Stability Chamber and Incubator Validation for Temperature-Controlled Solutions

Cold Storage Validation Services

Our experienced technicians perform validation services for various types of critical temperature-controlled units, from stability climatic chambers to simulate extreme environments to laboratory incubators crucial for creating lab-controlled environments, particularly for growing cultures. NEXA | EAM’s quality services help to ensure that your equipment meets critical temperature and control specifications before it is used to hold pharmaceuticals, lab samples, or product materials.

Our experienced technicians perform cold storage refrigerator validation services for various types of temperature-controlled units, from compact refrigerators to warehouse walk-in chambers. Transcat's quality services help to ensure that your equipment meets critical temperature and control specifications before it is used to hold pharmaceuticals, lab samples or product materials.

Qualifications for Temperature Validation

As part of our validation procedures, we can conduct IQ, OQ, and PQ controlled-temperature testing that fully covers your stability chamber or incubator qualification requirements. Our IQ services ensure that your unit is installed and operating properly. The IQ can also evaluate the environment where the storage is located. The operational qualification will:

• Test a container's controls and monitoring features
• Ensure the unit has been calibrated
• Verifies applicable alarms associated with the unit

Qualifications for Cold Rooms

As part of our validation procedures, we can conduct IQ, OQ, and PQ cold storage testing that fully covers your cold storage refrigerator qualification requirements. Our IQ services ensure that your unit is installed and operating properly. The IQ can also evaluate the environment where the storage is located. The operational qualification, or cold storage OQ, will:

• Test a container's controls and monitoring features
• Ensure the unit has been calibrated
• Verifies applicable alarms associated with the unit

The performance qualification consists of temperature mapping services. Data is collected during an empty state and a loaded state. Additionally, data is collected on temperature recovery following specific events, such as opening doors or power losses. Transcat gathers temperature mapping results by using highly reliable NIST-traceable data loggers and temperature probes.

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.

Transcat Services for cGMP Compliance

At Transcat, we can customize testing protocols to cGMP compliance requirements and your quality processing standards. We can also use protocols that have been previously established by your quality department. Our technical experts regularly called on to conduct accurate validations for pharmaceutical, food service and medical industry cold storage. For validation information tailored to your unit, request a quote from Transcat today.