Single Use System Testing

Single use systems are items that are used once and then discarded, such as disposable pipes, filters, connectors, etc. The single use system has the advantages of low pollution risk, high process flexibility and low cost, which is widely used in the whole process of biopharmaceutical production to simplify production steps and improve production efficiency.

However, single use systems may introduce leachates into pharmaceuticals that come into contact with them, which directly affects patient safety. The performance of single use systems also directly affects the level of pharmaceutical technology and is closely related to the quality of finished drugs. Therefore, single use system testing is essential to ensure the safety and effectiveness of drugs.

STEMart provides comprehensive testing and validation services for single use products used in biopharmaceutical processes to ensure the biocompatibility, safety and reliability of single use systems.

Test Samples

Bags, pipes, connectors, filters, bioreactors and other single use systems

Service Items

• Extractables and leachables testing
• SUS final product quality control
  • Integrity detection
  • Visual inspection
  • Cytotoxicity detection
  • Particle detection
  • Bacterial endotoxin detection
  • RNA enzyme & DNA enzyme detection
  • Sterility test
  • Packing and shipping confirmation
• Bacteria and mycoplasma testing
• Single use systems compatibility verification
• Sterilization and filtration process validation
  • Sterilizing filter performance verification
  • Filtration process validation
• Virus clearance verification
• Irradiation dose verification

For more information about our single use system testing services, please contact us.