Manufacturing
In every business there are essential secrets and mysteries! Some of them we are ready to reveal to you! Infusion solutions basis is specially refined water. Achieving high qualitative characteristics of apyrogenic water is possible only by availability of modern water preparation systems. This issue we have successfully settled down by application of the reverse osmosis plant of the German manufacturer “ROCHEM”. Besides water infusion solutions consist of active & additional adjuvant. Each raw material consignment is examined by admission inspection in the quality-checking department. All substances are registered & certified in Ukraine, their quality complies with the demands of current European, British & Japanese Pharmacopoeias. Using raw materials of the world-renowned producers such as Biotika (Slovak Republic), Roquette (France), Salinen (Germany), ISP International Corp., (USA) vouches for quality of manufactured medications.
Before bottling the solution goes through multi level system of sterilizing filtration, equipped with components from world leading companies “Pall” & “Sartorius”. The process is held in the highest purity level A areas – “clean rooms”. One of the requirements of GMP production is availability of “clean rooms” in the breaking points of the technological process. “Clean room facilities” complex is three-stage air rectification system that prevents infusion solution contamination by bacterium, pyrogen & other particles dangerous for man’s life. After that each bottle of medication is corked up with sterile stopper and rolled up by hood. For each product in our range to avoid falsification & forgery we use a certain colour on packaging, labels, hood to help identify that product. Thus for Rheopolyglucinum we have blue coloured label & the hood of the same colour, for Neohaemodesum – green colour, for Solutio natrii chloridi 0,9% - lilac colour, for Solutio Glucosi 5%, 10% pro infusionibus – orange colour.
Furthermore each batch of medicine is obligatory inspected in compliance with the analytical documentation by the laboratories. We use the modern equipped chemical, microbiological, pharmacological laboratories, quality inspection department & quality-ensuring department. All laboratories are equipped by modern devices for stability testing and defining. Each batch of medicine is tested on sterility, pyrogenity & toxicity. Current quality inspection system is implementing all researches & analyses laid down by the analytical documentation, not allowing application of finished products in case when they are not met the quality specification. This system is constantly improving taking into consideration GMP requirements: our laboratories are being reconstructed; equipment is being renovated.