Certicold Pharma, the quality label for cold chain equipment for health products
Certicold Pharma is a European certification. It aims to guarantee the performance and quality of transport and storage cold chain equipment for health products.
This certification process is awarded to equipment manufacturers and transporters whose solutions meet very demanding technical specifications. It concerns in particular :
- Cold chain equipment for transporting health products: insulated and temperature-controlled packaging and refrigerated vehicles ;
- Health product storage equipment such as refrigerated cabinets.
Certicold Pharma is a label created in 2014 by a committee made up of representatives of the administration, pharmaceutical laboratories, hospitals, transporters, equipment manufacturers and cooling experts.
ATER METROLOGIE, approved Certicold Pharma testing centre
The ATER METROLOGIE thermal testing centre is authorised to carry out the tests required for the initial issue and renewal of the Certicold Pharma label for pharmaceutical cold chain equipment: transport vehicles (refrigerated vehicles) and storage solutions (refrigerated enclosures and cold rooms)*.
ATER METROLOGIE is the laboratory that has been specialising in thermal testing of cold chain equipment for over 20 years. The laboratory works with the biggest names in the pharmaceutical industry in the qualification of cold chain transport solutions.
With a human-sized team and state-of-the-art testing equipment, the ATER METROLOGIE laboratory is very responsive and offers Certicold Pharma certification or renewal at very competitive prices.
* Ater Métrologie is not authorised to issue or renew the Certicold Pharma label for isothermal and refrigerated packaging.
A rigorous labelling process
The technical, thermal and mechanical requirements of the Certicold Pharma certification process go beyond the regulatory requirements.
Based on French, European or international standards and regulations, and supplemented by specific cold chain requirements, they provide the manufacturer and user with a guarantee of regulatory compliance for labelled cold chain equipment thanks to specifications drawn up with professionals and users.
When cold chain transport equipment is placed on the market, Certicold Pharma certifies that the equipment complies with the expected performances to guarantee the control of the cold chain of health products.
Certicold Pharma labelling process for refrigerated transport equipment
The Certicold Pharma labelling process for refrigerated vehicles includes :
- Thermal performance tests following a protocol defined by CEMAFROID
- Calibration of temperature recorders and/or temperature monitoring devices (according to pharmacopoeial temperatures)
- An annual quality audit of the manufacturing units carried out by an independent expert to guarantee the homogeneity of the production.
Do you want to label your cold chain equipment with Certicold Pharma? Your Certicold Pharma certificate is about to expire and you wish to renew it? Contact our teams!