Sterile bags are widely used for the transportation and temporary storage of
sterile solid raw materials, sterile pharmaceutical excipients, sterile
preparations, and other products due to their sterile, non-toxic, excellent
low-temperature resistance, good chemical stability, and electrical insulation
properties, as well as the transit packaging of sterile rubber stoppers from
cleaning to filling lines. In addition, in the food industry, sterile bags can
also be combined with cardboard and aluminum foil to form packaging containers
for food. The weight of sterile bags accounts for about 20% of the entire
packaging, mainly preventing liquid leakage and microbial invasion. What is the
production environment for sterile bags?
According to the new GMP standard, the production environment of sterile bags
needs to be carried out in workshops with a cleanliness level of C or above. The
cleanliness of the workshop needs to be graded based on the number of dust
particles and settling bacteria in the workshop. The higher the level, the fewer
dust particles and settling bacteria in the bag.
If aseptic bags want to meet the quality indicators and GMP aseptic
requirements in the standards of the National Drug Administration, each
production detail needs to consider the technical requirements of cleanliness
and sterility.
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