What´s the Best for sterile Transfer?

Related Vendors

DÜPERTHAL Sicherheitstechnik GmbH & Co. KG

Italvacuum, Srl

TRM Filter d.o.o.

Getinge la Calhène

Realisation of the Tests

The tests were carried out as follows: the Alpha port was mounted on a support attached to a flexible envelope. The envelope was filled with NH₃ then put under pressure to 1000 Pa. A revealing cloth was placed on the Alpha port for 30 seconds to verify leaktightness. Following this test, the connection between the flanges was tested by connecting a Beta port and opening the doors (now fastened together as a single unit).

The door unit was then closed, and taken apart. The Beta port was locked onto its lip seal, trapping a volume of NH₃ inside the Beta port at the test pressure (1000 Pa); thus we were able to check the leaktightness of the Beta ports. A revealing cloth was then used to detect leaks around the door.

Security

The DPTE is equipped with safety features which prevent any accidental rupture of containment:

• a) the Alpha door cannot be opened if the Beta port is not in position, is incorrectly equipped or incomplete;

• b) the chambers cannot be separated if the unit consisting of the two doors fastened together is open and transfer is not completely finalized.

These safety features guarantee correct use of the system.

So for each RTP, we did the following tests:

• (1) We checked if the Alpha port was prevented from opening when the Beta port was absent, then that the Alpha port did open when the Beta port was present.

• (2) Once the connections were made and the chambers connected (doors opened), we then attempted to disconnect the Beta port.

• (3) We removed the Beta door from the Beta flange. The modified Beta port was then connected to the Alpha port and we tried to open the Alpha door using this configuration.

This third test is particularly crucial because without the security linked to the presence of the Beta door, it could be possible to open the Alpha port with an incomplete Beta door.

Therefore it could be possible to expose a sterile system (e.g. isolator) to a non-sterile Beta container.

Multiple connections

This series of tests aimed to evaluate the robustness of the systems by checking if their performance was maintained after ten connections / disconnections.

Ten operations of this type were carried out, connecting the Beta ports to their respective Alpha ports, following which all the tests carried out previously (locking torque, leaktightness, security) were repeated.

Ergonomics

No specific test was done to evaluate the Rapid Transfer Port systems from the ergonomics aspect. The observations made (see “Ergonomic Check” in the Results Table) simply consist of feedback from users who manipulated the systems throughout the course of this study.

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