Qualifications are a collection of instructions and gathered documentation used in the validation of temperature-controlled units. During validation, we can qualify a freezer by progressively performing the following: Installation Qualification, Operational Qualification, and Performance Qualification. Freezer IQ/OQ/PQ procedures accomplish specific objectives:
- IQ ‚ determines proper freezer installation
- OQ ‚ confirms freezer operation within pre-established parameters
- PQ ‚ provides evidence of consistent, accurate performance
According to FDA regulations, companies must demonstrate that freezer storage spaces meet temperature requirements. To gain this documentation, a Temperature mapping validation will often be performed, along with the freezer qualifications. Transcat brings highly accurate, NIST-calibrated sensors onto your site for temperature mapping. We utilize the appropriate number of sensors, based on the size of your cold storage space, to capture and document measurements.