Aseptic bag, a high-tech new packaging material produced by using polyethylene pellets as raw material in ause.
Sterilizer bags are widely used in aseptic solid bulk drugs, aseptic pharmaceutical excipients, aseptic preparations, etc. due to their sterility, non-toxicity, excellent low temperature resistance, good chemical stability and electrical insulation properties. Transshipment and temporary storage, as well as transit packaging of sterile rubber plugs from cleaning to filling line processes. In addition, in the food industry, the aseptic bag can also be combined with cardboard and aluminum foil to form a packaging container for food. The weight of the aseptic bag accounts for about 20% of the entire package, and mainly blocks liquid leakage and microbial attack.
clean environment by blown film, cutting, heat sealing, vacuum packaging, sterilization and other processes.
Production environment and process
According to the new GMP standard, the production environment of the aseptic bag should be carried out in a clean grade C workshop. The cleanliness of the workshop needs to be graded according to the number of dust particles and settled bacteria in the workshop. Class A is the highest, the higher the level, the less the number of dust particles and settled bacteria in the bag.
The production process of aseptic bags is mainly divided into blown film, cutting, heat sealing bags, vacuum packaging and sterilization.
Blowing film: firstly open the air purification system in the workshop, disinfect and sterilize the workshop and operators, and make the operating environment reach the set standard, and blow the purified polyethylene particles at a certain temperature;
Cutting: The tubular film obtained after blown film is cut into different sizes according to the size required by the customer; heat-sealed bag: the film tube is sealed by a heat sealing machine;
Vacuum packaging: the sealed sterilization pouches is packed in multiple layers according to a certain amount;
Sterilization: The packaged sterilization pouches gamma rays are sterilized to achieve the sterility requirements of the product.
The essence of a sterilization pouches is a plastic bag, although the traditional concept of the bag is that the production process of the bag is very simple and the technical content is low. However, in order to meet the quality standards of the State Food and Drug Administration standards and the sterility requirements of GMP, its production process becomes complicated, and each production detail needs to take into account the cleanliness and sterility technical requirements.
The meaning of a sterilization pouches
It is well known that the packaging requirements for sterile injection powders such as antibiotics are very strict, and there is no physical and chemical reaction between the package and the drug, and it is not allowed to bring in any impurities including bacteria. For a long time, the packaging of such materials has been packaged in glass bottles or aluminum drums, but there are problems such as fragile packaging, difficult recycling, high cost, and the emergence of polyethylene aseptic bags has undoubtedly solved the above. Packaging problem for sterile injection powder.
The production of domestic aseptic bags is in its infancy. With the promulgation of the new GMP, stricter requirements are imposed on pharmaceutical packaging materials. This is undoubtedly a test of the survival of the fittest in the aseptic bag market. We look forward to the aseptic bag. The market can be perfected with this opportunity.