Infusion sets are commonly used sterile medical devices in clinical settings, used to deliver medication to patients through intravenous infusion. The production process of infusion sets must strictly follow medical device production standards (such as ISO 8536 series, GB 8368, etc.) to ensure safety, sterility, and infusion accuracy. The typical production process of infusion sets is as follows:
1.Raw material preparation and inspection
The infusion set is composed of multiple components. Different components are made of specific medical materials and must undergo strict screening and testing.
Component
Common Materials
Performance Requirements
Infusion tube
Polyvinyl chloride (PVC) or TPU
Good flexibility, resistance to medicinal corrosion, no leachables
Raw material inspection: Tests are conducted on the chemical safety (e.g., heavy metals, residual monomers) and physical properties (e.g., tensile strength, temperature resistance) of materials to ensure they meet medical-grade standards.
2.Component Production
Infusion Tube Extrusion Molding
Process: Molten PVC or TPU raw materials are extruded through an extruder die into a tubular shape, cooled and shaped in a cold water tank, then pulled to the cutting station by a tractor.
Key parameters: Control the extrusion temperature (PVC at approximately 160-190°C) and traction speed to ensure uniform inner diameter (usually φ2.6-3.0mm) and wall thickness of the infusion tube, with no bubbles or impurities.
Cutting: The infusion tube is cut into fixed lengths (e.g., 1.2m, 1.5m) by an automatic cutting machine according to the infusion set specifications, and then rolled for later use.
Production of Other Components
Piercer: The plastic hub is formed by injection molding, then assembled and fixed with a stainless steel piercing needle (after grinding and deburring).
Drip chamber: Produced by injection molding, requiring a smooth inner wall, no depressions, and precise interface dimensions matching the infusion tube.
Flow regulator: After injection molding, its adjustment range (from fully closed to maximum flow) and locking performance are tested.
Solution filter: The filter mesh (e.g., 15μm nylon mesh) is sealed with the plastic housing by ultrasonic welding to ensure no solution leakage and smooth filtration.
3.Cleaning and Pretreatment
Component cleaning: Injection-molded parts such as piercers, drip chambers, and filters undergo ultrasonic cleaning (to remove release agents and dust) and rinsing with purified water to ensure surface cleanliness.
Venous needle treatment: After grinding and forming, the stainless steel venous needle is deburred at the tip and then sterilized at high temperature (e.g., steam sterilization) to remove oil stains.
4.Assembly
Assembly is carried out in a Class 100,000 clean room with fully or semi-automated operations to reduce manual contamination:
Connection of drip chamber and infusion tube:
One end of the infusion tube is inserted into the bottom interface of the drip chamber and fixed by heat sealing (melting plastic with high temperature for adhesion) or ultrasonic welding to ensure tight sealing without leakage.
The other end of the drip chamber is connected to another section of the infusion tube (leading to the venous needle), also fixed by welding.
Piercer assembly:
The piercer (with a protective cap) is connected to the upper interface of the drip chamber and fixed by pressing or welding to ensure the piercer is perpendicular to the drip chamber without loosening.
Adding other components:
A flow regulator is installed in the middle of the infusion tube to ensure it can slide freely and adjust effectively.
For precision infusion sets, a solution filter is added near the venous needle and fixed on the infusion tube by welding.
Venous needle assembly:
The venous needle (with a protective cap) is connected to the end of the infusion tube and fixed by welding. Then, check if the needle tip is skewed and if the protective cap is secure.
Appearance inspection:
Visual inspection equipment (cameras + AI recognition) checks whether each interface is sealed, whether the infusion tube is damaged, and whether components are complete. Defective products are automatically rejected.
Flow Regulator Assembly Machine
Drip Chanmber Assembly Machine
Spike Needle Assembly Machine
5.Primary Packaging and Sterilization
Primary packaging: Assembled infusion sets are packed into medical dialysis paper bags (breathable and bacteria-resistant) according to specifications (e.g., single-piece packaging). The bag mouth is sealed by a heat sealer to ensure no damage or poor sealing.
Sterilization:The mainstream method is ethylene oxide (EO) sterilization: Packaged infusion sets are placed in a sterilization cabinet, and EO gas is introduced. Sterilization is performed at 37-55°C and 40-80% humidity for 6-24 hours to kill all microorganisms (including spores).
Special types (e.g., PVC-free infusion sets) may use gamma-ray sterilization, but the materials must be radiation-resistant.
EO desorption: After sterilization, products are placed in a ventilated desorption room (or vacuum desorption cabinet) to remove residual EO (required to be ≤10μg/g). Desorption usually takes 7-14 days (faster at higher temperatures), and residual EO is sampled and tested after desorption.
6.Final Inspection and Outer Packaging
Final quality inspection:
Sterility sampling inspection: Random samples are taken for sterility culture (e.g., incubation at 37°C for 14 days to check for microbial growth).
Physical performance testing: Testing infusion flow rate (e.g., infusion volume within 10 minutes under specified pressure), leakage resistance (checking for leakage at interfaces after pressurization), and filter efficiency (simulating solution filtration to test particle retention capacity).
Packaging integrity inspection: Ensuring no damage to packaging bags via negative pressure or dye penetration methods.
Outer packaging: Qualified products are packed into cartons by batch. The outer carton is labeled with product name, specifications, batch number, expiration date, manufacturer, sterilization method, etc., and accompanied by a qualification certificate.
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