A pharmaceutical factory for tabletted and capsular medications manufacture was put into operation on September 17, 1996 (according to the State Technical Commission Acceptance Certificate of completed object availability to be exploited). Factory project provided by Canadian Western Industrial Group according to Contract Э22 of 26.05.95 corresponds to Canadian (HPB) and American (FDA) Rules of high quality manufacture GMP.
Factory capacity is 950 million of pills and capsules per year. Output per shift is 1000 kg. Operating regime is two 8 hours production shifts and the third shift is for sanitation and equipment maintenance. There are 250 working days in a year. Production method of preparations' manufacture is pretreating and mixing of active substances and excipients, tableting and packing for consumers (in market
containers and blisters).
All premises of the production zone and also quality control laboratories are located in the "clear rooms" made of steel with the seamless flooring. actory's building is divided into production zone, change rooms and administrative blocks. In its turn the production block is divided into the following independent zones:
Production zone;
Packing zone;
Warehouse zone.
Production zones are located in a way to minimize the risk of raw products and materials cross-flow thus minimizing the contamination hazard. To prevent the contact with the outdoor environment during special transport loading and unloading the raw materials and finished products storage areas are equipped with the tambours with the sealed doors from the southern side of the building. The warehouse corridor provides the separate routes for warehouse maintenance staff and those having access to the production zone.
On May 26, 2006, the experimental biological clinic was opened under the management of "Stirolbiopharm", ltd. This clinic is supplied with up-to-date equipment, enabling to carry out researches on acute and chronic toxicity of new medicines. According to the opinion of international experts of the firm "Certipharm", this project meets all the requirements of international standard GLP. At present, the preparations for certification of the experimental biological clinic according to this standard are held. As a result of reconstruction and development of present vivarium, where a set of successful researches of liquid sterile medicines were carried out, all the conditions were provided for pre-clinical research of new advanced medicines.
Considering all mentioned above it is possible to conclude that our production corresponds to the highest quality standards proved by the Certificate of Lloyd's Register (January, 1998) testifying the quality management system of pharmaceutical manufacture corresponds to the requirements of international standard ISO 9002.
Nowadays "Stirolbiopharm" LTD is the first and the only pharmaceutical enterprise in Ukraine certified according to
standard ISO 9002. "Stirolbiopharm" pays a lot of attention to the strategic research in the field of potential abilities of pharmaceutical manufacture, long-term and promising programs, production of new medications, etc.
Adress:
http://gorlivka.com
Stirolbiopharm firm headquarters
Adress: Gorlovskoy divizii st., 97, Gorlovka, Donetsk region, Ukraine 84610
Phone:8 - 06242 7-88-99
E-mail: stirolbiopharm@mail.ru
