Guidelines
Storage for stability studies involves maintaining products in controlled conditions of temperature and humidity
We have a very large storage capacity worldwide with a volume of 12,200m3/430,00ft3 with over 430 chambers to support your projects.
Eurofins BPT offers storage capacities in accordance with extensive ICH/VICH and medical device requirements, ranging from vapor phase liquid nitrogen, -80°C to +90°C. Our qualified climatic chambers allow us to handle different temperature and humidity conditions.
Click here to view our ICH-VICH Storage Capabilities
In order to cover all the criteria to be taken into account for the correct implementation of storage and flows, our approach is based on the Ishikawa method
Security of samples
Because we know how important these samples are to your projects, we have invested in an optimal security system that allows us to store your samples in our chambers in complete safety thanks to:
- Continuous monitoring (temperature and humidity)
- Centralised alarm management with a 24/7 on-call system
- Qualified chambers (IQ/OQ/PQ) with in-house mapping in accordance with standard FD X 15-140
- A maintenance program
- Spare parts in stock
- On-site emergency generator
- Dual control system or back-up system
- Access management
Specific conditions
Biologics & Nucleic acid therapeutics
Biological and RNA-based medicines are often sensitive to temperature variations, and for some, storage at extremely low temperatures is essential to maintain their stability, efficacy and safety. In accordance with ICH guidelines, some biological medicinal products require storage at -70C or -80°C, a particularly stringent condition that preserves the molecular properties of these complex products.
Storage at -70C or -80°C is generally required for biological products that are particularly unstable at higher temperatures, such as certain vaccines, enzymes, or gene therapies. At this ultra-low temperature, protein degradation, aggregation, and other undesirable chemical changes are minimised, ensuring that the drug retains its therapeutic properties until it is used.
Psychotropic drugs and narcotics
Narcotics and psychotropic drugs require special management, with appropriate operational and administrative procedures and specialised staff, as well as secure storage areas and special traceability.
We have teams of registered pharmacists to help you with these issues.
Flammable/explosion-risk products
ATEX (explosion-proof) conditions are required for products presenting an explosion/fire risk, such as products containing a high percentage of alcohol or aerosols (propellant gas). We have a unique capacity of 270 m3 of ATEX (ex-proof) enclosures in France.
Semi-permeable packaging
Semi-permeable primary packaging covers a wide range of products and galenic forms, from blister packs to sticks or Blow-Fill-Seals, for example. In the case of semi-permeable packaging, the barrier effect is not total. This is an advantage for the industrialisation of innovative packaging, but also a risk to be taken into account in terms of product stability.
The focus is therefore on the impact of gas exchange, including hygrometry (moisture permeability), oxidation (oxygen permeability) and mass loss (evaporation). Eurofins BPT provides all the specific storage conditions for semi-permeable packaging with climate chambers regulated and qualified for low humidity:
- Long-term condition: 25°C/40%RH or 30°C/35%RH.
- Intermediate condition: 30°C/65%RH,
- Accelerated condition: 40°C/<25%RH.
These lower relative humidities require the use of suitable equipment to maintain humidity within specifications.
