Warm Global Customers
With China Plastic Machinery
With China Plastic Machinery
Polyethylene aseptic bags are a new type of high-tech packaging material made of polyethylene particles in a clean environment through processes such as film blowing, cutting, heat sealing, vacuum packaging, and sterilization.
Polyethylene aseptic bags are widely used in the transportation and temporary storage of sterile solid APIs, sterile pharmaceutical excipients, sterile preparations, and the transit packaging of sterile rubber plugs from cleaning to filling lines due to their sterility, non-toxicity, excellent low-temperature resistance, good chemical stability, and electrical insulation. In addition, in the food industry, aseptic bags can also be used together with cardboard and aluminum foil to form food packaging containers, of which the weight of aseptic bags accounts for about 20% of the entire packaging, mainly blocking liquid leakage and microbial invasion.
According to the new GMP standard, the production environment of aseptic bags must be carried out in a workshop with a clean level of C or above. The cleanliness of the workshop needs to be graded according to the number of dust particles and sedimentation bacteria in the workshop. Grade A is the highest. The higher the grade, the less dust particles and sedimentation bacteria in the bag.
The production process of aseptic bags is mainly divided into film blowing, cutting, heat sealing bag making, vacuum packaging, and sterilization.
Film blowing: First, turn on the air purification system in the workshop, and disinfect and sterilize the workshop and operators to make the operating environment meet the set standards, and blow the purified polyethylene particles at a certain temperature;
Cutting: The tubular film obtained after film blowing is cut into film cylinders of different sizes according to the size required by the customer; Heat sealing bag making: Use a heat sealing machine to seal the film cylinder;
Vacuum packaging: The sealed aseptic bags are vacuum packaged in multiple layers according to a certain number;
Sterilization: The packaged aseptic bags are sterilized by gamma rays to meet the sterility requirements of the product.
The essence of aseptic bags is a plastic bag, although people traditionally believe that the production process of bags is very simple and has low technical content. However, if the various quality indicators in the standards of the State Food and Drug Administration and the sterility requirements of GMP are to be met, its production process becomes complicated, and every production detail needs to take into account the technical requirements of cleanliness and sterility.
In order to effectively control the quality of drug and food packaging materials, the State Food and Drug Administration has formulated and promulgated the corresponding quality standards for pharmaceutical packaging materials and containers - medicinal low-density polyethylene films and bags (YBB00072005) since 2002, strengthening the control of the physical, mechanical, chemical and safety properties of the materials. Specifically, it includes requirements for appearance, barrier properties, heavy metal content, dissolution content, microbial limits and other items.
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 CLEANPACK polyethylene sterile bags produced on the basis of the quality standards for pharmaceutical bags, and has formulated the enterprise standard for pharmaceutical low-density polyethylene sterile films and bags (Q/01YC 01-2008). This standard is the first and only quality standard for sterile bags in China. At the same time, Shijiazhuang Yucai has also become the only pharmaceutical packaging material company in China to obtain the registration certificate for Class I polyethylene sterile film bags.
Inspect according to Appendix XI H of Part II of the 2010 edition of the Pharmacopoeia of the People's Republic of China - Sterility Test Method, requiring that no colonies should be detected.
As we all know, the packaging requirements for sterile injection powders such as antibiotics are very strict. No physical and chemical reactions are allowed between the packaging and the drugs, and no impurities including bacteria are allowed to be brought in. For a long time, such substances have been packaged in glass bottles or aluminum barrels, but there are problems such as fragile packaging, difficult recycling, and high costs. The emergence of polyethylene sterile bags has undoubtedly solved the above-mentioned packaging problems of sterile injection powder.
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