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Ultra Low Freezer Blast Freezer Controlled Rate Freezer Cryogenic Freezer Laboratory Freezer Liquid Nitrogen (LN2) Freezer
Ultra Low Freezer

Ultra Low Freezer Validation and Qualification Service

Ellab is a provider of onsite cGMP laboratory ultra-low freezer validation and qualification services, which often include temperature mapping. An ultra-low freezer is an environmental chamber designed to ensure stable and uniform conditions for your products and samples. Commonly, environmental storage areas are also known as ultra-cold freezers, ultra-low freezers, ultra-low temperature freezers, low-temperature freezers, lab freezers and deep temperature freezers.

Storage of biological material
Biological material is stored in sub-zero conditions to prevent product degradation and damage. Short-term storage can be achieved in freezers ranging from -80°C to -20°C, however, long term product storage (if product is stored over the course of a year or longer) is typically kept at cryogenic temperatures. This is because low temperatures will slow the biological processes that cause cellular degradation, and the glass transition temperature of water at -130°C indicates the point where those processes will no longer occur. Some of these chambers are upright reach-in chambers, and some are chest style reach-in freezers. Occasionally, there may be some freezer rooms down to -86°C.

Temperature mapping of Environmental Chambers
In highly regulated environments that need to comply with current Good Manufacturing Practices (cGMP) or current Good Laboratory Practices (cGLP) it is often required to map your environmental chambers to ensure that your product or sample is in fact in the desired environmental conditions. 

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Qualification Process of Laboratory Ultra-Low Temperature Freezers

The qualification process of a cryogenic vessel typically requires the same considerations as any other controlled temperature unit (CTU) would, with the possibility of additional parameters to be tested. While many CTUs may be mapped for a period of 24 hours under empty and/or loaded conditions, a cryogenic tank should be mapped for a period of three fill cycles to ensure proper operation of both the controller and LN2 supply system. When performing cryogenic temperature mapping, thermocouples must by placed within the storage envelope. Otherwise, temperatures may exceed the acceptable range.

Blast Freezer

Blast Freezer Validation and Qualification Service

A blast freezer is a storage unit used in the pharmaceutical industry to quickly reduce the temperature of the material just below the freezing temperature. This type of chamber is not commonly used and may be referred to as a blast freezing process instead. These blast chillers have the additional airflow and cooling capacity to remove the heat from the products or samples at a rapid rate.

Another way of looking at this is that the unit is shock freezing the material. By cooling rapidly, the water crystals are smaller due to the deep fast penetration of cold to the center of the product. Ultimately the product does not degrade as much going through the freezing process.

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Onsite Qualification Process of Laboratory Blast Freezers

Qualification must be performed periodically to ensure that the freezer is capable of accurate and repeatable performance. A specified number of loggers are placed throughout the freezer in the pre-determined critical mapping points while taking into account the expected gradient throughout the chamber. The temperature mapping is typically performed over a minimum period of 24 hours.

Potential challenges when validating a freezer system are:

  • To determine the cold and warm locations of the freezer
  • To confirm pre-defined operating temperature ranges
  • To identify and improve temperature equilibration
  • To determine the highest temperature fluctuations within the cold storage chamber
  • To calculate and document the minimum, maximum and average temperatures and their locations
Controlled Rate Freezer

Onsite Controlled rate Freezer Validation and Qualification Service

Controlled rate freezers are commonly known as process freezers that bring the product down to a particular freezing temperature through ramping the temperature down with plateaus, which allow the product to stabilize before moving to the next step. Commonly, controlled rate freezers can also be considered cryopreservation or cryogenic freezers.

Cold storage of biological materials
Proper cold storage of biological materials is essential to product preservation. In addition to the conditions in which product is stored, the method used to reduce its temperature is also crucial to have controlled and qualified, as the rate of temperature change will affect the product integrity. The controlled rate freezing of biological product is dependent on the prevention of biological activity, which in turn is dependent on the presence of water. As the material passes below the water transition temperature of -130°C, biological activity ceases to occur.

Several factors can affect the product quality
However, several factors can affect product quality as the temperature decrease is occurring. Managing the temperature change assures that damage will not occur to the product by compensating for release of latent heat released during the freezing process, and also mitigating the risk of cellular dehydration.

Temperature Distribution Test
In addition to the expected verifications performed for a controlled temperature unit qualification, the qualification of a controlled rate freezer will typically include a temperature distribution study using a mock load. Temperature sensors can be inserted into various load items, such as vials or containers, and placed throughout the chamber to simulate the change of product temperature as the equipment cycles through lower temperatures. The acceptable rate of change should be determined through testing of cell viability under different temperature profiles before equipment qualification. The most common use of a controlled rate freezer is to freeze cells in the safest way possible. This is also why controlled rate freezers are also called cell freezers.

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Cryogenic Freezer

Onsite Cryogenic Freezer Validation and Qualification Service

Ellab is a provider of onsite cGMP laboratory cryogenic freezer validation and qualification services, which often include temperature mapping. A cryogenic freezer is a mechanical freezer capable of maintaining stable and uniform temperatures below -140°C which keeps the product and samples below the glass transition temperature of water for long-term storage. Cryogenic storage areas are also known as mechanical cryopreservation. Biological material is stored in sub-zero conditions to prevent product degradation and damage.

Long-term Biological Storage
Cryogenic freezers offer mechanical refrigerated cryopreservation for long-term biological storage. These cryogenic storage units are often operated at -150°C or -140°C. This is below the -130°C glass transition temperature of water. Long-term product storage is necessary if product is stored over the course of a year or longer and is commonly kept at cryogenic temperatures. This is because low temperatures will slow the biological processes that cause cellular degradation and the glass transition temperature of water at -130°C indicates the point where those processes will no longer occur. Cryogenic freezers are commonly chest style reach-in freezers.

Mechanical cryo-freezers are an economical alternative to LN2 freezers. These units use coils around the storage volume to create an even temperature distribution, as opposed to the vertical temperature gradient resulting from the evaporation of LN2. 

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Laboratory Freezer

Onsite Laboratory Freezer Validation and Qualification Service

A laboratory freezer is a storage unit used in life science industries such as pharmaceutical, biotechnology, and medical device manufacturers to store contents such as samples and other medical material in freezing temperatures. Commonly, the two styles of freestanding freezers are chest freezers and upright freezers models. Laboratory freezers have a long lifespan with most models having an expected lifecycle of twenty years for chest models and shorter for uprights, especially self-defrost models. 

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Qualification Process of Laboratory Freezers

Qualification must be performed periodically to ensure that the freezer is capable of accurate and repeatable performance. A specified number of loggers are placed throughout the freezer in the pre-determined critical mapping points while taking into account the expected gradient throughout the chamber. The temperature mapping is typically performed over a minimum period of 24 hours.

Potential challenges when validating a freezer system are:

  • To determine the cold and warm locations of the freezer
  • To confirm pre-defined operating temperature ranges
  • To identify and improve temperature equilibration
  • To determine the highest temperature fluctuations within the cold storage chamber
  • To calculate and document the minimum, maximum and average temperatures and their locations
Liquid Nitrogen (LN2) Freezer

Liquied Nitrogen (LN2) Freezer Validation and Qualification Service

Ellab is a provider of onsite cGMP laboratory liquid nitrogen freezer validation and qualification services, which often include temperature mapping. A liquid nitrogen freezer is designed for long-term cryopreservation storage of pharmaceutical products and samples, and allows for a high level of product integrity. Biological material is stored in cryogenic sub-zero conditions to prevent product degradation and damage. Short-term storage can be achieved in freezers ranging from -80°C to -20°C. Long-term product storage is necessary if product is stored over the course of a year or longer and is typically kept at cryogenic ultra-low storage temperatures which can be attained inside of a LN2 freezer. The importance of the ultra-cold temperature is to slow the biological processes that cause cellular degradation. The glass transition temperature of water at -130°C indicates the point where those processes will no longer occur.

Cryogenic Temperatures
Cryogenic temperatures are achieved using liquid nitrogen (LN2) in either a liquid or vapor phase storage vessel. A liquid phase storage vessel requires the product to be submerged in liquid nitrogen thus risking the product to exposure if the packaging is compromised. Vapor phase units keep the liquid nitrogen separate from the stored product, but biological material may be exposed to elevated temperatures if the cryo-vessel is not adequately insulated and controlled. 

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Qualification Process of Laboratory Cryogenic Liquid Nitrogen (LN2) Freezer

The qualification of a cryogenic vessel typically requires the same considerations as any other controlled temperature unit (CTU) would, with the possibility of additional parameters to be tested. While many CTUs may be mapped for a period of 24 hours under empty and/or loaded conditions, a cryogenic tank should be mapped for a period of three fill cycles to ensure proper operation of both the controller and LN2 supply system. It is important to place temperature sensors within the storage envelope when performing cryogenic temperature mapping. Otherwise temperatures exceeding the acceptable range may be recorded if sensors are located a distance above the storage racks.

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