Testing & Validation Service
Tested and Validated Single-Use Systems.
Intellitech’s Testing and Validation Services ensures the highest quality and reliability of single-use systems. We achieve this through testing and validating against industry standards and regulatory requirements.
Product Testing Services
Intellitech can support customers in providing pressure testing of single-use systems, which is used to detect leaks and ensure the integrity of the assembly. By employing pressure decay testing, we can help customers prevent contamination, product loss, and costly production delays due to faulty fluid management components.
Validation Services
Intellitech collaborates with an accredited 3rd party testing lab to perform validation studies on processes to define critical quality attributes and acceptance criteria for single-use systems.
- Package Integrity Validation
- ASTM F2097 Bubble Emission Testing
- ASTM F88 Seal Strength Testing
- ASTM F1929 Dye Penetration Testing
- ASTM F1980 Accelerated Aging and Real Time Aging for Shelf-life Validation
- ANSI/AAMI/ISO 11737-1:2018 Bioburden Testing
- ANSI/AAMI/ISO 11137-2:2013 Sterilization Dose Audit
