Method for decontaminating starch hydrolysates for the preparation of glucose polymers for peritoneal dialysis
The subject matter of the invention is a method for decontaminating starch hydrolysates from which glucose polymers for producing peritoneal dialysis solutions will be prepared.
1. A method for decontaminating starch hydrolysates from which glucose polymers for producing peritoneal dialysis solutions will be prepared, said method comprising:
a) preparing a starch hydrolysate,
b) filtering said starch hydrolysate so as to remove any contaminant having the size of a yeast, mold or bacterium,
c) treating said starch hydrolysate so as to remove any contaminant having the minimum size of 50 Angstroms by means of a technique selected from the group consisting of activated carbon of “mesopore” type, activated carbon of “micropore” type, frontal microfiltration and tangential ultrafiltration,
d) treating the resulting starch hydrolysate on activated carbon with a high adsorption capacity, and
e) collecting the decontaminated starch hydrolysate.
2. The method of claim 1 , wherein the starch hydrolysate of step a) is prepared by enzymatic or chemical hydrolysis of starch so as to achieve a dextrose equivalent (DE) of less than 20.
3. The method of claim 1 , wherein the starch hydrolysate of step a) is prepared by acid hydrolysis of a waxy starch milk to give a DE between 8 and 15 and optionally by enzymatic hydrolysis using a bacterial alpha-amylase to give a DE between 11 and 18.
4. The method of claim 1 , wherein the step of removing any contaminant having the size of a yeast, mold or bacterium is performed by microfiltration or ultrafiltration.
5. The method of claim 4 , wherein the microfiltration step consists of a membrane filtration where the pore diameter is 0.22 μm, optionally preceded by a membrane filtration where the pore diameter is 0.45 μm.
6. The method of claim 4 , wherein the ultrafiltration step consists of a membrane of ultrafiltration where the cut-off threshold is 300,000 Da.
7. The method of claim 1 , wherein said activated carbon is activated carbon of “mesopore” type.
8. The method of claim 1 , wherein the tangential ultrafiltration step consists of a membrane ultrafiltration where the cut-off threshold is from 20,000 Da to 50,000 Da.
9. The method of claim 1 , wherein said treating with activated carbon with a high adsorption capacity consists of activated carbon of “micropore” type.
10. The method according to claim 1 , wherein said starch hydrolysate is treated with activated carbon of “mesopore” type so as to remove any contaminant having the minimum size of 50 Angstroms.
11. The method according to claim 1 , wherein said starch hydrolysate is treated with activated carbon of “micropore” type so as to remove any contaminant having the minimum size of 50 Angstroms.
12. The method according to claim 1 , wherein said starch hydrolysate is treated with frontal microfiltration so as to remove any contaminant having the minimum size of 50 Angstroms.
13. The method according to claim 1 , wherein said starch hydrolysate is treated with tangential ultrafiltration so as to remove any contaminant having the minimum size of 50 Angstroms.
14. A method for decontaminating starch hydrolysates from which glucose polymers for producing peritoneal dialysis solutions will be prepared comprising:
a) preparing a starch hydrolysate,
b) filtering said starch hydrolysate so as to remove any contaminant having the size of a yeast, mold or bacteria type,
c) treating said starch hydrolysate from which the contaminating microorganisms have thus been removed with enzymes selected from the group consisting of lysozyme and laminarinase for degrading the cell wall polysaccharide constituents, chosen laminarinase or lysozyme,
d) ultrafiltering the enzymatically treated starch hydrolysate,
e) treating the resulting starch hydrolysate on activated carbon with a high adsorption capacity, and
f) collecting the starch hydrolysate thus decontaminated.
15. The method of claim 14 , wherein the starch hydrolysate of step a) is prepared by enzymatic or chemical hydrolysis of starch so as to achieve a dextrose equivalent (DE) of less than 20.
16. The method of claim 14 , wherein the starch hydrolysate of step a) is prepared by acid hydrolysis of a waxy starch milk to give a DE between 8 and 15and optionally by enzymatic hydrolysis using a bacterial alpha-amylase to give a DE between 11 and 18.
17. The method of claim 14 , wherein step b) is carried out by microfiltration or ultrafiltration.
18. The method of claim 17 , wherein the microfiltration step consists of a membrane filtration where the pore diameter is 0.22 μm, optionally preceded by a membrane filtration where the pore diameter is 0.45 μm.
19. The method of claim 17 , wherein the ultrafiltration step consists of a membrane ultrafiltration where the cut-off threshold is 300,000 Da.
20. The method of claim 14 , wherein the enzymatic hydrolysis treatment is carried out at the enzyme concentration of 0.001% to 1% by weight of starch hydrolysates.
21. The method of claim 14 , wherein the ultrafiltration step d) consists of a membrane ultrafiltration where the cut-off threshold is from 20,000 Da to 50,000 Da.
22. The method of claim 14 , wherein the step of treating with activated carbon with a high adsorption capacity consists of a quality of activated carbon of “micropore” type.