ( 2 ) 2.4 ärke/ Innendurchmesser (µm) Wall thickness / Internal diameter (µm) 87 30/ 200 Füllvolumen (ml)/ Priming volume (ml) 136 Membran/ Membrane Gehäusematerial/ Vergussmaterial Housing material/ Potting compound Sterilisation/ Sterilization PUREMA Polyethersulfone Polycarbonate/ Polyurethane Electron Beam St. pro Karton/ Palette Units per box/ pallet 30/960.-./.-. EF / In-vitro Leistungsdaten entspr. EN ISO 8637 (UF- Koeffizient: Humanblut, Clearance: Q D =500 ml/min) In vitro performance according to EN ISO 8637 (UF coefficient: human blood, Clearance: Q D =500 ml/min) PUREMA is a trademark of Membrana GmbH, Wuppertal, Germany. *KoA in ml/min berechnet aus Clearance bei/ KoA in ml/min calculated from clearance at Q B =300 ml/min, Q D =500 ml/min /2

Diacap. Constant performance resulting in high quality dialysis. Avitum

Diacap. Constant performance resulting in high quality dialysis. Avitum Diacap Constant performance resulting in high quality dialysis Avitum B. Braun Avitum. Always with Passion. B. Braun is a leading international company in the healthcare market. With a long tradition stretching