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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: [email protected] · Head office: Else-Kröner-Straße 1 · 61352 Bad Homburg v. d. H.
www.fmc-ag.com