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.
Temptime manufactures temperature monitoring solutions for the pharmaceutical and medical device industries, including the producers of biological, vaccines and speciality 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
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.
Several years ago, Temptime asked an independent testing lab to source the five most commonly used packaging technologies used by speciality pharmacies and evaluate their performance against a commonly used testing standard and the packaging manufacturer’s own claims.
With the increase in temperature-sensitive medications due to the rise in complex biologics, as well as the increasing demands of compliance with new standards and regulations, there is an increasing need to have a reliable temperature monitoring solution that automates the process to reduce labour and resource drain while increasing cost efficiencies.
Although a temperature-controlled supply chain is essential for the transportation of an increasing number of pharmaceuticals, particularly newer generations of complex and expensive drugs, some of the products that are most sensitive to temperature fluctuations are decades older than today’s novel oncology or rheumatology therapeutics: vaccines.
Early this year, AIM announced the release of a sensor technical specification that would provide a universal method to interpret temperature threshold sensors used to enhance supply chain management and logistics in most industrial sectors.
Zebra Technologies has announced that it has completed an acquisition of Temptime Corporation, a privately-held developer and manufacturer of temperature monitoring solutions for mission-critical applications in the healthcare industry.
In 2018, Temptime Corporation expanded the range and flexibility of the company’s vaccine vial monitors (VVMs), which monitor the temperature exposure of vaccines to ensure that they have not been compromised by excessive heat.
Temptime has announced it will be attending a variety of events throughout 2019.
Temptime Corporation has unveiled a new technology to expand the range and flexibility of the company’s vaccine vial monitors (VVM), which monitor the temperature exposure of vaccines to ensure that they have not been compromised by excessive heat.
Temptime has announced it will be attending the Speciality Pharmacy Summit, which will feature a series of business workshops, educational seminars, exhibits and social events.
Temptime will be attending the USCAP Annual Meeting in Vancouver, Canada.
Temptime is attending and exhibiting at industry events that support the pharmaceutical industry.
Temptime has announced that those intending on visiting the BIOMEDevice exhibition in Boston can now register.
One of the largest specialty pharmacy annual conferences in the US, Asembia's Specialty Pharmacy Summit will return to Wynn / Encore Las Vegas.
Temptime has announced it will be present at the Distribution Management Conference (DMC) and expo in California, US.
Founded in 2003 by Dr Armando Bardisa, South Miami Pharmacy (SMP) aims to improve the quality of life for its customers and patients through personalised service.
A focus on best practices increases patient satisfaction and boosts business growth.
Pharmacy Advantage has implemented the TransTracker® F temperature indicators and revisits packaging to reduce reships and associated costs, while also improving patient satisfaction.
Temptime Corporation has announced its co-founder and senior vice-president Ted Prusik has been awarded Inventor of the Year.
Temptime Corporation has announced today that its board of directors has promoted President Renaat Van den Hooff to chief executive officer.