Temptime Temperature Monitoring Devices
Temptime manufactures temperature monitoring solutions for the pharmaceutical and medical device industries, including the producers of biological, vaccines and specialty medicines.
The company’s devices provide accurate monitoring of medical products in the pharmaceutical cold chain to improve storage, handling and transport. They ensure that the products have not been exposed to temperatures that could impact effectiveness.
Temperature indicators and electronic sensing systems
Temptime’s EDGE™ system of wireless temperature sensors and software packages enable efficient temperature monitoring, data-sharing and mobile connectivity for drug, vaccine and medical device manufacturers.
The electronic EDGE sensing system is equipped with Bluetooth® connectivity and Cloud-based data storage for sharing cold chain performance, as well as monitoring and control.
Temptime also has a wide range of time-temperature indicators for vaccines, pharmaceuticals, biologics, blood products, and medical devices, which monitor cumulative heat exposure, threshold heat events and freeze events during storage and shipment.
Cold chain monitoring and control for pharmaceutical and device manufacturers
Temptime’s products reduce costs and waste from unexpected temperature changes by monitoring facilities, inventory and transfers.
The EDGE electronic sensing system identifies environmental changes that risk causing damage to temperature-sensitive products. This clear demonstration that products are continuously monitored throughout all stages helps manufacturers meet regulatory requirements.
The EDGE M-300 is a wireless mobile temperature sensor that can be mounted in packages, containers or storage areas. It captures and transmits temperature measurements and geolocation data throughout transport and storage, as well as provides alerts for temperature changes outside pre-set parameters.
Remote-access mobile and web data monitoring apps
The M-300 is configured and monitored using the EDGEVue™ mobile and web app, which gives users easy access to information wirelessly. These apps also allow users to set preferences such as alarm parameters, datalogging intervals, startup options and time and temperature units.
EDGEVue data is easily uploaded to EDGECloud™ for sharing and can be exported or downloaded for reporting.
The EDGE W-200 long-range temperature and humidity Sensor (LoRaWAN™ long-range wireless connectivity) and EDGEConnect™ software app simplifies facility monitoring.
EDGEConnect is used to configure, manage and monitor W-200. EDGE W-200 and EDGEConnect automatically collect data from integrated or connected sensors, transmit the information to EDGECloud™ for remote access from anywhere, and generate regulatory reports and documentation.
Medication shipment monitors for specialty pharmaceuticals
Studies have shown that patient satisfaction is significantly higher when given the reassurance of a shipment temperature indicator. Specialty pharmacies have reported significant return on investment (ROI) as a result of reduced reshipments and unnecessarily disposed medications due to exposure uncertainties.
Temptime’s TransTracker® heat, freeze and combination single-use indicators provide an irreversible visual indication of temperature change events. These devices are a simple and cost-effective way to reliably monitor temperatures inside parcels of temperature-sensitive medicines.
Products such as LIMITmarker® and FREEZEmarker® visual temperature indicators are easy-to-read and patient-friendly, allowing patients to quickly determine if a shipment has been exposed to potentially damaging temperatures.
Heat and freeze indicators for medicine, vaccines and biologics
Thirty years ago, Temptime developed HEATmarker® VVM, a miniaturised technology designed to monitor the temperature of vaccine vials. That expertise has grown into a comprehensive suite of time-temperature and threshold indicators for heat and freeze monitoring. The company helps clients select indicator products that fit their stability profile and transport needs. Custom-made solutions are also available.
Biotech and pharmaceutical manufacturers worldwide rely on Temptime to help them reduce the costs and waste associated with unpredictable temperature events.
Temptime indicators are particularly useful:
- In countries and geographies with less robust cold chains
- With new or evolving distribution channels or shipping lanes
- To avoid package redesign or overdesign for 1% of temperature-exposed outliers
- For brand protection
Temptime holds two US Food and Drug Administration (FDA) 510(k) medical device clearances. Its quality management system is based on FDA quality system regulations to meet good manufacturing practices (GMP), as well as ISO: 9001 and ISO: 13485 standards
Products and Services
EDGE S-400 is a wireless, portable sensor for monitoring and controlling cold chain performance.
FREEZEmarker® is a single-use indicator that irreversibly changes colour from green to white to signal that a freeze event has occurred when transporting pharmaceutical goods.
EDGE™ M-300 is a Bluetooth®-enabled reusable mobile sensor with the flexibility to monitor temperature-sensitive products during shipment or when in storage.
HEATmarker Time-Temperature Integrator
Fast, automatic collection of multiple datalogger readings.
Long-range, wireless temperature and humidity sensors.
Best Practices and Lessons Learned from US Speciality Care
Speciality pharmacies provide service and support with complex medical conditions throughout the country. Along with this privilege comes the enormous responsibility of making sure these patients receive medications that are safe and stable to use.
Reducing the Costs of Speciality Pharmaceutical Shipments
The specialty pharmacy industry can reduce costs by $27.5 million annually (product and call centre staff costs only) if visual temperature indicators were used as decision-making tools to determine if medicine should be used or returned when patients suspect heat damage.
What You Need to Know About Thermal Shipping Technologies
This paper presents highlights from a thermal performance study conducted by Modality Solutions, which examined the performance of five shipping technologies commonly used by specialty pharmacies to transport high-value refrigerated specialty medicines against an industry accepted temperature profile standard.
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