Package making – Methods – Sterilizing complete package
Patent
1999-02-02
2000-12-19
Vo, Peter
Package making
Methods
Sterilizing complete package
53426, 53432, 53489, 53510, 141 7, 141 18, 141 25, 141 59, 141 95, 141198, B65B 5502
Patent
active
061613649
DESCRIPTION:
BRIEF SUMMARY
The invention relates to a process for filling and sealing syringes that are terminally sterilized. In this case, particular emphasis is placed on ensuring a problem-free insertion of the plunger into the syringe body. These syringes are provided preferably for the use of injectable diagnostic agents, especially contrast media that are injected into, for example, blood vessels, organs, organ parts, cavities, and other vessels or exert an imaging action there.
Publication EP 0 227 401 describes a process for the production of a filled, terminally sterilized plastic syringe. The syringe has a cylinder with a distal end with a syringe outlet piece. The syringe outlet piece is sealed by a closure. After being filled, the syringe is sealed with a flexible rubber plug, which can slide in the cylinder. The process begins with waste particles or other contaminants being removed from the closure and the plunger. Microbial contaminants on the closure and the plunger are destroyed. The cylinder is washed with a considerable number of water jets to remove pyrogens and waste particles. Then, silicone oil is applied to the inner wall of the syringe. The closure is then slipped onto the syringe outlet piece. The contrast medium is loaded into the syringe via the proximal end of the syringe. The syringe is then sealed with the plug. This assembled and filled syringe is sterilized in an autoclave. In this case, in addition to the usual autoclave pressure, an additional supporting pressure is generated in the autoclave. As a result, the pressure on the outer surface of the syringe is equal to or greater than the pressure on the inner surface of the syringe.
Terminal sterilization of prefilled cartridge-needle units is known from the publication by Venten and Hoppert (E. Venten and J. Hoppert (1978) Pharm. Ind. Vol. 40, No. 6, pages 665 to 671). The cartridge-needle units, which have a plug at the proximal end, are filled distally via the rolled edge. The rolled edge is then sealed with a sealing disk, whereby a flange cap secures the sealing disk to the rolled edge (M. Junga (1973) Pharm. Ind. Vol. 35, No. 11a, pages 824 to 829). The prefilled cartridge-needle units are then moved to an autoclave, which can be adjusted with respect to temperature and pressure. Thus, the sealing disk is not separated from the cartridge-needle unit, and supporting pressure is produced in the autoclave. The supporting pressure is built up by an additional gas. This makes it possible to keep the pressure on the inside of the sealing disk approximately equal to the pressure on the outside of the sealing disk. For this purpose, movement of the plunger that is already used is also avoided. With proper adjustment, it is even possible to sterilize terminally two-chamber cartridge-needle units that are filled with two solutions, without an unreliable plug movement or sealing disk leak occurring.
EP 0 553 926 describes a terminal sterilization process for prefilled syringes, in which no autoclave is used; rather only a pressure-resistant sterilization chamber is used. The distal or proximal filled syringe is introduced into said sterilization chamber. The chamber is heated using fuel gas. At the same time, this fuel gas also provides pressure that is to offset the increase in pressure in the syringe. To prevent the evaporation of liquid that can penetrate the plastic, steam is to be introduced optionally in addition to fuel gas. It is described in the industrial property right that the same reliability with respect to sterilization is to be achieved as in autoclaving.
WO 95/12482 describes a process for the production of prefilled plastic syringes that are filled with a contrast medium. The syringes consist of a cylinder and a syringe outlet piece at the distal end, which is prepared for a cannula attachment. In addition, the syringe comprises a plug, which can slide in the cylinder. It seals the proximal end of the syringe. The syringe has been produced according to a process that results in pyrogen-free objects. Also, particles are no longer present
REFERENCES:
patent: 1424187 (1922-08-01), Seelman
patent: 4628969 (1986-12-01), Jurgens, Jr. et al.
patent: 5207983 (1993-05-01), Liebert et al.
patent: 5531255 (1996-07-01), Vacca
Desai Hemant M.
Scherring Aktiengesellschaft
Vo Peter
LandOfFree
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