Transcat Calibration servicesTranscat Calibration services

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. 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.

Transcat Freezer Validation & Qualification Services

COVID Vaccine Distribution Challenges

As much as the COVID-19 vaccines present a real opportunity to mitigate the immense disruption to our lives that the disease has caused, real challenges remain before the vaccine can safely and efficiently be administered to the people. The sheer number of doses is nothing like the distribution chain has ever prepared for before. Additionally, the vaccines (especially Pfizer’s) have to be stored at very low temperatures in freezers that have been IQ/OQ/PQ validated compliant with 21 C.F.R. Part 11 regulations.

As many new freezers will need to be validated in the coming weeks and months, Transcat can help by providing validation services and rental equipment for this effort.

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.

Check out our Kaye Validator Rental Options or our Kaye Validator Used Equipment