Package making – Methods – Sterilizing complete package
Patent
1996-09-30
1998-09-01
Moon, Daniel
Package making
Methods
Sterilizing complete package
53426, 53432, 414786, B65B 3102
Patent
active
057994641
DESCRIPTION:
BRIEF SUMMARY
BACKGROUND OF THE INVENTION
The present invention relates to a method and a device for aseptic and automatic transfer of unsealed pharmaceutical containers, which have been aseptically filled with a pharmaceutical preparation, from a filling device to a subsequent unit.
As regards pharmaceutical formulations, it has always been a serious problem to maintain the required hygienic conditions during the transfer of solutions or substances aseptically filled in pharmaceutical containers from a filling machine to the subsequent process step, e.g. a freeze-drying step. During such a transfer, the hygienic conditions should always be the same as during the filling and freeze-drying process. Also, the authorities will in all probability tighten the requirements for higher purity levels in this technique area.
DESCRIPTION OF THE PRIOR ART
It is known to manually transfer trays with unsealed or partly sealed containers aseptically filled with pharmaceutical preparations from a filling machine to a freeze-drier. In such a case, the pharmaceutical preparation in the container is exposed to the surrounding air and the particles and microorganisms therein, and the hygiene class of the preparation is adversely affected. Preparations sensible to air are difficult to handle in such a manner.
In an automatic transfer process, it is also known to use a large shelf device and air sterilised by filtration as protective gas. However, the equipment required for such use takes up quite a lot of space, and the time required is too long and therefore harmful for the preparation.
EP 440 042 (Capsulite Spa) is related to a process and a device for the sterilisation of plants for filling e.g. pharmaceutical bottles by using a nitrogen injection system. The purpose of this device is to clean the filling plant at the end of a production cycle and to maintain a pressure with inert gas therein until the subsequent production cycle starts. The nitrogen injection is a complement to the injection of cleaning water and steam.
JP 03216174 (Iwatani International Corp.) relates to an aseptic freezing device, in which liquid nitrogen is used for freezing a pharmaceutical product. The liquid nitrogen is passed through a filter in the freezing chamber, such that microorganisms and dust are separated. The cleaned nitrogen is utilised for freezing the product.
However, there is still a need for a process for aseptic transfer of aseptically filled pharmaceutical containers, which enables the highest hygiene class to be maintained throughout the transfer process and which requires a relatively small space.
SUMMARY OF THE INVENTION
The object of the present invention is to eliminate the above-mentioned problems.
This object is achieved by a method which is of the type described by way of introduction and which is characterised by the steps of the chamber, and pharmaceutical containers are removed from the chamber, said protective gas being continuously and evenly distributed in steps b)-d) over the unsealed pharmaceutical containers.
The inventive object is also achieved by a transfer device for aseptic and automatic transfer of unsealed pharmaceutical containers, which have been aseptically filled with a pharmaceutical preparation, from a filling device to a subsequent unit, said transfer device comprising a controllable transport vehicle, a vertically adjustable platform provided thereon and a transportable and hermetically sealable chamber provided on the platform and holding the pharmaceutical containers during the transfer, said transfer device being characterised in that the chamber comprises containers during the transfer and with a closable opening for the introduction and removal of the pharmaceutical containers, said upper part and said lower part being separated by an intermediate, substantially horizontal flow distributor for even distribution of protective gas from the upper part over the pharmaceutical containers in the lower part.
The present invention is advantageous in that it enables an improved transfer of filled pharmaceutical
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Astra Aktiebolag
Moon Daniel
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