Single Lumen
Catheters

Multi-Lumen
Catheters

Blood Bags

Trochars

Occlusion Flow Tests for Tubes

Fiber Optic Laparoscopes

Valves

Needles

Cannulas

Blood Devices

Drainage or Urological Bags

Flasks, Bottles or Tubes

Solution Vials

Thermoform Trays

Dialysis Sets

Implantable Devices

Infusion Sets

Packaging Seal Strength

Packaging Leak Test

Vitamin Pouches

Pharmaceutical Blisters

Drug or Oxygen Pumps

Induction Seal Caps

Filters

Sealed Trays

Syringes

Condoms

Gloves

Balloon Catheters

Case Studies:

Seven Lumen Catheter Leak Testing
Leak and Flow Test of Dual Tube Dialysis Sets
Leak Testing Multi-Well PCR Cycle Plates
Seal Strength Testing of Tyvek® Pouches

Seven Lumen Catheter Leak Testing

The customer produces seven lumen catheters. The need was to configure a system that would simultaneously test the seven lumens of the catheter for leak integrity and occlusion. It was also important to the customer that the responsible lumen be identified if leaking was found. The TM Electronics ES7-1000, a leak test instrument containing a precision mass flowmeter and equipped with multiple ports, was paired with a radial sealing fixture. The radial sealing fixture, a pneumatically operated clamp that provides either a sealed leak tight access to a tubular product or a sealed leak tight dead end to the product during pressure decay leak testing, was used to close one end of the catheter. The seven individual lumens were each connected to a port on the ES7-1000 instrument, and a sequential pressure decay leak test was performed which presented the operator with a pass/fail audible and visual indicator that identified the lumen or lumens responsible for the failure.

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Leak and Flow Test of Dual Tube Dialysis Sets

The customer is a manufacturer of complex dialysis sets. These sets are comprised of three different lines that functioned independently of one another. The need was to provide test sets that would perform both leak and flow (occlusion) tests on two of the three lines and a flow test on the third. It was also necessary that the sets enable the operator to load the next system for testing while the current test was being performed. The TME Solution^© four port sequential leak and flow tester was custom programmed and a two-part fixture designed so Ports 1 and 2 would be testing the first system while the operator loaded the second onto the other half of the fixture and to Ports 3 and 4. The fixture was designed so in addition to connecting the luer ports to the instrument, the opposite ends of the tubes are clamped and unclamped sequentially for leak or flow testing by means of sealing the three open connectors using valves which will open for flow tests and close for leak tests. The combination of versatile design engineering and custom programming of the test instrument enabled this complex testing situation to be reduced to a simple and quick loading of the product by the operator and touching one command to the instrument.

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Leak Testing Multi-Well PCR Cycle Plates

The customer manufactures PC cycle plates with from 96 to 384 wells for various applications. The challenge was to design a test system that will verify the integrity of PCR cycle plates of varying sizes using clean, dry air. This was accomplished by combining the TME MDT-50 Leak Tester with a pneumatically operated test fixture with interchangeable die plates that can be quickly replaced to accommodate different configurations of the PCR cycle or culture plates. The die plates meet the challenge of sealing a device with as many as 384 different wells. The operator simply loads the cycle plate, presses the hand safe start switches, and then waits for the accept or reject signal by the automatic leak tester.

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Seal Strength Testing of Tyvek® Pouches

An OEM manufacturer places the final peelable seal on pre-manufactured Tyvek^® pouches and needs to confirm that his seal is a strong or stronger than the original manufacturer's seals. A seal strength testing system was designed based on the TME BT-1000 Automated Package Tester, the patented TME Package-Port^© entry system and a restraining plate fixture. The interior of the sealed pouch is accessed using an inflation and sensor probe through an attached Package-Port. The pouch is placed in restraining plates to concentrate the test pressure on the package seals in order to better identify the weakest seal, and a burst test is performed. The BT-1000 provides the test operator with a pressure versus time plot of the burst test, and the burst pressure value, a variable statistic, is included in the Datalog for mean, standard deviation calculation and control chart development.

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