Soffieria Bertolini S.p.A.

Quality

CERTIFICATES

  • ISO 9001 - 2015
  • ISO 15378 - 2011
  • ISO 14001 - 2015
  • OHSAS 18001 - 2007
  • DMF 14744 TYPE III FDA – USA
  • DMF-2005-010 HEALTH CANADA

QUALITY LEVELS

GMP

Soffieria Bertolini has been registered on 01/03/07 by BSI against ISO 15378:2011 (GMP standard for design, manufacture and supply of Primary Packaging Materials to Pharmaceutical industries).

MANUFACTURING PROCESS VALIDATION

IQ – OQ – PQ protocols for
  • ampoules manufacturing process
  • vials manufacturing process
  • 100% IPC text print (camera validation)
  • 100% IPC cosmetic defects (camera validation)
  • autoclave

ENVIRONMENTAL CONTROLS

  • airborne particles count (manufacturing depts class D; clean room class C)
  • air microbial contamination
  • surfaces microbial contamination

GMP TRAINING

WELL-ESTABLISHED COOPERATION WITH TURIN UNIVERSITY IN SEVERAL PROJECTS