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. At Transcat, we provide comprehensive validation services for freezers, refrigerators, and cold rooms that are designed to support cGMPs. We can customize Freezer 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 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.
Cold Storage Compliance Documentation
By relying on Transcat's validation expertise, you will have the resources to obtain documented evidence that your freezer equipment is in full compliance with operating standards. In addition to tailoring protocols to businesses, Transcat also provides flexible scheduling and service options, an advantage in cost and production management. For detailed information on cold storage validation processes, request a quote from Transcat today.