Compositions and methods useful for removing tablet coatings

Patent metadata

Field	Value
Publication number	US-10711224-B2
Application number	US-201415304582-A
Country	US
Kind code	B2
Filing date	Apr 16, 2014
Priority date	Apr 16, 2014
Publication date	Jul 14, 2020
Grant date	Jul 14, 2020

Abstract

The present invention relates to a liquid cleaning composition can be a cleaning composition for removing an acrylic-based polymeric material useful as enteric tablet coatings located on a surface of a vessel or other process equipment comprising: —diethylen glycol mono butylether; and —water.

First claim

What is claimed is:

1. A method for removing an acrylic-based polymeric material from a pharmaceutical equipment surface comprising:
(a) diluting a concentrate composition with water to form a diluted composition, the concentrate composition comprising:
about 50 wt.-% to about 90 wt.-% diethylene glycol monobutyl ether;
about 0.5 wt.-% to about 3 wt.-% of at least one C 2 to C 10 organic acid; and
water,

(b) contacting the pharmaceutical equipment surface with the diluted composition for 30 seconds to 2 hours at a temperature of about 23° C. to about 80° C. as part of a clean-in-place process, the diluted composition having a pH from about 4.5 to about 6.0
and
(c) removing the acrylic-based polymeric material with the diluted composition from the pharmaceutical equipment surface.

2. The method according to claim 1 , wherein the acrylic-based polymeric material is selected from the group consisting of: acrylic acid, acrylic acid esters, methacrylic acid, methacrylic acid esters and mixtures thereof.

3. The method according to claim 1 , wherein the diluted composition is employed at a temperature in the range of about 50° C. to about 75° C.

4. The method according to claim 1 , wherein the diluted composition is employed at a temperature about 75° C.

5. The method according to claim 1 , wherein the diluted composition is employed of about 1 minute to about 1 hour.

6. The method according to claim 1 , wherein the diluted composition is employed for 20 minutes.

7. The method of claim 1 wherein the concentrate composition further comprises:
at least one nonionic surfactant wherein the nonionic surfactant is a C 8 -C 18 fatty alcohol alkoxylate C 2 -C 6 alkylether having 3 to 15 ethylene oxide and/or propylene oxide units.

8. The method of claim 1 wherein the C 2 -C 10 organic acid is selected from the group consisting of: acetic acid, propionic acid, iso-propionic acid, butanoic acid, pentanoic acid, hexanoic acid, heptanoic acid, octanoic acid, nonanoic acid, decanoic acid, glycolic acid, citric acid, lactic acid, tartaric acid, fumaric acid, malic acid, itaconic acid, ascorbic acid, benzoic acid, salicylic acid, succinic acid and mixtures thereof.

9. The method of claim 1 wherein the C 2 -C 10 organic acid is citric acid.

10. The method of claim 1 , wherein the concentrate composition further comprises:
at least one nonionic surfactant; and optionally a sequestering agent or corrosion inhibitor.

11. The method of claim 1 , wherein the cleaning composition has a flash point above 70° C.

12. The method of claim 1 , wherein the cleaning composition is free of anionic surfactants, monoalcohols, silicates, and additional glycol ethers.

13. The method of claim 1 , wherein the diethylene glycol monobutyl ether and organic acid are present in a ratio of 150:1 to 30:1.

14. The method of claim 7 wherein the concentrate composition further comprises:
a sequestering agent selected from the group consisting of: sodium gluconate, diethylenetriamine pentaacetic acid (DTPA), sodium glucoheptonate, ethylene diamine tetraacetic acid (EDTA), hydroxyethyl ethylene diamine triacetic acid, nitrilotriacetic acid (NTA), diethanolglycine sodium salt, ethanoldiglycine disodium salt, hydroxymonocarboxylic acid compounds, hydroxydicarboxylic acid compounds, tetrasodium N,N-bis(carboxylato-methyl)-L-glutamate (GLDA), hydroxyethylethylene-diaminetriacetate (HEDTA), methyl-glycinediacetate (MGDA), and mixtures thereof.

15. The method of claim 7 wherein the concentrate composition further comprises:
a corrosion inhibitor selected from the group consisting of: silicate, sodium silicate, sodium disilicate, calcium acetate, calcium chloride, calcium gluconate, calcium phosphate, calcium borate, calcium carbonate, calcium citrate, calcium lactate, calcium sulfate, calcium tartrate, benzotriazole, 1,2,3-benzotriazole, and mixtures thereof.

16. A method for removing an acrylic-based polymeric material from a pharmaceutical equipment surface comprising:
(a) contacting the acrylic-based polymeric material located on the pharmaceutical equipment surface with a cleaning composition for 30 seconds to 2 hours at a temperature of about 23° C. to about 80° C. as part of a clean-in-place process, the cleaning composition comprising:
about 50 wt.-% to about 90 wt.-% diethylene glycol monobutyl ether;
about 0.5 wt.-% to about 5 wt.-%, of at least one C 2 to C 8 organic acid;
about 0 wt.-% to about 5 wt.-% of at least one nonionic surfactant;
about 0 wt.-% to about 5 wt.-%, of at least one sequestering agent;
about 0 wt.-% to about 3 wt.-% of at least one corrosion inhibitor; and
water added to 100 wt.-%; and

(b) removing acrylic-based polymeric material with the cleaning composition from the pharmaceutical equipment surface.

17. The method of claim 16 wherein the cleaning composition further comprises a weight-% ratio of diethylene glycol monobutyl ether to C 2 to C 10 organic acid from about 150:1 to about 30:1, based on the total weight of the cleaning composition.

18. The method of claim 16 wherein the cleaning composition further comprises a weight-% ratio of diethylene glycol monobutyl ether to C 2 to C 10 organic acid from about 85:1 to about 80:1, based on the total weight of the cleaning composition.

19. The method of claim 16 wherein the cleaning composition is employed at a temperature in the range of about 23° C. to about 75° C.

20. The method of claim 16 wherein the cleaning compositions is employed of about 10 minutes to about 30 minutes.

21. The method of claim 16 , wherein the cleaning composition has a flash point above 70° C.

22. The method of claim 16 , wherein the cleaning composition is free of a monoalcohol selected from the group consisting of ethanol, isopropanol, 2-butoxy ethanol, 1-decanol, benzyl alcohol, and combinations thereof.

23. The method of claim 16 , wherein the pH of the composition is from about 4.5 to about 6.0.

24. The method of claim 20 wherein the cleaning compositions is employed of about 10 minutes to about 30 minutes.

25. A method for removing an acrylic-based polymeric material from a pharmaceutical equipment surface comprising:
(a) contacting the acrylic-based polymeric material located on the pharmaceutical equipment surface with a cleaning composition for 30 seconds to 2 hours at a temperature of about 23° C. to about 80° C. as part of a clean-in-place process, the cleaning composition comprising:
about 1 wt.-% to about 2 wt.-% diethylene glycol monobutyl ether;
about 0.01 wt.-% to about 0.1 wt.-%, of at least one C 2 to C 8 organic acid;
about 0 wt.-% to about 0.1 wt.-% of at least one nonionic surfactant;
about 0 wt.-% to about 0.1 wt.-%, of at least one sequestering agent;
about 0 wt.-% to about 0.06 wt.-% of at least one corrosion inhibitor; and
water added to 100 wt.-%; and

(b) removing acrylic-based polymeric material with the cleaning composition from the pharmaceutical equipment surface.

26. The method of claim 25 wherein the cleaning composition is employed at a temperature in the range of about 23° C. to about 75° C.

27. The method of claim 25 , wherein the cleaning composition has a flash point above 70° C.

28. The method of claim 25 , wherein the cleaning composition is free of a monoalcohol selected from the group consisting of ethanol, isopropanol, 2-butoxy ethanol, 1-decanol, benzyl

Assignees

• Ecolab Usa Inc

Inventors

• Potocnik Vesna
• Altmann Thomas

Classifications

• C11D7/26

  containing oxygen · CPC title

• C11D3/20

  containing oxygen {(C11D3/162, C11D3/164, C11D3/166, C11D3/168 take precedence)} · CPC title

• C11D7/263

  Ethers · CPC title

• C11D3/33

  Amino carboxylic acids · CPC title

• C11D3/2086 Primary

  Hydroxy carboxylic acids-salts thereof · CPC title