Plasma Freezer FAQs

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 compliant plasma freezer should be able to maintain the required storage temperature under the conditions it is designed to operate in, while also providing reliable temperature recording and alarms. This is important because plasma products may later be used for transfusion, and storage outside the required range can compromise product suitability.

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. The freezer should also be checked, verified and maintained so that it continues to hold the required temperature after installation.

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.

The right plasma freezer depends mainly on the number of Fresh Frozen Plasma (FFP) packs you need to store, the space available, and how staff will access the freezer.

Under bench plasma freezers suit smaller sites or areas where space is limited. Chest freezers can provide more storage capacity in a compact footprint. Upright plasma freezers are generally better where higher capacity and easier front access to stored packs are required.

For frozen blood product storage, the freezer must meet Australian Standard AS 3864, Medical refrigeration equipment — For the storage of blood and blood products, Parts 1 and 2. It must also have the correct ARTG status before being supplied for use in Australia, unless another TGA exemption, approval or authority applies.

ENLAKE can help match the freezer type, FFP pack capacity, alarm system, temperature recording and service support to your facility requirements.

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.

Plasma freezers used for storing frozen blood products must be included in the Australian Register of Therapeutic Goods (ARTG) before they can be supplied in Australia.

ARTG inclusion is separate from AS 3864 compliance. ARTG relates to supply of the medical device in Australia, while AS 3864 relates to freezer performance and suitability for frozen blood product storage.

When choosing a plasma freezer, confirm that the model has the correct ARTG status and can be installed, verified and maintained in accordance with AS 3864.