What 3D bags are used to produce sterile bags in A-level 100-level clean rooms

3D Sterile Bags (Three-Dimensional Bags)
Definition: 3D bags are three-dimensional structures with heat-sealed or high-frequency welded bottoms and sides. They can stand or hang, suitable for packaging requiring larger capacity or complex shapes. Common Types:

Free-Standing 3D Bags
Structure: The bottom is heat-sealed to form a flat base, with vertically extending sides. The top is open or has a sealing strip.
Features:
Can be stored standing up, saving space.
Large capacity, suitable for liquids or bulk solids.
Applications:
Biopharmaceuticals (e.g., cell culture fluids, buffers).
Food (e.g., juices, sauces).
Cleanroom Requirements:
Bag making and filling must be completed in a Class A, Class 100 cleanroom to prevent contamination.
The sealing strip must pass leak testing (e.g., ASTM D3078).
Hanging 3D Bags
Structure: Top with hanging holes or hooks, vertically extending sides, and a closed or open bottom.
Features:
Easy to hang for storage or transport (e.g., hospital IV bags).
Can be designed as disposable or reusable. Applications:
Medical infusions (e.g., glucose solutions, nutrient solutions).
Industrial cleaning (e.g., chemical reagent distribution).
Cleanroom Requirements:
Hanging holes or hooks must be installed in a Class A, Class 100 cleanroom to prevent contamination.
Structural strength must be verified through a drop test (e.g., ISO 8317).
Specialized 3D Bags
Structure: Customizable according to product shape (e.g., round, conical, or with compartments).
Features:
Conforms to product contours, reducing space waste.
Multiple chambers can be designed for mixing or packaging.
Applications:
High-end medical devices (e.g., artificial joints, heart stents).
Precision electronic components (e.g., semiconductor chips).
Cleanroom Requirements:
Bags must be manufactured using precision molds in a Class A, Class 100 cleanroom to ensure dimensional accuracy.
Cleanliness testing (e.g., particle counting) must be performed to verify bag residue.