The FDA requires process validation of
medical devices such as a multi-lumen catheter, and, the design
of a multi-lumen catheter must permit each lumen to be tested
during the production process. Our Multi-lumen Catheter Leak
Test System (MLC) provides an efficient and convenient way to
validate up to 4 multi-lumen catheters simultaneously. It uses dry
air, or any gas, to automatically perform three tests on each
lumen for:
• external leakage
• inter-lumen leakage
• flow test for occlusions
For greater productivity, a second
station can be added to the MLC System so that one station is
leak testing while the other is unloaded/loaded. Automatic
removal of the fittings from the tester at the end of test is
another option that accelerates the testing process
Fully automated leak and flow test
• Fast—complete test cycles in
seconds
• Easy to operate
• 2, 3, 4 or 5 lumen catheters
• Leak rate sensitivity from
1cc/minute
• Pneumatic testing uses dry air or
any gas
• Direct readout of leakage in
cc/minute and flow rates in liters/minute (or other units if
desired)
• Optional digital printout for
permanent record
VIC’s Multi-Lumen Catheter Air Leak
Detector incorporates a process-validation plan into your
medical manufacturing process.
