Freeze-Thaw Units - precise processes and proprietary software ...
Pharmaceutical, biotechnological and medical markets comprise a lot of products that are lyophilized within their complex manufacturing. In this connection, the freezing process plays an important role. A controlled freezing and a controlled thawing are also both considered essential for many products which are not freeze-dried. In order to offer quality and GMP-compliant solutions in this sector too, HOF has developed powerful freezing and thawing devices, the so-called “Freeze-Thaw Units” (FTUs).
The FTUs are characterized by high process safety and reliability. Adjustable freezing rate and full control of the freezing and thawing process also belong to the top performance specifications. At the same time it is ensured that the entire filling quantity is frozen and thawed equally, regardless of the bag size. As a matter of course, a documentation of temperature and time will be made. In addition, the HOF FTUs work with little energy through indirect cooling and don’t consume any energy when idle. The large doors guarantee a quick loading and unloading. The inner section of the device is made from stainless steel and is easy to clean.
Already in 1992, the first freezing unit was manufactured as a new development in the field of blood donation centers. According to the specification, blood plasma needs to be frozen as quickly as possible: a temperature of -30°C in the core of the bag needs to be reached and exceeded within 45 minutes. HOF units guarantee these values and can hold up to 120 400ml bags at any one time.
Through specific compression of the temperature-controlled shelves, each product bag has the same freezing conditions at all times and at the end the same shape, so that bar codes can be automatically read on the flat surfaces. Blood donation services can use the configured "Freeze Viewer Professional" software for documentation purposes. This software records all relevant data like temperature sequence, barcodes and notifications, which can then be printed in the form of a report or transmitted electronically to a superordinate data acquisition system.
In the field of pharmaceutical and biotechnology industry, the devices are designed for bag sizes between four and twelve liters. The system control allows temperatures in the range of + 40°C to -60°C, even down to -70°C with a ramp function option. Our “Freeze Viewer Professional” Software is at your disposal. This system meets the FDA requirements (21 CFR Part 11) and has a recipe management, reporting system, data acquisition, trend graph and reporting function.
Of course, a configuration of different user-specific performance parameters is possible.