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Homogeneous dialysate flow for better clearances

  • The pinnacle structure at both ends of the polypropylene housing together with the potting technology provides an even, radial flow of the dialysate around the individual fibers of the bundle
  • The undulation of the hollow fibers prevents dialysate channeling and, thus, enhances the performance of the dialyzer. The higher packing density of the fiber bundle together with the undulation of the hollow fibers enables a uniform dialysate flow within the whole cross-section of fiber bundle

The FX-class® housing design

The FX-class housing design

The FX-class® housing design was optimized for efficient blood flow conditions

The FX-class® design

The FX-class design

The FX-class® design affects dialysate flow and hence dialyser performance

Dialyzer weight

Dialyzer weight is a crucial factor not only in logistics but also in waste management. The housing of FX-class dialyzers is made of polypropylene. In comparison to the widely used polycarbonate it is much lighter with the result that FX-class dialyzers weigh around half as much as most dialyzers.

FX 60 classix

107g

FX CorDiax 60

107g

The benefits of INLINE steam sterilization

No chemical residuals

No need for gamma sterilization – high energy ionizing radiation can degrade and alter the material chemistry. 
Low rinsing volumes

Minimal preparation time – since dialyzers are clean on arrival, rinsing times prior to use are substantially reduced.  
Lower costs

Lower rinsing volumes mean reduced preparation times and costs.

Technology

Better clearance through nanotechnology

Conventional pores

Conventional pores

The removal of uraemic toxins is enhanced by smooth and cylindrical pores

Helixone® pores

Helixone pores

The removal of uraemic toxins is enhanced by smooth and cylindrical pores

When FX-class® dialyzers were introduced into the market, an innovative spinning technology had been developed to produce its Helixone® membrane. The so called Nano Controlled Spinning (NCSTM) technology allowed the production of highly-defined pore structures. Opposed to the previously produced conventional pores which were rugged and uneven in shape, the pores at the inner layer of the Helixone® membrane are smooth and cylindrical. This reduces the resistance of the molecules when travelling through the pores and therewith allow for enhanced removal.

Optimized pore spectrum through nanotechnology

All Helixone® membranes offer optimized sieving properties as the pore size distribution has been tightened compared to previously produced membranes as used e.g. in the F-series. The average pore size is larger compared to F-series dialyzers and the variance in pore sizes is smaller. This results in a better selective permeability for middle molecules, i.e. a more favorable β2-m / albumin sieving proportion.

BAS011_pore-size-distribution

NCSTM results in optimized pore size distribution and larger average pore size

INLINE steam sterilisation

INLINE steam sterilisation

The INLINE steam sterilisation process

Purity enhanced — with steam

All FX-class® dialyzers are sterilized by the unique INLINE steam sterilization process:  

  1. Both the blood and the dialysate compartment of the dialyzers are rinsed continuously with steam at a temperature of or above 121°C for more a minimum of 15 minutes. Rinsing with hot steam and without chemicals results in extremely low levels of residuals in the dialyzer
  2. The dialyzer is rinsed with sterile water  
  3. Every dialyzer is tested for fiber integrity using a bubble-point test  
  4. The dialyzers are dried with warm, sterile air  
  5. Finally, after drying the blood inlet and outlet ports are closed

Benefits of the INLINE steam sterilization process

  • Highly pure, sterile and pyrogen-free dialyzers without any potentially harmful residuals from sterilization
  • Biocompatibility of membranes remains unaffected from sterilization
  • Optimized use of resources due to low rinsing volumes: Only 500 mL is required
  • Minimized risk of blood leakages and fiber ruptures due to 100% fiber integrity testing
  • Dry dialyzers with minimized risk of contamination due to microbial growth

Fibre integrity testing

Weber et al. (2003) compared endotoxin adsorption capacity of different dialyzers.

The Helixone® membrane of a FX 60 dialyzer had a higher endotoxin adsorption capacity compared to:

  • Gambro‘s Polyflux 140H - Polyethersulfone (Polyamid S)
  • Gambro‘s Nephral ST 400 - Polyacrylonitrile (AN69ST)
  • B.Braun‘s Diacap HI PS 18 - Alpha- Polysulfone
BAS011_endotoxin-retention-weber

Endotoxin adsorption per cm2 membrane surface area after 120 min in-vitro dialysis with contaminated dialysate1

Performance data

FX classix High-Flux dialysers FX 50 classix FX 60 classix FX 80 classix FX 100 classix

Clearance (QB = 300 mL/min)

Molecular weight (Dalton)

Cytochrome c

12,230

55

74

89

100

Inulin

5,200

72

95

113

122

Vitamin B12

1,355

137

162

185

201

Phosphate

132

204

225

244

253

Creatinine

113

224

243

259

264

Urea

60

253

266

279

280

Clearance (QB = 400 mL/min)

                                             

Cytochrome c

12,230

76

92

105

Inulin

5,200

99

119

129

Vitamin B12

1,355

175

202

222

Phosphate

132

252

279

291

Creatinine

113

277

300

309

Urea

60

312

334

336

  

Ultrafiltration coeff. (mL/h x mm Hg)

27

38

53

68

   

Sieving coefficients

Albumin

66,500

< 0.001

Myoglobin

17,053

0.1

β2-microglobulin

11,731

0.7

Inulin

5,200

1

In vitro performance: QD = 500 mL/min, QF = 0 mL/min, T = 37°C (ISO8637). Ultrafiltration coefficients: human blood, Hct 32 %, protein content 6 %.

Membrane material

Helixone

Sterilisation method

INLINE steam

Housing material

Polypropylene

Potting compound

Polyurethane

Units per box

24

   

Effective surface (m²)

  

1.0

1.4

1.8

2.2

K0A Urea

866

1,068

1,394

1,429

Priming volume (mL)

53

74

95

116

Article number

F00002385

F00002386

F00002387

F00002388

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1 Weber V. et al., Blood Purification (2003); 21: 365.