A fully enclosed aseptic liquid medicine ultrafiltration tank device

Abstract

The invention discloses a totally-enclosed ultrafiltration tank device for sterile liquid medicine, which comprises an ultrafiltration tank (1), an electronic scale (2), a supporting table (3) and a controller (4). The ultrafiltration tank device is a totally-enclosed device comprising the ultrafiltration tank, the electronic scale, the supporting table and the controller, wherein the ultrafiltration tank comprises a tank body and a tank cover; the tank body is provided with carrying handles, rotating shafts, cover locking machines, a liquid inlet valve, a liquid outlet valve and a liquid return valve; the tank body is internally provided with an annular sprayer and an inner long pipe; the tank cover is provided with a glass window and an air filter; the ultrafiltration tank is positioned above the electronic scale; the electronic scale is fixed above the supporting table; and the controller is fixed on one side of the supporting table. With the adoption of the technical scheme, the problems and defects that air tightness requirements of a new-edition GMP (Good Manufacturing Practice) are not met in the prior art are overcome. The totally-enclosed ultrafiltration tank device for the sterile liquid medicine allows operation of an ultrafiltration system to meet the air tightness requirements of the new-edition GMP through connection of a totally-enclosed structure with the ultrafiltration system.

Description

technical field [0001] The present invention relates to a sterile medicinal liquid container device for ultrafiltration, in particular to a fully-enclosed sterile medicinal liquid used for ultrafiltration concentration and ultrafiltration dialysis of sterile medicinal liquid in the production of medicines and biological preparations Ultrafilter device. Background technique [0002] Ultrafiltration (Ultrafiltratoin) refers to the production of active medicinal liquids and biologically active agents, such as the production of vaccines, through the filtration membrane separation technology called molecular sieve to filter out small molecular solutes and water in the original solution, so as to obtain concentrated pharmaceuticals. In the ultrafiltration system, the raw liquid of the preparation enters the ultrafilter from the ultrafiltration concentration container and flows through the surface of the filter membrane under the push of the pump pressure. Permeate, the permeate i...

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Problems solved by technology

[0003] In the prior art, large open vertical bottles or stainless steel barrels are used as ultrafiltration concentration containers, and non-airtight operation is performed under a high-efficiency laminar flow hood. Since there are many inlet and outlet pipes in the ultrafiltration concentration container, the operation is complicated and it is easy to be polluted. China's new version of GMP requires that in order to avoid contamination or cross-contamination of liquid medicine, it should be "produced in a closed system". If the medicine is a biological product that "cannot be terminally sterilized or sterilized", the quality of the final product cannot be guaranteed.

However, the prior art does not yet have a closed ultrafiltration concentration container device that meets the requirements of the new version of GMP and is specially used for the circulating operation of the ultrafiltration system. Therefore, the prior art has problems and deficiencies that do not meet the requirements of the new version of GMP.

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