Sterile bags are a kind of novel high-tech packaging material created from polyethylene pellets that have been blown, cut, heat sealed, vacuum packed, and sterilised in a sterile environment.
Due to their sterility, non-toxicity, excellent low temperature resistance, chemical stability, and electrical insulation, sterile bags are widely used in the transfer and temporary storage of sterile preparations and other products, as well as in the transit packaging of sterile plugs from the cleaning to the filling line process. Furthermore, in the food industry, sterile bags can be used with cardboard and aluminum foil to produce food packaging containers, with sterile bags accounting for approximately 20% of the total package weight. The functions of them are the primary barrier to liquid leakage and microbial infection.
According to the new GMP standard, the manufacturing environment for sterile bags must be in a class C or above clean room. The quantity of dust particles and sinking bacteria in the workshop determines the cleanliness of the workshop, with class A being the cleanest. The higher the class is, the less dust particles and sinking bacteria in the bags are. Film blowing, cutting, heat sealing, bag creation, vacuum packing, and sterilisation are the essential steps in the production of sterile bags.
(1) Film blowing: to begin with, the air purification system in the workshop is turned on, and the workshop and operators are sterilised to bring the operating environment up to a given standard. The purified polyethylene particles are then blown at a specific temperature.
(2) Cutting: the blown film is then cut into tubular film cylinders of various diameters based on the needs of the client; then heat sealing and bagging: the cylinders are sealed using a heat sealing machine.
(3) Vacuum packing: the sealed sample bags are vacuum packed in several layers based on the amount required.
(4) Sterilization: to ensure product sterility, the packed sterile bags are sterilised using gamma radiation.
Although the traditional opinion is that the production method of sterile bags for microbiology is relatively easy and has a low technical content, the essence of sterile sampling bags for microbiology is plastic bag. However, in order to achieve the quality indicators of the AQSIQ standards as well as the aseptic requirements of GMP, the manufacturing process becomes complicated, requiring that every production detail consider the technical requirements of cleanliness and asepsis.
The strict packaging requirements for sterile injectable powders such as antibiotics are well recognized, and they prohibit any physical or chemical interactions between the packings and any contaminants (including bacteria) from outside. For a long time, these substances were packaged in glass bottles or aluminium drums, but there were issues with fragile packaging, recycling difficulties, and high costs, so the introduction of polyethene sterile bags for microbiology has undoubtedly solved the packaging problem for these sterile injectable powders.