Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Patent
1997-06-19
2000-10-10
Stright, Jr., Ronald K.
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
604110, 604200, 604227, 604263, 141 2, 141 18, A61M 532
Patent
active
061297119
DESCRIPTION:
BRIEF SUMMARY
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates to a process for filling and sealing a fluid-containing plastic disposable syringe that is to be sterilized, whereby the disposable syringe comprises a barrel with a nozzle part that is molded at the front, an at least one-piece plunger or plunger plug, and a plunger stop element that is placed in the area of the cylinder gripping plate
2. Description of the Prior Art
To date, ampoules and injection vials have primarily been used for parenteral administration of liquid pharmaceutical agents. In addition, a hypodermic syringe with a matching injection cannula is required to administer the liquid or free-flowing substances that are decanted in these containers. This means, however, that the pharmaceutical agent must be transferred to such a hypodermic syringe before final use. This is not only time-consuming but also creates considerable opportunities for contamination.
To keep the liquid pharmaceutical agent from being contaminated, therefore, prefilled disposable syringes are already available on the market. Such a disposable syringe is known from EP-B 0 227 401. There, a process for the production of filled, sterile plastic syringes is described. The disposable syringe, whose design corresponds to DIN 13 098 Part 2, is sterilized in a special process to preserve its geometric shape. To prevent the plastic disposable syringe from being deformed in an autoclave under the action of high internal syringe pressure, the pressure is increased in the autoclave by adding compressed air until the internal syringe pressure is reached.
In addition to a pneumatic pump, this process required a steam generator with low inertia since although the compressed air that is introduced into the autoclave raises the internal autoclave pressure, it considerably lowers the temperature that is necessary for sterilization. It is also disadvantageous that heat transfer is reduced by the presence of air in the air/vapor mixture, which leads to a prolonged retention time in the autoclave.
Another drawback arises from the design of the disposable syringe that is used. It must be filled with the preparation through the opening on its plunger rod side. With this method of filling, a gas bubble is included in the barrel under the plunger plug that is to be used which further increases the internal syringe pressure during sterilization and thus forces the plunger plug to be pushed out and/or the syringe body to deform.
This drawback also exists for a subcutaneous syringe with a partial glass structure that is known from U.S. Pat. No. 5,069,670. The syringe has a glass barrel, a mounted cylinder gripping plate with an internal collar, a mounted head element with a standard connecting part for attaching medical cannulae, a plunger plug, and a sealing part. It cannot be sterilized in the filled state, however, since its glass cylinder cannot withstand high internal pressure during a sterilization process in the autoclave.
SUMMARY OF THE INVENTION
This invention therefore focuses on the problem of developing a process for filling and sealing a fluid-containing plastic disposable syringe that is to be sterilized, by which the disposable syringe can be sterilized in the filled state in a standard type of autoclave, without the danger arising of plastic deformation owing to the internal syringe pressure of the syringe parts. In this case, the disposable syringe is to be configured in such a way that largely gas-free filling is made possible. Further, the syringe components are to be simple to clean and to handle. Also, the drawbacks that are known from the area of prior art are to be avoided.
The problem is resolved, i.e., by virtue of the fact that the plunger or plunger plug, after insertion into the empty barrel, is inserted all the way up to its front end with or without the specific plunger rod and then the fluid medium is forced into the barrel under pressure via the nozzle part, whereby the fluid medium pushes the plunger or plunger plug in the direction of th
REFERENCES:
patent: 3667657 (1972-06-01), Chiquiar-Arias
patent: 3828775 (1974-08-01), Armel
patent: 4051850 (1977-10-01), Tischlinger
patent: 4981472 (1991-01-01), Ennis, III et al.
patent: 5009640 (1991-04-01), Pyret et al.
patent: 5053020 (1991-10-01), Manchester
patent: 5059172 (1991-10-01), Sutherland et al.
patent: 5084017 (1992-01-01), Maffetone
patent: 5147325 (1992-09-01), Mitchell et al.
patent: 5380300 (1995-01-01), Pritchard et al.
patent: 5538506 (1996-07-01), Farris et al.
patent: 5540666 (1996-07-01), Barta et al.
Schering Aktiengesellschaft
Stright Jr. Ronald K.
LandOfFree
Fluid-containing plastic disposable syringe that is to be steril does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Fluid-containing plastic disposable syringe that is to be steril, we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Fluid-containing plastic disposable syringe that is to be steril will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-2253061