STATE-OF-THE-ART TECHNOLOGY AND THE HIGHEST SAFETY STANDARDS

ENERGY-EFFICIENT AND WITH INDIRECT COOLING

THE AREA IN CONTACT WITH THE PRODUCT IS EASY TO CLEAN

CUSTOMIZED QUALITY - RELIABLE AND FUTURE-PROOF

THE SPECIALIST FOR INDIVIDUAL SOLUTIONS

HOF FTU PHARMA:

FREEZE-THAW UNITS FOR THE PHARMACEUTICAL INDUSTRY AND BIOTECHNOLOGY

www.hof-sonderanlagen.com

Safe control of all parameters

Reliable process control is indispensable when freezing and thawing pharmaceutical and biotechnological products. The same applies to the adjustable freezing and thawing speed. Here, with the individual Freeze Thaw Units (FTUs), HOF meets all the requirements of professional users from the industry.

The FTUs are each developed and manufactured according to customer-specifi c requirements. Products that have to be fed into bag systems can be transported into the plant either manually or by means of a semi-automatic loading aid developed by HOF.

Custom requirements – individual plant sizes

Two types are offered in order to respond fl exibly to on-site installation possibilities. The compact design accommo-dates all process-relevant and electrotechnical components inside the device.

On the other hand, there is the possibility of split-cons-truction to lower the sound pressure level directly on the device. Here, the refrigeration components outside the unit are mounted on a separate machine frame.

HOF FTU PHARMA: FREEZE-THAW UNITS EXACT PROCESSES AND PROPRIETARY SOFTWARE

Adjustable freezing speed and full control over the free-zing process are among the top specifi cations for freezing systems from HOF.

The total fi ll quantity is frozen evenly and independent of the bag size.

Each product bag has the same freezing conditions and, at the end, the same shape. This allows bar codes to be machine-read on the fl at surface, for example of a plasma bag. Reliable temperature and time documentation is a matter of course.

ADJUSTABLE FREEZING WITH FULL CONTROL AND PROPRIETARY SOFTWARE

RELYING ON KNOWLEDGE AND EXPERIENCE

With almost 30 years of experience, HOF Sonderanlagenbau GmbH has been the leading specialist in manufacturing individual freeze drying systems, loading and unloading systems, and Freeze-thaw units for the pharmaceutical and biotechnology industries.

At our company locations in Lohra and Mornshausen near Marburg, highly motivated and highly qualified employees work on our own production area of ap-proximately 13,500 square meters. Close contact with our customers - nationally and internationally - is main-tained by the fl exible service team, which supervises the HOF systems and their users.

Reliable cooling, reliable heating

Product tempering takes place within the FTU via a plate system. The control panels are designed to freeze the entire load evenly and regardless of bag size.

For temperature control, silicone oil is cooled with a sepa-rate cooling system or heated with the built-in electric heater. The integrated refrigeration system’s design is specified according to customer requirements. Optionally, a R452A type hydrofluorocarbon compressor system, a natural refrigerant compressor system (ethane/propene), or a liquid nitrogen system are available.

Included in delivery: „HOF Freeze Viewer Professional“

The FTUs are equipped with a visualization system for process control, the „HOF Freeze Viewer Professional“. This system complies with FDA requirements according to 21 CFR Part 11. With this software, specially developed by HOF, all process-relevant data, such as batch reports

and temperature profiles can be printed out in the form of a process report or sent to a superordinate system. Customers can create respective recipes for the indivi-dual products individually.

Service is one of them

HOF’s FTUs always comply with state-of-the-art technology and meet high safety standards. Apart from production, HOF stands for comprehensive project support. At the same time, the entire project - from plant planning and

production at HOF to commissioning - is entirely managed on-site by a project team. HOF is also available during transport and during introduction of training courses and the annual service and maintenance units.

SPECIFICATIONS FTU PHARMA:

HOF Freeze Viewer Professional Manually adjustable pressure system Integrated control cabinet

Number of adjusting plates: 5+1 Adjusting plate dimensions: 1250 x 700 x 17,5 mm Adjusting plate spacing: max. 90 mm Temperature homogeneity: +/- 1 K at (+30 °C / -15°C)

+/- 2 K at (-60 °C) Control range shelf temperature: -73 °C - +40 °C Minimum shelf temperature: -70 °C Maximum shelf temperature: +40 °C Shelf cooling (without product): +20 °C bis -60 °C < 90 min Shelf heater (without product): +1 K/min Refrigeration systems: Compressor system with R452A

Compressor system with natural refrigerants (ethane/propene) Liquid nitrogen (LN2) Installation dimensions FTU: approx. 2350 x 1400 x 2500 mm

approx. 2350 x 2300 x 2500 mm (with open door) approx. 3300 x 1400 x 2500 mm (additional support arm) Weight FTU: approx. 2300 kg Sound pressure level: approx. 75 dB(A), in clean room Transportation dimensions FTU: approx. 2350 x 1400 x 2200 mm

Required media supply:

Cooling water supply: max. 6 m³/h; max. 16 °C; G 1 ¼“ Cooling water return: max. 6 m³/h; max. 22 °C; G 1 ¼“

Pressure difference fl ow / return: approx. 1.5 bar Compressed air: 100 Nl/min; min. 3 bar; G ½“ Electric: Power supply: 400 Volts, 50 Hz, 3 Phases/N/PE

Total power: approx. 34 kW Current load: 60A Pre-backup: 80A

THE SPECIALIST FOR INDIVIDUAL SOLUTIONSFreeze-drying systems Loading and unloading systems Freeze-thaw units Service

HOF SONDERANLAGENBAU GMBH Ludwig-Rinn-Str. 1-3 35102 Lohra Germanyphone + 49 6462 9169-0 fax + 49 6462 9169-199www.hof-sonderanlagen.com