A biopharmaceutical manufacturer required a cleanroom-compatible leak test system for reusable bioprocess containers used in regulated GMP environments. The system needed to accommodate multiple container sizes, support repeatable production testing, and integrate seamlessly into cleanroom and washdown operations.
To meet these requirements, we engineered a custom, dual-chamber, turnkey leak test system using the helium hard vacuum leak test method. The system supports multiple container models while maintaining consistent test sensitivity and fast cycle times. Built with stainless steel construction and enclosed for controlled environments, the solution delivers reliable leak detection while supporting automated and manual operation modes for production flexibility.
| Application: | Leak testing reusable bioprocess containers |
| Industry: | Medical |
| Production Volume: | Medium to high volume |
| Tracer gas: | Helium |
| Controller: | AB PLC |
| Leak Test Method: | Helium hard vacuum |
| Leak rate: | 1 x 10-5 atmcc/sec |
| Test Pressure: | 15 ±1 psig helium |
| Cycle Time: | < 3 min |
| Configuration: | Heavy-duty stainless steel workstation |
| Chamber: | Dual 12″ DIA x 30″ H vertical cylindrical chambers |
| Leak Detector: | Mass spec helium leak detector |
