cGMP Storage & Distribution / Validated Cold-Chain Storage

Validated Cold-Chain Storage for Pharmaceutical and Life Sciences Products

Temperature-sensitive product needs more than a cold room. It needs validated space, documented proof that the space holds temperature, and a plan for when something fails. Euro-American operates 25,000 sq. ft. of validated temperature-controlled storage in a facility that is GMP-compliant to 21 CFR Parts 210 and 211, FDA registered, and FDA audited.

Looking to request validation documentation or schedule a facility walkthrough?

Three temperature zones

These zones run across four separate temperature-controlled rooms, so each client’s product can be segregated. A single 2°C–8°C room holds 100 pallet positions. No wood enters a temperature-controlled room: inbound product on wooden pallets is moved to plastic pallets first.

What happens if the power goes out

We maintain full redundancy in both refrigeration equipment and power, including a generator sufficient to run all critical systems.

Continuous monitoring and alarms

Every temperature-controlled room is logged continuously. Alarms tie into our building alarm system and IT network, and the facility is monitored 24/7 with video.

Inbound inspection and quarantine

Every inbound shipment is inspected in a dedicated staging area before it is received. Product on hold goes to a gated, locked GMP quarantine area with separate access control. Many clients have their vendors ship directly to us, so we become part of their incoming quality check.

Validation documentation, available on request

Your QA team will want evidence before you sign. We share temperature-mapping and validation documentation (IQ/OQ/PQ) with prospective clients on request, and you’re welcome to tour the facility and see the rooms in person.

From overseas origin to cold storage, one partner

Many cold-chain shipments start outside the U.S. As a licensed customs broker and international freight forwarder, we can manage the import, clear customs, and receive the product into validated storage, without a handoff between three vendors.

Frequently asked questions

Yes. Our 25,000 sq. ft. of temperature-controlled space is validated, and temperature-mapping and IQ/OQ/PQ documentation is available to prospective clients on request.

2°C–8°C refrigerated, 15°C–25°C controlled room temperature, and ultra-low temperature (ULT) frozen storage.

Yes. We maintain full redundancy in both refrigeration equipment and power, including a generator for all critical systems.

Yes. Euro-American is FDA registered and audited, and the facility is GMP-compliant to 21 CFR Parts 210 and 211.

Yes. Contact us to schedule a walkthrough.

Contact Us

Need validated storage you can defend in an audit? Request our validation documentation or schedule a facility walkthrough.

Headquarters: 508-755-5050

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