Temperature Monitoring Devices
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Temptime produces time-temperature monitoring devices to help improve the storage and handling of hundreds of medical products and to help healthcare workers immunise children worldwide.
Monitoring of temperature exposure of vaccines
Temptime's team of scientists developed the first miniaturised technology to monitor temperature exposure of vials containing the oral polio vaccine.
Also referred to as the vaccine vial monitor (VVM), this time-temperature monitoring device is the only technology that meets strict specifications of World Health Organization (WHO) for distributing vaccines to developing countries.
Pharmaceutical and biotechnology companies, as well as medical product distributors and hospitals, use Temptime's devices to improve storage and handling of medical products.
The device visually identifies when a temperature excursion has occurred. It also meets WHO's performance, quality, and safety requirements. Temptime follows WHO guidelines for manufacturers of vaccine vial monitors (VVMs).
Indicators for temperature-sensitive pharmaceuticals
A wide range of patented time-temperature indicators are available for temperature-sensitive vaccines, pharmaceuticals, biologics, blood products, and medical devices.
The company's range of products monitors cumulative heat exposure (HEATmarker), threshold heat events (LIMITmarker and Safe-T-Vue), freeze events (FREEZEmarker) or a combination of heat and freeze events during shipment (TransTracker).
Temptime works with clients to help them select and customise indicator products that fit the medical product's stability profile and shipping needs.
In addition, the company can develop a customer specific logistical implementation plan.
Temptime manufactures two US Food and Drug Administration (FDA) cleared 510(k) medical devices. The company's quality management system is based on the FDA's quality system regulation requirements to meet good manufacturing practices (GMP), as well as ISO: 9001 and ISO: 13485 standards.
The company is audited by the FDA, major global vaccine manufacturers and by some of the largest pharmaceutical and medical device companies worldwide.
Monitoring temperature-sensitive products provides information that can reduce unnecessary costs, prevent wastage and protect lives.
Speciality pharmaceutical drugs
Temptime partners with small, medium and large national speciality pharmacies in mail order, retail and hospitals to control high-speciality drug costs by reducing returns and reships.
Monitoring temperature-sensitive shipments can improve patient outcomes by protecting the integrity of the brand and maximising value for the manufacturer and speciality pharmacy.
The company aims to provide patients and healthcare providers with medications that have not been adversely exposed to extreme temperatures.
Visual cues for safe vaccines
Temptime delivers vaccines with the HEATmarker VVM to ensure healthcare workers use a visual cue to determine if a vaccine has been exposed to a heat or freeze event.
The HEATmarker VVM meets stringent specifications of WHO for distributing vaccines to developing countries and WHO's PQS VVM performance specification.
HEATmarker VVMs, FREEZEmarker, TransTracker and LIMITmarker indicators, can be used to:
- Establish well-recognised quality systems for vaccines that protect citizens
- Ensure best practices as a steward of monies donated or made available for vaccination efforts
- Adopt best practices in global distribution
Temptime offers the Safe-T-Vue (STV) indicator, designed to monitor whole and red blood cells (RBCs) that are dispatched to perform a life-saving function.
STV meets AABB compliance standards and FDA regulations. It monitors the temperature of blood to identify heat excursions and supports restocking, as well as reduces blood wastage due to suspected heat events and decreases costs.
Temptime's TransTracker ranges of temperature-monitoring devices for shipments help to address increasing requirements for temperature monitoring during distribution with cost-effective devices that can identify and isolate temperature-exposed products and supplies.
Temptime partners with biotechnology and pharmaceutical manufacturers to reduce costs and waste caused by unpredictable temperature events.
By using products such as HEATmarker, FREEZEmarker, LIMITmarker and TransTracker, manufacturers are using devices that provide a clear visual cue.
Available White Papers
How to Reduce Costs of Specialty Pharmaceutical Shipments and Increase Patient Satisfaction 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.