How to ensure secure sterility in pharma

Getinge discusses how wireless integrity testers make it easy to secure sterility.

It is both necessary and well-known that pharmaceutical manufacturers have to comply with rigorous rules and regulations when producing life-saving drugs and medicines. But in order to secure sterile transfer integrity in the manufacturing and transport of components, even more new solutions are required. Not only to meet demands to keep trace of the system’s lifecycle and its components, but also to account for normal wear and tear. These were the steps Swedish Life Science group Getinge took into consideration when developing its new Transfer Leak Tester. Here, Didier Papin, systems developer and Paolo Liverani, product line manager at Getinge, explain the process.

“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 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.”

When visiting customers, Getinge had noticed end users’ concerns about providing evidence of the integrity of transfer systems. Regardless of the transfer system used, not all customers take into consideration 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 cytotoxic 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 (low pressure at the start of a test cycle in combination with moving pipes).

That is why the new Getinge GLT – Glove Leak Tester – and TLT – 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 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 the TLT and GLT operator-friendly, convenient and easy to use, both when transferring between different sites and on fixed installations – whatever the orientation of the port 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 recognise when it is time to change system parts. The TLT and GLT are designed to keep track of the lifecycle of product and components in the customer’s records with compliancy to the FDA CFR21 PART 11 and GAMP5 standards according to the latest orientations. In short, they make life a little bit easier for the validators,” concludes Paolo Liverani, product line manager at Getinge.