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COVID-19 Resource Center

Healthcare professionals can find help and guidance on how to benefit from our offerings to treat your patients, as well as other practical information and advice.

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Filling line operator using the DPTE® system

Sterility testing

Reliability in the critical steps of the testing process.

Safe and reliable sterility testing

Contamination of samples during mandatory sterility testing of parenteral and other sterile preparations / devices is a potentially costly problem. With tight controls in a well-managed GMP production area, it is perhaps unlikely that the product and samples are contaminated at source. Logically, it is more likely that sample contamination will occur during handling and transport, or in the testing environment. Such "false positive" results create real and extensive costs of extra investigation and retesting. Moreover, products may not be released for sale until such rework is complete with reliable (i.e. negative) 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.

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.

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DPTE-BetaBag®

A maintenance-free Single-Use transfer solution for an efficient, flexible and scalable manufacturing process. The prefilled bag with components can be sterilized on-site or can be delivered ready-to-use by our different partners.

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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.

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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.

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Getinge Isotest Isolators

Getinge Isotest is an isolator designed for sterility testing of sterile drugs, components, and devices. Continuous workflow, easy access, and fast bio-decontamination help increase productivity.

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Getinge Isoflex-R Isolators

The Getinge Isoflex-R Isolator protects the product against contamination during aseptic operations such as sterility testing. The isolator maintains an enclosed and sterile environment throughout transfer, manipulation, and bio-decontamination.

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Getinge Isoflex-S Isolators

Getinge Isoflex-S isolators combine the robustness of a 316L stainless steel working base with the comfort of working with glove sleeves on a flexible wall.

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Glove Leak Testers (GLT)

Ensure a safe production and process control with the paperless Glove Leak Tester that enables seamless in-situ glove testing.

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DPTE® Transfer Leak Testers (TLT)

Wireless integrity testers for DPTE® Alpha ports and Beta containers ensuring safe production and process control. Meet current and future regulations with reliable, repeatable, traceable leak detection for rapid transfer port systems.

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Isolator Manipulation Devices

Fitted to Getinge isolators

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