Production environment for sterile bags

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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