Maintaining continuous cold storage until delivery is important for laboratories regularly transporting temperature-sensitive biological products between sites.
Laboratory products represent significant investments of time and resources. Having an efficient cold supply chain helps protect your facility’s biological assets and ensures their integrity, particularly if they are being used to treat patients. Pharmaceutical biological products that are temperature sensitive are required to be delivered at the approved storage temperature. [1]
Finding reliable storage equipment that can avoid temperature fluctuations for specimen management is essential for any facility involved in distribution and supply. Refrigerators and freezers are an important link in the temperature-controlled supply chain.
Bioline Global’s Premium range offers the first portable commercial ultra-low temperature freezer available in Australia. The Stirling Ultra Portable Freezer has a 25-litre capacity to store non-flammable laboratory biomaterials without the need for dangerous coolants, such as liquid nitrogen (LN2) or dry ice.
The biomaterial cold chain
Cold chain is a monitored temperature and humidity controlled supply chain to keep biological materials within a specific temperature range during all stages of delivery, processing and storage. [2]
The role of the cold chain for temperature-sensitive biomaterials is crucial for their viability. Many biological samples deteriorate when exposed to heat, sunlight or fluorescent light causing irreversible loss.
During transit and storage, biological materials must be managed carefully at all times to maintain their cold or frozen state to limit potential damage from exposure to environmental conditions.
Depending on the type of biological products that are transported and stored, there are serious consequences to poor quality assurance in the cold chain, including patients administered an unsafe product, liability from a lack of compliance with global regulatory and standards-based requirements or thermal variability for inconsistent results between batches in clinical trials.
Having the most reliable equipment during transit helps maintain safe temperature and humidity ranges during shipment to or from your laboratory.
Portable freezers assist cold chain management for a variety of laboratory functions, such as:
- Biorepositories for outsourcing biological storage of research samples
- Pathology laboratories for transport of biological samples, such as blood
- Tissue banks
- Regenerative medicine
- Clinical or diagnostic medicine
- Pharmaceutical distribution, such as vaccines
- Distribution of refrigerated patient kits for multicenter clinical trials.
The Stirling Portable Ultra-low temperature freezer is called the ShuttleTM Model ULT-25NE. The freezers offer a wide temperature range between -86oC to -20oC that can be used for cold-chain management during the transport of biological specimens or for space saving benchtop applications in the laboratory.
The portable units are built with the Stirling guarantee of refrigeration, including heavy-duty cabinet construction and internal monitoring systems for freezer performance.
The refrigeration system is made up of entirely natural refrigerants R-170 (ethane), and includes the helium charged free-piston Stirling cooling engine with continuous modulation. It is built with high performance vacuum insulated panels and environmentally friendly polyurethane foam for insulation. Given the quality of the materials used, the whole unit is surprisingly lightweight weighing only 18kg when empty.
The ultra-low freezer can plug into any outlet worldwide and including into a mobile power supply during transport of samples between difference site locations running on 12V, DC power. This ensures the integrity of temperature-sensitive biomaterial, throughout the cold chain process.
The ShuttleTM ULT-25NE portable freezer comes with a one-year warranty for parts and labor worldwide.
To find out more about the Stirling Ultra Portable ShuttleTM ULT-25NE portable freezers or to speak to one of our friendly and experience technicians, please contact us at 1800 210 805 or via our online contact form.
[1] Australian Government Department of Health Therapeutic Goods Administration; Guidance 14: Stability testing for prescription medicines; July 2013 available at https://www.tga.gov.au/book/144-specific-requirements-stability-biological-medicines
[2] PREDICT One Health Consortium; Guide for Implementing a Cold Chain for Safe Sample Transport and Storage July 2013 available athttp://www.vetmed.ucdavis.edu/ohi/predict/PREDICT_Publications.cfm#Protocols