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.
ATEX certified temperature and humidity data loggers, delivered, set up and collected by our own technicians. An independent record of what your product actually experienced.
ATEX & IECEx certified for hazardous atmospheres
ISO 17025 accredited calibration certificate
Our technician sets up and collects
Rented per calendar day, from one day
Penang, Kulim & the Klang Valley
For pharmaceutical, medical device, hospital and validation teams.
Your equipment reports what it is set to. It does not report what your product actually experienced.
A chamber set to 50 °C will report 50 °C. The product inside it, packaged in a blister pack and stacked on a pallet, may never reach that temperature. The same gap applies to autoclaves, clean rooms, incubators and any equipment whose own readout is the only record of a cycle. Our data loggers are placed with the product itself, providing an independent second record of the conditions that actually occurred.
Wherever a cycle or a controlled environment has to be evidenced rather than assumed, an independent record strengthens the result.
Equipment verification
Equipment readouts record the conditions within the chamber rather than those reached by the load. An instrument alongside the product gives a second, independent record of the cycle, which matters most where packaging or load configuration affects heat penetration.
Controlled environments
Mapping and requalification protocols need instruments distributed across the space rather than a single monitoring point. Our specialists set the placement and study duration with you before your requirements are confirmed.
Consultants & service providers
For validation consultants working for their own clients, requirements are defined in advance and timelines are short. We supply the specified instruments with the documentation required, and confirm availability promptly.
The instrument is only part of what a rental provides. The documentation accompanying it is what supports your protocol under audit.
Calibration
Every instrument, annually
Certificate
ISO 17025 accredited, supplied with the loggers
Data export
[FORMAT — GT2 to confirm]
Audit trail
[DETAIL — GT2 to confirm]
A GT2 technician delivers the instruments, sets them up onsite and configures them for your application, because correct placement decides whether the data is usable.
For a short session the technician stays onsite throughout. For monitoring that runs overnight or across several days, they return to collect at the agreed time. Either way, the handling stays with us.
Delivery and onsite administration by a GT2 technician
Configuration for your specific application
Placement guidance: measuring the product, not the equipment
Collection on completion, no handling on your side
Reporting included
Your report is generated from the recorded data, with the same discipline we apply to our own validation work.
Both are ATEX and IECEx certified for potentially explosive atmospheres, under pressure and vacuum. Each is supplied configured for your application.
ATEX & IECEx
Autoclave and steriliser cycle verification, cold chain environments.
Range
−40 to +80 °C
Resolution
0.01 °C
Calibrated accuracy
±0.5 °C
Memory
65,280 readings
ATEX & IECEx
Clean rooms, stability chambers and warehouse mapping.
Range
−40 to +80 °C · 0–100 % RH
Resolution
0.01 °C · 0.1 % RH
Accuracy
±0.5 °C · ±3 % RH
Memory
32,640 readings
Validation instruments are a substantial capital commitment, used intermittently. Between studies they sit in storage, still accruing annual recalibration costs.
We rent per calendar day, so the period matches the monitoring your study requires. Our specialists advise on what your protocol calls for before anything is committed.
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Rented per calendar day, sized to your monitoring.
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A GT2 technician delivers and sets up onsite.
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Without interruption, for the whole period.
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The technician collects and returns them to GT2.
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Generated from the recorded data and issued to you.
Why monitor separately when our equipment already records the cycle?
Equipment records the conditions it maintains within the chamber, which is not necessarily the condition reached by the product inside it. Packaging, load configuration and position all affect the result. An instrument placed with the product records what the product actually experienced.
What does ATEX certification mean, and why does it matter?
ATEX (from the French Atmosphères Explosibles) and IECEx confirm an instrument may be operated safely within potentially explosive atmospheres, including under pressure and vacuum. Many lower cost loggers are not certified and cannot be used in an ethylene oxide chamber or a pressurised vessel.
What temperature range do the instruments cover?
−40 °C to +80 °C, with a calibrated accuracy of ±0.5 °C and a resolution of 0.01 °C. For monitoring outside this range, please speak with us.
Is rental limited to GT2 sterilisation clients?
No. Any organisation requiring monitoring instrumentation can rent, whether or not our sterilisation services are used.
What is the minimum rental period?
One calendar day. The period is set to suit the monitoring your study requires.
Does GT2 prepare the report?
Yes. The instruments return to GT2 and your report is generated from the recorded data.
Are the instruments calibrated?
Yes. They are calibrated annually, and the temperature and humidity loggers are supplied with an ISO 17025 accredited calibration certificate.
Tell us the application, the equipment or environment, and your timeline. A specialist will come back with the right instruments and a considered view of what your monitoring needs.