21 CFR compliant data acquisition
Stability chamber monitoring using the DXP DAQSTATION.
Validation
Gallenkamp's many years of experience within a broad pharmaceutical client base enables us to offer a high-level validation service combining security, assurance and exceptional value for money. A fully documented on-site validation package (IQ, OQ , PQ ) is available for all models. On site work is carried out by our specialist engineers or fully trained local representatives.
Typical validations include:
- Up to 15 temperature points logged over 24 hours.
- Up to 12 humidity points logged over 24 hours.
- Independent verification of each shelf's light source, output level and light totalisation function.
- Full integrated lighting system calibration for each shelf area.
- Validation equipment complies with 21 CFR part 11 when carried out by Gallenkamp engineers.
Pharma-Safe independent monitoring centre
- Status indicator of current channel being displayed.
- Alarm status indicator.
- Channel descriptor including measurement units.
- Alarm status indicator with channel identification.
- Channel bargraph display showing channels 1 to 3 or 4 to 6.
- Fan fold chart produces continuous paper trace of temperature, humidity and lighting levels.
The independent monitoring centre displays
- Accumulated lamp life hours per shelf.
- Totalised UVA and VIS exposure per shelf.
- Exposure level per shelf UVA (W/m²) and VIS (K.Lux). Chamber conditions temperature (°C) and humidity (%rh).
