Validation & Compliance Guide: Pharmaceutical Cold Rooms, Chambers & Stability Rooms

vaccines in pharmaceutical cold room

When it comes to cold storage, no one has more exacting needs than the pharmaceutical industry. Sensitive biologics, vaccines, Active Pharmaceutical Ingredients (APIs), and other temperature-controlled pharmaceuticals need to be constantly maintained within precise ranges to ensure efficacy and comply with federal and global regulations.

Because cold storage needs tend to fluctuate over the product lifecycle — usually lower during research and development and higher during clinical trials, production, and distribution — finding the right pharmaceutical cold room or chamber rentals that meet the industry’s exacting standards can give you the ability to scale the amount of space available with your changing demand.

Why validation matters in pharmaceutical cold storage

If your sensitive pharmaceuticals are stored outside specified temperature ranges — even for a few minutes — their potency can degrade, potentially impacting the health of patients, triggering costly product recalls, and incurring regulatory penalties. The effects can be very costly. Every year, temperature excursions cost the pharmaceutical industry an estimated $35 billion.

That’s why the FDA enforces current Good Manufacturing Practice (GMP) regulations to ensure that the quality of products is not reduced by unsafe handling during the manufacturing process.

Validation provides documented proof that a system has been methodically tested to maintain temperature within tight tolerances across a variety of conditions.

Auditors look for:

Signed IQ/OQ/PQ protocols that include probe locations, acceptance criteria, and full pass/fail reports
Continuous 24/7 temperature logs with 21 CFR Part 11-compliant audit trails and secure electronic signatures
Calibration certificates (NIST-traceable) for every sensor, data logger, and monitoring device
Alarm & deviation records showing time-stamped alerts, response actions, and closure of CAPAs
Preventive-maintenance logs for refrigeration, backup power, and remote-monitoring systems, demonstrating MTTR targets and service history

At Polar Leasing, we perform a variety of validation tests before our pharmaceutical cold room rentals can be placed in the field, including:

Visual inspection to ensure high installation standards
24-hour empty unit thermal mapping
Empty unit open door temperature recovery tests at various setpoints
Empty unit power failure tests at various setpoints

This thorough examination helps ensure that each rental unit performs as expected when it leaves the factory and sets companies up for successful on-site verification.

Regulatory requirements

A number of regulations and guidelines govern the handling of pharmaceutical products, including:

Regulation	What it’s for	Applicable industries
FDA Current Good Manufacturing Practices (cGMP)	Quality systems for manufacturing, processing, packing & holding of drugs; ensures consistent safety and efficacy	U.S. drug manufacturers, contract labs, CMOs, packaging sites
USP <1079> Good Storage & Distribution Practices	Temperature-controlled storage, transportation, monitoring, and documentation for pharmaceuticals	Manufacturers, 3PLs, wholesalers, pharmacies following USP standards
21 CFR Part 11 – Electronic Records & Signatures	Requirements for data integrity, audit trails, and electronic signatures in FDA-regulated records	Any pharma organization using electronic systems to meet FDA rules
CDC Vaccine Storage & Handling Guidelines	Proper storage temperatures, equipment, and handling procedures for vaccines	U.S. clinics, hospitals, pharmacies, public-health programs
WHO Technical Standards for Temperature-Controlled Shipments	Validation and control of global cold-chain shipping, especially for vaccines and biologics	International manufacturers, logistics providers, NGOs in global supply chains

These regulations apply to every temperature range and require proper documentation, monitoring, and controls that are ready to act if something goes wrong.

Redundant systems for maximum protection

Because even short power outages can potentially compromise critical pharmaceuticals worth thousands — or even millions — of dollars, you may be searching for a system with dual compressors as part of your risk-mitigation strategy. If a compressor fails in one of these systems, the second compressor can seamlessly take over the load, protecting the products from changes in temperature.

Polar Leasing’s flexibility & validation

At Polar Leasing, we not only build units to meet the unique needs of pharmaceutical companies, but we also have the largest fleet of temperature-controlled walk-in rentals in North America, ready to ship fast from our nationwide distribution centers.

Our validated walk-in cold storage units meet the highest pharmaceutical standards, and we help make it easy for pharmaceutical companies to meet compliance and validation requirements by providing:

Pre-validated outdoor pharmaceutical cold rooms

Every Polar Leasing walk-in unit for pharmaceutical applications is put through rigorous validation testing before it leaves the factory. Your walk in cooler or freezer will arrive ready to go with just a simple electrical connection and be ready for site-specific qualification, saving time and reducing compliance risk.

Typical site-specific qualifications include:

Installation Qualification (IQ) to ensure that the unit is delivered and installed correctly according to manufacturer specifications and site requirements.
Operational Qualification (OQ) to test the system under controlled conditions to see if it performs as expected.
Performance Qualification (PQ) to demonstrate that the unit maintains temperatures in use on site during typical working conditions.

Fully documented qualification support

We provide comprehensive documentation to support your onsite validation process. Our Validation Summary includes:

Validation equipment calibration verification
Insulation and equipment installation inspection
24-hr empty unit thermal mapping
Empty unit open door temperature recovery testing
Empty unit power failure testing

Redundant temperature monitoring

We partner with Rastrac and KE2 Therm to improve efficiency up to 50% and to monitor units remotely.

Rastrac provides us with a range of data points for tracking, including:

real-time temperature
door openings/closings
defrost cycles

We can provide this information to our customers if they need to replace missing information from a lapse in their monitoring data or for troubleshooting.

Ultra-efficient KE2 Therm technology is available in two Polar Leasing walk-in units: the WL820 Temperature-Controlled Cold Room and the DT820RP Redundant Walk-In Cooler and Freezer. These units have a temperature alarm and outside display showing temperature and light readings. Users can access real-time control, alerts, and data 24/7.

Nimble deployment

Whether you need one pharmaceutical cold room or want to expand your network of walk in coolers or freezers, we can deliver quickly from our nationwide network of distributors. This rapid scalability is an excellent solution for:

Clinical trial sites
Vaccine distribution hubs
Temporary expansions during product rollouts or seasonal demand

The Polar Leasing Fiberglass Advantage

Instead of using foamed-in insulation that can cause hot spots that allow heat to enter the unit, we take thick polyisocyanurate rigid board insulation and encapsulate it in durable, seamless fiberglass. This patented process creates an extremely durable, one-piece unit that sets a new standard for cleanliness and efficiency.

Seamless fiberglass construction eliminates cracks and crevices that accumulate bacteria.
Easy-to-clean surfaces make cleanup simple and effective.
Units are compatible with cleanroom-adjacent operations.