Meeting cGMP Standards with Cryometrix Freezers

A New Era of Cold Storage for Life Sciences

In today’s pharmaceutical, biotechnology, and clinical research sectors, maintaining strict compliance with Current Good Manufacturing Practice (cGMP) is a non-negotiable requirement. From vaccine development to cell therapy production, laboratories and manufacturers are held to stringent standards that demand precise, traceable, and reproducible processes—especially when it comes to cold storage.

Cryometrix, a leader in advanced liquid nitrogen (LN2) freezer technologies, is transforming the way facilities achieve ultra-low temperature storage while remaining fully aligned with cGMP expectations. With a product portfolio that spans rapid blast freezers, upright storage units, and cryogenic systems reaching –160 °C, Cryometrix freezers are purpose-built to deliver performance, documentation, and operational integrity at every scale of production.

Whether you’re launching a new biologic, scaling a cell therapy suite, or optimizing an existing cold chain, Cryometrix offers the tools to meet regulatory demands without compromising efficiency or sustainability.

Understanding cGMP: What’s at Stake?

cGMP (Current Good Manufacturing Practice) regulations, enforced globally by agencies such as the FDA (U.S.), EMA (Europe), and WHO (international), are designed to ensure that drugs and biologics are produced with consistent quality, safety, and efficacy. These regulations extend beyond just processes—they include equipment, personnel training, facilities, and importantly, environmental controls like storage and freezing.

Why Cold Storage is Critical to cGMP

For biologics, mRNA vaccines, plasma products, and cell therapies, maintaining a precise thermal environment is crucial. Any deviation from defined temperature setpoints can lead to:

Degradation of active pharmaceutical ingredients (APIs)
Loss of cell viability
Batch failure and product recall
Regulatory observations or warning letters

This makes your freezer system a validated component of your GMP process—not just a storage box.

Cryometrix Freezers: Built for cGMP Performance

Cryometrix offers an array of models, including:

MB-90: Lab-scale blast freezer with thawing capability (–90 °C to +40 °C)
B-90: Production-scale ultra-low blast/thaw freezer (26 cu. ft. capacity)
MC-135: Compact LN2 chest freezer for deep cryogenic storage (–140 °C)
T-90: Upright GMP-ready storage freezer (–90 °C with 33.5 cu. ft. capacity)
T-160: High-capacity upright freezer reaching –160 °C for advanced cryogenic applications

What all models share is a compressor-free, LN2-driven cooling engine that simplifies compliance while maximizing uptime, efficiency, and sustainability.

cGMP-Aligned Features and Advantages

1. Regulatory-Ready Control Systems

Cryometrix freezers feature integrated digital controls designed for 21 CFR Part 11 and EU Annex 11 compliance, including:

Tiered user access with up to 100 logins
Electronic signatures for changes and acknowledgments
Audit trails for door events, alarms, and temperature changes
Tamper-evident storage and checksum validation of exported CSV logs
Encrypted Ethernet (AES-256) for SCADA and MES integrations

These features allow facilities to demonstrate full control of critical parameters, a central requirement during installation and operational qualification audits.

2. Ultra-Fast Temperature Pull-Down and Uniformity

Unlike traditional mechanical systems that rely on refrigerants and compressors, Cryometrix freezers use liquid nitrogen vapor flow across stainless-steel coils to absorb heat rapidly and evenly.

MB-90: Pull-down to –90 °C in just 3 minutes
B-90: ~10 minutes to reach –90 °C for large payloads
MC-135: ~15 minutes to –135 °C
T-90 & T-160: ~45–150 minutes to reach cryogenic temperatures

Temperature stability is ±3 °C for most models, ensuring uniform freezing without hot/cold zones—a critical feature when freezing biologics or plasma products.

3. Redundancy and Uptime Protection

Cryometrix systems are engineered for fail-safe reliability, including:

Redundant LN2 cooling valves
Manual override valves for emergency LN2 flow
Battery backup systems (up to 7 days on T-160) for power loss protection
Continued cooling capability during blackouts thanks to pressure-driven LN2 systems

These features ensure uninterrupted protection of high-value materials—an essential component of any validated GMP process.

4. Scalable Infrastructure with Low Power Draw

Because Cryometrix freezers do not use compressors, their energy consumption is dramatically reduced:

Up to 90% lower electricity usage than mechanical ultra-low temperature (ULT) freezers
Minimal heat rejection = reduced HVAC load
Operates on standard 120–220V outlets, enabling facilities to scale capacity without infrastructure changes

Labs can add multiple units without the need for new electrical panels, breakers, or costly cooling system upgrades.

5. Built-in Cleanroom Compatibility

Cryometrix freezers emit no particles, refrigerants, or heat and feature:

All 304 stainless-steel construction, inside and out
Quiet, vibration-free operation
No HVAC exhaust
No need for air filters or special ventilation

As such, Cryometrix freezers can be installed in ISO Class 7 cleanrooms and other GMP-classified areas without modification.

Use Cases in Regulated Environments

Biopharma Manufacturing

Blast freeze APIs, proteins, or buffer solutions in single-use bags
Eliminate bottlenecks with dual freeze/thaw capability
Maintain chain of custody with SCADA/MES integration

Cell & Gene Therapy

Preserve autologous and allogeneic therapies at ultra-low temperatures
Enable fast pull-down for minimal intracellular ice formation
Uphold viability and function post-thaw

mRNA & Lipid Nanoparticles

Store at –130 °C to prevent degradation
T-160 and MC-135 are ideal for cold chain logistics and quarantine storage

Biobanking and Clinical Trials

Long-term sample storage with full audit traceability
Modular scalability to support expanding trial sizes
Simple temperature data export for documentation

Environmental Responsibility

Cryometrix freezers promote sustainability in cGMP environments:

No HFC or CFC refrigerants (zero GWP emissions)
LN2 is environmentally benign (composes 78% of Earth’s atmosphere)
Systems last 3–4x longer than mechanical freezers, reducing landfill waste
Lower facility-wide energy consumption = smaller carbon footprint

Combined, these benefits align with green lab initiatives and corporate ESG goals.

Support Ecosystem for Compliance

Validation Documentation: IQ/OQ/PQ protocols available
Live Technical Support: Free remote diagnostics and training
Spare Parts Availability: U.S.-based warehousing ensures rapid delivery
Onsite Testing & Trials: Freezer performance can be tested with your SOPs

From initial setup to audit preparation, Cryometrix partners with facilities to ensure a smooth, compliant implementation.

Cryometrix—Your Partner in GMP Excellence

As regulatory standards grow more complex and storage demands more exacting, Cryometrix freezers offer a path to compliance without compromise. By eliminating mechanical failure points, reducing energy use, and supporting comprehensive data integrity, Cryometrix models like the MB-90, B-90, T-160, and MC-135 set a new benchmark for ultra-low temperature storage in regulated environments.
If you’re ready to reduce audit risk, lower TCO, and enhance throughput, it’s time to consider Cryometrix.

Take the Next Step

Request a demo
Download validation documentation
Contact a Cryometrix GMP specialist today