Manufacturing and Quality Control of Drug Eluting Balloons
Manufacturing drug eluting balloons is a highly specialized process that requires precision engineering and strict quality control. Each device must meet rigorous standards to ensure consistent performance and patient safety.
The manufacturing process begins with the design of the balloon catheter, focusing on flexibility, durability, and inflation characteristics. The drug coating process is carefully controlled to ensure uniform distribution and accurate dosage.
Quality control measures include testing for coating stability, drug release efficiency, and mechanical integrity. Sterility assurance is critical, as these devices are used in invasive procedures.
Advanced inspection technologies are used to detect microscopic defects that could affect performance. Each batch undergoes validation before being approved for clinical use.
Through meticulous manufacturing and quality assurance, drug eluting balloons maintain reliability and consistency across clinical applications.