REPRESENT A MODERN PRODUCTION COMPLEX FOR INJECTING PREPARATIONS, ESTABLISHED BY GMP STANDARDS
Each workshop of the production complex is equipped with inflow and exhaust ventilation to provide microclimatic conditions in the premises (t = 22 +/- 2 degrees on the scale of Celsius), with the delimitation of the classes of cleanliness of premises in accordance with GMP EU requirements (42-01-2001), and the most critical Production points are separately provided with air purification units with a laminar flow. The microclimate in the premises within the limits of corresponding indicators is provided by a system of inflow-exhaust ventilation with integrated air conditioners in it. Workplaces are staffed and equipped in accordance with the requirements of the Particleboard 9.9.5-080-2002.
Sterivap HP IL 9618-2 steam sterilizer with a chamber volume of 1 275 liters for sterilization of ampoules according to TC purchased from the well-known Czech company BMT Medical Technology. This is a completely automatic European production machine that meets the GMP quality standard with an integrated printer for a report on the completed sterilization cycle that prevents the operator from interfering with the sterilization process, which excludes the human factor. Another feature of the device is the availability of sealing sealed vials (vacuum crushing test). The device is manufactured with a certified quality system in accordance with European directive on the manufacture of medical devices №93 / 42 / EEC, pressure chamber and steam generator are designed in accordance with European Directive No. 97/23 / EC. The standard equipment of the device includes 20 programs and unique technical characteristics, among which are the most important:
Thermal deaeration of nutritious desensitized water for steam generator with minimization of the content of non-condensed gases to increase the reliability of sterilization;
Powerful low-noise two-stage vacuum pump for high efficiency and reliability;
Innovative color touch screen “touch-screen” 12 with the possibility of ergonomically optimal installation;
Two-processor control unit based on two independent systems (Master and Slave) to provide a high level of security;
Cycle management using dual independent indicators of absolute pressure and temperature, ensuring accuracy, control and independent documentation of cycles;
A unique solution to the principle of steam distribution for heating and sterilization process allows to ensure the exact observance of physical parameters in accordance with EN 285 and EN 554;
Automatic start-up of the unit in the morning – pre-heating and vacuum test – no service.
The enterprise is equipped with a water treatment system with a capacity of 600 l / h. Withconduct of the product at the output of 0,1 microsensis.
To determine the content of the active substance and other components of the finished preparation, a high-abrasive chromatograph AGILENT 1 260 was set up to cost more than 400 thousand $.
For the analysis of liquid and solid samples purchased spectrometer AGILENT CARY-60, which costs about $ 140 thousand. This is a unique device for routine measurements with virtually unlimited expansion capabilities due to a wide selection of various constants and accessories.
The company «OLKAR-AgroZoVet-Service» – the manufacturer of veterinary preparations №1 in Ukraine – has opened the modern GMP standard according to all standards of the production complex of injectable preparations, which includes: a shop of powder forms, a shop for the manufacture of aseptic preparations, a shop for sterile preparations, a shop Injectable ampoule drugs, and others. Leading industry experts noted that this is the best laboratory of veterinary production in Ukraine. Analogues of this laboratory with equipment, technical support and quality control in our country do not exist.