Life Sciences

Pharmaceuticals, vaccines, biologics, and other products from the life science industry, must be kept at optimum temperature and humidity levels throughout the supply chain in order to maintain their efficacy. Any temperature abuse, either above or below the safe limit, can result in compromised efficacy or even total loss of products. DeltaTrak provides solutions for monitoring environmental conditions to help improve cold chain management from manufacturing and distribution, to storage at hospitals, healthcare facilities, and pharmacies.

Hospitals and Blood

Hospitals and Blood

Hospitals and Health Care Facilities

Hospitals and health care facilities manage hundreds of perishable goods and temperature-sensitive items every day, including pharmaceuticals, blood, chemicals and vaccine storage. These commodities must be kept at their optimum temperature for patient safety, JCAHO regulatory compliance, and to prevent spoilage and loss. Temperature monitoring is an important component of the cold chain, and DeltaTrak provides cold chain management solutions for hospitals and health care facilities, helping them to ensure the safety and efficacy of their temperature-sensitive goods.

Blood Banks and Blood Centers

Facilities that collect and store blood have unique temperature monitoring requirements. Blood must be kept at optimum temperature before testing and transfusion, and once tested and separated into components, each component is stored at a different temperature. Maintaining correct temperature is a critical part of the cold chain and a requirement for safe storage and transportation of blood from collection points to transfusion. Proper cold chain management practices are essential for handling perishable blood and blood products in the life science industry.

Solutions

Pharmaceutical

Pharmaceutical Solutions

Pharmaceutical and biologic manufacturers, wholesalers and distributors must ensure that product safety and efficacy is maintained as these products travel through the logistics supply chain; starting from the manufacturer and, ideally, extending all the way to the end user. Optimal environmental conditions of many pharmaceutical and biologic products require a very narrow range of tolerance. Temperature monitoring is an essential part of ensuring that peak efficacy is maintained at all times. New global GDP and GSP regulations require all parties handling cold chain and controlled pharmaceutical products must introduce controls aimed at assuring a regulatory compliant supply chain. DeltaTrak offers cost-effective, FDA, plus CDC compliant and WHO pre-qualified hardware and software cold chain management tools for temperature and humidity monitoring, recording and data analysis to help ensure proper handling of these highly sensitive, perishable goods.

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Clinical Trials

Clinical Trial Solutions

Clinical Trials can range from very small quantities to hundreds of shipments of Clinical Trial Materials (CTM) or Investigational Medicinal Products (IMP), many of which have limited thermal stability data available. Manufacturers are required to apply more cautious supply chain and storage strategies to comply with global regulatory agencies and ensure CTMs and IMPs are transported under optimal conditions between sites. Selecting a temperature monitoring solution is a critical component of setting up cold chain management, provisioning and distribution strategies for Clinical Trial Materials. Using validated temperature data loggers and software provides compliance with GDP and GSP guidelines, and can drastically reduce compromised products due to product temperature deviations and excursions. DeltaTrak offers validated, cost effective temperature monitoring solutions focused on CTM and IMP distribution, to ensure proper cold chain management during transport of these perishable goods as they travel through the supply chain to the recipient delivery point.

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Vaccines

Vaccines Solutions

DeltaTrak offers a full range of monitoring devices designed for tracking temperature during vaccine storage and transport through the supply chain. Whether you are a local pharmacy storing and administering influenza vaccines for a local community program, or a major distribution centre storing multiple types of vaccines for global or domestic programs, the same GDP and GSP regulations and compliance rules apply. Continuous temperature monitoring must be part of your procedures to confirm whether these vital products have been exposed to adverse conditions. DeltaTrak ‘s WHO prequalified FlashLink Certified Vaccine Data Logger with Glycol Bottle meets CDC and FDA requirements for collecting temperature data as a permanent electronic record for audit purposes. The logger alerts when excursions occur, so corrective action can be taken to prevent the loss of stored vaccines, and ensure their efficacy for patient safety. The unit has a temperature probe enclosed in a liquid glycol buffer, to avoid false alarms during expected temperature fluctuations under normal use, such as, frequent door openings.

Solutions