B Medical Systems, a global leader in medical cold chain solutions, has announced that the company’s RCW25 transport box has been certified by CERTICOLD Pharma to comply with EU Good Distribution Practices (GDP). It is the first medical transport box to be granted this certification.
For medical professionals, it is important to be reassured that the temperature-sensitive specimens they use at work are distributed according to the Good Distribution Practices guidelines. This is where independent labels such as CERTICOLD Pharma provide the solution by helping the end users make the right choice. This European conformity label for the cold chain of health products certifies compliance imposed by the GDP guidelines. It is managed by an independent committee of cold chain experts and guarantees high refrigeration performance and strict temperature regulations.
The RCW25 transport boxes from B Medical Systems are used for the safe transportation or the temporary storage of vaccines, medicines, and other laboratory preparations at their intended temperature range. This cold chain solution offers a broad range of storage temperatures varying from -80°C to +8°C, depending on the use of ice packs, Phase Change Materials (PCMs) or dry ice, and are designed to keep biologicals safe at ambient temperatures ranging from -20°C to +43°C.
“Having the CERTICOLD Pharma label for our product is a testament to the quality and standards that B Medical Systems offers in the field of the medical cold chain. We test and audit our solutions using the help of independent bodies to give necessary reassurance to our customers of the high quality and performance of our solutions. I am also proud that the RCW25 is the first medical transport box to receive the CERTICOLD Pharma label.” – said Mr Luc Provost, CEO of B Medical Systems.
B Medical Systems’ RCW25 medical transport boxes received the certification after a series of audits and verification tests, which included insulation control and seasonal temperature variations, in addition to examinations of their mechanical strength, which is verified in multiple manners, including the efficiency of the products’ closing and opening systems. The labelled products must fulfil strict quality assurance requirements related to thermal, mechanical and technical aspects.