Insulation Bag 10L: 2 (°C) to 8 (°C) for 8 to 12 hours
BlueLine Bag 10L for Clinical Trial Phase II and Phase III
TransporterBlueLine VIP series insulated bags are the right choice to efficiently maintain the cold chain of drugs in phase II and phase III clinical trials. They are lighter than the WHO certified containers and have larger capacity.
Solution
For utmost performance and efficacy of any pharmaceutical, from production to the end user, successful storage and temperature sensitive transportation is critically important, especially for clinical trials. For successful completion of clinical research and evaluations, all factors that may impact with the performance of the drug and accuracy of the research results must be eliminated.
Delta T products have been used in a many clinical trials all around the world for many years. delta T has extensive experience in the field of providing constant temperature transportation and can ensure constant temperature of 2(°C) to 8(°C) as well as timely delivery of medicines from the supplier to patients receiving clinical treatment.
The following case study was specifically designed according to the clinical research teams and patient requirements. The BlueLine Bag 10L was used in conjunction with 4C Fluid Elements to ensure the constant temperature transportation requirements of medicines at 2 (°C) to 8 (°C) were met throughout the transport process.
The entire system was validated with 6 pieces of 4C elements – 200ml for at least 8 to 12 hours.
This protocol and configuration has been used many times in a number of global Phase II and Phase III clinical trials by major pharmaceutical companies.
The system consists of
This transport system for clinical studies at 2 to 8 ° C consists of a BlueLine Bag 10L and 6 pieces of 4C elements – 200ml.
The delta T fluid technology and its detailed validations make it possible to pack the pharmaceutical payload into direct contact with the fluid elements and thus guarantee the highest temperature stability. Packaging instructions and validation reports are available for all configurations.
Technical performance
Application: clinical trial phase 2, clinical trial phase 3, in-house clinic
Transport time (2 to 8 ° C): 8 to 12 hours
Product dimensions: up to 5 medication packs
Weight: 2.5 kg
The temperature graph on the right shows the temperature parameters of the transportation BlueLine bag when the temperature of the medicine in the bag changes continuously when the external temperature is higher than 25(°C). Therefore, the efficacy of the product will not change due to the temperature of the elements itself.
With the different sizes of BlueLine Bags, delta T can optimally cover all possible product configurations and sizes.
Learn more about the BlueLine Bags for clinical trials
If you plan or need to use temperature-sensitive pharmaceuticals or therapeutics for clinical trials, please contact us by phone or email. We will ensure that the medicines you use for clinical trials safely reach the patients.
In clinical trials, delta T insulated elements and BlueLineBags series are the safest systems on the market. All of the available solutions have been verified by exhaustive and comprehensive temperature testing. The BlueLineBag series of thermal insulation bags combine high-quality textile fabrics and the latest thermal insulation technology.