Plastic-ampule sterile preparation process and system based on sterile preparation and three-in-one function of blowing, filling and sealing
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A blow-fill-seal, three-in-one technology, applied in the field of plastic ampoule aseptic preparation process, plastic ampoule aseptic preparation technology and system field, can solve the problems of lack of sterilization function and the preparation system is not paid much attention, to reduce sterilization. Bacteria energy consumption, high quality effect
Inactive Publication Date: 2017-09-26
ZHONGQI PHARMA IND HENGSHUN ZHONGQI
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[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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Embodiment 1
[0052] The three-in-one plastic ampoule aseptic preparation process integrating aseptic preparation and blow-fill-seal is characterized in that it includes the following steps:
[0053] 1) Preparation before preparation, including:
[0054] A. Confirm that the supply pressure of compressed air is 4bar, the supply pressure of pure steam is above 3bar, and the water for injection has been supplied.
[0055] B. Online cleaning and sterilization of mixing tanks and sterile storage tanks,
[0056] C. Close the bottom valve of the mixing tank, collect the process water for injection in the mixing tank, turn on the magnetic stirrer, set the speed at 45Hz,
[0057] D. Run the laminar flow hood for 30 minutes before weighing; by extracting the air in the room, filtering it, and then removing it from the top laminar flow hood of the negative pressure weighing chamber, and continuously purifying the air in the negative pressure weighing chamber, it takes 20 minutes to Guarantee the sel...
Embodiment 2
[0083] The three-in-one plastic ampoule aseptic preparation process integrating aseptic preparation and blow-fill-seal is characterized in that it includes the following steps:
[0084] 1) Preparation before preparation, including:
[0085] A. Confirm that the supply pressure of compressed air is 2bar, the supply pressure of pure steam is 2bar, and the water for injection has been supplied.
[0086] B. Online cleaning and sterilization of mixing tanks and sterile storage tanks,
[0087] C. Close the bottom valve of the mixing tank, collect the process water for injection in the mixing tank, turn on the magnetic stirrer, set the speed at 35Hz,
[0088] D. Run the laminar flow hood for 20 minutes before weighing;
[0089] 2) Weighing, specifically including:
[0090] A. Select a scale with a weighing range close to the weighing value of raw and auxiliary materials in the negative pressure weighing chamber.
[0091] B. Adjust the base of the scale so that the air bubbles are ...
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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...
Claims
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Application Information
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