Getinge launches new paperless, wireless and pipeless Integrity Testers
Getinge wireless Integrity Testers make it easy and convenient to secure transfer integrity in gloves, the DPTE® Alpha ports (the original RTP) and DPTE® Beta parts, which is essential not only to keep track of the system’s lifecycle and its components, but also to account for normal
wear and tear.
Pharmaceutical manufacturers have to comply with rigorous rules and regulations when producing life-saving drugs and medicines and in order to secure sterile transfer integrity in the manufacturing and transport of components, ever more new solutions are required.
Getinge’s new Integrity Testers have been developed to meet these demands.
“The importance of checking the integrity of the gloves or the equipment, in addition to the isolator itself, is well-known in the industry”, says Didier Papin, Systems Developer at Getinge “But what is not equally well-known is that it is possible and highly recommended in certain guidelines to also check the rapid transfer ports and/or Beta parts included in the barrier system for aseptic and containment applications. In both cases, it is important to be able to detect breaches in sterility and give the requested evidence – traceability – to the inspecting bodies and regulators.”
The Integrity Testers secure repeatability and are reliable instruments in the Maintenance Management System ensuring the system’s performance over time and helping the end-user to detect when it is time to change system parts.
“Our Integrity Testers have been designed to keep track of the lifecycle of products and components in the customer’s records with compliance to the FDA CFR21 PART 11 and GAMP5 standards according to the latest orientations. In short, they make life a little bit easier for the validators,” concludes Paolo Liverani, Product Line Manager at Getinge.
Glove Leak Tester (GLT)
Gloves constitute the most vulnerable link in the containment barrier and must be tested for leakage prior to each production batch (new Annex 1 to the GMP guidelines issued by the European Commission).
The GLT allows for accurate and repeatable testing for gloves and sleeve integrity, i.e. checking for perforations not visible to the naked eye. It’s based on a concept of inflatable gaskets with easy installation, not requiring any specific tools, and push-button functionality.
The tester is supplied together with a multi-functional tablet and a choice of battery chargers.
HMI is available either with the external tablet or with onboard version, integrated (through SCADA) for Getinge isolators.
Transfer Leak Tester (TLT) – part of the DPTE® system
The modern operator-friendly TLT allows end-users to check the integrity of DPTE® transfer systems prior to or after production cycles, using pressure with reliable and accurate repeatability and full traceability. Simple to install using a lightweight plug, the TLT is compatible with all rigid DPTE® Alpha and Beta parts on the market (105 – 350 mm). Transfer assemblies can be tested in various orientations.
The tester is supplied together with a multi-functional tablet and a choice of battery chargers.
THE DPTE® SYSTEM
The DPTE® system is the industry benchmark for leak-tight transfer. In aseptic biopharma production, it’s crucial to insert and/or remove sterile materials from one area to another ultra-clean area without microbial contamination. Because it manages sterile transfer without any requirement for intermediate bio-decontamination, the DPTE® system is a useful solution for easy throughput on a busy biopharma production line and helps to drastically reduce the risk of contaminating pharmaceutical production.
The same is also true for containment applications (HAPI handling), where the DPTE® system provides protection for the environment and for the people working outside the enclosure.
Getinge’s patented transfer system consists of DPTE® Alpha ports fixed onto the walls of clean rooms, RABS or isolators, to which a variety of DPTE® Beta parts can be connected. Getinge supplies Beta parts – PE or stainless steel containers, Tyvek™, PU or PE bags – for multiple connections. Single-use DPTE-BetaBags® can be connected up to 5 times. Transfer using Getinge’s DPTE® Alpha and Beta parts is secure and validated.
For further information, please contact
Anna Appelqvist,
Vice President Corporate Communications
Phone: +46 (0)10 335 5906
E-mail: anna.appelqvist@getinge.com
About Getinge
Getinge is a global provider of innovative solutions for operating rooms, intensive-care units, sterilization departments and for life science companies and institutions. Based on our first-hand experience and close partnerships with clinical experts, healthcare professionals and medtech specialists, we are improving the every-day life for people, today and tomorrow.
Tags: