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Pharmaceutical storage is a critical component in the healthcare industry. It’s not just about keeping products cold; it’s about ensuring that medicines, vaccines, and biological materials maintain their integrity, efficacy, and safety from production to delivery. With advancements in technology, the approach to pharmaceutical storage has evolved significantly, leading to enhanced preservation methods and optimized storage solutions.

The Importance of Precision in Pharmaceutical Storage

The storage of pharmaceutical products demands precision and care due to several critical factors:

1. Temperature Sensitivity: Many pharmaceuticals, especially biologics and vaccines, have a narrow temperature range within which they remain stable and effective. Even minor fluctuations can lead to degradation of the active ingredients, reducing their efficacy or even rendering them unsafe for use.
2. Regulatory Compliance: The pharmaceutical industry is subject to strict regulations from bodies like the FDA and EMA. These agencies set stringent guidelines for the storage and handling of pharmaceutical products to ensure patient safety. Non-compliance can result in severe consequences, including product recalls, legal penalties, and damage to the manufacturer’s reputation.
3. Product Longevity and Efficacy: Proper storage conditions extend the shelf life of pharmaceutical products, ensuring they remain effective until their expiration date. This is not only important for patient safety but also for the economic viability of pharmaceutical companies. Effective storage reduces waste caused by spoiled products, ensuring a steady supply to meet market demands.
4. Diverse Storage Requirements: Different pharmaceuticals require different storage conditions. For instance, some vaccines need ultra-cold storage at temperatures as low as -70°C, while others may require refrigeration or ambient conditions. This diversity necessitates a range of storage solutions capable of meeting varied requirements.
5. Global Distribution Challenges: With the global distribution of pharmaceutical products, ensuring that the cold chain is maintained from the point of manufacture to the point of use is a complex logistical challenge. Breaks in the cold chain can compromise product quality and patient safety.

Advanced Freezing Technologies: A Game Changer

The advent of advanced freezing technologies marks a significant milestone in pharmaceutical storage. These sophisticated systems bring several transformative benefits to the industry:

• Ultra-Precise Temperature Control: Unlike traditional freezers, advanced systems provide exact temperature regulation. This precision is crucial for storing sensitive pharmaceuticals, where even minor temperature fluctuations can lead to product degradation.
• Rapid Temperature Adjustment: Advanced freezers can quickly reach the desired low temperatures, which is vital for the swift preservation of heat-sensitive materials immediately after production.
• Enhanced Energy Efficiency: Modern freezing technologies are designed to be more energy-efficient compared to traditional methods. This not only reduces operational costs but also supports environmental sustainability initiatives within the pharmaceutical industry.
• Customizable Storage Conditions: These freezers often come with customizable settings, allowing for specific temperature and humidity conditions tailored to different types of pharmaceutical products.
• Improved Safety Features: Advanced freezers include features like alarm systems, backup power options, and temperature logging, ensuring product safety and regulatory compliance.
• Space Optimization: Modern designs tend to have a smaller footprint, maximizing storage capacity and efficiency in limited laboratory or storage spaces.

These technological advancements in freezing not only enhance the storage quality but also contribute to the overall reliability and efficiency of pharmaceutical logistics, from manufacturing to distribution.

Liquid Nitrogen: The Backbone of Modern Storage

Liquid nitrogen (LN2) is increasingly becoming the cornerstone of advanced pharmaceutical storage for several compelling reasons:

• Ultra-Low Temperatures: LN2 has a boiling point of -196°C, allowing freezers to reach and maintain extremely low temperatures essential for preserving sensitive pharmaceuticals.
• Rapid Cooling: This technology enables quick cooling, vital for materials that might degrade if not rapidly brought to the required low temperature.
• Enhanced Stability: LN2 provides consistent cooling, crucial for maintaining the integrity of temperature-sensitive materials over extended periods.
• Environmentally Friendly: With no harmful refrigerants like CFCs, LN2 is a greener choice, aligning with global environmental sustainability goals.
• Energy Efficiency: LN2 freezers typically consume less energy compared to traditional refrigeration methods. This not only lowers operating costs but also reduces the carbon footprint.
• Safety: Unlike some refrigerants used in conventional freezers, LN2 is non-flammable and non-toxic, offering a safer alternative for both the storage facility and the environment.
• Versatility: Liquid nitrogen can be used in a variety of freezer types, from small-scale laboratory freezers to large industrial units, making it a versatile solution for different needs in pharmaceutical storage.

The Broader Impact on Pharmaceutical Logistics

The integration of advanced freezing technologies has far-reaching implications in the pharmaceutical supply chain. This impact is felt in several key areas:

• Transportation and Distribution: With products often needing to be transported over long distances, maintaining the required cold chain during transit is crucial. Advanced freezers enable safe transportation of temperature-sensitive pharmaceuticals, ensuring they remain effective upon reaching their destination.
• Global Reach: Advanced storage solutions expand the reach of pharmaceutical companies, allowing them to distribute products globally while maintaining quality. This is particularly important for vaccines and biologics that require strict temperature control.
• Emergency Response: In emergency situations, such as epidemics or natural disasters, the ability to quickly and reliably transport pharmaceutical products can be life-saving. Advanced freezing technologies play a vital role in these scenarios, ensuring medications reach those in need in optimal condition.
• Cost Management: Efficient logistics reduce waste and associated costs. By maintaining the integrity of pharmaceutical products throughout the supply chain, companies can avoid the financial losses associated with product spoilage.
• Compliance and Traceability: Advanced freezers with data-logging capabilities help in maintaining detailed records of storage conditions throughout the supply chain, aiding in regulatory compliance and traceability.

Cryometrix Freezers: Enhancing Pharmaceutical Storage

Cryometrix freezers represent a significant leap in pharmaceutical storage technology. Their advanced freezers, such as the T-90 Storage Freezer and T-160 Ultra Low Freezer, offer specific benefits:

• Rapid Temperature Attainment: Achieving desired temperatures quickly, crucial for sensitive materials.
• Uniform Temperature Distribution: Ensuring the integrity of stored pharmaceuticals.
• Reduced Energy Consumption: Offering an eco-friendlier and cost-effective solution.
• Minimal Maintenance: Due to the absence of mechanical compressors, these freezers require less upkeep, translating to lower long-term costs.
• Safety and Compliance: Meeting stringent industry regulations and ensuring the safety of stored products.

The integration of Cryometrix’s liquid nitrogen technology in their freezers adds another layer of efficiency and reliability, making these freezers a prime choice for pharmaceutical companies looking for top-tier storage solutions.

Challenges and Opportunities

While technology has advanced, challenges remain. These include managing the cost of high-tech storage solutions and ensuring that facilities worldwide can access and implement these technologies. However, these challenges also present opportunities for innovation and development in the field.

Forward-Thinking: Securing the Future of Pharmaceuticals

The optimization of pharmaceutical storage is not just about embracing current technological advancements; it’s a forward-thinking approach to ensuring public health and safety. As the pharmaceutical industry continues to evolve, the methods and technologies used for storage must not only keep pace but also anticipate future needs. Investments in advanced storage solutions like those offered by Cryometrix are crucial in ensuring that life-saving drugs and vaccines are preserved effectively and reach those in need safely and reliably. This commitment to innovation and quality in pharmaceutical storage is essential for the well-being of people around the world, today and in the future.

In the fast-evolving world of biotechnology, pharmaceuticals, and medical research, preserving and processing vital materials with maximum efficiency and reliability is paramount. This is where the innovative solutions from Cryometrix come into play, offering lab managers a groundbreaking approach to cryogenic cooling.

The Cryometrix Edge

Foundation of Patented Innovation

Cryometrix’s edge in the market is deeply rooted in its extensive patent portfolio, featuring over 30 patents specifically related to the use of liquid nitrogen. This rich foundation of intellectual property is not just a testament to their commitment to innovation but also a beacon of their expertise in cryogenic technology. It’s this core competency that allows Cryometrix to develop state-of-the-art freezers and chilling systems that cater to a wide array of industries, including biotechnology, medical, pharmaceutical, extraction, and transportation.

Advanced Cryogenic Solutions

At the heart of Cryometrix’s products is the use of proprietary liquid nitrogen technology. Unlike traditional refrigeration methods that rely on mechanical compressors and harmful CFCs, Cryometrix’s approach harnesses the power of liquid nitrogen for cooling. This method is not only more environmentally friendly but also more efficient in terms of energy usage. The cutting-edge application of this technology ensures that high-value pharmaceutical products, which require stringent cold conditions during transportation, are adequately preserved.

Competitive Advantages: A Deeper Dive

Cryometrix’s competitive edge can be attributed to several key factors:

• Unmatched Cooling Speed: The use of liquid nitrogen enables rapid cooling, significantly faster than conventional methods. This feature is particularly crucial in situations where the quick freezing of biological samples or pharmaceuticals is essential to maintain their integrity.
  
• Temperature Uniformity: The ability to maintain a consistent temperature throughout the storage space is vital, especially for sensitive materials. Cryometrix’s technology ensures uniform temperature distribution, minimizing the risk of sample degradation due to temperature fluctuations.
  
• Low Maintenance and Operational Costs: The design of Cryometrix freezers minimizes moving parts, significantly reducing the wear and tear that typically leads to maintenance. This aspect, combined with the energy efficiency of liquid nitrogen cooling, results in substantially lower operational costs compared to traditional freezers.
  
• Patented Technology and Environmental Responsibility: The patented liquid nitrogen technology not only sets Cryometrix apart in terms of performance but also reflects their commitment to sustainability. By eliminating the use of CFCs and reducing electricity consumption, Cryometrix aligns with environmentally responsible practices.
  
• Electric Refrigeration Pumps: These pumps enhance the efficiency and reliability of the cooling process, further distinguishing Cryometrix’s products in the marketplace.
  
• Space Efficiency and User-Friendly Design: The compact design of Cryometrix freezers ensures they occupy minimal floor space, a valuable attribute in space-constrained labs. Additionally, the upright design of these freezers facilitates easy access, simplifying the process of storing and retrieving samples.

Technological Superiority

Cryometrix’s technological edge is defined by its innovative use of liquid nitrogen, setting a new standard in the realm of cryogenic cooling. Here’s an in-depth look at what sets these freezers apart:

Revolutionary Liquid Nitrogen Technology

Unlike traditional freezers that rely on mechanical compressors using refrigerants like Freon, Cryometrix freezers employ a next-generation liquid nitrogen (LN2) technology. This method is not only quieter but significantly reduces electricity consumption, operating with seven times less energy than comparable lab freezers.

Low Energy Usage and Reliability

Cryometrix freezers stand out for their minimal energy requirements. The LN2 operates purely on pressure, eliminating the need for electricity to maintain cooling. This unique feature allows the freezers to function even in emergency situations where power is unavailable. Additionally, the absence of mechanical compressors means there are hardly any moving parts, drastically reducing the likelihood of mechanical failures and extending the lifespan of the freezers up to four times longer than traditional models.

Ambient Operation and Easy Expansion

An extraordinary aspect of Cryometrix freezers is their ability to operate in any ambient environment without the need for additional HVAC cooling. This capability not only simplifies installation but also enhances the flexibility of placing these units in various laboratory settings. Due to their low electricity consumption, adding more units to a facility is straightforward, without the usual electrical complications. With an effective footprint of less than 8 square feet and minimal side clearance requirements, these freezers easily integrate into existing spaces.

Versatility in Freezing

Conventional blast freezers often restrict usage to flat and thin objects due to their reliance on metal plates for freezing. In contrast, the B-90 Blast Freezer from Cryometrix utilizes liquid nitrogen efficiently, enabling the freezing of a wide range of items, regardless of their shape or size. This versatility is crucial for labs handling diverse types of biological samples or pharmaceutical products.

Long-Term Warranty and Sustainability

Cryometrix demonstrates confidence in its technology by offering a 20-year warranty on their freezer cooling systems. This long-term commitment underscores both the durability and the sustainable design of their products. By emitting only nitrogen, which is a major component of Earth’s atmosphere, these freezers align with environmentally friendly practices.

Safety and Sample Integrity

The safety and integrity of samples are of utmost importance in laboratory settings, particularly when dealing with sensitive biological, pharmaceutical, or chemical materials. Cryometrix’s liquid nitrogen freezers excel in this domain by incorporating advanced features and design elements that prioritize both operator safety and the preservation of sample integrity.

Advanced Closed Nitrogen System

1. Zero Contact with LN2: The closed system design ensures that liquid nitrogen does not come into contact with the operator or the samples, significantly reducing the risk of contamination or accidental exposure.
   
2. Autonomous LN2 Storage: The storage of LN2 is designed to be completely self-contained and autonomous, minimizing the need for constant monitoring and manual intervention.

Safety in Design

1. Non-Flammable and Non-Explosive: Unlike many refrigerants used in compressor-based technologies, nitrogen is neither flammable nor explosive, reducing the risk of accidents in the laboratory.
   
2. Ease of Cleaning: The interior and exterior of the freezer, made entirely of stainless steel, are designed for easy cleaning without the need for harsh industrial chemicals. This not only maintains a safer environment but also protects the integrity of stored samples.

Maintaining Sample Integrity

1. Self-Contained Cooling System: The design ensures that no LN2 is exposed to the sample, maintaining the samples’ integrity and preventing cross-contamination.
   
2. Data-Logging Capability: Cryometrix freezers are equipped with automatic data-logging features, enabling precise tracking of temperature and other vital parameters. This feature is crucial for ensuring the integrity of samples over time and facilitating compliance with various regulatory standards.
   
3. Emergency Valve for Power Outages: The inclusion of redundant manual valves is a critical feature. In the event of a power outage, these valves can maintain the temperature in the payload bay, ensuring that the samples remain at the required conditions.
   
4. Temperature Uniformity: The freezers are designed with multiple fans that create a high flux of airflow, ensuring uniform temperature distribution within the payload bay. This uniformity is vital for preventing the degradation of samples and ensuring consistent results in experiments and analyses.

Comprehensive Warranty and Support

Cryometrix’s commitment to safety and sample integrity is further reinforced by their comprehensive 20-year warranty on cooling systems. This warranty not only underscores the durability and reliability of their products but also provides lab managers with peace of mind, knowing that their investment is protected.

In Summary

Cryometrix’s liquid nitrogen freezers represent a leap in cryogenic cooling technology. Their products offer lab managers a host of advantages from unmatched cooling speed, low maintenance costs, to environmental friendliness and complete safety. This makes Cryometrix an ideal choice for those looking to optimize their biorepository needs with cutting-edge technology.

Explore more about Cryometrix and their innovative solutions at Cryometrix.com.

April 10-11, 2024 – Hyatt Regency San Francisco Airport

A New Era in Biomanufacturing with Cryometrix

As the prestigious American Biomanufacturing Summit celebrates its 10th Anniversary, Cryometrix is set to be a highlight, showcasing its innovative cryogenic technology to industry experts and leaders. With a robust portfolio of over 30 patents, Cryometrix’s liquid nitrogen technology is a game-changer in cryogenic cooling and freezing, offering unparalleled benefits to the biotechnology, medical, and pharmaceutical industries.

Showcasing Advanced Cryogenic Solutions

Cryometrix’s display at the American Biomanufacturing Summit will showcase its innovative cryogenic technology that stands out in energy efficiency, reliability, and environmental friendliness. Their cutting-edge products, like the B-90 Blast/Thaw Freezer and T-160 Ultra Low Freezer, represent a leap in cryogenic cooling, using next-gen liquid nitrogen technology that eschews traditional mechanical compressors. This approach not only reduces energy consumption — using 7x less electricity than standard lab freezers — but also enhances operational reliability and safety.

Key to their design is the use of liquid nitrogen, which operates independently of electricity, ensuring functionality even in power outages. With minimal moving parts, these freezers are incredibly durable, lasting up to four times longer than traditional models with little maintenance. Compact and versatile, Cryometrix’s freezers fit seamlessly into various settings, accommodating diverse biomanufacturing needs.

The environmental impact of these innovations is significant. Cryometrix freezers emit only nitrogen, vastly reducing the carbon footprint and aligning with global sustainability goals. Their commitment to green technology is further reflected in their 20-year warranty, ensuring long-term, eco-friendly operation.

This blend of efficiency, reliability, and environmental stewardship positions Cryometrix as a leader in cryogenic solutions, perfectly aligning with the summit’s themes of operational excellence, sustainability, and innovation in biomanufacturing.

Integration with Summit Themes

The themes of the 2024 summit resonate with Cryometrix’s mission and technology. The summit focuses on manufacturing agility, operational excellence, and regulatory compliance, areas where Cryometrix’s patented technologies offer compelling advantages. Their solutions, particularly in the realm of digital transformation and quality assurance, align with the industry’s shift towards more sustainable, efficient, and compliant practices.

Revolutionizing Biomanufacturing Processes

Cryometrix’s participation is more than a product showcase; it’s a contribution to the future of biomanufacturing. Their unique technology facilitates faster, more reliable, and eco-friendly cooling and freezing solutions. This plays a crucial role in addressing current challenges in biopharma manufacturing, such as the need for rapid scale-up, stringent quality controls, and efficient supply chain management.

A Hub for Networking and Collaboration

The American Biomanufacturing Summit provides an ideal platform for Cryometrix to network with over 150 industry leaders. It’s an opportunity to exchange ideas, share strategic insights, and explore collaborations that could shape the future of biomanufacturing. Cryometrix is positioned not just as a solution provider but also as a thought leader in this evolving field.

Educational Sessions and Workshops

Cryometrix will be participating in various educational sessions and workshops during the summit. These sessions will cover topics such as the role of cryogenic technology in enhancing quality metrics, strategies for effective supply chain management using advanced cooling systems, and the integration of Cryometrix’s technology in creating flexible, automated manufacturing facilities.

A Commitment to Sustainability and Efficiency

A key aspect of Cryometrix’s presentation will be its commitment to sustainability. Their products, utilizing patented liquid nitrogen technology, offer a greener alternative to traditional cooling methods, with no CFC emissions and significantly lower energy usage. This aligns with the global push towards more environmentally responsible manufacturing practices.

Looking Ahead: Cryometrix’s Vision for the Future of Biomanufacturing

The 2024 American Biomanufacturing Summit is an unmissable event for those in the biopharma sector, and Cryometrix’s presence promises to be one of its highlights. By offering advanced cryogenic solutions, Cryometrix is not only showcasing its technological prowess but also reinforcing its role as a catalyst for innovation and sustainability in biomanufacturing.

Discover more about Cryometrix and their revolutionary products by visiting Cryometrix.com. Join us at the Hyatt Regency San Francisco Airport for this landmark event and experience the future of biomanufacturing technology firsthand with Cryometrix.

Unlike compressor-based systems and cryovats, liquid nitrogen freezers safely deliver temperature-controlled freezing down to -160°C in minutes to preserve drug products, active ingredients, and biological samples

For decades, the pharmaceutical industry has relied on compressor-based systems to freeze drug products, active ingredients, vaccines, protein biologics, and biospecimens in all phases from research and development to storage, transport, and manufacturing.

Unfortunately, traditional mechanical freezers are limited in significant aspects. Compressors are known to break down frequently and require constant maintenance. Cooling and electrical requirements are high. These systems also utilize refrigerant, which limits cooling to approximately -100°C and is known to have a negative impact on the environment. Compressor-based systems also take considerable time to reach the desired temperature, which can lead to cryoconcentration, damage protein structures, degrade active ingredients, and reduce potency.

More recently, liquid nitrogen (LN2) cryovats have been utilized for faster freezing at cryogenic temperatures below -150°C. However, because the liquid nitrogen is not contained, there is some risk of exposure for technicians. Controlling temperature in vats is also difficult, even impossible, since there is no safe, reliable means of adjusting the temperature of the LN2 within the vat.

Now a game changing technology in the form of liquid nitrogen cryogenic freezers combines the best features of compressor-based systems and cryovats, but without the limitations.

Liquid nitrogen freezers circulate contained LN2 within their walls for safe, fast freezing down to -160°C. The units provide the convenience of an upright freezer with sophisticated temperature controls. By eliminating the need for compressors, liquid nitrogen freezers require much less maintenance or replacement, less energy, and are more eco-friendly since refrigerant is not required.

“Liquid nitrogen freezers cool faster because LN2 has a boiling point of -196°C, enabling units [using it] to cool to temperatures as low as -196°C. Most refrigerants have boiling points higher than -100°C, making it difficult for compressor-based freezers [using refrigerants] to operate at temperatures below that. Since the LN2 is self-contained, there is no exposure to the user or products,” says Kim Boyce, President of Reflect Scientific, Inc. (symbol: RSCF), an Orem, Utah-based manufacturer that develops and markets innovative, proprietary cryogenic cooling technologies for the pharmaceutical, biotechnology, medical, and transportation markets. The company has more than 30 patents relating to the use of liquid nitrogen with low-temperature freezers, chillers, and refrigerated systems.

According to Boyce, advanced LN2 freezers are available for the pharmaceutical industry in a variety of configurations and models, under the Cryometrix brand.

Upright LN2 freezers

Upright liquid nitrogen freezers provide adjustable temperatures from +20°C to -160°C. This is considerably lower than conventional upright freezer options, enabling significantly faster freeze times.

LN2 freezers minimize the risk of sample warming and quality deterioration due to door open-close events and offer one of the fastest recovery times in the industry. To safeguard sample integrity, state-of-the-art temperature and data logging can be easily accessed, and multiple security levels set. A redundant cooling system and onboard 7-day battery backup further ensure that processes can continue uninterrupted even upon loss of power.

The approach also uses up to 90% less energy than mechanical, compressor-based units, which significantly reduces operating costs. Unlike compressor-based systems, no heat is exhausted to the room, eliminating the need for expensive HVAC systems for cooling. The freezer has a small footprint that suits space-constrained storage environments.

Pharmaceutical Case Use: Biorepositories

In the pharmaceutical and medical industries, liquid nitrogen freezers are utilized as biorepositories for the long-term collection, cataloging, and preservation of biospecimens such as tissue, cells, DNA, protein, blood, plasma, or urine. These biorepositories are essentially “libraries” where biospecimens are stored for clinical or research purposes.

Biorepositories are vital for understanding diseases, genetics, developing prophylactic and therapeutic agents, and monitoring human population health including outcomes related to environmental exposures.

Advanced LN2 blast freezers can reliably lower the temperature of pharmaceutical and biological products to as much as -90°C in minutes with a greatly reduced risk of sample damage and significantly increased production throughput.

As an option, blast freezers can be designed to “do double duty” by rapidly thawing product when required using one machine. This can streamline throughput and eliminate the need for separate freezing and thawing equipment.

Pharmaceutical Case Use: Drug substances, vaccines, protein biologics, blood plasma

LN2 blast freezers are used to slow the rate of active-ingredient degradation of drug substances, vaccines, and protein biologics during storage.

For pharmaceutical research and at blood banks, blast freezers are used to rapidly freeze and store a range of thermally sensitive products such as blood plasma and cryoprecipitate. How quickly various blood plasma products are processed and frozen can affect the value and type of product produced, and even its viability.

Mini LN2 Blast Freezers

As the name indicates, mini LN2 blast freezers are smaller benchtop versions for pharmaceutical use where very quick freezing is necessary in a constrained space. Using only a small amount of LN2 from a portable dewar tank, these systems can cool from 20°C to -80°C in under two minutes. The temperature is adjustable from +40°C to -90°C.

Pharmaceutical Case Use: R&D, limited production

Pharmaceutical manufacturers use mini LN2 blast freezers to rapidly freeze and thaw thermally sensitive materials in the R&D phase for new drugs, vaccines, and biological products. It is important to establish the temperature profile of these materials to determine how products will respond to expected temperature fluctuations during transport, storage, and distribution. The compact units can simplify testing with temperature profile recipes to further expedite R&D, quality control, and even low-volume production.

The pharmaceutical industry has long used conventional compressor-based freezers and cryovats while tolerating the limitations. Now liquid nitrogen freezers are proving to be safer, faster, more reliable, eco-friendly alternatives that enable superior temperature control with less maintenance and energy use.

For more information: call 801-226-4100; email info@cryometrix.com; visit www.cryometrix.com; or write to the Cryometrix brand at Reflect Scientific, Inc., 1266 South 1380 West, Orem, Utah 84058.

Unlike compressor-based systems and cryovats, liquid nitrogen freezers safely deliver temperature-controlled freezing down to -160°C in minutes to preserve drug products, active ingredients and biological samples.

For decades, the pharmaceutical industry has relied on compressor-based systems to freeze drug products, active ingredients, vaccines, protein biologics and biospecimens in all phases from research and development to storage, transport and manufacturing.

Unfortunately, traditional mechanical freezers are limited in significant aspects. Compressors are known to break down frequently and require constant maintenance. Cooling and electrical requirements are high. These systems also utilise refrigerant, which limits cooling to approximately -100°C and is known to have a negative impact on the environment. Compressor-based systems also take considerable time to reach the desired temperature, which can lead to cryoconcentration, damage protein structures, degrade active ingredients and reduce potency.

More recently, liquid nitrogen (LN₂) cryovats have been utilised for faster freezing at cryogenic temperatures below -150°C. However, because the liquid nitrogen is not contained, there is some risk of exposure for technicians. Controlling temperature in vats is also difficult, even impossible, since there is no safe, reliable means of adjusting the temperature of the LN₂ within the vat.

Now, a game-changing technology in the form of liquid nitrogen cryogenic freezers combines the best features of compressor-based systems and cryovats, but without the limitations.

Liquid nitrogen freezers circulate contained LN₂ within their walls for safe, fast freezing down to -160°C. The units provide the convenience of an upright freezer with sophisticated temperature controls. By eliminating the need for compressors, liquid nitrogen freezers require much less maintenance or replacement, use less energy, and are more eco-friendly since refrigerant is not required.

“Liquid nitrogen freezers cool faster because LN₂ has a boiling point of -196°C, enabling units [using it] to cool to temperatures as low as -196°C,” said Kim Boyce, President of Reflect Scientific. “Most refrigerants have boiling points higher than -100°C, making it difficult for compressor-based freezers [using refrigerants] to operate at temperatures below that. Since the LN₂ is self-contained, there is no exposure to the user or products.”

Advanced LN₂ freezers are available for the pharmaceutical industry in a variety of configurations and models, under Reflect Scientific’s Cryometrix brand.

Upright LN₂ freezers

Upright liquid nitrogen freezers provide adjustable temperatures from +20 to -160°C. This is considerably lower than conventional upright freezer options, enabling significantly faster freeze times.

LN₂ freezers minimise the risk of sample warming and quality deterioration due to door open-close events and offer one of the fastest recovery times in the industry. To safeguard sample integrity, state-of-the-art temperature and data logging can be easily accessed, and multiple security levels set. A redundant cooling system and onboard seven-day battery backup further ensure that processes can continue uninterrupted even upon loss of power.

The approach also uses up to 90% less energy than mechanical, compressor-based units, which significantly reduces operating costs. Unlike compressor-based systems, no heat is exhausted to the room, eliminating the need for expensive HVAC systems for cooling. The freezer has a small footprint that suits space-constrained storage environments.

Pharmaceutical use case: biorepositories

In the pharmaceutical and medical industries, liquid nitrogen freezers are utilised as biorepositories for the long-term collection, cataloguing and preservation of biospecimens such as tissue, cells, DNA, protein, blood, plasma or urine. These biorepositories are essentially ‘libraries’ where biospecimens are stored for clinical or research purposes.

Biorepositories are vital for understanding diseases and genetics, developing prophylactic and therapeutic agents, and monitoring human population health including outcomes related to environmental exposures.

LN₂ blast freezers

Advanced LN₂ blast freezers can reliably lower the temperature of pharmaceutical and biological products to as much as -90°C in minutes with a greatly reduced risk of sample damage and significantly increased production throughput.

As an option, blast freezers can be designed to do ‘double duty’ by rapidly thawing product when required using one machine. This can streamline throughput and eliminate the need for separate freezing and thawing equipment.

Pharmaceutical use case: drug substances, vaccines, protein biologics, blood plasma

LN₂ blast freezers are used to slow the rate of active-ingredient degradation of drug substances, vaccines, and protein biologics during storage.

For pharmaceutical research and at blood banks, blast freezers are used to rapidly freeze and store a range of thermally sensitive products such as blood plasma and cryoprecipitate. How quickly various blood plasma products are processed and frozen can affect the value and type of product produced, and even its viability.

Mini LN₂ blast freezers

As the name indicates, mini LN₂ blast freezers are smaller benchtop versions for pharmaceutical use where very quick freezing is necessary in a constrained space. Using only a small amount of LN₂ from a portable dewar tank, these systems can cool from +20 to -80°C in under two minutes. The temperature is adjustable from +40 to -90°C.

Pharmaceutical use case: R&D, limited production

Pharmaceutical manufacturers use mini LN₂ blast freezers to rapidly freeze and thaw thermally sensitive materials in the R&D phase for new drugs, vaccines and biological products. It is important to establish the temperature profile of these materials to determine how products will respond to expected temperature fluctuations during transport, storage and distribution. The compact units can simplify testing with temperature profile recipes to further expedite R&D, quality control and even low-volume production.

The pharmaceutical industry has long used conventional compressor-based freezers and cryovats while tolerating the limitations. Now liquid nitrogen freezers are proving to be safer, faster, more reliable, eco-friendly alternatives that enable superior temperature control with less maintenance and energy use.

*Del Williams is a technical writer based in Torrance, California.

Working with an OEM that offers an experimental test run of your product provides evidence-based research that a freezer fulfills your operational requirements

Pharmaceutical and medical researchers rely on blast freezers to quickly freeze drug products, active ingredients, and biospecimens to extremely low temperatures during R&D storage, transport, or manufacturing.

Today, state-of-the-art liquid nitrogen blast freezers can quick freeze products, ingredients, and specimens to ultra-low temperatures much faster and with greater control than conventional technology. However, verifying that a unit can handle specific products with the necessary speed of cooling, accuracy, and reliability is crucial prior to purchase.

To help researchers considering a blast freezer to verify that a unit meets their requirements before purchase, Reflect Scientific now offers a trial test run of its product with complete documentation of the results.

“With a test run, you can understand the process inputs and outputs required by your product and blast freezer before finalizing a purchase. You can design the test with any process requirements or restraints, and we will provide you with the results,” says Sheldon Larson, Customer/Product Engineer, Cryometrix Freezer and Chiller Products at Reflect Scientific, Inc., an OEM of cryogenic cooling technologies for the pharmaceutical, biotechnology, medical, and transportation markets.

According to Larson, the experimental test run report, conducted on a B-90 Cryometrix blast freezer with thawing capability, can help researchers determine key data such as:

• freeze and thaw times of drug substances or drug substance substitutes;
• estimated liquid nitrogen use during a standard designed batch freeze/thaw cycle; and
• other items specified during the design stage of the experimental run cycle.

The Cryometrix B-90 blast freezer by Reflect Scientific utilizes safely contained liquid nitrogen at -196°C to freeze products with cooled air. The system is designed so there is no contact between the LN2 and the operator or product, which helps to ensure safety. It can cool product inside from 20°C to -90°C in less than 10 minutes. The temperature is adjustable from +40°C to -90°C, with temperature uniformity of ± 3°C throughout.

To ensure product quality, the B-90 provides state-of-the-art temperature and data logging, which can be easily accessed through a touch screen or downloaded to a computer. The latest software upgrade allows up to 250 users and 8 security levels. Managers can easily control who can open the freezer, change the setpoint, and adjust the setting.

The blast freezer also offers optional rapid thawing capability up to 40°C in the same machine. With this option, the end user does not need two separate machines but can perform both rapid freezing and thawing procedures with one unit.

According to Larson, the experimental test run report typically provides a summary of test results for the duration of freeze and/or thaw cycle, LN2 consumption for the test run, any abnormalities in testing, and suggestions for production level runs.

In addition, an outline is provided of how the test was set up. This includes the location of each thermocouple that gathered data, along with photos and video of the set up and test if desired. Raw data files of all sensors used during the test can also be provided as specified in the experimental test run design.

When researchers need to verify that a blast freezer effectively meets their needs prior to finalizing a purchase, selecting an OEM that offers an experimental test run with its product can provide the evidence-based research needed to make a fully informed buying decision.

For more information: call 801-226-4100; email info@cryometrix.com; visit www.cryometrix.com; or write to the Cryometrix brand at Reflect Scientific, Inc., 1266 South 1380 West, Orem, Utah 84058.

By Brian Buntz | January 31, 2023

Reflect Scientific’s Cryometrix T‐160 ultra‐low temperature freezer is designed to be a safer, more reliable and more efficient option for the pharmaceutical and medical industries than cryogenic freezers requiring liquid nitrogen. The refrigerator also replaces the compressor and refrigerant design present in most biorepositories.

The upright liquid nitrogen freezer boasts adjustable temperatures from +20°C to –160°C, providing faster freeze times than traditional upright freezer options. The freezer also offers temperature uniformity of ±7°C, ensuring sample preservation.

Eco‐friendly design and other features

The manufacturer notes that the Cryometrix freezer is eco‐friendly, with a simplified design and minimal moving parts. It says the design supports reliability and lowers maintenance costs. Reflect Scientific also offers a 20‐year warranty on the cooling system.

The freezer minimizes the risk of sample warming and deterioration related to door events. The temperature and data logging can be readily accessed, and multiple security levels can be set for enhanced sample protection. The redundant cooling system and onboard seven‐day battery backup ensure uninterrupted processes even during a power loss.

It also offers automatic tracking of temperature and other data.

Furthermore, the Cryometrix freezer is said to use up to 90% less energy than mechanical, compressor‐based units, lowering operating costs. The freezer also eliminates the need for expensive HVAC systems as it doesn’t emit heat into the room.

The ultra‐low temperature freezer offers a redundant emergency valve for use during a power outage to maintain the temperature in the payload bay.

Compact design

Its compact design is suitable for space‐constrained storage environments.

The ultra‐low temperature freezer measures under 8 ft2.

Reflect Scientific also offers products supporting a range of life‐science applications, including plasma freezing, CAR‐T cell storage, stem cell storage and various cGMP processes.

The company’s blast freezers can quickly freeze and thaw temperature‐sensitive materials during R&D for new

drugs, vaccines and biologics. It also supports temperature profiling, which can shed light on how products will handle temp changes during transport, storage and distribution. Blast freezers also store blood plasma, cryoprecipitate, vaccines and other substances.

About the Author: Brian Buntz

The pharma and biotech editor of WTWH Media, Brian is a veteran journalist with more than 15 years of experience covering an array of life science topics, including clinical trials, drug discovery and development and medical devices. Before coming to WTWH, he served as content director focused on connected devices at Informa. In addition, Brian covered the medical device sector for 10 years at UBM. At Qmed, he overhauled the brand’s news coverage and helped to grow the site’s traffic volume dramatically. He had previously held managing editor roles on two of the company’s medical device technology publications.