Insulation bag 10L, 2 ° C to 8 ° C for 8 to 12 hours
BlueLine Bag 10L for phase II and phase III clinical studies
The BlueLine Bags are the right systems for maintaining the cold chain of your medication in phase 2 and phase 3 clinical studies on the last mile.
The solution offered
In clinical trials, it is extremely important that the integrity of the drug is fully preserved from manufacture to the patient. For a successful study, it must therefore be ensured that all influences that can negatively influence the properties of the drug are avoided.
Temperature-related thermal influences can therefore significantly influence the results of a clinical study with a thermolabile drug.
In numerous clinical studies, delta T has gained experience in how medicines that are subject to cold chains, from the pharmaceutical manufacturer to the patient, are kept at 2 to 8 ° C during transport.
This case study shows how the BlueLine Bag 10L can be used together with 4C fluid elements for the 2 to 8 ° C on the last mile.
The entire system was validated with 6 pieces of 4C Accu 200ml for at least 8 to 12 hours.
It has been used 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 battery 200ml.
The delta T Fluid technology and its CE certification make it possible to bring the medication into direct contact with the fluid elements and thus guarantee the highest temperature stability. Packaging instructions and validation reports are available.
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
On the right, the temperature profile of a drug in the interior of the bag is shown above the outside temperature of 25 ° C. Since the temperature of the drug and the delta T fluid elements are identical, there can be no temperature damage to the product.
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
You are planning or operating a clinical trial with a cold chain drug or another drug that need temperature control? Call us or send us an email. We will make your clinical trial temperature safe.
For clinical studies, delta T Fluid elements together with the insulated BlueLine Bags are the safest system on the market. The validated systems ensure that the prescribed temperatures between 2 and 8 ° C are maintained. The bags are equipped with very stable textiles and the latest insulation technology.