GB2029363A

GB2029363A - A Package

Info

Publication number: GB2029363A
Application number: GB7929530A
Authority: GB
Original assignee: Pharmacia AB
Current assignee: Pfizer Health AB
Priority date: 1978-08-25
Filing date: 1979-08-24
Publication date: 1980-03-19
Also published as: SE413304B; NO792586L; DK353879A; SE7808995L; JPS5564072A; FR2433940A1; DE2933071A1; FI792602A

Abstract

In packages containing solutions for parenteral administration and comprising an inner, closed plastics container enclosing said solution, and an outer protective cover enclosing said container, the plastics from which the inner container is made is prevented from becoming opaque during sterilization of the package, by arranging a physiologically acceptable drying agent in the space between the inner container and the outer protective cover. The drying agent exists in solid form at the various temperatures and conditions to which the package is subjected and is able to absorb water vapour from air, at least within a temperature range of from 10 DEG to 30 DEG C. <IMAGE>

Description

SPECIFICATION A Package The present invention relates to a package for solutions intended for parenteral administration, said package comprising an inner closed plastics container in the interior of which said solution is enclosed, and an outer plastics protective cover which is impermeable to micro-organisms and which surrounds said inner container.

Packages of this kind are generally known.

The choice of the material from which the inner container is made is limited to those materials found acceptable by the authorities, said material preferably being polyvinyl chloride (PVC) and polypropylene. The outer protective cover has been produced from divers plastics materials and, in addition to serving as a protective cover, also serves to reduce the passage of moisture therethrough from the enclosed solution.

When heat sterilizing such a package in an autoclave with steam, water is taken up in the material of the inner container which material becomes opaque. rhis opacity remains after termination of the sterilizing process, and has been seen to remain in the case of packages which have been stored for several years. Since this opacity prevents the inspection of the enclosed solution, or renders such inspection difficulty to carry out, it is a considerable disadvantage.

According to the present invention it has now been found that this disadvantage can be eliminated or reduced with a package of the aforementioned kind which is characterised by the fact that both the inner container and the outer protective cover comprise transparent plastics material and in that in the space between the inner container and the outer protective cover there is arranged at at least one location a physiologically acceptable agent which exists in solid form at the different temperature-conditions and other conditions to which the package is subjected, and which when contacting moist air is able to absorb water vapour from the air, at least within a temperature range of from 100 to 300C.

The invention will now be described in more detail with reference to the accompanying drawing, which illustrates in perspective one embodiment of a package according to the invention.

The drawing illustrates an inner container 1 which is provided with a seal 2, an outer protective cover 3 and a source 4 of drying agent located between the container 1 and the outer protective cover 3.

The source 4 convenientiy comprises a container having walls comprising a material permeable to water vapour, such as paper or a textile material, and in which a drying agent, which is finely divided to a greater or lesser extent, is enclosed.

The drying agent used may be any known drying agent provided that it is approved by the authorities as being sufficiently acceptable from a physiological point of view for the purpose to which it is intended and exists in solid form at the various temperatures and conditions to which the package is subjected, which includes the condition that it is still solid form at the temperature of sterilization and will not melt or decompose at said temperature and that it will not pass into solution when coming into contact with large quantities of water vapour. (The drying agent selected may, of course, also be one which will take up water vapour from the air over a much wider temperature range (e.g. 0--500C) than the above mentioned and at varying relative humidities (e.g. 90 to 100%, 80 to 100% or 70 to 100% or, naturally, wider intervals).).Examples of suitable substances in the present context include dry, pure clay and silica gel. The quantity of drying agent used depends upon the ability of the substance to absorb water, the duration of the sterilization period, the specific surface area of the package and the materials from which the inner container and the outer protective cover are made. In the case of packages containing 500 ml of solution, a quantity of 5-10 g of dried, pure clay is generally fully sufficient to provide the desired effect. However, quantities which lie beneath the lowest of these values may be sufficient to provide said effect. On the other hand, quantities lying above the highest of said values will also provide the said effect, of course.

The size of the package may vary within wide limits, enabling the package to be used for solutions of, for example, 100 to 3000 ml. Thus, the invention can be applied to packages containing 100--300 ml of solution as well as packages containing, for example, 500 ml, 1000 ml and 3000 ml of solution. Depending upon the size of the package, the drying agent should normally be capable of absorbing 0.3 to 5 grams of water at those conditions which prevail in the interspace between the inner container and the outer protective cover.

The volume of air between the inner container and the outer protective cover is selected in dependence upon the size of the package and generally lies within the range of 30 to 500 ml.

The source of drying agent may be located at any position relative to the inner container. In the figure illustrating the exemplary embodiment, the source of drying agent has been placed adjacent one short end of the inner container for reasons of clarity, although in practice it is more advantageous when manufacturing the package to place said source above or beneath the inner container as seen in the drawing.

As will be readily understood, a multiplicity of relatively small sources of drying agent may be used instead of a single large source. It is desirable, however, that the drying agent is spread to the least possible extent, in order to enable the interior of the package to be seen to the greatest possible extent.

The drying agent source is preferably drysterilized prior to being introduced into the package. The package is manufactured in a known manner, the drying agent being introduced into the space between the inner container and the protective cover in combination with the step of applying said cover around said container and prior to sealing said cover.

One advantage is that the whole packaging procedure, and subsequent sterilization, can be carried out in one sequence.

Conveniently, the plastics material from which the inner container is made is a transparent PVC.

The outer protective cover can, to advantage, comprise a transparent plastics laminate, for example a laminate comprising polypropylene and polyester (or optionally polyamide or a fluorohalocarbon plastics material (e.g. Aclare).

One important advantage resides in the fact that the solution in the inner container can be seen not only subsequent to the outer protective cover having been removed but also when said cover is seated around said inner container.

Example Transparent plastics bags of PVC (having a thickness of 0.35 mm in respect of the plastics material) accepted for parenteral infusion solutions and having a volumetric capacity of 500 ml, were filled with physiologically acceptable saline solutions (i.e. containing 0.9 g NaCI per 100 ml of aqueous solution) and were subsequently sealed. The thus filled PVC-bags were packed in an outer protective casing made of a transparent plastics laminate with a total thickness of 0.1 12 mm and comprising an outer layer of polypropylene and an inner layer of polyester (thickness of 0.012 mm) whilst simultaneous therewith there was introduced into the space between the inner bag and the protective cover a small paper bag filled with 5 grams of pure clay, which clay had previously been dry-sterilized at 1 400C for 8 hours. The outer protective cover was then sealed completely around the inner container by being folded there around and heat sealed. The packages were then heat-sterilized in an autoclave with steam at 121 C for 10 minutes.

The solution in the thus produced packages could be inspected with the outer protective casing in piace around the inner plastics bag.

Claims

1. A package for solutions for parenteral administration, comprising an inner, sealed plastics container in the interior of which said solution is enclosed, and an outer plastics protective cover which is impermeable to microorganisms and which encloses said inner container, wherein both the inner container and the outer protective cover comprise transparent plastics material, and wherein in the space between the inner container and the outer protective cover there is arranged at at least one location a physiologically acceptable agent which exists in solid form at the various temperatures and conditions to which the package is subjected and which when coming into contact with watercontaining air is able to absorb water vapour from the air, at least within a temperature range of from 100 to 300C.

2. A package as claimed in claim 1 in which the inner container is made of transparent polyvinyl chloride.

3. A package as claimed in claim 1 or 2 in which the outer cover is made of a transparent plastics laminate.

4. A package as claimed in claim 3 in which the laminate is of polypropylene and polyester.

5. A package as claimed in any one of claims 1 to 4 in which the physiologically acceptable agent which absorbs water vapour is dried steriiized clay.

6. A package as claimed in claim 5 in which the quantity of clay amounts to 5 to 10 g per 500 ml of solution.

7. A package as claimed in any one of claims 1 to 6 which is of a size sufficient to hold 100 to 3000 ml of solution.

8. A package as claimed in claim 7 in which the space between the inner container and the cover has a volume of 30 to 500 ml.

9. A package as claimed in any one of claims 1 to 8 in which the solution is physiologically acceptable saline.

1 0. A package as claimed in claim 1 and substantially as hereinbefore described with reference to and as illustrated in the accompanying drawings.

11. A package as claimed in claim 1 and substantially as hereinbefore described with reference to the Example.