Prefilled ampoules and manufacture thereof

Details Prefilled ampoules and manufacture thereof Prefilled ampoules and manufacture thereof

1998-09-22

2001-09-18

Seidel, Richard K. (Department: 3763)

Surgery

Means for introducing or removing material from body for...

Treating material introduced into or removed from body...

C211S074000, C141S237000

Reexamination Certificate

active

06290680

ABSTRACT:

TECHNICAL FIELD
The present invention relates to a syringe type ampoule having a) a barrel with a front end and a rear end defining an axis therebetween, the barrel having substantially constant cross-section between the front end and the rear end, at least the front end ending in an opening, b) a sealer attached to the front end and sealing the opening, c) at least one piston movably and sealingly arranged within the barrel and d) a sleeve extending along at least a part of the barrel, the sleeve having a front part and a rear part, the front part being connected to the sealer. The invention also relates to method and means for manufacture of prefilled ampoules.
BACKGROUND
Ampoules prefilled with various components are manufactured for diverse purposes. The present invention is mainly concerned with products of this kind for applications in which the demands are especially high. A representative example is prefilled ampoules for medicals or medical applications on which are placed severe demands quite generally for integrity, sealing, sterility, purity, amounts, rigidity etc. The ampoules can be plain breakable ampoules, sealed vials etc. More elaborate ampoule types further push the demands. Syringe type ampoules for example add considerations to piston friction and sealing and restrict front end sealing options. Dual or multi chamber type ampoules additionally require openable sealings between chambers and arrangements for mixing or reliable sequential delivery. Although the present invention have a more general utility it will mainly be described in terms of these demanding applications.
Each product quality and tolerance demand translates into corresponding manufacturing problems. Generally many components and process steps are required with intermediate controls. The components as such may be a contamination source as when glass, rubber or aluminum particles are released from ampoules, sealings and cappings respectively. Most steps have to be conducted in a pure or even sterile zone with the exception of some initial and final steps. Use of human operators in sterile environments is cumbersome and the fully mechanized alternative becomes complicated when increasing the number of steps and components involved. Bulk handling of components is simple but tend to increase problems with component damage, destruction and particle release. Individual manipulation on the other hand complicates machinery and reduces throughput. Use of cassettes or carriers for multiple components only represents a tradeoff between the extremes. When the ampoules are to contain a lyophilized compound there are further constraints on the equipment used as several steps, such as closure of the ampoules, has to be conducted within a closed freeze-drying chamber and should provide for e.g. vapor transfer and uniform heat exchange and should be compatible with the necessary temperature and pressure changes involved. Syringe type ampoules generally give limited access to the interior as the openings are mainly adapted for the pistons and needle attachments and temperature and pressure changes may displace pistons inserted. Multi-chamber ampoules further add to processing and may require turning and two-way access and the additional features, such as by-pass structures, complicate manipulation.
A typical dual-chamber syringe and a process for automated manufacture of prefilled such syringes is disclosed in Neue Verpackung, No.3, 1988, p. 50-52; Drugs Made in Germany, Vol. 30, Pag. 136-140 (1987); Pharm. Ind. 46, Nr. 10 (1984) p. 1045-1048 and Pharm. Ind. 46, Nr. 3 (1984) p. 317-318. The syringe type ampoule is a dual chamber device with a front bottle type opening for needle attachment, two pistons and an exterior type by-pass for mixing a lyophilized powder in the front chamber with a reconstitution liquid in the rear chamber. The process described includes the main steps of washing and siliconizing the syringe barrels, insertion of multiple barrels in carrier trays, sterilization, introduction of middle piston through barrel rear end, turning the trays upside down, introduction of the powder solution through the front opening, lyophilization to dry powder, closure of front opening while in the lyophilizing chamber, turning of trays, introduction of the reconstitution liquid through barrel rear end, insertion of rear piston, removal of products from trays and final control and packaging. This known process express most of the general problems outlined above. It is highly restricted to the specific product processed, e.g. by requiring a special closure system and by having the barrels resting on the exterior by-pass structure in the trays.
A general problem with prior art devices is the limited considerations to combined manufacturing and construction simplicity. The U.S. Pat. No. 5,435,076 discloses a dual chamber syringe construction with reduced demands for attachment and holding structures on the ampoule proper, still with features facilitating manufacture. In embodiments shown a central barrel is surrounded by a sleeve extending from a front opening to barrel rear end, thereby making superfluous any and all fastening structures on the barrel itself. At the opening the sleeve acts to secure a sealer in sealing position and eliminates the need for a separate capping. At the rear end a fingergrip, a plunger or a delivery mechanism can be attached to the sleeve part. In spite of barrel simplicity sealer and sleeve may, if desired, be joined into a single closure component allowing sealing in a simple axial movement, also in a lyophilizing chamber. Whenever present in the manufacturing process the sleeve also protects the central barrel and, e.g. in case of damage, confines or restricts barrel debris from spreading to other products or the plant itself. Yet there are room for improvements, especially adaptations for manufacture in highly automated processes.
Accordingly there remains a need for both ampoule constructions and ampoule filling processes and equipment better suited to meet high demands in the production of prefilled ampoules.
SUMMARY OF THE INVENTION
A main object of the present invention is to offer a system of ampoule constructions, manufacturing methods and manufacturing equipment better meeting the demands and avoiding the problems described. A more specific object is to offer a system in all its components simplified in relation to existing art. Another object is to offer a system easily adaptable to product variations. Still another object is to provide a system suitable for application in highly automated manufacture. Yet another object is to provide a system suitable for use with lyophilizing steps. A further object is to provide a system suitable for manufacture of syringe type ampoules and especially dual or multi chamber ampoules. Still another object is to provide a system allowing manufacture of improved reliability, less malfunction and more reproducible results.
These objects are reached with the characteristics set forth in the appended patent claims.
The invention may be used with the already improved syringe type device described, having a sleeve around a central barrel. According to the invention such a device can be still more simplified by using a barrel of substantially the same diameter at its front opening as its overall diameter, allowing use of e.g. a plain cylinder. This design further facilitates filling operations through the front opening but above all allows a piston to be inserted through the front opening and not only through the rear opening, which may be used to reduce necessary manufacturing steps and facilitate equipment design by allowing more steps to be conducted form the same side. The design also makes it easier to use a sealer or stopper for the front opening extending out to and beyond the barrel diameter. In the product this property allows the sealer to better center and buffer the external sleeve and in manufacture the same property makes it possible to grip and hold the sealer in an equipment cavity adapted to the barrel diameter, which in turn

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