Package making – Methods – Sterilizing complete package
Patent
1995-12-18
1998-12-01
Moon, Daniel
Package making
Methods
Sterilizing complete package
422 25, 422 26, B65B 5502
Patent
active
058423265
DESCRIPTION:
BRIEF SUMMARY
TECHNICAL FIELD
The invention relates to a method for fabricating a sterile ready-pack and a container for such a ready-pack with at least one sealed-in, especially blister-type container with a filling, especially with a medication, a diagnostic means, or the like, especially a syringe, bag, bottle, or other medical utility object, whose package, especially a blister pack, has a region which is permeable preferably to the diffusion of steam, and for the rest is tight, such that the material used for the container is stable at least 125.degree. C. (degrees Celsius), preferably at 130.degree. C., and such that the sealed, tightly closed pack is exposed to an autoclaving process.
When water is heated in a closed pressure vessel, an over-pressure of 1 bar is reached at 121.degree. C. 15 to 20 minutes action of the "confined" steam is sufficient to kill all micro-organisms capable of reproduction.
PRIOR ART
With a known ready-pack of this kind, the individual parts of the plastic syringe are gassed with ethylene oxide in order to sterilize them. Then the syringe is assembled under sterile conditions and is filled with the previously sterilized fill under aseptic conditions, and is then sealed. Then the filled syringe is blistered into a sealed package, which then is gassed with ethylene oxide for sterilization. The gas then penetrates through porosities in the covering and flushes the syringe from the outside.
With this method, it is expensive to fabricate the filled syringe, since this is done under sterile conditions. Also, expensive precautions must be taken to prevent ethylene oxide residues or decomposition products from finding their way from the gassing process of the syringe and of the finished pack into the fill of the syringe and remaining there.
The U.S. Pat. No. 4,828,797 shows the fabrication of a biological test kid e.g. of an ethylene oxide sterilization process can be tested. Here, an open plastic throw-away syringe in a blister is freed of germs by means of a Tyvek (registered trademark) film through sterilization. A test strip is here situated in the interior of the syringe, and it changes color if the sterilization is adequate, e.g. through ethylene oxide.
The U.S. Pat. No. 5,033,252 discloses a sterilization method, in which a bottle filled with a sterile salt solution is placed into a blister, which subsequently is exposed to gassing by ethylene oxide or by confined steam. The exterior of the bottle is thus freed of germs. This method presupposes that the bottle must be filled completely, without any residual air in its interior, and that the bottle must be filled under aseptic conditions. This regularly involves an overflow of the fill, in order to assure that no air is present in the interior of the bottle. Consequently, the bottle itself and its environment must be cleaned after the filling process. In conjunction with the aseptic filling process and sealing process, this method is very expensive and consequently not very economical.
The EP 0 227 401 B1 describes a method for the end sterilization of a plastic syringe together with its content (liquid) by means of steam and a support pressure. This method has already been described for ready-to-use syringes made of glass, in detail and with pictures, in Venten & Hoppert, Pharm. Ind., Volume 40 (1978), Page 665 ff Point 4.
EXPLANATION OF THE INVENTION
The first object of the invention is to simplify the fabrication of a sterile ready-pack of the type mentioned in the introduction, and to make possible economic and ecologically friendly fabrication with autoclaving of the final package.
The inventive method is specified by the features of claim 1. Advantageous designs and modifications are the subject of the subclaims.
The inventive method accordingly is characterized in that, in a single operating step, both the fill is sterilized for at least 15 minutes, preferably 20 minutes, at a minimum of 121.degree. C., by means of a steam-air mixture rotary method, and the outer surface of the container as well as the package are also steri
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Farco-Pharma Gesellschaft Mit Beschrankter Haftung Pharmazeutisc
Moon Daniel
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