DPTE® Transfer Leak Testers (TLT)
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. Leak test performed with a pressure decay method.
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. There is a need to check the integrity of rapid transfer systems before starting the manufacturing batch to ensure safe production and process control.
Overview
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.
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.
The 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).
Full connectivity and traceability
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.
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 21 CFR part 11,
- GAMP 5.
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 trolley offers a charging station for four testing plugs.
Application
Sterile transfer
The DPTE® transfer system is a safe method for bidirectional transfer in aseptic or toxic working areas, without breaking containment or sterility. To support the basic principle of isolation technology – to separate a process from the environment – there is a need to check the integrity of transfer systems before starting a manufacturing batch.
Downloads
Related products
DPTE® Alpha
The core of the DPTE® transfer system is the Alpha Port, the original Rapid Transfer Port, designed to ensure flexible, optimized and cost-effective production with the highest level of process and patient safety. The DPTE® Alpha Port’s safety interlock and lip seal are rigorously tested to ensure reliable and 100% leak-tight transfer.
DPTE® Beta Containers
Available in polyethylene or stainless steel, the reusable DPTE® Beta Containers are designed for efficient loading and unloading of components and equipment into a sterile zone. The optional racks stabilize items inside the canisters while they are transferred and sterilized.
DPTE® Transfer Trolley
The smart, mobile transfer platform for use with all DPTE® Beta solutions. Using the DPTE® Transfer Trolley safeguards optimum production efficiency and filling line uptime, guaranteeing the complete integrity of the product inside the DPTE® aseptic transfer system.