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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 with its secure interlock enabling totally safe connections and disconnections. The DPTE® system enables material to be moved from one sterile zone to another through a non-sterile zone, with leak-tight, risk-free reconnection.

Read more about DPTE® Alpha

DPTE-BetaBag®

The DPTE® system is based on the interaction of an Alpha part with a Beta part – each fitted with a door, a lock and a sealing function.

Read more about DPTE-BetaBag®

DPTE® Beta Containers

Stainless steel or plastic DPTE® Beta Containers allow for safe transfer into and out of a barrier system in various life science applications. The Getinge DPTE® system is based on the interaction of an Alpha part with a Beta part – each fitted with a door, a lock and a sealing function.

Read more about DPTE® Beta Containers

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.

Read more about ISOFLEX-R Isolators

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.

Read more about ISOFLEX-S Isolators

Glove Leak Testers (GLT)

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

Read more about Glove Leak Testers (GLT)

Transfer Leak Testers (TLT)

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.

Read more about Transfer Leak Testers (TLT)

Isolator Manipulation Devices

Fitted to Getinge isolators

Read more about Isolator Manipulation Devices