FARMAK, a.s. production program is partially composed of products for which we are a contract manufacturing organization. In such cases, we provide full support for the transfer and optimization of custom production, including support for DMF compilation.
When verifying the technology, we use several stages of production. Thanks to this we can smoothly move from volumes of units of liters to production in reactors with a volume of 6300 L. The individual stages of production are described below.
Laboratories form the basic stage of research and development of FARMAK, a.s. They are equipped with glass reactors with a volume of 5, 10 and 15 L. Mixing is provided by mechanical stirrers with a programmable speed of 1-640 rpm. Correct reaction kinetics is assured by programmable thermostats.
Kilolab forms link between production and the research and development department. Its task is to verify procedures and technologies of preparation of new products before their implementation into production. It is also engaged in production of active substances in weight range of hundreds of grams to several kilograms, which is not suitable for main operations.
From the devices included, we can mention top cryogenic reactors with a volume of 60 L, allowing reactions in temperature range from -80 °C to +300 °C. This unit operates fully in Good Manufacturing Practice (cGMP) mode.
Small API Unit
Small API Unit (SAU) is the newest operating unit in our company. It is equipped with 400 L reactors allowing reactions in temperature range from -80 °C to +300 °C. Terminal part is equipped with a process filter for isolation and drying. Due to its size, it enables the production of batches from approx. 5 to 25 kg, which smoothly fills the gap between Kilolab and large-capacity production. This unit operates fully in Good Manufacturing Practice (cGMP) mode.
Large-scale production is equipped with reactors with a volume of 400 - 6300 L, most of which are enamelled reactors with a volume of 1600 L. Important part of the production chain are centrifuges, process filters and dryers made of stainless steel and Hastelloy C22. Physical operations, especially grinding and micronization can be set according to customer needs. Production works fully in Good Manufacturing Practice (cGMP) mode.