TempTale Ultra
Single-trip monitoring for vaccine and regulated pharmaceutical distribution
- WHO pre-qualified
- Single-use monitoring
- Electronic trip record
- Configurable alarms
- Vaccine logistics
- Minimum order: 250 units
This WHO-prequalified single-use data logger is intended for vaccine and pharmaceutical programmes that require recognised temperature-monitoring performance and clear shipment documentation. It accompanies the consignment from dispatch to destination and records the temperature profile throughout the journey.
Introduction
TempTale Ultra is a validated USB temperature data logger developed for mission-critical life-sciences and cold-chain shipments. Its thin profile fits easily into standard packaging, while the large LCD gives receiving teams a clear view of trip status and alarm information.
The logger supports single-use, single-use with programmable overwrite, and multi-use recording options. It is designed for simple implementation, fast data retrieval and automatic report generation without requiring additional software for basic shipment review.
Advanced Alarm Monitoring
TempTale Ultra supports up to six programmable alarms. Available alarm logic includes high and low limits, single-temperature limits, temperature ranges, dual-temperature ranges, mean kinetic temperature (MKT), and trip-duration criteria.
Alarm delays may be based on continuous single events or cumulative exposure. This allows monitoring profiles to be aligned with specific product stability limits and shipment requirements.
Automatic PDF and PDF/A Reports
When connected to a USB port, the logger automatically generates a secure PDF or PDF/A report together with an encrypted TTV data file. Reports can include shipment information, trip statistics, alarm status and time-and-temperature records.
Configurable reports may support local time zones and multiple receiving-site languages. The USB flash-drive area can also be write protected to reduce the risk of virus transfer.
Fast Direct USB Download
The USB 2.0 interface provides direct access to trip data and supports download speeds up to five times faster than earlier devices. Data can be reviewed immediately or uploaded to approved cold-chain information systems.
Validated Life-Sciences Performance
The logger's low thermal mass supports compliance with USP <1118> response-time expectations. It is designed for validated temperature monitoring and includes traceable calibration and quality documentation for regulated cold-chain workflows.
Clear LCD Trip Visibility
The display shows whether the logger is started, delayed, running or stopped. It also presents current temperature, OK or alarm status, average, minimum and maximum trip values, time remaining or elapsed against alarm thresholds, and marked events.
Data Management Compatibility
Trip data can be handled through TempTale Manager Desktop or ColdStream Select where advanced configuration, archiving, analysis, exception management and traceable release decisions are required.
Applications
TempTale Ultra is suitable for pharmaceutical, biotechnology, clinical-trial, vaccine and other life-sciences shipments requiring validated temperature monitoring and documented trip records.
Specifications
| Model | TempTale Ultra |
|---|---|
| Recording Options | Single use, single-use with user-programmable overwrite, or multiple use |
| Temperature Measurement Range | −30°C to +70°C |
| Temperature Accuracy | ±0.5°C from −10°C to +45°C; ±1.0°C from +45°C to +70°C; ±1.0°C from −30°C to −10°C |
| Temperature Resolution | 0.1°C/°F across the full measurement range |
| Memory Type | Non-volatile 16K flash memory |
| Data Capacity | 16,000 data points |
| Battery Life / Type | 12-month operating life with non-replaceable 3.0V lithium coin cell; multi-use version uses two 3.6V lithium coin cells |
| Sampling Interval | Programmable from 30 seconds to 120 minutes |
| Protection Rating | IP64 with protective cap over USB connector |
| Start-Up Delay | 0 minutes to 24 hours |
| Programmable Alarms | Up to 6 alarm types including single temperature limit, temperature range, dual temperature range, MKT and duration |
| Alarm Delay | Continuous single event or cumulative exposure |
| LCD Indicators | Start, delay, running and stopped status; OK or alarm status; average, minimum and maximum; current reading; remaining or elapsed alarm time; marked event |
| Start Options | Manual push-button start or automatic launch |
| Dimensions | 108 × 50.2 × 12.5mm; multi-use version: 108 × 50.2 × 15.2mm |
| Weight | 51g; multi-use version: 65g |
| Certifications | CE, UKCA, RTCA DO-160G, RoHS, USP <1118>, EN12830, 3-point NIST-traceable calibration certificate and validation manual |
| Computer Requirements | Windows 7 or later; Adobe Reader 9.0 or later |
| Data Management | TempTale Manager Desktop 8.0 or later; ColdStream Select |
| Computer Interface | USB 2.0, Type-A plug |
| Transport Compliance | IATA Dangerous Goods Regulations, UN3091, US DOT 49 CFR Parts 171–180 and IMDG requirements |
