DPTE® Transfer Leak Tester (TLT) secures compliance and integrity

Wireless and pipeless for DPTE® Alpha and Beta parts

Meet current and future regulations
We know you are under pressure from ever increasing demands on testing for process integrity. Not least from the new Annex 1 Consultation document of the GMP. This is why the modernized, wireless Getinge TLT is designed to meet these demands and secure the ease and convenience of checking the integrity of both DPTE® Alpha and Beta parts using pressure with reliable andaccurate repeatability.

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

• Full traceability compliant to FDA 21 CFR part 11 and EU Annex 11
• A modern tool compliant to international guidelines*
• Wireless, paperless and pipeless (no cables and pipes between the remote head and the main unit)
• Based on pressure decay method according to ISO Guidelines
• Simple and easy to apply on both Alpha and Beta asemblies, both PE and stainless steel
• Compatible with all rigid DPTE® Alpha and Beta parts on the market (105 - 350 mm)
• HMI available either with external tablet or with onboard version, integrated (through SCADA) for Getinge isolators

Further information for asecptic transfer auf unserer Webseite: Aseptic transfer

* European Commission, EudraLex, Volume 4, EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use,
   Annex 1, Manufacture of Sterile Medicinal Products, December 2017 (draft for comment).
   FDA Aseptic Processing Guidance
   PIC/S Pharma Inspection Convention Cooperation Scheme, Section 9.5.3