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Transfer Leak Testers (TLT)

Transfer Leak Testers (TLT)

 Secure compliance and integrity

Meet current and future regulations with the wireless and pipeless Transfer Leak Tester for DPTE® Alpha ports and rigid Beta parts. Leak test performed with a pressure decay method.

Testing for process integrity

DPTE® Transfer Leak Testers secures compliance and integrity in the aseptic process. Compatible with all DPTE® Alpha and rigid Beta parts on the market (105 - 350 mm).

Overview

Transfer integrity in DPTE® Alpha ports (the original RTP) and DPTE® Beta parts is essential not only to keep track of the system’s lifecycle and its components, but also to account for normal wear and tear.

During contained transfer of materials into or out of isolators or other classified environments, or during aseptic container storage between processes, Getinge’s operator-friendly TLT allows you to check the integrity of the DPTE® systems prior to or after the production cycles.

Wireless for ease of use

Wireless and pipeless (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 multi-functional TLT tablet contains a touch screen that allows the operator to carry out tests on multiple plugs simultaneously.

Charging station for 4 plugs on trolley are supplied.

Designed for simplicity

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 rigid Beta parts. No specific tools required.

Push button operation for gasket inflation and deflation.

Secure compliance

Compliant with FDA CFR 21 part 11, GAMP 5, EU Annex 1,  and PIC/S.

Applications

Sterile transfer

To support the basic principle of isolation technology – to separate a process from the environment – there is a need to check the integrity of gloves and transfer systems before starting a manufacturing batch.

Stopper and closure processing

Closures, rubber stoppers and plungers are a vital part of the drug administration system. Getinge equipment washes and sterilizes these stoppers and closures, and keeps them clean, sterile and dry.

The DPTE® system provides a proven method of maintaining sterility when transferring sterile components into a filling line.

Sterility testing

Be certain about your sterile products. Contamination of samples during sterility testing can be a costly problem, leading to false positive test results. Getinge’s sterility testing isolators and patented DPTE® sterile transfer systems provide a safe and sterile self-contained environment for the most critical steps of the testing process.

API-handling

Active Pharmaceutical Ingredients (APIs) and Highly Potent Active Pharmaceutical Ingredients (HPAPIs) may be highly toxic substances contained in a significant proportion of today’s drugs. Getinge isolation technology and cleaning systems helps protect laboratory staff and the environment, ensuring the safe handling of APIs and HPAPIs.

Aseptic filling

Protect operators and reduce the risk of product contamination with DPTE® Containers. Modern filling lines increasingly incorporate full-barrier isolators or restricted-access barrier systems (RABS) around the filling equipment. Getinge supports you with solutions for a safe and contamination-free aseptic filling process.