You are visiting a website that is not intended for your region

The page or information you have requested is intended for an audience outside the United States. By continuing to browse you confirm that you are a non-US resident requesting access to this page or information.

 

Covid-19 Resource Center
Select region
Submit

DPTE® Transfer Leak Testers (TLT)

Secure compliance and integrity in the aseptic process

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.

Watch the video to view the full testing process.

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. The TLT solution is aligned with recommendations to perform integrity testing regularly as stated by the following guidelines:

  • Annex 1 to EU GMP: Manufacture of Sterile Medicinal Products
  • FDA Aseptic Processing Guidance: Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practice
  • PIC/S Pharma Inspection Convention Cooperation Scheme

Related products

Operator using the DPTE® Transfer Leak Tester (TLT)

Full traceability

Connectivity

The HMI available either with an external tablet or with an onboard version, integrated (through SCADA) for Getinge isolators offers full connectivity and traceability. The multi-functional TLT tablet contains a touch screen that allows the operator to carry out tests on multiple plugs simultaneously.

The DPTE® Transfer Leak Tester offers full connectivity to your site IT system and traceability on SQL Database.

An operator using a DPTE® Transfer Leak Testers (TLT) to test the integrity of a DPTE® Stainless Steel Beta containers

Designed for simplicity

Operator-friendly

Simple to install, whatever the orientation of the DPTE® Beta assembly tested.

The lightweight plug is equipped with inflatable gaskets for easy fastening to flanges of DPTE® Alpha and container Beta parts. No specific tools are required.

Push-button operation for gasket inflation and deflation.

Wireless integrity testers for DPTE® Alpha ports and Beta containers ensure safe production and process control

Wireless and pipeless

Modern

Both DPTE® Transfer Leak Tester alpha and beta plugs are wireless for ease of use.

There are no cables and pipes between the remote head and the main control unit. The testing plugs have integrated batteries and micro-pumps for inflation.

The trolley offers a charging station for four testing plugs.

DPTE® Transfer Leak Tester (TLT) models

Operator testing a DPTE® Alpha rapid transfer port with a DPTE® Transfer Leak Tester

For DPTE® Alpha port

  • Compatible with all types of DPTE® Alpha port
  • Compatible with 105, 190, 270, and 350 diameters
An operator using a DPTE® Transfer Leak Testers (TLT) to test the integrity of a DPTE® Stainless Steel Beta containers

For DPTE® Container Beta Parts

  • Compatible with PE and Stainless Steel containers
  • Compatible with 105, 190, 270, and 350 diameters