advanced technology in blood separation lmb technologie gmbh
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ADVANCED TECHNOLOGY IN BLOOD SEPARATION
Lmb Technologie GmbH
ErySep ! Unique and New Blood Separation Technology
• Blood Separation without mechanical devices» Without Centrifuge» Without Separation Press» Without Power Supply
• Blood Separation by gravity force» ErySep separates whole blood into two components ( RED
CELL and PLASMA ) by itself without any other instruments
• Separated Blood Components in perfect quality» Cells Free PLASMA» Leukocyte Free RED CELL» Concentrated RED CELL ( 55%-60% HTC )
ErySep ! Unique and New Blood Separation Technology
• Approved Clinical Results» Studying on different parameters such as; pH, LDH, K, P, NH3, Osmolality, 2,3-DPG, Total
protein, Hemoglobin in TU (g/unit), Loss of Hb, Haemolysis, Leucocytes, F VIII activity, Platelets, the results have been published in international scientific magazines.
• Validation in different Country Blood Banks
German Blood Banks Indonesia Blood BanksUK Blood Banks Malaysia Blood BanksSpain Blood Banks Myanmar Blood BanksBulgaria Blood Banks Taiwan Blood BanksGreece Blood Banks Philippines Blood BanksChech Blood Banks Egypt Blood BanksSlovakia Blood Banks Yemen Blood BanksBelgium Blood Banks Jordan Blood BanksTurkish Blood Banks Saudi Blood BanksRussia Blood Banks
• All results meets with European Blood Components Standard• Guide to the preparation, use and quality assurance of blood components - 15th Editio
n (2009)
ErySep ! Unique and New Blood Separation TechnologyWHY ERYSEP?
• ErySep is user friendly• No necessary special education
• Work in all kind of environment• (outdoor/indoor)
• It is activated in 5 minute, and no need extra efforts
• Staff can do their other daily work• ErySep complete process by itself
within 75 minutes.• ErySep is a Closed Sterile System
• It can not effect outside conditions• Cost Reduction
• No centrifuge & extractor investment• No maintainance cost in routine usage• No power supply
• Easy Handling• 24 month shelflife in room condition• Easy Product exchange & replacement• Portable & ready work wherever
needed• Ready to use any time for any amount
• Expert can obtain specific demanded quantity
• ErySep can answer night time demand
ErySep ! Unique and New Blood Separation Technology
ErySep® is a disposable system
• has standard triple blood bag
whole blood bag
red cell bag
plasma bag with an integrated air drainage bag
• has standard leukocyte filter
• has test bag with vacu-container port
• has membrane filter embedded into separation chamber unit
ErySep ! Unique and New Blood Separation Technology
HOW ErySep® WORKS?
• Donor Blood is taken into Mother bag by using an integrated needle on the system.
• ErySep works by gravity force, does not need any other instruments or power supply.
• System can activate just by breaking internal plastic valves, after hanging to a infusion stand.
• Tubular membrane with a diameter of <1 mm and hollows (pores) 0,2 µm make physical separation; Red Cells are pushed into Red Cell Bag, Plasma are pushed into Plasma Bag through the membrane filter.
ErySep ! Unique and New Blood Separation TechnologyMedical ADVANTAGES of ErySep®
•ErySep supplies Leuko-depleted Red Cell & Plasma•Erysep supplies high HTC level into the Packed Red Cell Bag.•ErySep supplies plasma, which is ready for FFP•ErySep supplies Packed Red Cell Bag, which can be store 42 days.
•Leuko-depleted components are precious for Oncology and Hematology Patients•Make available the fresh components at hospital for surgical operation purposes.•Make available the fresh components for the patients need routine transfusion at hinterland.
Time Day 0 Day 42
pH Average value7.2348
576.89328
6
LDH (µkat/l) Average value0.9592
864.95785
7
K (mmol/l) Average value1.2542
8639.2507
1
P (mmol/l) Average value0.9692
863.66071
4
NH3 (µmol/l) Average value10.207
71153.692
9
Osmolality (mOsm/l) Average value333.42
86352.857
1
ATP (µmol/g Hb) Average value2.6214
290.71857
1
DPG (µmol/g Hb) Average value12.165
430.36364
3
Hemolysis Average value0.1407
14 0.7205
Datas from Hospital Prag Dr. Bohaniek
Rating and Validation of ErySepe..aıood donation and Blood separation device
Dr. med.Dr.rer.nat Kurt Mannemann-Pohl
Germany – Hamburg - Pohl Fachaat fOr Laboratoriumsmedizin Facharzt fOr Transfusionsmedizin DipL. Chem.
BACKGROUND: ErySep Blood Donation and Blood separation device has been validated in Hamburg at Marien Krankenhaus Blood bank. Whole results have
been reported as clinical study.
STUDY DESIGN AND METHODS: The used analysis methods performed in the laboratory of the Marienkrankenhaus Hamburg and are listed below. All
analysers and reagents were CE certified.All analysis methods were under permanent supervision of our quality control
system with permant internal and four external controls per year.
RBC Results German Studies ( n=15 )
Value
Avarage volume unit 346 ml
Hb 17,4 g/dl
Haematocrit 54%
Leucocytes in unit on day 1 0,03x10 6
Protein / unit 3,3 g/unit
K+ in RBC on day 1 0,28mmol/l
Free Hb on day 1 all<0,03 g/l
Free Hb on day 42 1,5 g/lUnits were sterile as tested with BacT/Alert Culture System of BioMerieuxPlasma Results German Studies ( n=15 )
Plasma volume 232 ml
Protein concentration 53,5 g/l
Leukocytes per unit 0,02 WBC/unit
Fibrinogen 191 mg/dl
ATIII 82% of normal
vWF-antigen 82% of normal
F VIII 82% of normal
Units were sterile as tested with BacT/Alert Culture System of BioMerieux
CONCLUSION: Easy to perform blood separation without the need for centrifuge, separator or even electricity; For donor and patient the procedure do not change;
Plasma has a very good quality and is better than the standard blood bank quality; RBC’s are better compared to standard blood bank quality. Remarkable is the very low WBC contect of far less than 1 WBC/µl ( effect of the hollow fibres ); Variation of measured parameters were all within the accepted limits for blood
bank routine.The ErySep-Device is a ready to use blood donation and separation system.
It is allowing, to produce leukocyte depleted erythrocyte concentrate and a cell free plasma with an elegant and save procedure with less equipment and limited
manpower. In one of the last validations of ErySep (09.01.2009). we can say, that the results
of the related labor tests are identical with the standards of the European Guidelines.
The ErySep is separating the donor blood only by earth gravitation, without electricity or using of centrifuges etc.
Cord Blood separation for obtaining fetal erithrocytes.Preliminar results. / December 2009.
Marta Torrabadella
Spain / Cord Blood Bank. Banc de Sang i Teixits. Barcelona
BACKGROUND: Cord blood separation with membrane filter technology is totally new and available in 2009 commercially. The first clinical study made
by Dr Brune in Germany. This is 2nd study, which was perfomed in December 2009.
STUDY DESIGN AND METHODS: The aim of the study is to show characterization of cord blood components after separation with ErySep
system. ErySep system offers the possibility of blood separation of plasma and erythrocyte concentrate by gravity
RBC concentration Value Range
Mean fetal Hb 67,8% 76- 58,6
Median Hb obtained in RBC concentrate 5,5 1,8-10,6
Percentage hemolysis 0,26%0,13 –
0,48
LDH (U/L) : Basal (n= 3 ) 143 114 - 186
K+ (mmol/l) : Basal (n= 3) 1,631,54 -
1,76
Plasma Value Range
Plasma Volume (ml) (n= 11) 31.36 5 - 85
Platelet concentration (CellDyn) in Plasma (n= 13) 77.30 0 - 490
Protein (g/L) in Plasma (n= 12) 2,45 2- 3,3
K+ mmol/l in Plasma (n= 7) 4,38 3,13- 5,96
LDH (UI) in Plasma (n= 7) 370,85 206- 612
Free Hb (n= 12) 0.022 0,00- 0,06
WBC/µL (n= 13) 0.076 0- 1