High pressure steam sterilized plastic container holding infusion solution and method for manufacturing the same
First Claim
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1. 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, anda 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.
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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.
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Citations
21 Claims
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1. A high pressure steam sterilized plastic container holding an infusion solution, comprising:
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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. - View Dependent Claims (2, 3)
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4. A method for manufacturing a high pressure steam sterilized plastic container holding an infusion solution therein, comprising the steps of:
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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. - View Dependent Claims (5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21)
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Specification