Container Closure Integrity (CCI) Leak Testing
Proven InterTech Microscale Technology measures leaks down to the equivalent of a 0.5 micron defect diameter.
A careful review of application requirements including the Maximum Allowable Leakage Limit (MALL) will dictate the test method used.
Testing is consistent with ASTM requirements (F-3287-17, F-2338-09).
Proprietary technology is available for testing with minimal headspace volumes.
Pressure change, mass flow, and mass extraction under vacuum and positive pressures are available.
These technologies are non-destructive and deterministic allowing manufacturers to comply with GMP guidelines.
Applications include the CCI testing of vials, assay kit assemblies, cups and combined products.
- Standard or custom designed test fixtures meet unique customer application requirements
- The InterTech TechPressTM is an off-the-shelf solution for product development and audit testing.
- High speed inline test cells are delivered ready to integrate into the production line.
ASSAY KIT TEST CELL
MicroScale Leak Test Cell tests Medical Assay Base Assembly to < 0.02 sccm (20 microliters/minute) at 0.2 bar, at rate of 180 parts per hour.
READY TO INTEGRATE TEST CELL
Parts are leak tested to a 0.008 sccm (8 microliters/minute) at 700 mbar, at a rate of 150 parts per minute.
SEALED PACKAGE AUDIT TEST CELL
Parts are leak tested to 0.1 sccm (100 microliters /minute) limit at 8.5 psig, at a rate of 120 parts per hour.
Summary: Test Features and Benefits
- InterTech’s proprietary MicroScale leak test technology is reliable and offers speed and accuracy superior to competitive pressure testing methods.
- MED75 Microscale Test Instruments are ready to use for both in the lab and on the production line.
- Ethernet/IP capability of test instruments allows seamless integration of test data with all quality assurance systems.
- Remote access creates significant savings in maintenance, product change-over times and reduces time to market
- The implementation of InterTech’s deterministic test technology results in a robust product quality and traceability system.
- 21 CFR Part 11 data requirement compatibility are built into InterTech test instruments and testing solutions. This protects manufacturers and end-users from negative product safety events.