About production
The production areas classified and qualified according to the International GMP standards, include sterile production of eye ointments and parenterals, as well as non- sterile production of solid, liquid and soft dosage forms.
The processes of granulation, tabletting, capsule filling and packing in blisters are carried out in the isolated areas.
Preparation, bottling and labeling of syrups for internal use is carried out at the syrups workshop.
Separated area is reserved for the production of topical use liquids.
The preparation of gels ointments (ophthalmic and topical) and creams and filling up in tubes is carried out in the soft dosages workshop.
Industrial equipment and technological processes are validated according to the international standards. The personnel strictly adhere to the procedures relating to the sanitary-hygienic, coverall, exit and entry rules and all the production functions. Human intervention in technological processes is minimized as much as possible.
The quality control laboratory inspects equipment cleanliness before any production processes. Sampling, expertizing and checking are introduced to assess all the indicators related to the quality. All the performed actions are being properly documented. The compiled documents are being reviewed and stored.
Due to the great production capacities, the company delivers contract manufacturing service, by the request of other organizations.
In the sterile production workshop, the entrance/exit procedures are supervised more strictly. In order to get to the highest cleanliness room, the staff puts on coveralls three times (when passing from one clean zone to the other), specific for each certain zone.
The production of sterile dosage forms is carried out in clean rooms designed according to GMP standards, where self-regulating air conditioning systems and HEPA filters provide clean air, proper temperature and humidity. Airborne microbiological standards are regularly monitored.
The process of preparation and filling of sterile eye ointment and small volume parenteral solutions is carried out under the laminar flow. Here human intervention is excluded. The injectables are packed on the automatic ampoule filling and sealing machine produced by the German ROTA company. Due to the above mentioned filling conditions, sterility of each production unit is ensured.
The ready ampoules pass the final sterilization in the saturated steam sterilizer produced by the Spanish Telstar company. Then, all the ampoules go through visual inspection.