Haemodialysis

Low-Flux Dialysers
High Performance E-beam (HPE)

E-beam sterilised dialysers

Medical devices can be sterilised with radiation by exposing them either to gamma-rays (electromagnetic waves) or beta-rays (electrons) (1). Beta-ray, or electron beam sterilisation, does not involve any radioactive materials, but works with accelerated electrons created in a cathode-ray tube (figure 1). In both gamma- and e-beam sterilisation, secondary electrons are created in the irradiated material, which act as the sterilising agent. A number of publications illustrate that e-beam sterilisation has several advantages over gamma radiation (1-4). The main advantage is due to the differences in the exposure time of irradiation. E-beam sterilisation takes only seconds (2), while gamma sterilised products are exposed to radiation for hours. Thus, in e-beam sterilisation, oxygen simply does not have enough time to diffuse into the polymer and to

become activated by the irradiation (formation of oxygen radicals), resulting in less alterations to the chemical structure of the polymer.

Advantages of e-beam sterilisation

Due to the short time of exposure to the radiation, e-beam sterilisation has a minor effect on the polymer and thus on its properties in comparison to gamma sterilisation. Furthermore the e-beam sterilisation procedure results in less residuals compared to gamma sterilisation. Besides its environmental friendliness (no radioactive materials needed), sterilisation with electronbeams is a safe and gentle method of sterilising products that are well tolerated by the dialysis patient.

Generation of high voltage Hot cathode Concrete shielding Irradiation Product

Fig: 1 Principle of e-beam sterilisation setting

In-vitro dialyser performance

Ultrafiltration coefficient (mL/hmm Hg) Clearance: QB 200 (mL/min) Urea Creatinine Phosphate Vitamin B12 Urea Creatinine Phosphate Vitamin B12

F6 HPE 11 182 168 135 82 233 206 155 88

F8 HPE 15 187 174 150 95 244 217 178 104

Clearance: QB 300 (mL/min)

The in vitro performance data were obtained with QD = 500 mL/min; QF = 0 mL/min ; T = 37 C (EN 1283, ISO 8637). The ultrafiltration coefficients were measured using human blood, Hct = 32 %, protein content 6 %.

Technical Data Sheet Effective surface area (m2) Wall thickness / inner diameter (m) Blood priming volume (mL) Membrane material Housing material Potting compound Sterilisation method Form of treatment Art. No.

1.3 40 / 200 78 Fresenius Polysulfone Polycarbonate Polyurethane Electron-beam radiation HD 500 8701

1.8 113

500 8691

Due to the state-of-the-art Fresenius Polysulfone membrane, the low-flux high performance e-beam (HPE) dialysers have the following features: High performance profile due to the new micro-ondulation of the fibres ensuring an efficient dialysate flow around the fibres and resulting, in particular, in a high phosphate clearance. Excellent blood biocompatibility attributed to the original Fresenius Polysulfone membrane. High endotoxin retention capacity of the membrane avoiding pyrogen transfer into the blood and thereby ensuring patient safety.

References:
1. Gavioli G, Gennari M, Bruns S: Methods of sterilisation and their effects on membrane performance and safety. In: Ronco C, La Greca G (eds): Hemodialysis Technology. Contrib Nephrol 137: 78 - 84, 2002. 2. Sadler G, Chappas W, Pierce DE: Evaluation of e-beam, gamma- and x-ray treatment on the chemistry and safety of polymers used with prepackaged irradiated foods: a review. Food Additives and Contaminants 18 (6): 475 501, 2001. 3. Ishigaki I, Yoshi F: Radiation effects on polymer materials in radiation sterilization of medical supplies. Radiat Phys Chem 139 (6): 527 - 533, 1992. 4. Bly JH: Sterilization of medical disposable devices with electron beam vs. cobalt 60. Radiat Phys Chem 33 (2): 179 180, 1989.

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