Specific Conditions

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 -80°C, a particularly stringent condition that preserves the molecular properties of these complex products.

Storage at -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. 

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.  

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.

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.