Before dispensing, it takes long time about half year and great attention for all glass vessel and vials to be purified and prepared for dispensing. Sterilization is made at 300ºC temperature. Dispensing procedure carries out in laminar box in stream of super pure air under sterilize conditions in special dispensing machinery. For purification and sterilization of vessels and vials at box entrance permeate strains by nuclear filter with middle size of interstice 0.22 µ.
Used special multi-stage system of influx-and-extract ventilation. First stage purifies from big parts of dust. On the second used filters with degree of purification EU5. Next are installed filters with class of purification EU7, EU9, EU12 and EU14. For air ionization used many ultraviolet exciter. The effectiveness of air purification is 99.999% for particle size 0.3 µ.
Dispensing made on special package line with a high degree of accuracy, ±0.01gm.
The final product is dispensed in pre-sterilized vials which are then closed with rubber stoppers. Rubber stoppers autoclaves at 120ºC during 3 hours. Only after sealed with an aluminum crimp cap. Before that crimp cap is scoured in ultrasound bath. And after autoclaves at 120ºC during 3 hours. And then dry in laminar sterility air stream.
All works on dispensing is provided according to GST's regulation documents.
Previous