High Containment

What´s the Best for sterile Transfer?

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Testing Performance of Transfer Systems

Tests were carried out in order to evaluate the performances of these transfer systems (Alpha port) together with their respective Beta ports (containers) on the essential parameters of any transfer operation:

  • locking torque (friction resistance of connection)
  • leaktightness
  • security operation
  • multiple connections
  • ergonomics

In addition, we looked at the compatibility of the standard RTPs with the DPTE system itself, to verify manufacturers’ claims of total compatibility between systems.

Locking torque test

The aim of this test was to check a crucial aspect of the use of the transfer system, occurring in the first and final stages of a transfer operation — whether each of the systems tested could be easily connected and disconnected by a typical user.

A dynamometric key was used to measure the force required a) to connect and disconnect a Beta port from an Alpha port and b) to connect and disconnect the Beta door from its flange.

Leaktightness test

Another essential aspect of transfer operations, perhaps the most important of all, is to maintain containment, guaranteeing both the security of the user and the integrity of the contained process.

The objective in this case was therefore to test the leaktightness of the 4 assemblies:

  • Alpha port
  • Beta port
  • interface between the flanges
  • interface between the doors

We carried out a series of qualitative tests where the leaks were visualized using a 1 % concentration of NH3 and a revealing cloth. The leak rate was not quantified.

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