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In the field of modern production and packaging, aseptic bags, as a new type of high-tech packaging material, are becoming the focus of industry attention with their unique advantages and wide application fields.
Aseptic bags are high-tech packaging materials made of polyethylene particles in a clean environment through processes such as film blowing, cutting, heat sealing, vacuum packaging, and sterilization. It has shown a wide range of application prospects in many industries with its sterility, non-toxicity, excellent low-temperature resistance, good chemical stability and electrical insulation.
The essence of aseptic bags is a plastic bag, but compared with traditional plastic bags, its production process is more complicated and has higher technical content. It needs to be produced in workshops with cleanliness levels of C or above to ensure that every production detail meets the technical requirements of cleanliness and sterility. This high-standard production environment makes aseptic bags irreplaceable in the pharmaceutical and food industries.
The production process of aseptic bags mainly includes film blowing, cutting, heat sealing bag making and sterilization. In the film blowing stage, the purified polyethylene particles are blown at a certain temperature to form a tubular film. Subsequently, the tubular film is cut into film cylinders of different sizes according to the size required by the customer. Then, the film cylinder is sealed with a heat sealer to make sterile bags. Finally, the packaged sterile bags are sterilized with gamma rays to meet the sterility requirements of the product.
The production environment of sterile bags has extremely high requirements for the cleanliness of the workshop. The cleanliness of the workshop needs to be graded according to the number of dust particles and sedimentation bacteria in the workshop, with grade A being the highest level. The higher the level, the fewer dust particles and sedimentation bacteria in the bag, thus ensuring the sterility of the sterile bag.
In order to ensure the quality of sterile bags, the State Food and Drug Administration has formulated and promulgated the corresponding quality standards for pharmaceutical packaging material containers - medicinal low-density polyethylene films and bags. These standards strictly regulate the appearance, barrier properties, heavy metal content, dissolution content, microbial limits and other items of sterile bags.
On this basis, some companies have also formulated more stringent corporate standards. For example, Shijiazhuang Yucai Pharmaceutical Packaging Materials Co., Ltd. has added sterility testing, visible foreign matter testing, clarity testing, bubble testing, and ultraviolet absorbance testing to the quality standards for pharmaceutical bags, and has formulated corporate standards for pharmaceutical low-density polyethylene sterile films and bags. This standard is the first and only quality standard for sterile bags in China, providing a strong guarantee for the production and quality control of sterile bags.
With its unique advantages, sterile bags have been widely used in the pharmaceutical and food industries. In the pharmaceutical industry, sterile bags are used for the transportation and temporary storage of sterile solid APIs, sterile pharmaceutical excipients, sterile preparations and other products, as well as the transit packaging of sterile rubber stoppers from cleaning to filling lines. In the food industry, sterile bags, cardboard and aluminum foil together form food packaging containers, which mainly play a role in blocking liquid leakage and microbial invasion.
