When producing life-saving drugs and medicines, pharmaceutical manufacturers need to comply with rigorous rules and regulations. And to make it easier for them to secure sterile transfer integrity in the manufacturing and transport of components, Getinge has developed new wireless integrity testers, the Transfer Leak Tester and the Glove Leak Tester.
In order for pharmaceutical manufacturers to secure sterile transfer integrity in the manufacturing and transport of components, new solutions are required. Not only to meet demands to keep trace of a system’s lifecycle and components, but also to account for normal wear and tear. When Getinge developed the new Transfer Leak Tester, all this was taken into consideration.
“The importance of checking the integrity of the gloves or the equipment, in addition to the isolator itself, is well known in the industry. But what is not equally well known is that it is possible and highly recommended in certain guidelines to also check the rapid transfer ports (DPTE® Alpha parts) and/or Beta parts included in the barrier system for aseptic and containment applications. In both cases, it is important to be able to detect breaches in sterility and give the requested evidence – traceability – to the inspecting bodies and regulators,” explains Didier Papin, Systems Developer and Paolo Liverani, Product Line Manager at Getinge.
Regardless of the transfer system used, it is not always taken into consideration the age and ordinary tear and wear – with potential consequences such as unexpected downtime in manufacturing or impact on operator safety, in the case of toxic and cyto-toxic substances.
Several other factors might also affect the performance of systems used to measure and test transfer integrity. One is the use of cumbersome tools to fasten the transfer integrity tester to the transfer ports. Another more critical factor is the risk of uneven pressure in the flexible pipes if handled incorrectly by operators.
That is why Getinge’s new Glove Leak Tester and Transfer Leak Tester are not only pipeless; they are also wireless, paperless and use lightweight plugs equipped with inflatable gaskets allowing for easy fastening to glove ports or to flanges of both DPTE® Alpha and DPTE® Beta parts. This negates the need for specific tools to fasten the testers using a particular torque. Instead you just push a button, and the gasket inflates securing an air-tight seal.
“This makes our new products operator-friendly, convenient and easy to use, both when transferring between different sites and on fixed installations – whatever the orientation of the part tested. They secure repeatability and are reliable instruments in the Maintenance Management System ensuring the system’s performance over time and allowing the end-user to recognize when it is time to change system parts. They are designed to keep trace of the lifecycle of product and components in the customer’s records. In short, they make life a little bit easier for the validators,” concludes Paolo Liverani.
Getinge Transfer Leak Tester is the only validated and patented system capable of checking the integrity of the DPTE® original Alpha rapid transfer ports and Beta parts, prior to manufacturing, and also checking for sterility integrity to avoid risk of contamination during transport.