Aseptic packaging method of large volume injection
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A packaging method and a technology for injections, which are applied in the field of aseptic packaging of large-capacity injections, can solve problems such as potential safety hazards, high levels of microbial contamination, and inability to effectively remove them, achieving safety assurance, control of heat source content, and improved aseptic assurance levels Effect
Inactive Publication Date: 2013-05-01
ZHONGQI PHARMA IND HENGSHUN ZHONGQI
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[0002] At present, the terminal sterilization process is mostly used for large-volume injections to ensure the sterility level, but the traditional process has a high level of microbial contamination before filling, which is followed by an increase in the content of the heat source, and due to the particularity of the heat source, its High temperature resistant, soluble in water, and small in size, cannot be effectively removed, causing a lot of heat source reactions, which brings great safety hazards to its clinical use
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Embodiment 1
[0017] Take the production of large-capacity glucose injection as an example, such as figure 1 shown, including the following steps:
[0018] (1) Weigh the raw and auxiliary materials of glucose injection according to the process ratio under the negative pressure weighing hood, then add them to the pre-sterilized batching pot in turn, add water for injection to dilute, and mix well;
[0019] (2) With the cooperation of the weighing system of the batching pot, supplement the water for injection according to the process ratio to the total amount of preparation, adjust the pH value of the glucose injection to 4.1-5.0, and then the liquid medicine passes through the double 0.22um sterilization level of the redundant filtration system Filter for sterilization by filtration;
[0020] (3) The filtered sterile medicinal liquid is injected into the plastic bottle blow-fill-seal integrated machine through the sterile pipeline system, and plastic particles are added to the other end of ...
Embodiment 2
[0022] Take the production of large-capacity sodium chloride injection as an example, such as figure 1 shown, including the following steps:
[0023] (1) Weigh the raw and auxiliary materials of sodium chloride injection according to the process ratio under the negative pressure weighing hood, then add them to the pre-sterilized batching pot in sequence, add water for injection to dilute, and mix well;
[0024] (2) With the cooperation of the weighing system of the batching pot, supplement the water for injection according to the process ratio to the total amount of preparation, adjust the pH value of the sodium chloride injection to 5.0-6.5, and then the liquid is removed through the double 0.22um of the redundant filtration system Bacteria-grade filter for filtration sterilization;
[0025] (3) The filtered sterile drug solution is injected into the plastic bottle blow-fill-seal machine through the sterile pipeline system, and plastic particles are added to the other end of...
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Abstract
The invention discloses an aseptic packaging method of a large volume injection. The aseptic packaging method comprises the following steps: (1) weighing raw materials and auxiliary materials of an injection according to a process proportion under a negative-pressure weighing hood, sequentially adding the materials into a pre-sterilized batching pot, adding water for injection to dilute, and mixing uniformly; (2) supplementing the water for injection to achieve the preparation total amount according to the process proportion in combination with a weighing system of a batching pot, adjusting the pH value of the liquor, and filtering and sterilizing the liquor through double 0.22 microns sterilizing grade filters of a redundancy filtering system; and (3) injecting the filtered aseptic liquor to a plastic bottle-blowing, filling and sealing integrated machine through an aseptic pipeline system, finishing the bottle blowing, filling and sealing under the protection of a grade-A laminar flow hood, and finally sterilizing at high temperature to obtain a finished product. According to the aseptic packaging method of the large volume injection, double 0.22 microns sterilizing grade filters are added before filling, and the high-temperature sterilization is performed after filling, so that the aseptic assurance level of the large volume injection is greatly improved in comparison with the traditional terminal sterilization process, the content of a heat source is controlled effectively, and the security of clinical use is strongly guaranteed.
Description
technical field [0001] The invention relates to the field of pharmaceutical production, in particular to a method for aseptic packaging of large-capacity injections. Background technique [0002] At present, the terminal sterilization process is mostly used for large-volume injections to ensure the sterility level, but the traditional process has a high level of microbial contamination before filling, which is followed by an increase in the content of the heat source, and due to the particularity of the heat source, its High temperature resistant, soluble in water, and small in size, cannot be effectively removed, causing a lot of heat source reactions, which brings great safety hazards to its clinical use. Contents of the invention [0003] The technical problem to be solved by the present invention is to provide a method for aseptic packaging of large-capacity injections, which can effectively control the heat source content of large-capacity injections, and the le...
Claims
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