Refrigerator and Freezer Validation Services
It is critical that temperature-sensitive biologic products, samples, and pharmaceuticals are stored within controlled temperature spaces. In the interest of quality control and regulatory compliance, refrigerators and freezers must be validated. Transcat provides comprehensive validation services for freezers, refrigerators, and cold rooms that are designed to support cGMPs. We can customize Freezer Validation and Refrigerator Validation protocols to meet each company's Quality System or execute protocols that the customer already has.
Freezer & Cold Storage IQ/OQ/PQ Qualification
Qualifications are a collection of instructions and gathered documentation used in the validation of temperature-controlled units. During validation, we can qualify a freezer or cold chain equipment by progressively performing the following: Installation Qualification, Operational Qualification, and Performance Qualification. 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 and refrigerator storage spaces meet temperature requirements. To demonstrate the equipment meets these requirements, a temperature mapping validation and equipment qualification will be performed. 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.
