Production

Production

Production space is built to the highest requirements of GMP with its functional layout, installations, modern equipment made by recognized European manufacturers and the provided environmental conditions. It offers a possibility for the production of liquid, semi-solid formation of creams, ointments, and gels, as well as the production and packaging of the solid dosage forms. Production facility of the “clean rooms” satisfies primarily two basic requirements of good manufacturing practices:

  • purified water that meets the requirements of pharmacopoeia and
  • air cleanliness class 100 000 units.

With the process of reverse osmosis we obtain purified water.

  • Department of Water treatment is equipped with a device of reverse osmosis system, with the addition of a block of demineralization (MIX bad), microbiological filters and UV sterilizers. To distribute water recirculation system is used where water is continuously recirculated through a UV lamp which provides microbiologically safe water.

Plant for pure air

  • Class of purity 100 000 and the pharmaceutical purity air means triple air filtration with an adequate number of changes. Cleanliness is provided by cascading flow of air from the space of higher classes in the area of the lower classes, and of utmost importance is that dirty air is not contaminated with cleaner air. Additional insurance is the interlock system.
  • Department of scaling
  • Department for production of liquid and semi-solid form
  • Department of Production and packaging of solid forms of Inbulk
  • Department of packing in secondary packaging
  • Laboratory
  • Department of Computer control air conditioning system
  • Department for washing equipment with hot tap and demineralized water
  • Department for equipment for hygiene
  • Closet space
  • Management staff office
  • Department for process control

In a separate area there are the Department for receipt of raw materials and packaging with separate areas for quarantine, Department for storage of raw materials, quarantine ward for finished products, the volatile and flammable materials compressor station. Storage space is connected with the manufacturing space by elevator . Systems for heating, ventilation and air conditioning are provided with defined over pressures that prevent cross-contamination of products.