Avoid the loss of any product because of improper storage and distribution
The main purpose of low temperature storage is to avoid further biological activity i.e. genetic or enzymatic. Ellab offers a wide range of options to fit your Cold Storage needs. Learn more about Cold Storage requirements and discover our recommended solutions.
Due to the severity of damage resulting from insufficient temperature control for certain types of goods, strict temperature monitoring requirements are set by the government and federal agencies to standardise a high level of safety throughout the pharmaceutical industry.
The required temperature is based on the biological activity level of the sample and the expected storage period. The following guidelines are used in the pharmaceutical industry:
- Short storage period (weeks): can be done at -18 to -30°C using mechanical freezers.
- Medium storage period (1-3 months): can be done at -30 to -50°C using mechanical freezers.
- Long storage period (6-12 months): can be done at -50 to -80°C using ultra low mechanical freezers.
- Extended storage period (years) can be done at -131°C or lower using special cryogenic freezers or liquid nitrogen.
The process of freezing down and storing samples is done by using mechanical freezers or special storage tanks using LN2 (liquid nitrogen). This is typically used within the following medical/pharma applications:
- Stem cell storage
- Cord blood storage
- Cell line storage
- Other biological material storage
Although temperature is usually the most critical measuring parameter, in situations where bulk powders are stored, relative humidity is equally as important. High levels of humidity will cause powders to congeal, which can affect product quality or deem ingredients unusable.
Validation & Monitoring Requirements
Validation must be conducted regularly to ensure that a low temperature cabinet or cryogenic freezer is capable of accurate and repeatable performance. Ellab has a variety of wireless loggers that are capable of monitoring down to -80°C. Well-designed wireless loggers with an efficient battery management system are required for cold storage applications.
At every point in the cold storage and supply chain, precautions can be taken to minimize the effect of external conditions on the quality and stability of the products, for both internal QA and external audits by regulatory bodies.
Environmental monitoring software is required to record data in a consistent manner that meets strict regulatory requirements. A centralized monitoring system allows data to be collected from all cold storage areas, so that users benefit from gap-free data throughout the entire cold chain, whilst also maintaining a clear record of data for auditing purposes.
Cold storage systems vary in design based on storage volume and temperature range. The only parameters of interest are temperature and humidity. Samples are often placed in closed containers so that no cross contamination is possible.
Qualification, Validation and Monitoring of cold storage freezers/tanks generally fall into three main categories.
Standard laboratory freezers/cabinets
Standard laboratory freezers/cabinets with a temperature range of -10 to -30°C do not usually pose any special challenges as the required parameters are simple to maintain.
Low temperature freezers
Low temperature freezers that operate between -30 to -80°C require special low temperature loggers.
Ultra-low temperature freezers
Ultra-Low temperature freezers (or Cryogenics) as well as LN2 tanks require special equipment as temperature exposure will make most materials very fragile thus breakage by mechanical stress can happen. When using cable based equipment metal sheeted SSU-MM sensors are ideal. It is recommended that the logger body is kept outside of extreme conditions.
Depending on the length of the validation process, the sample rate for data collection may need to be adjusted to match the logger memory capacity.
The FDA regards Mean Kinetic Temperature (MKT) as a calculation that will show if a product has exceeded storage conditions. MKT can also be used to determine if storage, handling, or shipment, etc. has affected the shelf life of the product. MKT is a calculated fixed temperature that replicates the effects of temperature variations on a product over a period of time. It expresses the cumulative thermal stress experienced by a product at varying temperatures during storage. In addition to MKT it is recommended that min and max values are calculated including a description of the time and place of occurrence.
Potential challenges when validating a cold storage system are:
- To determine the cold and warm zones of the cold storage system
- To confirm pre-defined temperature / humidity ranges
- To identify and improve temperature / humidity equilibration
- To determine the highest temperature / humidity fluctuations within the cold storage chamber
- To calculate and document the Mean Kinetic Temperature
Cold Storage Solutions
Wireless solutions solve many of the challenges presented during each stage of the cold storage process. A centralized monitoring system allows data to be collected from all cold storage areas, so that users benefit from gap-free data throughout the entire cold chain, whilst also maintaining a clear record of data for auditing purposes.
However for validation and qualification of very small and low volume freezers/chambers using thermocouples could be advantageous to reduce impact on chamber volume (if access port(s) available).
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