AdvantaFlex Biopharmaceutical Tubing Weld Testing

Comparison to C-Flex® 374 Formulation

AdvantaFlex® Weld Burst and Tensile Testing Results

Test Type Number of Lots Tested Avg Burst Reading – PSI Avg Max Tensile Load – lbf
Gamma Irradiated1
AdvantaFlex® to AdvantaFlex® 3 99.17 19.66
C-Flex® 374 to C-Flex® 374 3 74.03 13.99
Combined Sterile Methods: Gamma Irradiated1 to Autoclaved2
AdvantaFlex® to AdvantaFlex® 3 103.43 21.18
C-Flex® 374 to C-Flex® 374 3 75.53 13.99

1 Gamma irradiation exposure defined as a range with a minimum dose of 25 kGy and a maximum dose of 45 kGy. 2 Steam autoclave, one cycle at 121°C for 1 hour.

All tubing welds were made on the Terumo SCD® IIB sterile tube welder. All tests were performed on 1/8″ ID X 1/4″ OD size tubing using the pre-programmed setting in the welder. A new welding blade was used for each individual test article. Ten samples were tested per lot, per the test method defined.

Burst Test Procedure:

Samples are visually inspected after the completion of the welding operation. Each sample is attached to a pressure source with a pressure gauge using a stainless steel mini Tri-Clamp® and secured with an Oetiker® one-ear stepless clamp. Tubing is filled with water and the open end closed off with a pinch clamp. Pressure is slowly increased in the sample until it begins to balloon or burst. Maximum pressure is recorded.

Tensile Weld Strength Test Procedure:

Samples are visually inspected after the completion of the welding operation. Plug gages with rounded ends are inserted into each end of the sample to prevent crushing of the tubing by the grips during testing. The sample is secured and aligned in the tensile test machine using pneumatic grips with vee jaws. The tensile test is conducted at a crosshead speed of 20 in/min. The maximum force, elongation, and failure mode are recorded after the weld fails.

AdvantaFlex Weld Strength

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Weld Test Video

C-Flex® is a registered trademark of Saint Gobain Performance Plastics and is not endorsed, sponsored, affiliated or associated with NewAge Industries, Inc. Terumo and SCD® IIB are registered trademarks of Terumo Corporation. Tri-Clamp® is a registered trademark of The Ladish Company, Tri-Clover division. Oetiker® is a registered trademark of Oetiker, Inc. All other trademarks are the property of their respective owners.

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