Filtering process and filtering system for use in preparation of injection liquid medicament

Abstract

The invention discloses a filtering process and a filtering system for use in preparation of an injection liquid medicament. The filtering process comprises the following steps of: preparing an injection in a preparation container (1), circulating by using a liquid medicament pump (2), filtering through a group of polypropylene filter cores (3), and reflowing a filtered solution into the preparation container (1) through a small circulating pipeline (8); and filtering by connecting the same group of polypropylene filter cores (3) with two groups of polyether sulfone filter cores (4, 7), forming a discharge port on a large circulating pipeline (5) behind the two groups of polyether sulfone filter cores, connecting the discharge port with the preparation container (1), and supplying a liquid medicament through another large circulating pipeline to perform production and quality detection of an injection. Through large and small circulations, impurities, heat sources, pigments and the like in the liquid medicament are removed effectively, and the aim of refining the liquid medicament is fulfilled; the filtering loads of the polypropylene filter cores and the pressure difference between moments before and after steam sterilization are lowered; and the use of active carbon in the conventional process is reduced, the requirement of environmental protection is better met, the possibility of adsorption of major components by active carbon is avoided simultaneously, and the quality of the liquid medicament is ensured.

Description

technical field [0001] The invention belongs to the technical field of pharmacy, and relates to a filtration process and a filtration system in the preparation of injection liquid medicine. technical background [0002] In the traditional process of injection, there are two kinds of filtration of liquid medicine: one is to use activated carbon to absorb liquid impurities and microorganisms, and then use a set of polypropylene filter elements and a set of polyethersulfone filter elements to decarbonize through titanium rods. Filtration for production; another without adding activated carbon to directly filter with a set of polypropylene filter elements and a set of polyethersulfone filter elements for production. The disadvantages of the traditional process are: the former is in the form of dust due to the activated carbon, which will pollute the clean area of ​​pharmaceutical production when used, and pollute the environment after use, which does not meet the requirements of...

AI Technical Summary

Problems solved by technology

The disadvantages of the traditional process are: the former one is in the form of dust due to the activated carbon, which will pollute the clean area of ​​pharmaceutical production when used, and pollute the environment after use, which does not meet the requirements of environmental protection

In the latter case, if the continuous filtration time is too long, microorganisms cannot be effectively removed

[0003] The use of polyethersulfone sterilizing filtration in the filtration of injections also has certain shortcomings. Because the polyethersulfone filter element has good permeability to water and has the effect of sterilizing filtration, but the permeability to steam is poor, so on-line sterilization The steam cannot effectively pass through the bacteria, and there is a large pressure difference between the front and rear of the filter element, which will cause internal damage and external deformation of the filter element at high temperature, thereby affecting the service life of the filter element, and there is a serious quality risk

Images