In the world of biopharmaceuticals, the storage and handling of temperature-sensitive materials are critical to ensuring product quality and safety. Adherence to current Good Manufacturing Practices (cGMP) is essential for manufacturers seeking to meet regulatory standards and maintain the integrity of their products. Cryometrix’s state-of-the-art cGMP process freezers are specifically designed to address these challenges, offering advanced liquid nitrogen technology that ensures both precision and compliance while optimizing operational efficiency.

Why cGMP Compliance is Critical

cGMP regulations, enforced by bodies such as the FDA and EMA, ensure that products are consistently produced and controlled to meet quality standards appropriate for their intended use. These guidelines apply to several aspects of pharmaceutical production, from raw material handling to the final storage of the product. In particular, cGMP mandates strict control over environmental conditions, especially temperature regulation, to ensure that sensitive products like biologics, vaccines, and plasma retain their efficacy.

For biopharmaceutical companies, cGMP compliance is non-negotiable. A failure to comply with these regulations can result in costly recalls, loss of consumer trust, and potential legal repercussions. That’s why having reliable, cutting-edge freezing technology is essential. Cryometrix’s cGMP freezers meet these stringent standards by providing precise temperature control, robust data logging, and advanced security features, all of which are crucial for maintaining product integrity and ensuring regulatory compliance.

Advanced Freezing Technology for cGMP Applications

Cryometrix freezers leverage liquid nitrogen (LN2) technology to deliver ultra-low temperatures required for the safe storage and processing of biopharmaceuticals. Unlike traditional mechanical freezers, which use compressors and refrigerants, Cryometrix’s LN2-based freezers offer numerous advantages, including faster freeze times, lower energy consumption, and reduced maintenance costs.

The key to Cryometrix’s success in the cGMP space is its ability to provide precise and uniform cooling without direct nitrogen exposure to the products. This means that sensitive biological materials remain uncontaminated while benefiting from rapid and uniform temperature decreases. Here’s why Cryometrix freezers are ideal for cGMP environments:

• Temperature Control and Uniformity: Cryometrix freezers offer adjustable temperature ranges from +20°C to -160°C, ensuring precise control over the storage environment. The temperature uniformity within the freezer is typically within ± 3°C, which is critical for maintaining the stability and quality of pharmaceuticals.
• Data Logging and Traceability: cGMP regulations require detailed documentation of all processes to ensure product safety and quality. Cryometrix freezers feature built-in data logging, allowing operators to track temperature, usage, and operational history. The optional 21 CFR Part 11 compliance package ensures that this data meets FDA requirements for electronic records, making it easy to provide regulatory authorities with the necessary documentation during audits.
• Durability and Reliability: Constructed from 304 stainless steel, Cryometrix freezers are built to last. They come with a 20-year warranty on the cooling system, offering peace of mind for companies that rely on consistent and uninterrupted freezing capabilities. Additionally, with minimal moving parts, Cryometrix freezers experience fewer breakdowns compared to traditional mechanical systems, further enhancing reliability.
• Energy Efficiency: Cryometrix freezers use up to 90% less energy than mechanical freezers. This is made possible by the LN2 cooling system, which operates efficiently without the need for compressors or refrigerants. This results in significant cost savings over time, especially in large-scale operations.

Key Features of Cryometrix cGMP Freezers

Cryometrix offers a range of freezers designed to meet the needs of cGMP environments, with each model providing specific advantages for biopharmaceutical applications. Below are some of the standout models:

T-160 Ultra Low Temperature Freezer

• Temperature Range: Adjustable from +20°C to -160°C.
• Applications: Ideal for long-term storage of sensitive biological materials such as Car-T cells, vaccines, and other cellular therapies.
• Redundant Cooling System: Ensures continuous operation even during power outages, with a 7-day battery backup and manual LN2 valves for emergency operation.
• Compliance: Fully designed for cGMP applications with 21 CFR Part 11 compliance, making it a trusted choice for pharmaceutical companies.

B-90 Blast Freezer

• Freeze Time: Reaches -90°C in just 10 minutes, significantly improving throughput by up to 800%.
• Energy Efficiency: Operates without compressors or HVAC systems, reducing both energy consumption and maintenance costs.
• Applications: Ideal for rapid plasma freezing and blast freezing processes in pharmaceutical and biotechnological sectors. The B-90 also has built-in thawing capabilities, making it a versatile solution for biopharma manufacturing.

MC-135 Chest Freezer

• Compact Design: Offers 4.2 cu ft of storage in a chest-style freezer, making it perfect for labs with limited space.
• Temperature Range: Capable of maintaining temperatures as low as -140°C.
• Applications: Best suited for smaller batch sizes and critical storage needs, where precise and secure freezing is paramount.

T-90 Storage Freezer

• Storage Capacity: Can store up to 72,000 vials (2mL) in a 33.5 cubic feet payload bay.
• Temperature Recovery: Recovers from door openings in under 10 minutes, ensuring minimal temperature fluctuation during routine access.
• Applications: Ideal for long-term cryopreservation of samples in pharmaceutical, medical, and research environments.

The Cryometrix Advantage in cGMP Environments

Cryometrix’s cGMP process freezers offer a distinct competitive edge in pharmaceutical manufacturing and storage:

• Precise Temperature Management: Maintaining product integrity during freezing and thawing processes is critical. Cryometrix freezers offer unparalleled temperature control, ensuring product quality is preserved throughout the storage process.
• Compliance and Security: Cryometrix freezers come equipped with user access controls and on-board data logging, ensuring that only authorized personnel can access the system and make changes. These features support compliance with cGMP and FDA regulations, making the freezers a top choice for companies that prioritize data security and traceability.
• Low Energy Costs and Minimal Maintenance: By eliminating compressors and reducing the need for HVAC systems, Cryometrix freezers offer significant savings in energy and maintenance costs. The liquid nitrogen technology used by Cryometrix not only cools products efficiently but also operates silently and with minimal energy input.
• Sustainability: Cryometrix freezers are also environmentally friendly. Liquid nitrogen is non-toxic and safe to use, and it produces zero emissions, contributing to the sustainability goals of pharmaceutical companies.

Environmentally Friendly Solutions

Cryometrix’s commitment to sustainability is reflected in its freezer design. The liquid nitrogen-based cooling systems used in these freezers emit only nitrogen, a gas that already makes up 78% of the Earth’s atmosphere. By avoiding harmful chemicals like CFCs and HFCs, Cryometrix supports companies in reducing their environmental impact.

The stainless steel construction of Cryometrix freezers also ensures easy cleaning and sterilization, further reducing the need for harsh industrial chemicals and supporting a clean manufacturing environment.

Why Cryometrix cGMP Freezers Are the Ideal Choice for Biopharmaceutical Storage and Compliance

For companies operating in the biopharmaceutical industry, maintaining cGMP compliance while optimizing operational efficiency is paramount. Cryometrix’s range of cGMP process freezers delivers on both fronts. By offering advanced liquid nitrogen technology, precise temperature control, and robust data logging, Cryometrix ensures that your products are stored and handled according to the highest industry standards.

With models designed for both small-scale laboratories and large pharmaceutical manufacturers, Cryometrix provides scalable solutions that improve throughput, reduce energy consumption, and ensure regulatory compliance. Contact us today to learn how our cGMP freezers can elevate your manufacturing and storage processes.