Producing On-Line Ultrapure Dialysis Fluid

Author(s):  
Beat von Albertini
Keyword(s):  
2002 ◽  
Vol 13 (suppl 1) ◽  
pp. S78-S83
Author(s):  
Ingrid Ledebo

ABSTRACT. On-line preparation, i.e., continuous mixing and immediate use, was introduced for dialysis fluid in 1964, and it contributed significantly to the expansion of dialysis therapy through simplified handling, improved microbiology, and enhanced efficiency. On-line prepared replacement solution for hemofiltration was shown to be clinically safe as early as 1978, but the implementation was delayed for 20 yr because of regulatory conservatism. On-line preparation of sterile and pyrogen-free solutions for infusion is based on the use of water and concentrates that contribute a minimum of microorganisms and are mixed and distributed in a hygienically designed and maintained flow path. Ultrafilters with known retention capacity are placed in strategic positions and dimensioned to remove bacteria and endotoxins, which gives a sterility assurance level of at least six magnitudes, as required by the Pharmacopoeia for sterile products. Microbiologic testing of the fluid should be applied when designing, validating, and troubleshooting on-line systems but not for routine quality control, because it only gives retrospective information. Quality assurance has to be built into a system and the way it is operated. On-line fluid preparation, when properly performed, is safe, simple, and cost-effective and enhances the efficiency as well as the biocompatibility of dialysis therapy.


1998 ◽  
Vol 21 (6) ◽  
pp. 335-340 ◽  
Author(s):  
C. Weber ◽  
H.K. Stummvoll ◽  
S. Passon ◽  
D. Falkenhagen

With the on-line preparation of substitution fluid, an easy-to-operate and cost-effective alter-native to conventional hemodiafiltration (HDF) has been realized. The continuous filtration of dialysis fluid, furthermore, allows high volumes of exchange. Microbial contamination and subsequently endotoxins, however, may be present in dialysis fluid, and thus the microbiological safety has become a pivotal issue. In this clinical study we evaluated the safety of the Fresenius Medical Care on-line HDF system which is based on a two-stage filtration of dialysis fluid with upstream DIASAFE® and downstream on-line HDF filter. During the three-month study period we failed to detect germs or endotoxins in the substitution fluid. Augmented plasma interleukin-1β (IL-1β) and tumor necrosis factor α (TNFα) concentrations were found neither during the intradialytic period nor when pre-session values at study begin and study end were compared. In addition, changes in the anti-endotoxin core antibody levels and soluble CD14 (sCD14) concentration, or pyrogenic episodes were not observed. On-line HDF with DIASAFE® and on-line HDF filter thus represents a safe treatment modality by effectively depleting dialysis fluid of cytokine-inducing substances.


Author(s):  
William Krakow

In the past few years on-line digital television frame store devices coupled to computers have been employed to attempt to measure the microscope parameters of defocus and astigmatism. The ultimate goal of such tasks is to fully adjust the operating parameters of the microscope and obtain an optimum image for viewing in terms of its information content. The initial approach to this problem, for high resolution TEM imaging, was to obtain the power spectrum from the Fourier transform of an image, find the contrast transfer function oscillation maxima, and subsequently correct the image. This technique requires a fast computer, a direct memory access device and even an array processor to accomplish these tasks on limited size arrays in a few seconds per image. It is not clear that the power spectrum could be used for more than defocus correction since the correction of astigmatism is a formidable problem of pattern recognition.


Author(s):  
A.M.H. Schepman ◽  
J.A.P. van der Voort ◽  
J.E. Mellema

A Scanning Transmission Electron Microscope (STEM) was coupled to a small computer. The system (see Fig. 1) has been built using a Philips EM400, equipped with a scanning attachment and a DEC PDP11/34 computer with 34K memory. The gun (Fig. 2) consists of a continuously renewed tip of radius 0.2 to 0.4 μm of a tungsten wire heated just below its melting point by a focussed laser beam (1). On-line operation procedures were developped aiming at the reduction of the amount of radiation of the specimen area of interest, while selecting the various imaging parameters and upon registration of the information content. Whereas the theoretical limiting spot size is 0.75 nm (2), routine resolution checks showed minimum distances in the order 1.2 to 1.5 nm between corresponding intensity maxima in successive scans. This value is sufficient for structural studies of regular biological material to test the performance of STEM over high resolution CTEM.


Author(s):  
Neil Rowlands ◽  
Jeff Price ◽  
Michael Kersker ◽  
Seichi Suzuki ◽  
Steve Young ◽  
...  

Three-dimensional (3D) microstructure visualization on the electron microscope requires that the sample be tilted to different positions to collect a series of projections. This tilting should be performed rapidly for on-line stereo viewing and precisely for off-line tomographic reconstruction. Usually a projection series is collected using mechanical stage tilt alone. The stereo pairs must be viewed off-line and the 60 to 120 tomographic projections must be aligned with fiduciary markers or digital correlation methods. The delay in viewing stereo pairs and the alignment problems in tomographic reconstruction could be eliminated or improved by tilting the beam if such tilt could be accomplished without image translation.A microscope capable of beam tilt with simultaneous image shift to eliminate tilt-induced translation has been investigated for 3D imaging of thick (1 μm) biologic specimens. By tilting the beam above and through the specimen and bringing it back below the specimen, a brightfield image with a projection angle corresponding to the beam tilt angle can be recorded (Fig. 1a).


Author(s):  
G.Y. Fan ◽  
J.M. Cowley

In recent developments, the ASU HB5 has been modified so that the timing, positioning, and scanning of the finely focused electron probe can be entirely controlled by a host computer. This made the asynchronized handshake possible between the HB5 STEM and the image processing system which consists of host computer (PDP 11/34), DeAnza image processor (IP 5000) which is interfaced with a low-light level TV camera, array processor (AP 400) and various peripheral devices. This greatly facilitates the pattern recognition technique initiated by Monosmith and Cowley. Software called NANHB5 is under development which, instead of employing a set of photo-diodes to detect strong spots on a TV screen, uses various software techniques including on-line fast Fourier transform (FFT) to recognize patterns of greater complexity, taking advantage of the sophistication of our image processing system and the flexibility of computer software.


Author(s):  
John F. Mansfield ◽  
Douglas C. Crawford

A method has been developed that allows on-line measurement of the thickness of crystalline materials in the analytical electron microscope. Two-beam convergent beam electron diffraction (CBED) patterns are digitized from a JEOL 2000FX electron microscope into an Apple Macintosh II microcomputer via a Gatan #673 CCD Video Camera and an Imaging Systems Technology Video 1000 frame-capture board. It is necessary to know the lattice parameters of the sample since measurements are made of the spacing of the diffraction discs in order to calibrate the pattern. The sample thickness is calculated from measurements of the spacings of the fringes that are seen in the diffraction discs. This technique was pioneered by Kelly et al, who used the two-beam dynamic theory of MacGillavry relate the deviation parameter (Si) of the ith fringe from the exact Bragg condition to the specimen thickness (t) with the equation:Where ξg, is the extinction distance for that reflection and ni is an integer.


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