What´s the Best for sterile Transfer?

Related Vendors

DÜPERTHAL Sicherheitstechnik GmbH & Co. KG

Italvacuum, Srl

TRM Filter d.o.o.

Getinge la Calhène

What´s about Compatibility?

Many of the Rapid Transfer Port systems on the market claim to be compatible with the DPTE Beta ports manufactured by Getinge-La Calhène.

We decided to verify these assertions by connecting a) the Alpha port of each of the five RTP systems to a DPTE container and b) a DPTE Alpha port to a Beta port from each of the systems tested.

When a connection was possible, we carried out performance tests on the resulting assemblies (leaktightness and security).

Analysis of the results

Firstly, it is important to note that each of the RTPs examined in this study has its strong points and its weak points. The choice of an RTP system depends on the user’s requirements and the manufacturing process concerned, as well as other factors e.g. purchase price.

When selecting equipment some users may create, very often for financial reasons, hybrid transfer systems consisting of an Alpha port and a Beta port from different manufacturers. We would like to draw attention to the risks inherent in this approach. Indeed, the tests we carried out do not demonstrate any functional compatibility between a DPTE port (whether Alpha or Beta) and the corresponding port from another manufacturer. Hence even if the two ports can effectively connect, their performances are not guaranteed.

After completion of the study we noted that none of the RTPs tested achieved the same level of performance on the whole of the testing program as the DPTE system. We were in fact unable to obtain total conformity on all our tests for each RTP, even if some of them present comparable or similar results to the DPTE system.

In the leaktightness tests, some RTPs did not even achieve an adequate performance level, which can imply a higher risk of leakages when these systems are used and a resulting increase in the risk of danger to people (operators and final users) in the case of transfer of sterile products or the environment in the case of transfer of toxic products. In these particular cases, the basic premise of sterile transfer is compromised.

Conclusion

The study reaffirms the position of the DPTE as the most reliable solution, despite some weaknesses — mainly in terms of ergonomics. This transfer system has continually evolved since its creation over 50 years ago, constantly improving its performance in particular in terms of security.

* * C. Mounier is Isolation Technology Expert and C. Guilmet is Innovation Manager, Getinge-La Calhène, Vendôme/France

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