Pressure leak tester DPTE®

for the pharmaceutical industryportable

Meet current and future regulations with the wireless and pipeless Transfer Leak Tester (TLT) for DPTE® Alpha rapid transfer ports and Beta transfer containers. Safe production and process control with reliable, repeatable, traceable leak detection systems. Integrity testers for DPTE® Alpha and Beta containers Simple and easy to install on both DPTE® Alpha and Beta container Wireless, paperless and pipeless Full connectivity and traceability Compliant with FDA 21 CFR part 11, EU Annex 11, and GAMP 5 Supports the equipment integrity and preventive contamination control strategy Patient safety rhymes with process integrity Patient safety is ensured with an unbroken chain of sterility throughout the process. Quality of production batches must be secured during every step. Transfer integrity in DPTE® Alpha rapid transfer ports and Beta containers is essential not only to keep track of the system’s lifecycle and its components but also to account for normal wear and tear. Getinge’s operator-friendly TLT allows you to check the integrity of the DPTE® systems prior to or after the production cycles to ensure safe production and process control. Leak test performed with a pressure decay method. Preventive maintenance The DPTE® Transfer Leak Testers (TLT) support a preventive maintenance program. Check the leak tightness of your transfer system before and after production batches to ensure that your processes are compliant with international standards and regulations. Support requalification of your installed base – DPTE® Alpha and Beta, guaranteeing product and patient safety.