Production Process

The products made by FAVIMA comply with the ISO and USP standards of the Pharmaceutical Industry:

  • ISO 9187-1 / ISO 9187-2 / ISO 8362-1 / ISO 11418-7 / ISO 4142
  • ISO 4802-2 / ISO 9001: 2015

The Central Computerized Programming and Process Control System, with Hot and Cold End vision units in all production lines, allows us to monitor and have complete traceability of all the processes and thereby of all products manufactured. With the emission of statistics of the behavior of the process of each batch produced.

Permanent training of personnel as well as the Quality Management System allows us to ensure compliance with the rules and specific requirements of every one of our clients.

All Favima products are manufactured using perfeXion ™ glass tubes FIOLAX® clear, or FIOLAX® amber, borosilicate, hydrolytic class I, ISO 719 certified. For our production process we use only glass produced by Schott, a company certified under ISO 9001: 2015

Quality

  • Dimensional control and online printing using electronic vision systems
  • Online sampling according to the method defined in the Defect Evaluation List 5th edition 2016, for our quality control and that of the client
  • Electronic opening of the ampoule to test OPC requirements are carried out during the process with automatic issuance of a statistical reports for the client
  • Ampoule eccentricity test
  • Hydrolytic resistance test of the inner surface of the ampoules, vials, and test tubes according to ISO 4802-2 flame photometry
  • Control of glass tensions by Polariscope
  • Emission of physical and chemical Quality protocols for each production batch