Biofine®

The innovative material for PD

Peritoneal Dialysis

Protect our environment

Economic growth and industrial development are

causing an increasing burden to the environment.

At Fresenius Medical Care we are sensitive to the

problem. Today, we value safety and protection

of the environment just as highly as

competing on the international

market.

Fresenius Medical Care is thinkingahead

For a long time experts have been discussing the

possible risks of PVC especially where disposal

problems could have important unknown

consequences. Many medical products consist of

different plastic materials, some of which are

inseparably bonded. In order to minimize the

potential environmental and health hazards,

alternatives must be seriously considered.

Biofine® – The new material from Fresenius Medical Care Research

Biofine®, a new material developed by Fresenius

Medical Care Research is a substance from the

group of polyolefines. Polyolefines are polymers,

constructed exclusively from hydrogen and carbon

atoms. The various properties of the material such

as flexibility are defined by the different three-

dimensional configurations of the carbon atoms.

This permits to refrain from the use of plasticizers

such as di-2 ethylhexyl phthalate (DEHP) that are

commonly used to vary properties of materials made

of polyvinylchloride (PVC).

Bibliography: 1, 2, 3, 4, 5.

Biofine® excels by its versatility

The new Fresenius Medical Care CAPD system

generation stay•safe® is the first product

manufactured from Biofine® material. All system

components that come into contact with the

dialysate provide higher biocompatibility, from

the solution/drainage bag, lines and connector to

the DISC.

Biofine® protects

to the surface, but are also taken up into the matrix

of the PVC-containing object. Absorption is the even

distribution of one substance in another.

The consequence:

the medication loses part of its effect. Example: if

insulin is added into a PVC bag, a substantial

amount will be adsorbed onto the wall of the bag.

This strong adsorption can be attributed to the polar

nature of PVC. Polyolefines however are absolutely

non-polar and the adsorption is much lower.

Bibliography: 10, 11, 12.

During the storage of CAPD solution bags, water

evaporates through the film. Biofine® has been

tested under stress conditions and proved to be a

far superior barrier to water vapour. Therefore we

can guarantee an excellent consistency of the

solution during the entire storage period.

Bibliography: 7, 8, 9, 13.

Sterilisation process

A good example of the sterilisation process is given

by the stay•safe® system. After complete assembly

and sealing with the outer wrapping the entire

system consisting of Biofine® material undergoes

steam sterilisation at 121°C. Thus all parts contained

within the outer wrapping foil are sterile.

Bibliography: 6.

Biofine® minimises adsorption andabsorption of medication

The adsorption of therapeutic substances is the

attachment of particles of one substance to the

surface of another. Adsorption occurs in the material

of bags and tubes made of PVC. In the case of

absorption the substances are not only adsorbed

Biofine® allows recycling

In the new CAPD system generation stay•safe®, all

system components are manufactured from Biofine®,

making them easier to recycle.

Biofine® is more ecological

During the product life cycle – production, usage

and disposal – the Biofine® material is not harmful to

the environment. Biofine® will degrade to carbon

dioxide, carbon monoxide and water upon complete

incineration without release of hydrochloric acid and

the formation of its reaction products.

Bibliography: 5, 14, 15, 16.

Biofine® does not contain plasticizers

Although health risks could never be directly

attributed to the use of plasticizers in PVC, several

studies have reported that di-2-ethyl-hexylphthalate

(DEHP), one of the most frequently used plasticizers,

is not firmly integrated into the PVC matrix. Whether

or not plasticizers are harmful in

the field of peritoneal dialysis

is no longer a point of

discussion – Biofine®

does not contain any.

Bibliography: 1, 2, 3, 4, 5.

Biofine®PVC

Biofine® – a high-tech material

Biofine® has a different molecular structure to that

of PVC. In producing the bags for the stay•safe®

CAPD system, the Biofine® foil is 60% thinner, thus

saving valuable raw materials and reducing waste.

The multi layer foil contains no glue and the foil

structure is optimized to meet the requirements for

CAPD bags.

DEHP

Less material = lower environmental burden

Bibliography

1 Solary E, Cabanne JF, Tanter Y, Rifle G: Evidence for a Role of Plasticizer in Eosinophilic Peritonitis in Continuous Peritoneal Dialysis. Nephron 42, 341–342, 1986.

2 Rubin RJ, Ness PM: What Price Progress? An Update on Vinyl Plastic Blood Bags. Transfusion 29, 358–361, 1989.

3 Fracasso A, Coli U, Landini S et al: Plasticizer from Plastic Devices –Effect on Peritoneal Membrane. Peritoneal Dialysis, Wichtig, Milano,57–60, 1988.

4 Fracasso A, Coli U, Landini S, Marachiello P, Righetto F et al:Peritoneal Sclerosis – Role of Plasticizer. Trans. Am. Soc. of Artif.Intern. Organs 33, 676–682, 1987.

5 Dooren van AA: PVC as Pharmaceutical Packaging Material – ALiterature Survey with Special Emphasis on Plasticized PVC Bags.Pharmaceutisch Weekblad Scientific Edition 13, 109–118, 1991.

6 Fresenius Medical Care: Own investigations, not published. 1995.

7 Domininghaus H: Die Kunststoffe und ihre Eigenschaften. VDI Verlag,Düsseldorf, 3rd Edition, Page 193/Picture 111, 1988.

8 Fresenius Medical Care: Own investigations, not published. 1995.

9 Henderson IS: Composition of Peritoneal Dialysis Solutions. CurrentConcepts of CAPD, Blood Purification 7, 86–94, 1989.

10 Petty C, Cunningham NL, Major MC: Insulin Adsorption by GlassInfusion Bottles, Polyvinylchloride Infusion Containers and IntravenousTubing. Anesthesiology 40, 400–404, 1974.

11 Kowaluk EA, Roberts MS, Blackburn HD, Polack AP: Interactionbetween Drugs and Polyvinyl Chloride Infusion Bags. AmericanJournal of Hospital Pharmacy 38,1308–1314, 1981.

12 Hirsch Jl, Wood JH, Thomas RB: Insulin Adsorption to PolyolefinInfusion Bottles and Polyvinyl Chloride Administration Sets. AmericanJournal of Hospital Pharmacy 38,995–997, 1981

13 Fresenius Medical Care: Own investigations, not published. 1995.

14 Without author: “PVC im Krankenhaus – Einsatzbereiche, Risiken,Alternativen im medizinischen Bereich.” Greenpeace. 1995.

15 Fresenius Medical Care: Own investigations, not published. 1995.

16 Paton SJ: Ecological advantages of PVC-free foils. Nieren- undHochdruckkrankheiten 26, Suppl. 1, 17–19, 1997.

Our development work will not cease

We want to continue to make innovative contribu-

tions for the benefit of the dialysis patient. Biofine®

is a milestone opening up far reaching possibilities

for us in many different fields of application.

Biofine® and stay•safe® are trademarks of Fresenius Medical Care AG,Bad Homburg.

PVC Biofine®

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Fresenius Medical Care Deutschland GmbH · 61346 Bad Homburg v. d. H. · Germany · Phone: +49 (0) 6172-609-0 · Fax: +49 (0) 6172-609-2191E-mail: dialysis-marketing@fmc-ag.com · Head office: Else-Kröner-Straße 1 · 61352 Bad Homburg v. d. H.

www.fmc-ag.com