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Cell culture consumable packaging method meeting requirements of GMP (good manufacturing practices)

A cell culture and packaging method technology, applied in the field of biopharmaceuticals, can solve problems such as easy breakage, high risk of bacterial contamination, and inability to guarantee sterility of products, and achieves the effects of being less prone to breakage, reducing the risk of bacterial contamination, and avoiding contamination

Inactive Publication Date: 2020-03-27
上海韵飞生物科技有限公司
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  • Abstract
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  • Claims
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Problems solved by technology

However, a layer of film is easily damaged, and the damaged product cannot be guaranteed to be sterile, and there will be a high risk of bacterial contamination during use

Method used

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Embodiment 1

[0012] The invention provides a method for packaging cell culture consumables meeting the requirements of GMP, comprising the first step of producing cell culture consumables according to a normal non-sterile process, characterized in that: the second step is to produce non-sterile On the basis of cell culture consumables, the product is vacuum-packed in three layers, and the third step is to sterilize the vacuum-packed product to obtain the final product. During GMP production, the outermost packaging bag is peeled off at the designated position, and then the consumables are delivered to the high-level clean room. The product can be used safely by peeling off the innermost packaging bag. Among them, irradiation sterilization is an effective method to kill microorganisms on most substances by using electromagnetic waves generated by ionizing radiation. A layer of outer packaging is removed every time a clean level is entered, which avoids the pollution and damage caused by th...

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PUM

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Abstract

The invention relates to the technical field of biological pharmacy, in particular to a cell culture consumable packaging method meeting the requirements of GMP (good manufacturing practices). According to the technical scheme, the cell culture consumable packaging method comprises the steps that first, cell culture consumables are produced according to a normal non-sterilization process; second,three-layer vacuum packaging is performed on products based on the produced non-sterilized cell culture consumables; and third, irradiation sterilization is performed on the vacuum-packaged products to obtain final products. According to the cell culture consumable packaging method meeting the requirements of GMP, the integrity of the product packaging can be intuitively judged through the three-layer vacuum packaging, damage is not prone to being caused, pollution to clean areas is avoided, the products can be better ensured to be sterilized, the risk of bacterial contamination is reduced, and the cell culture consumable packaging method is suitable for high-level purification requirements.

Description

technical field [0001] The invention relates to the technical field of biopharmaceuticals, in particular to a packaging method for cell culture consumables meeting the GMP requirements. Background technique [0002] GMP (GOOD MANUFACTURING PRACTICES), the Chinese meaning is "production quality management specification" or "good operating practice", "good manufacturing standard". GMP is a set of mandatory standards applicable to pharmaceutical, food and other industries. It requires enterprises to meet the hygienic quality requirements in accordance with relevant national regulations in terms of raw materials, personnel, facilities and equipment, production processes, packaging and transportation, and quality control, and form a set of operational standards. The operation specification helps enterprises to improve the sanitary environment of the enterprise, discover problems in the production process in time, and improve them. Briefly speaking, GMP requires pharmaceutical an...

Claims

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Application Information

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IPC IPC(8): B65B31/00B65B31/04B65B55/10B65B55/02B65B69/00B65C3/08B65C9/26
CPCB65B31/00B65B31/04B65B55/02B65B55/10B65B69/0008B65C3/08B65C9/26
Inventor 陶小敏
Owner 上海韵飞生物科技有限公司
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