Sensitive pharmaceutical products often need to be freeze-dried to help preserve shelf life. OPTIMA provides solutions for all freeze-drying requirements with a broad range of machines, from high-tech to high-efficiency production machines for vials, syringes, injectables, and ampoules both as single units and in bulk.
OPTIMA has a modern, state-of-the-art, manufacturing site with all of the required equipment for different processes available. We can install, test and operate freeze-drying equipment under real conditions, saving time and money for both the qualification (IQ/OQ) and final site installation (SAT).
Lyophilization SolutionsLyophilization can extend the life of highly sensitive pharmaceutical and biotechnical produced drugs significantly. Therefore, the production of many pharmaceutical drugs and heat-sensitive medications are inconceivable without it. OPTIMA’s portfolio includes freeze dryers for both the mass production and small batches of pharmaceutical products. As a leading freeze dryer manufacturer, OPTIMA designed freeze driers specifically for the pharmaceutical industry. OPTIMA Pharma’s state-of-the-art building provides the latest technology to meet customer needs. The following media are available for all necessary processes: pure steam, CIP medium, and liquid nitrogen. The assembly, commissioning and FAT are completed in a two-story building, facilitating tests and machine inspections under real-life conditions. Therefore, saving valuable time during installation, qualification (IQ, OQ) and the final performance test (SAT). From start to finish, OPTIMA is your partner to design the perfect lyophilization system.
Freeze drying systems from OPTIMA pharma
Innovative, forward-looking technology to meet your unique requirements in lyophilization
Your needs are in focusProcess requirements, product characteristics, spatial limitations and desired level of automation are considered during the design. The manufacturing, testing, installation, and commissioning can be performed at our pharmaceutical facility in Mornshausen.
Modern building infrastructureSingle and dual floor units can be built and installed to mimic the architecture of the final site, allowing the simulation of potential conflicts before equipment installation. The installation, de-installation, and transportation of the machine are fully prepared in the factory and the machine units are shipped in sealed trucks. This method ensures optimal delivery and quick installation.
Further InformationGet 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, Managing Director Optima Pharma
What is lyophilization?
Freeze-drying, also known as lyophilization or sublimation drying, is a method of careful drying of high-quality products. In freeze-drying, the ice crystals sublimate without passing into a liquid state. The end product of freeze-drying is known as lyophilization which is completed in a batch process.
As a rule, freeze-drying equipment consists of two containers. The chamber and condenser are connected to each other with a valve and the product to be lyophilized rests on temperature controlled surfaces. During the lyophilization cycle, the product is freeze-dried under atmospheric pressure.
In the primary freezing phase, the water contained in the material is sublimated. To achieve this, a vacuum is created and energy is absorbed through sublimation. In order to keep the product temperature constant, the surfaces are subjected to the same amount of heat that is being used by the water as sublimation energy.
Next in the freeze-drying cycle is secondary drying, whereby, through further heating, more strongly bonded water is removed from the product to make it dry. The cooling of the set-up surfaces is completed using heat exchangers that are connected to the primary refrigeration system. A condenser creates a low-temperature atmosphere, typically between -75 °C and −90 °C.
Economic Freeze-Drying of Small BatchesIn 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.