- cascade of clean rooms of A, B, C and D cleanliness class according to the EN ISO 14644-1 standard;
- automatic ventilation and air conditioning system;
- purified water and water for injection system, meeting the Russian State Pharmacopoeia requirements;
- FDF automated production line: lyophilic dryers; monoblock for filling and sealing with a rubber stopper and (or) an aluminium cap under aseptic conditions of 4R, 6R glass vials, with suitable stoppers and caps; dry heat and steam sterilizers; sterile filtration units.
The license for the production of medicines was issued to the autonomous nonprofit organization “Institute of Engineering Physics” by the Ministry of Industry and Trade of the Russian Federation on January 27, 2016, №00168-LS, for unlimited time.
- high-tech manufacturing facilities;
- annual inspection of all engineering systems (the entire list of qualification and validation works);
- highly qualified staff;
- effective pharmaceutical quality system;
- collecting prototypes for research;
- technological development to expand production;
- distribution of finished pharmaceutical lyophilized products that do not require special separation;
- long-term mutually beneficial partnership.
Active pharmaceutical substance (APS)
Active pharmaceutical substance (APS) is manufactured in accordance with the Russian technology (patent № 2673452, dated 11/27/2018. “Method of obtaining active pharmaceutical substance, presenting aminodihydrophthalazinedione of sodium”).
Developer and producer: Autonomous nonprofit organization “Institute of Engineering Physics”
Entry number in the Russian State Register of Medicines: №FS-002112 dated 18.11.2020
Producer: BION LLC
Technology benefits:
- substance production in accordance with the Good manufacturing practice (GMP) requirements, using the patented sterile filtration technological process;
- complete suppression of the formation of resinous substances, linear oligo- and polyimides, isomeric phthalimides;
- production of an APS in the form of stable crystals with precise fixation of the amount of water in the substance, which guarantees quality and a high degree of reproducibility during the production;
- it is characterized by the exclusion of the use of toxic hydrazine hydrate and other raw materials, high conversion, increased ergonomics, and environmental friendliness;
- the use of the patented Russian technology for the production of the APS aminodihydrophthalazinedione sodium guarantees high quality and reproducibility of the result in the complete absence of mechanical, chemical, and biological impurities;
- this method of producing the APS in the form of a lyophilizate allows to achieve better absorption of the drug and, thus, increases its bioavailability;
- one-step process for obtaining the APS and the possibility of using inexpensive commercial reagents allows achieving low-cost price.
