Temptime

Temperature-Monitoring Solutions for Storage, Handling and Transport of Pharmaceuticals and Medical Devices

116 The American Road, Morris Plains,New Jersey, United States of America

116 The American Road, Morris Plains,New Jersey, United States of America



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

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.

HEATmarker

HEATmarker® is a time-temperature integrator that is applied to temperature-sensitive products to monitor the combined effects of time and temperature.

FREEZEmarker®

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® S-400

EDGE S-400® is a wireless, portable sensor for monitoring and controlling cold chain performance.

Edge® M-300

When you have to ship temperature-sensitive goods, it is important to know whether or not the cold chain was respected during transport.

Developing Good Distribution Practices in Specialty Pharmacy

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.

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%.

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.

Compliance Gaps Persist In the Vaccine Cold Chain

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.

AIM and GS1 Introduce New Technical Specification

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 Purchased Temptime

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.

Temptime Unveils Technology to Support Medical Product Safety

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

116 The American Road

Morris Plains

New Jersey

United States of America

+1 973 630 6000 www.temptimecorp.com