At GT2 Healthcare, we combine cutting-edge technology and industry best practices to offer:
• ETO Sterilisation Services for heat - or moisture-sensitive devices
• Product Validation at our on-site laboratory
• Bioburden Testing to meet regulatory standards
• Certification & Reporting for compliance
• Training & Qualification Programmes accredited by government bodies
We are building something extraordinary and would love for you to be part of it. Stay tuned for exciting developments and progress photos of our facility.
Together, let’s shape a safer and healthier future for medical devices.
Reliable, compliant and hassle free. Our rental programme provides ATEX certified data loggers together with onsite installation by a GT2 technician, so that your study is supported from placement through to reporting.
Every validation activity carries its own requirements. We tailor the instrument type, the configuration and the study approach to the application in front of us.
Ethylene oxide validation demands instruments certified to operate under pressure and vacuum while producing defensible data throughout the cycle. As ethylene oxide sterilisation is our own core discipline, cycle profiles, probe placement and load configuration are areas in which our team works continuously.
For validation consultants working on behalf of their own clients, requirements are usually defined in advance and timelines are short. We supply the specified instruments with the documentation required, and confirm availability promptly so that project schedules are maintained.
The instrument is only part of what a rental provides. The documentation accompanying it is what supports your protocol under audit. Our instruments are calibrated on an annual basis, and results are supplied together with their calibration records, so that you receive not simply a solution but a solution with integrity.
Our rental programme includes onsite specialist support as standard. The instruments do not travel alone. A GT2 technician accompanies them, because the instrument is rarely the point at which a validation study encounters difficulty.
The demanding decisions concern how the instruments are positioned, how long the study should run, and the appropriate response when a sensor records an excursion mid-run. For organisations conducting validation only periodically, that expertise is difficult to retain internally. Our specialists provide it for the duration of the rental.
Our instruments are presented by application rather than by model, reflecting the way validation requirements are usually defined. All units are wireless and supplied configured for your study.
Validation instrumentation represents a substantial capital commitment, and for most organisations it is required only intermittently. A mapping study or a requalification exercise draws on a full set of instruments for a defined period, after which they return to storage until the following cycle, accruing annual recalibration costs throughout.
Rental aligns the cost with the study that requires it. Packages are prepared according to the scope and duration of your project, and our specialists will advise on what your protocol calls for before anything is committed.
ATEX is derived from the French Atmosphères Explosibles, and it certifies that an instrument may be operated safely within potentially explosive atmospheres, including under pressure and vacuum. This matters because many lower-cost data loggers are not ATEX certified and cannot be used within an EO sterilisation chamber, a pressurised vessel, or comparable environments such as petroleum and gas applications. Our ATEX certified instruments carry approval for intrinsic safety Zones 0 to 2.
The quantity depends on the volume and complexity of the space and on the requirements of your protocol. Our specialists will establish this with you before your requirements are confirmed.
Our instruments operate across a range of -40 °C to +80 °C, with an accuracy of ±0.1 °C. This covers cold chain, cold room, warehouse, incubator and ethylene oxide sterilisation applications. For monitoring above this range, please speak with us regarding your requirements.
No. The rental programme is available to any organisation requiring monitoring instrumentation, whether or not our sterilisation services are used.
Instruments are rented on a per calendar day basis, with a minimum period of one day. The rental period is set to suit the monitoring your study requires.
Yes. We prepare the validation report as part of the rental programme.
Yes. Our instruments are calibrated on an annual basis, and results are supplied together with their calibration records.
Share the application, the space or cycle concerned, and your required timeline. A specialist will respond with the appropriate instruments, the recommended approach, and a considered view of what your study requires.