Temptime Temperature-Monitoring Solutions for Storage, Handling and Transport of Pharmaceuticals and Medical Devices
Temptime is a developer of cost-effective heat and freeze indicators, which accurately monitor temperature-sensitive products such as blood, vaccines and speciality medications to ensure their viability following storage, handling and transport.
The company works closely with producers of vaccines and biologicals, speciality pharmacies, blood banks and hospitals to address their cold chain needs, in order to maintain the effectiveness of temperature-sensitive pharmaceutical and medical devices.
Humidity can also be measured using the electronic EDGE™ wireless sensor system, which is equipped with Bluetooth® for Cloud-based storage and sharing.
Temperature indicators for identifying adverse temperature events in storage and transport
Temptime’s temperature-monitoring solutions help to reduce costs and waste from unexpected temperature events while also maintaining the viability of products and optimising patient outcomes.
The easy-to-use time-temperature and threshold heat indicators quickly identify products that have been exposed to temperatures outside a pre-set range to help clients meet regulatory guidelines.
The HEATmarker is a label designed for vaccine vials that contains a heat-sensitive material to register heat exposure and has US Food and Drug Administration (FDA) 510(K) clearance for use with heat-sensitive medical devices. The LIMITmarker threshold heat indicator is a self-adhesive label that is applied directly to products.
Blood temperature indicators for blood banks and hospitals
Temptime’s Safe-T-Vue® blood temperature indicators are used to preserve blood supplies by monitoring container temperatures in temporary storage and transport.
This innovative solution provides hospitals, blood banks and transfusion services with an irreversible visual indication that specified temperature ranges were maintained, which reduces the risk of temperature-compromised supplies.
Temptime’s indicators also prevent waste costs while meeting AABB compliance standards and the US Food and Drug Administration (FDA) regulations.
With a 10oC indication, Safe-T-Vue 10 has FDA 510(K) clearance and provides +/- 0.4oC accuracy. It is also available in 6oC indication ranges.
Temperature and humidity monitoring for pharmaceutical manufacturing and distribution facilities
Temptime’s EDGE™ products are Bluetooth® enabled temperature sensors that provide wireless tracking, mobile connectivity and data-sharing for drugs, biologics, vaccines and medical devices.
All EDGE™ sensors monitor and track products with the EDGEVue™ or EDGEConnect Mobile and Web Apps. Cloud data-sharing and storage is also available using EDGECloud™ services.
The EDGE™ W-200 monitors both temperature and humidity, utilising a unique connectivity for long-range and expanded installations. The EDGE M-300 is a reusable mobile sensor with the flexibility to monitor temperature-sensitive products during shipment and storage.
End-to-end speciality pharmacy temperature monitoring solutions
TransTracker®, LIMITmarker® and FREEZEmarker® are visual temperature indicators designed to demonstrate the validity of medicines and related devices to patients.
Placed inside secondary packaging, the indicators monitor temperature ranges during transportation and provide easy-to-read colour indications to show if the product was subject to changing temperatures. They feature detailed instructions and can be customised with branding and messages from the shipper or supplier.
Performance qualification (PQ) of shipment pack-outs can be easily monitored in transit or storage using cost-effective EDGE™ M-300 wireless sensors and the EDGEVue™ app. The EDGE platform lets you upload and share data, as well as download and export information for reporting and regulatory requirements.
Founded in 1987, Temptime created the HEATmarker® VVM, a miniaturised technology designed to monitor vaccine vials and alert users to exposure to unsafe time-temperature profiles. The company has grown its expertise and developed this technology into a comprehensive set of time-temperature and threshold indicators.
The systems meet the requirements of the ISO 9001 Quality System Standard, ISO 13485 Medical Devices and the FDA’s Quality System Regulation.
Biotech and pharmaceutical manufacturers worldwide work with Temptime to help reduce costs and waste associated with unpredictable temperature events. Temptime indicators are beneficial:
- In new 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
Products and Services
LIMITMarker® Threshold Heat Indicators
The easy-to-read LIMITmarker threshold heat indicator monitors heat exposure and provides a visual indication when temperature limits have exceeded the response temperature.
LIMITMarker F – Delayed Indication
LIMITmarker F is a heat indicator that monitors temperature and indicates when the cumulative time of heat exposure, at or above the response temperature, exceeds the response time (two hours).
LIMITMarker I – Immediate Indication
LIMITmarker I is a high-heat threshold indicator that monitors temperature and immediately indicates when the heat exposure is at or above the response temperature.
TransTracker Shipment Temperature Indicators
TransTracker® temperature indicators are single-use devices that monitor heat, freeze or dual heat-freeze exposures of temperature-sensitive products during shipping and storage.
EDGE™ M-300 is a Bluetooth®-enabled reusable mobile sensor with the flexibility to monitor temperature-sensitive products during shipment or when in storage.
Safeguarding the Integrity of Medications: Shipping Matters
The US Food and Drug Administration (FDA) approves medications only after vigorous clinical trials demonstrate the stability, safety and efficacy of the product. Since many medications, such as biologics, can be sensitive to temperature, manufacturers provide a specific temperature range that must be maintained for each drug.
EDGE™ M-300 – Mobile Sensor for Wireless Temperature Tracking
The Edge™ M-300 is an advanced temperature sensor that can wirelessly track temperature data of trucks, containers and packaging-in-transit using sensors with robust Bluetooth connectivity.
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.Read more