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Frequently Asked Questions

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Blood fridges used in Australia for the storage of blood and blood products are covered by AS 3864, Medical refrigeration equipment — For the storage of blood and blood products.

AS 3864 is split into two parts. AS 3864.1-2012 covers the manufacture and performance of the fridge itself, including temperature control, alarms, temperature recording and testing. AS 3864.2-2012 covers what happens after installation, including care, maintenance, performance verification, calibration and ongoing monitoring.

When selecting a blood fridge, check that the model complies with AS 3864.1-2012 and that it can be installed, verified and maintained in line with AS 3864.2-2012.
Blood fridges used in Australia must meet strict compliance requirements because they are used to store blood and blood products that may later be transfused into patients. The key Australian Standard is AS 3864, Medical refrigeration equipment – For the storage of blood and blood products. AS 3864.1-2012 covers the manufacture and performance requirements of blood storage refrigeration equipment, including temperature control, monitoring, alarms and recording systems. AS 3864.2-2012 covers user-related requirements after installation, including care, maintenance, performance verification and calibration. At the time of installation, this may include checking that the fridge has been installed correctly, verifying temperature performance in the installed location, confirming that alarms and monitoring are working, and ensuring the required documentation is available before the fridge is used for storing blood or blood products. A compliant blood fridge should be assessed against the following requirements:
Requirement What to check
Temperature range Maintains blood and blood products between 2°C and 6°C
Australian Standard Complies with AS 3864.1-2012 for manufacture and performance
Installation and use Can be checked, maintained, verified and calibrated in line with AS 3864.2-2012
Alarm system Alarm system is separate from the temperature control system
Temperature records Provides reliable temperature recording and audit trail capability
ARTG / TGA Confirm ARTG inclusion where required for supply in Australia
Calibration / verification NATA-accredited calibration, mapping or performance verification required
Support ENLAKE can arrange calibration, verification and service support through suitable partners
  Before a blood fridge is stocked, NATA-accredited calibration, temperature mapping and performance verification should be arranged. These checks help confirm that the fridge is operating correctly in its installed location and can maintain the required storage conditions for blood and blood products. This process may include NATA-endorsed certificates and verification against AS 3864.2 requirements. Blood fridges also need to be included in the Australian Register of Therapeutic Goods (ARTG), which is administered by the Therapeutic Goods Administration (TGA). ARTG inclusion is separate from AS 3864 compliance and relates to whether the medical device can be supplied in Australia. ENLAKE can supply compliant blood fridges and arrange calibration, verification and service support through our partners where required.  

A blood fridge should be built specifically for blood and blood products, not general medical stock.

Important features include stable temperature control, forced air circulation, continuous temperature recording, high and low temperature alarms, a power failure alarm, suitable internal storage, and rated blood pack capacity.

The alarm and monitoring system matters as much as the fridge itself. Temperatures need to be recorded securely, sensors need to reflect the temperature of the stored blood packs, and alarms need to be available where staff can respond if the fridge moves outside range.

The fridge should also be supplied with operating instructions, installation requirements, cleaning and maintenance instructions, and details of the ambient temperature range it is designed to operate in.

ENLAKE can help specify a blood fridge with the right capacity, monitoring, documentation and service support for your facility.

A compliant plasma freezer must meet Australian Standard AS 3864, Medical refrigeration equipment — For the storage of blood and blood products, Parts 1 and 2.

AS 3864 sets the requirements for freezer performance, temperature control, alarms, temperature recording, construction, documentation, care and maintenance. In practical terms, a compliant plasma freezer must maintain frozen plasma and plasma products at -25°C or lower, provide reliable temperature recording, include temperature and power failure alarms, and have suitable internal storage for plasma packs.

The freezer should also be supplied with the information needed for installation, operation, cleaning and maintenance, including its rated plasma pack capacity and the ambient temperature range it is designed to operate in.

ENLAKE can help specify a plasma freezer that meets AS 3864 requirements and suits your facility, storage capacity, monitoring arrangements and service support needs.

A plasma freezer is a purpose built medical freezer designed to store frozen plasma and other frozen blood products at -25°C or lower.

Plasma freezers are used for products such as Fresh Frozen Plasma (FFP), cryoprecipitate, cryodepleted plasma and other frozen blood products that may later be used for transfusion. Because these are blood products, they require controlled freezer storage, reliable temperature recording, alarm systems and documented monitoring.

A plasma freezer is not the same as a general laboratory freezer. In Australia, plasma freezers used for frozen blood product storage must comply with Australian Standard AS 3864, Medical refrigeration equipment — For the storage of blood and blood products, Parts 1 and 2. They must also be included in the Australian Register of Therapeutic Goods (ARTG), unless another TGA exemption, approval or authority applies.

A platelet shaker, also called a platelet agitator, keeps platelet bags in gentle, continuous motion during storage. This helps reduce settling and clumping while the platelets are stored at controlled room temperature.

Platelet shakers are commonly used in hospital blood banks, blood centres, transfusion services and clinical research laboratories.

A blood fridge is built for storing blood and blood products. A vaccine fridge is built for vaccines and temperature-sensitive medicines. They are not the same product category, and the compliance requirements are different.
Requirement Blood fridge Vaccine fridge
Main use Blood and blood products that may be transfused into patients Vaccines and temperature-sensitive medicines
Storage range 2°C to 6°C Typically 2°C to 8°C
Australian Standard AS 3864, Medical refrigeration equipment – For the storage of blood and blood products Vaccine cold chain requirements
Alarm system Separate from the temperature control system Not usually equivalent to AS 3864 blood storage requirements
Temperature records Reliable temperature recording and audit trail capability Temperature records required, but to a different standard
ARTG / TGA Must be included in the Australian Register of Therapeutic Goods (ARTG), unless a specific exemption, approval or authority applies ARTG inclusion is generally not required for standard vaccine refrigeration equipment
Because blood products may later be transfused into patients, blood fridges have more specific requirements for storage temperature, alarms, monitoring, documentation and testing. A vaccine fridge should not be used for blood storage unless it is specifically designed and compliant for that purpose.

The difference is both performance and compliance. Plasma freezers are built to hold frozen plasma products at much lower temperatures than many standard laboratory freezers, with models operating around -35°C and no higher than -30°C under heavy use and defrost conditions. They also include more comprehensive monitoring and alarm features, such as high and low alarm testing, probe failure alarm, door alarm, battery-backed temperature recording and remote alarm contacts.

Plasma freezers used for frozen blood product storage must meet Australian Standard AS 3864, Medical refrigeration equipment — For the storage of blood and blood products, Parts 1 and 2. They must also have the correct ARTG status before being supplied in Australia.

A general laboratory freezer may be suitable for laboratory materials, but it is not usually suitable for frozen blood product storage. Frozen plasma and plasma products should only be stored in a compliant plasma freezer.