Parameter’s state-of-the-art cGMP facility in Wilson, North Carolina contains rooms and chambers to accommodate any storage request.
All of our rooms meet or exceed ICH guidelines and have been mapped and validated for FDA mandated long and short-term shelf life studies under various temperature and humidity requirements. This includes intermediate testing and accelerated testing per ICH Q1A (R2).
Sample Validation Charts
Click thumbnails to view larger charts.
Features of Parameter’s off-site stability storage facility:
- ICH validated
- Various temperature and RH conditions available
- 100% redundant controls and conditioner
- Electric generator back-up (automatically switches on power loss)
- Continuous monitoring of each chamber that is Part 11 compliant
- Space and capacity to grow with your needs
Benefits of Parameter’s off-site stability storage facility:
- Exceeds required ICH and GMP specifications for temperature and humidity control
- Validated storage available at various conditions including 25°C/60%, 30°C/65%, 40°C/75%, and 5°C
- -20°C freezers
- Insurance against mechanical failure or utility service failure
- Capability to meet future storage needs or contingency requirements
View Photos of our Facility
Click the photos to enlarge.
Contact
For information about stability storage options and services, please email Ken Edwards, director of stability storage & validation, or call 252-243-2242.