Plastic-ampule sterile preparation process and system based on sterile preparation and three-in-one function of blowing, filling and sealing

Abstract

Provided are a plastic-ampule sterile preparation process and system based on sterile preparation and a three-in-one function of blowing, filling and sealing. The process comprises the following steps of (1) preparation work before compounding the preparation, (2) weighing, (3) feeding, (4) sampling for detection, (5) filtering and (6) filling. By using the plastic-ampule sterile preparation process based on the sterile preparation and the three-in-one function of blowing, filling and sealing, products do not need high-temperature sterilization, the pH values of medical solutions are not changed, new materials are not produced, and the interior quality of the products is high, stable and reliable. Since the plastic ampules produced by the process do not need the high-temperature sterilization, the plastic ampules are very suitable for production of non-heat-resisting products. LDPE is used as a raw packing material for the plastic ampules free of terminal sterilization, the LDPE is soft in material quality, and the LDPE can be provided with a Ruhr opening at the neck after shaping. When an injector is used for obtaining medicine, the plastic ampule body is sucked to be flat, and ambient air can not come into the ampule body, so that the medicine can be obtained in a sterile mode during use of the products. Compared with a sterilization process for production, the plastic-ampule sterile preparation process based on the sterile preparation and the three-in-one function of blowing, filling and sealing can decrease a great amount of sterilization energy consumption, save power and reduce emission.

Description

technical field [0001] The invention relates to a plastic ampoule aseptic preparation process, in particular to a plastic ampoule aseptic preparation process and system integrating aseptic preparation and blow-fill-sealing three-in-one, belonging to the field of pharmaceutical manufacturing. Background technique [0002] Ampoule bottles are mainly used as packaging bottles for medical injections. Traditional ampoule bottles are made of glass, which are fragile, inconvenient for transportation and recycling, and need to use grinding wheels and other instruments to break the neck of the bottle body to open. , It is easy to scratch the operator's hands or gloves, causing injury to the operator, and glass debris is also likely to be generated at the moment of opening the bottle, polluting the operating table environment, and glass debris may also enter the ampoule bottle and cause liquid medicine pollution. At the same time, glass shards and glass dust generated during opening c...

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Problems solved by technology

[0006] It is not difficult to find from the above patents that at present, domestic and international research and production are mainly focused on the technical field of blow-fill-seal plastic ampoules, and do not pay much attention to the preparation system. However, BFS (blow-fill-seal) machines can only do The blowing / filling / sealing process is completed in a sterile state to ensure that the product is not contaminated and does not have the function of sterilization (mainly rely on the sterilization filter to remove the microorganisms in the liquid medicine)

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