Analysis on the key points of technological preparation and quality control of medical infusion set
I. Key Points in Manufacturing Process
Raw Material Selection
The main raw materials for medical infusion sets include plastic tubing, connectors, filters, etc. These materials must comply with relevant hygiene standards and possess properties such as high-temperature resistance and corrosion resistance to ensure the safety and reliability of the infusion set.
The selection of raw materials should also consider factors such as drug adsorption, chemical stability, and biocompatibility.
Production Process Control
- Injection Molding: During injection molding, parameters such as temperature, pressure, and injection speed must be strictly controlled to ensure product appearance and dimensional accuracy.
- Assembly: Strict assembly inspections and leakage testing are required during assembly to ensure the sealing of connection points. Additionally, care must be taken to avoid introducing contaminants or damaging the product during assembly.
- Sterilization: Sterilization is critical to ensuring the aseptic quality of infusion sets. Appropriate sterilization methods (e.g., ethylene oxide sterilization, steam sterilization) should be selected, and the dosage and duration of sterilizing agents must be strictly controlled to guarantee product sterility.
II. Key Points in Quality Control
Establishing a Quality Management System
A scientific and comprehensive quality management system is the foundation for quality control. This includes setting quality standards, establishing quality control procedures, training employees, and assigning dedicated quality monitoring roles.
By rigorously implementing the quality management system, product quality can be effectively enhanced, ensuring the safety and reliability of medical infusion sets.
Conducting Quality Sampling
Regular quality sampling of infusion sets during production should be performed to test indicators such as appearance, functionality, and performance.
Sampling results must be promptly communicated to relevant departments to address any deficiencies in the production process.
Performing Regular Quality Audits
Regular quality audits should be conducted to assess and address issues and risks in the production process.
Audits help identify and resolve potential problems, thereby improving product quality.
Continuous Improvement
Quality control efforts should be ongoing, with close collaboration between production, R&D, and other departments to address quality issues.
Continuous improvement drives enhancements in product quality and competitiveness.
Specific Testing Items
- Visual Inspection: Check for cleanliness, absence of damage, and stains on the infusion set.
- Dimensional Measurement: Verify that all dimensions of the infusion set meet design specifications.
- Connection Strength Testing: Ensure that connection points have sufficient strength to prevent detachment or leakage during use.
- Leakage Testing: Simulate real-world conditions to test the sealing integrity of the infusion set.
- Drug Solution Flow Rate Testing: Ensure stable and accurate flow rates during drug delivery to meet clinical requirements.
