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.

About Temptime

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

Make an enquiry

Press Release

How Wireless Technologies and IoT Help Automate Shipping and Storage

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.

Product and Services
White Papers

Case Study: EDGE W-200 Outperforms the Industry Standard

This whitepaper is a case study showing how a medical device manufacturer started with EDGE W-200 as a back-up to its industrystandard chart recorders and quickly learned Temptime’s wireless device delivered everything it needed more efficiently at an estimated savings of 67%.

Address
Temptime

116 The American Road

Morris Plains

New Jersey

United States of America

+1 973 630 6000 www.temptimecorp.com

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Press Release

25 June 2019

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.

Read more
19 March 2019

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.

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13 March 2019

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.

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6 March 2019

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.

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28 February 2019

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.

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21 February 2019

Temptime has announced it will be attending a variety of events throughout 2019.

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15 October 2018

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.

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12 March 2018

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.

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5 March 2018

Temptime will be attending the USCAP Annual Meeting in Vancouver, Canada.

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Regional Offices

Temptime

116 The American Road

Morris Plains

New Jersey

United States of America

+1 973 630 6000 www.temptimecorp.com
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