CoolPac offers a range of services for Equipment Validation and Qualification of small storage fridges and freezers, large warehouse type distribution fridges and freezers, and stability chambers.
Our extensive experience in the pharmaceutical, medical device and food industries ensures your equipment will be right for the job.
There can be many obstacles to validation.To assist in a quick implementation CoolPac can:
• Scope out your project and document the requirements.
• Provide additional labour to achieve targets.
• Streamline execution by using document templates that we have developed.
• Provide specialist equipment as required.
These may include:
o Data loggers -80°C to +100°C, alarm linked to SMS modem.
o Portable loggers.
o Temperature and humidity stability chambers.
o -40°C freezers.
o +2 to +8°C fridges.
Under-estimating the required validation effort is a frequent project management mistake. CoolPac can get you get up and running quickly.
CoolPac also performs audits on your third party providers. Often third party providers are commissioned without ensuring their approach and equipment complies with the relevant regulatory standards / guides such as the Good Automated Manufacturing Practice (GAMP) “V” model used by most pharmaceutical companies and NATA calibration references.