Freeze drying systems

From hightech pilot plants up to high efficiency production plants

OPTIMA pharma - freeze drying systems / lyophilization
Sensitive pharmaceutical products often need to be freeze dried to extend shelf life. The Klee brand provides solutions for all requirements with its broad range of machines. From hightech pilot plants up to high efficiency production plants for vials, syringes, ampoules as single units or in bulk.

Optima Pharma’s modern manufacturing site is state of the art. All the required media for the different processes are available: Clean steam, CIP water and liquid nitrogen. The construction, commissioning and FAT of the freeze drying unit takes place in our split level facility. Freeze drying units can be installed, tested and operated under real conditions, saving time and money for qualification (IQ/OQ) and the final site installation (SAT).
Process based
3D engineering
Phase-oriented
Project management
IQ/OQ/PQ
Quality assurance
Integration in
Turnkey lines

Freeze drying systems from OPTIMA pharma

Innovative forward-looking technologies to meet your unique requirements

Freeze drying system - loading system

Your needs are in focus

The design of new plants and the refurbishment or upgrading of existing plants is dependent on many factors. Process requirements,
product characteristics and your spatial limitations are all being considered during design. The desired level of automation (manual, semi-automatic or fully automatic) is a key factor in the selection of the loading system. Optima pharma offers exactly the right solution for your requirements. Manufacture, test, installation and commissioning of loading and unloading systems and freeze drying
units can be performed at the facility in Mornshausen.
Freeze drying system - Modern building infrastructure - OPTIMA pharma

Modern building infrastructure

For the installation and operation of the units under real conditions. Single floor as well as dual floor units can be built and installed to mimic the architecture of the final site, thereby allowing simulation of potential conflicts prior to site installation. The installation / de-installation as well as the transport is fully prepared in the factory. The units are shipped in sealed trucks. This ensures optimal delivery at the installation site and speeds the installation on-site, saving valuable time to commissioning and production.

Further Information

Get more information on freeze drying systems, solutions and services from OPTIMA pharma.

Lyophilization Process Technology

Focus on process safety and efficiency. Interview partner: Stephan Reuter, CEO Optima Pharma

What is lyophilization?

Information about lyophilization technology

Freeze-drying, also known as lyophilization or sublimation drying is a method for the careful drying of high quality products. In freeze-drying the ice crystals sublimate directly without passing into liquid state. The end product of freeze-drying is known as lyophilization. Lyophilization in the pharmaceuticals industry is undertaken as a batch process.


Process

As a rule the freeze-drying system is comprised of two containers. Chamber and condenser vessel are connected to each other via a valve (intermediate valve). The product to be dried stands on heatable and coolable surfaces and is frozen under atmospheric pressure. Coiled pipes are built into the condenser with a flow-through directly via injection of refrigeration agent or through a freezing solution.


Primary drying

In the primary drying phase the water contained in the material is sublimated. This is based on the principle that also when frozen, water has sufficiently high vapor pressure to pass from frozen directly to gaseous state. For this a vacuum is created.
Energy is taken up in sublimation. This energy is drawn from the surrounding temperature and so in the course of the process the temperature of the set-up surface would drop. In order to keep the temperature constant the set-up surfaces are subjected to the same amount of heat as is taken up by the water as sublimation energy. In the course of the drying process the atmosphere in the chambers consists almost exclusively of water vapor that precipitates as ice on the cold coiled pipes of the condenser. 


Secondary drying

In the further process comes the secondary drying, whereby through further heating, more strongly bonded water is removed from the product. Cooling of the set-up surfaces is via heat exchangers connected to the primary refrigeration system, the condenser can be directly charged with refrigeration agent. Temperatures of the condenser are typically between -75 °C and −90 °C. Defrosting the condenser is undertaken with steam in vacuum.