Diatomaceous earth composition with a low endotoxin content

Patent metadata

Field	Value
Publication number	US-12420258-B2
Application number	US-202418420145-A
Country	US
Kind code	B2
Filing date	Jan 23, 2024
Priority date	Oct 17, 2017
Publication date	Sep 23, 2025
Grant date	Sep 23, 2025

Abstract

The present invention relates to a diatomaceous earth composition with a low endotoxin content, comprising an agglomerated mixture of calcined diatomaceous earth particles and water, wherein the mass ratio of calcined diatomaceous earth particles and water is in the range of 1:1.0 to 1:2.0, and wherein the endotoxin content of the diatomaceous earth composition is equal to or less than 0.5 EU/mL. In a further aspect, the present invention relates to a method for producing the diatomaceous earth composition with a low endotoxin content. In another aspect, the present invention relates to the use of the diatomaceous earth composition with a low endotoxin content as a precoat agent for the precoat filtration in biopharmaceutical applications.

First claim

The invention claimed is:

1. A diatomaceous earth composition with a low endotoxin content, comprising an agglomerated mixture of calcined diatomaceous earth particles and water, wherein the mass ratio of calcined diatomaceous earth particles and water is in the range of 1:1.0 to 1:2.0, and wherein the endotoxin content of the diatomaceous earth composition is equal to or less than 0.5 EU/mL.

2. The diatomaceous earth composition according to claim 1 , wherein the mass ratio of calcined diatomaceous earth particles and water is in the range of 1:1.1 to 1:1.7.

3. The diatomaceous earth composition according to claim 2 , wherein the mass ratio of calcined diatomaceous earth particles and water is in the range of 1:1.2 to 1:1.4.

4. The diatomaceous earth composition according to claim 1 , wherein the average particle size of the calcined diatomaceous earth particles is in the range of 0.5 μm to 10 μm.

5. The diatomaceous earth composition according to claim 1 , further comprising a water-impermeable and γ-sterilizable packaging sealing the agglomerated mixture of calcined diatomaceous earth particles and water.

6. The diatomaceous earth composition according to claim 5 , wherein the water-impermeable and γ-sterilizable packaging is composed of a four-layered laminate comprising the following layers (i) to (iv) from the inside to the outside of the packaging:
(i) a layer of polyethylene or polypropylene having a thickness in the range of 30 μm to 150 μm;
(ii) a layer of polyethylene terephthalate or oriented polyamide having a thickness in the range of 5 μm to 20 μm;
(iii) a layer of aluminum having a thickness in the range of 5 μm to 20 μm; and
(iv) a layer of polyethylene terephthalate having a thickness in the range of 5 μm to 20 μm.

7. A precoat agent for a precoat filtration in a biopharmaceutical application comprising: a diatomaceous earth composition with a low endotoxin content, comprising an agglomerated mixture of calcined diatomaceous earth particles and water, wherein the mass ratio of calcined diatomaceous earth particles and water is in the range of 1:1.0 to 1:2.0, and wherein the endotoxin content of the diatomaceous earth composition is equal to or less than 0.5 EU/mL.

8. The precoat agent of claim 7 , wherein the biopharmaceutical application is precoat filtration of and/or prokaryotic cells in an aqueous medium.

9. The precoat agent of claim 7 , wherein the mass ratio of calcined diatomaceous earth particles and water is in the range of 1:1.1 to 1:1.7.

10. The precoat agent of claim 7 , wherein the mass ratio of calcined diatomaceous earth particles and water is in the range of 1:1.2 to 1:1.4.

11. The precoat agent of claim 7 , wherein the average particle size of the calcined diatomaceous earth particles is in the range of 0.5 μm to 10 μm.

12. The precoat agent of claim 7 , further comprising a water-impermeable and γ-sterilizable packaging sealing the agglomerated mixture of calcined diatomaceous earth particles and water.

13. The precoat agent according to claim 12 , wherein the water-impermeable and γ-sterilizable packaging is composed of a four-layered laminate comprising the following layers (i) to (iv) from the inside to the outside of the packaging:
(i) a layer of polyethylene or polypropylene having a thickness in the range of 30 μm to 150 μm;
(ii) a layer of polyethylene terephthalate or oriented polyamide having a thickness in the range of 5 μm to 20 μm;
(iii) a layer of aluminum having a thickness in the range of 5 μm to 20 μm; and
(iv) a layer of polyethylene terephthalate having a thickness in the range of 5 μm to 20 μm.

Assignees

• Sartorius Stedim Biotech Gmbh
• Sartorious Stedim Biotech Gmbh

Inventors

• Pflanz Karl
• Hebenstreit Florian
• Pickl Andreas

Classifications

• A61L2103/05

  Living organisms or biological materials · CPC title

• C12M47/10

  Separation or concentration of fermentation products (bioreactors combined with means for distillation or extraction of liquid fuel C12M43/02) · CPC title

• C12M47/02

  Separating microorganisms from the culture medium; Concentration of biomass (separating microorganisms from their culture media C12N1/02) · CPC title

• B65D65/40

  Applications of laminates for particular packaging purposes {(B65D1/0215, B65D1/28, B65D3/22, B65D5/0281, B65D5/563, B65D9/30, B65D29/02, B65D31/02, B65D75/26, B65D77/2024, B65D81/1275, B65D81/3811, B65D81/3823, B65D81/3834, B65D81/3846, B65D81/3858, B65D81/3874, B65D81/3886, B65D81/3897 take precedence; laminates per se or laminated packages characterised by the composition or)} · CPC title

• B65B55/02

  Sterilising, e.g. of complete packages · CPC title