Device for introduction and/or withdrawal of a medium into/from

Measuring and testing – Sampler – sample handling – etc. – Withdrawing through conduit or receptacle wall

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G01N 112

Patent

active

060325437

DESCRIPTION:

BRIEF SUMMARY
The present invention relates generally to a device for introduction and/or withdrawal of a medium into/from a container, and more particularly to such devices for introduction and/or withdrawal of media into/from a container as are intended for use in areas with very strict requirements on low contamination risks inside the container and/or in the container environment.
Within for instance the pharmaceutical and biotechnology fields and to some extent in the food manufacturing and cosmetic industries there is a continuous need for sampling of media, for example for micro-biology checks, cell counts, or for chemical analysis, or for addition of regulating or active media, such a pH-buffer of a biological starting culture, during a certain processing step in the production of products within each field. When such production is carried out under conditions of low contamination requirements with respect to the media that are taking part in the process, the production normally is carried out in a sealed container. However, contamination risks arise when a medium is to be added to or a sample be withdrawn from the container.
One example of a prior-art device for withdrawing samples from a container for the above mentioned usages is shown in U.S. Pat. No. 3,779,082. The device comprises a self-sealing membrane disposed in an aperture in the container. A plurality of channels interconnect the membrane with the area exteriorly of the container. A transfer member fitted with a hypodermic needle may be received in one of the channels, it being possible to introduce the hypodermic needle through the membrane into communication with the container interior. In this manner samples may be withdrawn from the container or a medium be introduced into the container via the hypodermic needle. A vinyl tape or the like covers the upper ends of the channels until the transfer member is inserted into the channels. The device may be pre-sterilised, in which case the channels are not exposed to contamination risks until a transfer member is inserted therein.
A drawback inherent in this construction is that the upper part of the membrane may be contaminated in connection with the transfer member contacting the membrane. Impurities and the like may be drawn into the container via the hypodermic needle. In addition, a small amount of the medium will always accompany the hypodermic needle as the latter is withdrawn from the membrane. In this manner the area exteriorly of the container is exposed to contamination risks when this prior device is in use, which is particularly serious when for instance specimen of toxic media are being withdrawn.
In U.S. Pat. No. 3,776,042 is shown another device for withdrawal of samples from a container. This device comprises two self-sealing membrane parts which are sealingly disposed in a hose fitting in a container. An aseptic medium, such as steam or the like, flows from an inlet to an outlet in the hose fitting intermediate the membrane part. The hypodermic needle of a transfer member pierces the outer membrane part and is disinfected by the steam before being introduced into the inner membrane into communication with the container interior. In this position a sample may be withdrawn. When the hypodermic needle is pulled out, it is again sterilised by steam in the area intermediate the membrane parts.
The drawback inherent in this device is that to use steam requires expensive special equipment. Steam may be useful for sterilising against bacteria but this equipment cannot be used for sampling media that must not contaminate the environment and that are not destroyed by steam, since they may accompany the hypodermic needle as the latter is withdrawn from the two membrane parts or contaminate the area between the membrane parts or the steam tube system connected to the area between the membrane parts. In addition, the sample and the environment may come into contact with one another via the hypodermic needle tunnel, once the hypodermic needle has been withdrawn from the membrane parts, which in itsel

REFERENCES:
patent: 3736099 (1973-05-01), Begg et al.
patent: 4941517 (1990-07-01), Galloway
patent: 5535635 (1996-07-01), Shaw

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