Stability Testing - Stability Storage Facilities

NDA Analytics has a highly specified stability storage suite, including:

• Five 20m³ custom designed walk-in rooms.
• Ten 200 and 500 litre reach-in cabinets.

Providing:

• 25°C / 60 % RH.
• 30°C / 60 % RH.
• 30°C / 65 % RH.
• 30°C / 70 % RH.
• 40°C / 75 % RH.
• 2 – 8°C.
• Photostability cabinet – compliant with ICH option 2.
• Sub-zero cabinets (to – 80°C).
• High and low humidity cabinets.
• Customer-specified conditions.

Maintenance includes:

• Each room has a backup system which intervenes to ensure that conditions are maintained in the event of failure of the active system.
• Conditions within each unit are regularly qualified (mapped).
• Recording and mapping devices are regularly calibrated with reference to national standards.
• Conditions (temperature, humidity and where appropriate, lighting) within the units are continuously recorded.
• All units have hard wire and electronic alarm systems which are monitored around the clock and regularly tested.
• Control panels and recording devices have battery backup.
• In the event of mains power failure, the stability storage facility has backup generators which activate automatically and are regularly tested.