IP Library › Granted Patent US 7,328,549
Granted Patent B2
US 7,328,549 · App. 11/657,814 · Granted Feb 12, 2008

Process for aseptic vacuum filling and stoppering of low viscosity liquids in syringes

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Quick Facts
Patent No.
US 7,328,549
App. No.
11/657,814
Granted
Feb 12, 2008
Kind
B2
Abstract

A process by which low viscosities liquids are filled into syringes without gas bubbles utilizing lowered temperature and valves to isolate the filling system from the vacuum. The liquid may be drug, device, pharmaceutical, and/or biotech products.

Claims (14)

1. A process for removing gas bubbles from a low viscosity fluid, the process comprising filling containers under aseptic conditions with a sterile, low viscosity fluid; and stoppering the containers, wherein filling and stoppering steps are performed in a vacuum chamber under a vacuum utilizing check valves to isolate fill lines, and lowered temperature to suppress vapor pressure of the low viscosity fluid being filled.

2. The process according to claim 1 , wherein the lowered temperature is obtained by a procedure selected from at least one of, cooling product feed into filling pumps, placing an in-line chiller on the filling pumps, placing an in-line chiller on the fill lines, reducing filling room temperature, chilling the containers on-line with a cold gas, and pre-chilling the containers.

3. The process according to claim 1 , further comprising, prior to filling the containers, applying a pre-vacuum.

4. The process according to claim 1 , wherein the gas bubbles comprise air.

5. The process according to claim 1 , wherein the gas bubbles comprise a gas other than air.

6. The process according to claim 1 , wherein the extent of the vacuum is at least about 28 inches of mercury and the temperature is less than about 8 C.

7. The process according to claim 1 , wherein the extent of the vacuum is at least about 29 inches of mercury and the temperature is less than about 8 C.

8. The process according to claim 1 , wherein the volume of the fluid is about 0.01 ml to about 100 ml.

9. The process according to claim 1 , further comprising prior to filling, sterilizing the fluid by filter sterilization.

10. The process according to claim 1 , wherein the filling and stoppering is automated.

11. The process according to claim 10 , wherein the automated process is high-throughput.

12. The process according to claim 1 , wherein the containers are selected from at least one of the group of vials, hypodermic syringes, bottles, cartridges, and capsules.

13. The process according to claim 1 , wherein the fluid comprises a product selected from at least one of a protein, polymer, a polysaccharide, a vaccine, an anti-serum, a mucoprotein, a nucleic acid, and a lipoprotein.

14. The process according to claim 13 , wherein the product is recombinantly produced.

Assignments (11)
ASSIGNMENT OF SECURITY INTEREST IN INTELLECTUAL PROPERTY, RECORDED ON SEPTEMBER 1, 2017, AT REEL/FRAME 043746/0621 Recorded Mar 17, 2025
From: BARCLAYS BANK PLC, AS EXISTING AGENT
To: APOLLO ADMINISTRATIVE AGENCY LLC, AS SUCCESSOR AGENT
Reel/Frame 070531/0279 →
SECURITY INTEREST Recorded Sep 6, 2021
From: CURIA GLOBAL, INC. (FKA ALBANY MOLECULAR RESEARCH, INC.); CURIA MASSACHUSETTS, INC. (FKA AMRI BURLINGTON, INC.); CURIA WISCONSIN, INC. (FKA CEDARBURG PHARMACEUTICALS, INC.); CURIA INDIANA, LLC (FKA AMRI SSCI, LLC); CURIA NEW MEXICO, LLC (FKA OSO BIOPHARMACEUTICALS MANUFACTURING, LLC); CURIA IP HOLDINGS, LLC
To: WILMINGTON TRUST, NATIONAL ASSOCIATION, AS COLLATERAL AGENT
Reel/Frame 057423/0665 →
RELEASE OF SECURITY INTEREST Recorded Oct 29, 2020
From: MORGAN STANLEY SENIOR FUNDING, INC., AS COLLATERAL AGENT
To: ALBANY MOLECULAR RESEARCH, INC.; AMRI BURLINGTON, INC.; CEDARBURG PHARMACEUTICALS, INC.; EUTICALS INC.; OSO BIOPHARMACEUTICALS MANUFACTURING, LLC
Reel/Frame 054252/0687 →
FIRST LIEN SECURITY AGREEMENT Recorded Sep 1, 2017
From: ALBANY MOLECULAR RESEARCH, INC.; AMRI BURLINGTON, INC.; CEDARBURG PHARMACEUTICALS, INC.; EUTICALS INC.; OSO BIOPHARMACEUTICALS MANUFACTURING, LLC-BY ITS SOLE MEMBER: ALO ACQUISITION LLC
To: BARCLAYS BANK, PLC AS COLLATERAL AGENT
Reel/Frame 043746/0621 →
SECOND LIEN SECURITY AGREEMENT Recorded Sep 1, 2017
From: ALBANY MOLECULAR RESEARCH, INC.; AMRI BURLINGTON, INC.; CEDARBURG PHARMACEUTICALS, INC.; EUTICALS INC.; OSO BIOPHARMACEUTICALS MANUFACTURING LLC-BY ITS SOLE MEMBER:ALO ACQUISITION LLC
To: MORGAN STANLEY SENIOR FUNDING, INC.
Reel/Frame 043746/0657 →
RELEASE OF SECURITY INTEREST Recorded Jul 9, 2014
From: WELLS FARGO
To: ALBANY MOLECULAR RESEARCH, INC.
Reel/Frame 033283/0357 →
SECURITY AGREEMENT Recorded Apr 20, 2012
From: ALBANY MOLECULAR RESEARCH, INC.; AMRI BURLINGTON, INC.; AMRI BOTHELL RESEARCH CENTER, INC.; AMRI RENESSELAER, INC.
To: WELLS FARGO BANK, NATIONAL ASSOCIATION
Reel/Frame 028078/0227 →
TERMINATION Recorded Apr 19, 2012
From: BANK OF AMERICA, N.A.
To: ALBANY MOLECULAR RESEARCH, INC.; AMRI BOTHELL RESEARCH CENTER, INC.; AMRI BURLINGTON, INC.; AMRI RENESSELAER, INC.
Reel/Frame 028072/0335 →
INTELLECTUAL PROPERTY SECURITY AGREEMENT Recorded Jun 6, 2011
From: ALBANY MOLECULAR RESEARCH, INC.; AMRI RENSSELAER, INC.; AMRI BOTHELL RESEARCH CENTER, INC.; AMRI BURLINGTON, INC.
To: BANK OF AMERICA, N.A., AS ADMINISTRATIVE AGENT
Reel/Frame 026397/0001 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 22, 2010
From: HYALURON, INC.
To: AMRI BURLINGTON, INC.
Reel/Frame 024723/0048 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 11, 2007
From: KINNEY, SHAWN; WAGNER, ANDREA
To: HYALURON, INC.
Reel/Frame 020230/0972 →