US4657540A
Expired / Lapsed
US
⏱️ 0.0 years remaining
High pressure steam sterilized plastic container holding infusion solution and method for manufacturing the same
Assignee: Terumo Corp
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Filing: 1985-07-23
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Granted: 1987-04-14
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Expires: 2005-07-23
Abstract
Abstract A high pressure steam sterilized plastic container holding an infusion solution therein is prepared first by providing a flexible container made of plastic material and holding an infusion solution. The container is then sterilized in a saturated steam atmosphere which is pressurized by a gas inert to the infusion solution and does not contain oxygen. The infusion solution in the container is not deteriorated after the sterilization.
Inventors
- 👤 Tomiyuki Iwamoto
- 👤 Naoki Hayakawa
- 👤 Shigeru Matsubara
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-25 22:35
CPC Classifications
A; A61; A61J; A61J1/00; A61J1/05; A61J1/10; A61J1/14; A61J1/1462; A61L; A61L2/00; A61L2/02; A61L2/04; A61L2/06; A61L2/07; A61L2/26; A61J1/16; A61L2103/00; A61L2103/05
Claims Analysis
Total Claims: 23
Claim 1
Independent Claim
176 words
A high pressure steam sterilized plastic container holding an infusion solution, comprising: a flexible container of a plastic material, an infusion solution contained in said flexible container, said infusion solution containing at least one component which is deteriorated substantially upon contact with oxygen, said infusion solution being selected from the group consisting of a concentrated amino acid solution containing tryptophane and a fat emulsion, and a gas-impermeable package made of gas-impermeable material and within which said flexible container with said infusion solution therein is contained after sterilization of said flexible container, said gas-impermeable package preventing deterioration of said infusion solution over a period of time, the container being sterilized with said infusion solution contained therein, by: placing said container with said infusion solution therein in a substantially oxygen-free sterilization atmosphere consisting essentially of saturated steam and nitrogen gas which is inert to said infusion solution, said nitrogen gas pressurizing said saturated steam so that said container with said infusion solution therein is sterilized in said sterilization atmosphere without substantially deteriorating said infusion solution in said container.
Claim 2
Dependent Claim
176 words
A high pressure steam sterilized plastic container holding an infusion solution, comprising: a flexible container of a plastic material, an infusion solution contained in said flexible container, said infusion solution containing at least one component which is deteriorated substantially upon contact with oxygen, said infusion solution being selected from the group consisting of a concentrated amino acid solution containing tryptophane and a fat emulsion, and a gas-impermeable package made of gas-impermeable material and within which said flexible container with said infusion solution therein is contained after sterilization of said flexible container, said gas-impermeable package preventing deterioration of said infusion solution over a period of time, the container being sterilized with said infusion solution contained therein, by: placing said container with said infusion solution therein in a substantially oxygen-free sterilization atmosphere consisting essentially of saturated steam and nitrogen gas which is inert to said infusion solution, said nitrogen gas pressurizing said saturated steam so that said container with said infusion solution therein is sterilized in said sterilization atmosphere without substantially deteriorating said infusion solution in said container.
Claim 3
Dependent Claim
30 words
A container according to claim 1, wherein a wall of the container is made of a member selected from the group consisting of polyvinyl chloride and an ethylene-vinyl acetate copolymer.
Claim 4
Dependent Claim
44 words
A container according to claim 1, wherein said gas-impermeable material is a laminate film having a polypropylene film as an outer film, an ethylene-vinyl alcohol copolymer film as an intermediate film, and a polypropylene film as an inner film layer of said gas-impermeable package.
Claim 5
Independent Claim
126 words
A method for manufacturing a high pressure steam sterilized plastic container holding an infusion solution therein, comprising the steps of: preparing a flexible container of a plastic material holding the infusion solution therein; placing said container with said infusion solution therein in a substantially oxygen-free sterilization atmosphere consisting essentially of saturated steam and nitrogen gas which is inert to said infusion solution, said nitrogen gas pressurizing said saturated steam whereby said container with said infusion solution therein is sterilized in said sterilization atmosphere without substantially deteriorating said infusion solution in said container; and packaging said flexible container in a gas-impermeable package which is made of a packaging material which is impermeable to gases, to thereby prevent deterioration of said infusion solution over a period of time.
Claim 6
Independent Claim
126 words
A method for manufacturing a high pressure steam sterilized plastic container holding an infusion solution therein, comprising the steps of: preparing a flexible container of a plastic material holding the infusion solution therein; placing said container with said infusion solution therein in a substantially oxygen-free sterilization atmosphere consisting essentially of saturated steam and nitrogen gas which is inert to said infusion solution, said nitrogen gas pressurizing said saturated steam whereby said container with said infusion solution therein is sterilized in said sterilization atmosphere without substantially deteriorating said infusion solution in said container; and packaging said flexible container in a gas-impermeable package which is made of a packaging material which is impermeable to gases, to thereby prevent deterioration of said infusion solution over a period of time.
Claim 7
Dependent Claim
22 words
A method according to claim 4, wherein the infusion solution contains at least one component which easily deteriorates upon contact with oxygen.
Claim 8
Dependent Claim
18 words
A method according to claim 5, wherein the infusion solution is at least one total parenteral nutrition component.
Claim 9
Dependent Claim
18 words
A method according to claim 6, wherein the infusion solution is a concentrated amino acid solution containing tryptophane.
Claim 10
Dependent Claim
14 words
A method according to claim 6, wherein the infusion solution is a fat emulsion.
Claim 11
Dependent Claim
16 words
A method according to claim 5, further comprising the step of cooling the container after sterilization.
Claim 12
Dependent Claim
13 words
A method according to claim 9, wherein sterilization is performed in an autoclave.
Claim 13
Dependent Claim
26 words
A method according to claim 10, wherein nitrogen gas is introduced into the autoclave for maintaining the interior of the autoclave at the pressure during sterilization.
Claim 14
Dependent Claim
16 words
A method according to claim 11, wherein cooling is performed by introducing water into the autoclave.
Claim 15
Dependent Claim
15 words
A method according to claim 4, wherein a sterilization temperature is 100° to 130° C.
Claim 16
Dependent Claim
22 words
A method according to claim 13, wherein the infusion solution contains at least one component which easily deteriorates upon contact with oxygen.
Claim 17
Dependent Claim
25 words
A method according to claim 4, wherein a saturated steam at the sterilization temperature is pressurized by the nitrogen gas by about 10 to 200%.
Claim 18
Dependent Claim
22 words
A method according to claim 15, wherein the infusion solution contains at least one component which easily deteriorates upon contact with oxygen.
Claim 19
Dependent Claim
29 words
A method according to claim 4, wherein a sterilization temperature is 115° to 126° C. and an atmosphere pressure is 1.2 to 2.0 kg/cm 2 in a gauge pressure.
Claim 20
Dependent Claim
22 words
A method according to claim 17, wherein the infusion solution contains at least one component which easily deteriorates upon contact with oxygen.
Claim 21
Dependent Claim
30 words
A method according to claim 4, wherein a wall of the container is made of a member selected from the group consisting of polyvinyl chloride and an ethylenevinyl acetate copolymer.
Claim 22
Dependent Claim
22 words
A method according to claim 19, wherein the infusion solution contains at least one component which easily deteriorates upon contact with oxygen.
Claim 23
Dependent Claim
44 words
A method according to claim 4, wherein said gas-impermeable material is a laminate film having a polypropylene film as an outer film, an ethylene-vinyl alcohol copolymer film as an intermediate file, and a polypropylene films as an inner film layer of said gas-impermeable package.
References Cited (Backward Citations)
US3064652A
Cited
DE1933542A1
Cited
DE2363468A1
Cited
DE2800484A1
Cited
US4453940A
Cited
DE2933071A1
Cited
US4334535A
Cited
USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 1990-04-13 | 1990-10-13 | 1991-04-14 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 1994-04-13 | 1994-10-13 | 1995-04-14 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 1998-04-13 | 1998-10-13 | 1999-04-14 | $7700.00 | Window Closed / Lapsed |