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Manufacture

Manufacture is completed in premises of Novofarm-Biosintez Pharmaceutical Plant, which specializes in manufacturing a wide range of infusion solutions and protein blood substitutes. The Plant has the newest modern technologies and equipment, modern microbiological and biochemical laboratory, highly professional personnel, multi-stage control system for all manufacture stages, which all guarantees a high product quality.

All technological processes are completed in clean premises of cleanliness levels – A, C and D. Necessary cleanliness level is secured by three-stage air filtration system. At first stage, the filter were installed in order to protect equipment against pollution coarse; at second stage – fine filters of class F9 were installed with efficiency of 95%; at third stage filters of class Н 13 were installed with filtration efficiency of 99.97%. Climate control system secures a constant control over temperature, relative humidity, pressure difference, particles allowable level and micro-organisms allowable level in working zone air.

In order to ensure a constant visual control over pressure difference in clean premises the sensors Magnehrlik by Dwyer were installed.

Clean premises enclosing constructions, partitions and floor surfaces are resistant to necessary disinfection.

We use raw materials from leading world producers for intra-tissue implants NUBIPLANTтм manufacture.

Quality control system includes inspection tests for raw materials and appliances, intermediate and final products control of every batch to be produced. After completion of control in accordance with all characteristics foreseen by technical conditions, certificate of compliance for each batch is to be issued.

It is foreseen that the intra-tissue implants shall be packed into disposable syringes by BBraun with volumes of 1 ml, 2 ml, 4 ml, 10 ml, 20 ml, 50 ml and Luer-Loc + Combi Stoper System ensuring safe tightness and comfortable use.

Form-stable implants are packed into packages of STERIKING Sterile Barrier System, with individual control testing for compliance with sterilization regimen.

The intra-tissue implants having specific characteristics, for example, stimulating metabolic and reparative processes, local and general immunity, proper collagen synthesis, and inhibiting tissues destructive processes are in phase of manufacturing application.






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