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 freezers or cold chain equipment by progressively performing the following: Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
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 Irish regulations, companies must demonstrate that freezer and refrigerator storage spaces meet temperature requirements. To demonstrate that equipment meets these requirements, a temperature mapping validation and equipment qualification are performed.
Transcat brings highly accurate, NIST-calibrated sensors onsite for temperature mapping. We utilize the appropriate number of sensors based on the size of your cold storage space to capture and document temperature measurements.
Cold Storage Compliance Documentation
By relying on Transcat’s validation expertise, you will have the resources to obtain documented evidence that your freezer, refrigerator, and cold chain equipment is in full compliance with operating standards. In addition to tailoring protocols to businesses, we also provide flexible scheduling and service options, an advantage in cost and production management. For detailed information on cold storage validation processes, request a quote from us today.