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Production

Production
The production facilities include two work for the production of sterile dosage forms (solutions in vials), and non-sterile dosage forms (tablets, suppositories, nasal and ear solutions). At the basement of the production building there is a warehouse for the storage of raw materials and materials for the short-term production period, and also for the quarantine storage of finished products at the quality control stage  before transferring them to the wholesale warehouse.
Raw and starting materials pass the coding procedure and are automatically monitored when entering the production area in order to eliminate the risks of  confusion. Before entering the production area, all the materials undergo a multistage receiving control.
The finished products have a digital electronic code to ensure their addressed  storage.
In 2017, a new automated warehouse complex with an area of 4,000 m2 will be launched.
The production facilities are outfitted with the state-of-the-art equipment by the leading European manufacturers (Bosch, Fette, Marchesini, Sarong) that meet GMP requirements.

Currently the new production lines are being modernized. Every year 3-4 units of the production equipment are purchased.
For the production of tablet mass the fluid bed granulators, as well as the high shear mixers are used. Tableting is carried out on a tablet press of high productivity. The coater is used for the functional and cosmetic coating.
For the manufacture of solutions and suppositories, different reactors equipped with mixing devices (anchor, magnetic) and homogenizers (depending on the purpose of the equipment) are used. The reactors can function in a heating and cooling mode under both excess and negative pressure. That gives wide opportunities to use various technologies of manufacture of medical products.

Loading and transferring the product to subsequent stages is carried out in a dust-free manner to prevent cross contamination.
Primary and secondary packaging is carried out on automatic lines (blister, cartoning and labeling machines).
The production facilities include an R&D unit that has all laboratory equipment  for performing a wide range of works on the development and introduction of new medicines, as well as improving the existing methods. All the equipment of the R&D unit corresponds to the production one, but in a smaller size and capacity. This principle facilitates the transfer of the process and the reproducibility of the methods.

The layout of the production facilities is based on the principle of separation of raw materials, starting materials and the personnel. The finishing of the rooms is made of inert, wear-resistant materials that provide easy access to cleaning. Depending on the purpose, various classes of purity (A, C, D) are maintained. The whole plant is covered by the cascade of air pressure drops in the supply and exhaust ventilation system (GEA), and a multi-stage purification system is used to prepare the incoming air to the rooms. The parameters of the production environment (temperature, humidity) are maintained automatically. For monitoring, continuous monitoring systems are used, and microbiological monitoring is also performed according to the established procedure.  The flow of the personnel and raw materials is carried out through a system of airlocks. To ensure the operation of the utility systems and the equipment a technical floor has been built. All utility systems are connected to the network and can be controlled remotely, all parameters of the operation of the systems are recorded electronically.
All the media entering the  production area (water, compressed air) are adequately treated. The company operates three water treatment systems (for each workshop, as well as a separate system for the laboratory), to produce purified water and water for injection (BWT, Bosch).

The development of new medicines is synchronized with the process of modernization and designing new works.

Rubikon 2017
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