Sterile packaging method for small-volume injection
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A packaging method and injection technology, applied in the field of aseptic packaging of small-volume injections, can solve problems such as hidden safety hazards, easy embolism, and content reduction, and achieve the effect of safety assurance
Inactive Publication Date: 2013-04-24
ZHONGQI PHARMA IND HENGSHUN ZHONGQI
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[0002] At present, most small-volume injections use terminal sterilization technology to ensure the sterility level. However, due to the special properties of some products, their content drops significantly after high-temperature sterilization, and related substances exceed the standard. greater safety hazard
Moreover, during the heating and sealing process of the traditional glass ampoule, a negative pressure is formed inside the ampoule, and the operation of cutting the ampoule during use will produce hundreds of thousands of fine glass particles. Inhalation of medicinal liquid, after injection into the human body, it is easy to cause embolism
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Embodiment 1
[0018] Take the production of small volume trimethoprim injection as an example, such as figure 1 shown, including the following steps:
[0019] (1) Weigh the raw and auxiliary materials of trimethoprim 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;
[0020] (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 the preparation, adjust the pH value of the trimethoprim injection to 3.85-3.95, and then the liquid is removed through the 0.22um redundant filter system Bacteria-grade filter for filtration sterilization;
[0021] (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 the plas...
Embodiment 2
[0023] Take the production of small volume racemic anisodamine hydrochloride injection as an example, such as figure 1 shown, including the following steps:
[0024] (1) Under a negative pressure weighing hood, weigh the raw and auxiliary materials of racemic anisodamine hydrochloride injection according to the process ratio, then add them to the pre-sterilized batching pot in sequence, add water for injection to dilute, and mix evenly;
[0025] (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 racemic anisodamine hydrochloride injection to 4.6-5.3, and then the liquid passes through the redundant filter system at 0.22 um sterilization grade filter for filter sterilization;
[0026] (3) The filtered sterile medicinal liquid is injected into the plastic bottle blow-fill-seal integrated machine through the sterile pipeline system, and p...
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Abstract
The invention discloses a sterile packaging method for small-volume injection. The sterile packaging method includes steps of (1) weighing injection raw and auxiliary materials under a negative-pressure weighing cover according to the technical proportion, sequentially adding the weighed injection raw and auxiliary materials into a dosing pot which is sterilized in advance, adding injection-used water to dilute and uniformly mix; (2) replenishing injection-used water to the total dosing amount according to the technical proportion by the aid of a weighing system of the dosing pot, adjusting the pH (potential of hydrogen) value of a drug liquor, and filtering and sterilizing the drug liquor through a 0.22-micrometer sterilizing level filter of a redundant filter system; and (3) injecting the filtered sterile drug liquor into an integrated plastic bottle blowing and filling and sealing machine through a sterile pipeline system, and obtaining a finished product after completing bottle blowing, filling and sealing under protection of an A-level laminar flow cover. The sterile packaging method has the advantages that terminal sterilization is omitted, original chemical characteristics of the injection are guaranteed, and further plastic ampoules are used for package, so that no craps are generated during use, embolism of blood vessels is avoided as well, and strong guarantee is provided for safety in clinical use.
Description
technical field [0001] The invention relates to the field of medicine production, in particular to a method for aseptic packaging of small-capacity injections. Background technique [0002] At present, most small-volume injections use terminal sterilization technology to ensure the sterility level. However, due to the special properties of some products, their content drops significantly after high-temperature sterilization, and related substances exceed the standard. a greater security risk. Moreover, during the heating and sealing process of the traditional glass ampoule, a negative pressure is formed inside the ampoule, and the operation of cutting the ampoule during use will produce hundreds of thousands of fine glass particles. Inhalation of the liquid medicine and injection into the human body can easily cause embolism. Contents of the invention [0003] The technical problem to be solved by the present invention is to provide a method for aseptic packaging of sma...
Claims
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