Why Temperature/RH Mapping?

Clause 3.19 of the PIC/S GMP guide states:

“Storage areas should be designed or adapted to ensure good storage conditions. They should be clean and dry and maintained within acceptable temperature limits. Where special storage conditions are required (e.g., temperature, humidity) these should be provided, checked, and monitored.”

What will happen if?

• If your facility lost power over a weekend, would you face setbacks of months or even years in research and development?
• In the event of a refrigerator motor short circuit, would you risk having to discard valuable materials or otherwise sellable inventory?
• If you were faced with a surprise audit, is your QA team prepared? Do you have readily available documentation to avoid any deviations?

Facility, warehouse, laboratory equipment and storage area temperature/RH mapping services

Trident Engineering offers comprehensive turnkey thermal validation/mapping services for entire facilities, encompassing clean rooms, QC laboratories, warehouses, freezer rooms, cold rooms, temperature-controlled storage areas, quarantine areas, receiving and loading bays, and more. Our thermal validation/mapping adheres strictly to WHO guidelines and Food and Drug Administration (FDA) standards, ensuring thorough compliance and accuracy from protocol to report.

Temperature mapping/validation is performed using 21 CFR part - 11 compliance software