+ 39 011 9621221 GOVERNANCE Organizational model Starting from 2010, Soffieria Bertolini applied the ORGANIZATIONAL MODEL according with Italian Legislative Decree n.231/2001. Governance Mog Policy Ethical code Soffieria Bertolini operates in compliance with the applicable laws regulating the entire work reality and its related processes, including the environmental norms (ISO 14001) and those related to the health and safety of our employees (ISO 45001). Soffieria Bertolini intends to comply with the requirements of the Quality System Management (ISO 9001) and to operate according to the certification of Primary Packaging materials following the GMP rules (ISO 15378). Ethical Code The 100% of our production is intended to the Pharmaceutical market In order to guarantee the safety of the patients and the best performances of our customers all our processes are integrated with our Quality Department. Structure SOFFIERIA BERTOLINI S.p.A. Via Sestriere, 7 10060 Candiolo (TO) Italy Ph + 39 011 9621221 Fax + 39 011 9625516 info@soffieriabertolini.it VAT Number: IT00456600014 Capitale sociale 1.034.000 int. vers. C.C.I.A.A. Torino 00456600014 REA 176465 HOME COMPANY AMPOULES VIALS TECHNOLOGY R & D QUALITY CONTACT Cookies • Privacy • Credits dpsonline*

+ 39 011 9621221 R & D SERVICES Soffieria Bertolini provides technical and scientific supports in cooperation with the Turin University Chemical Department. Product development in cooperation with Turin Politech University (FEM model, algorithms development). The most required services are the following: USP 1660 durability test – extractable & leachable Nitrates in WFI. Aluminum leaches. Morphological and elementary analysis (i.e. SEM-EDX, TEM, X-ray Diffraction; IR-Microscopy, Raman). Customized product design. Our glass experts will be at your disposal for: New packaging solutions. Quality assistance (Including glass packaging sorting out at your plant). PROCESS MONITORING Our main parameters are continuously monitored during manufacturing process. Six Sigma Method We use statistical criteria to investigate and minimize defects from the manufacturing process. A further step can be achieved by using DOE (design of experiment). ACHIEVEMENTS Cosmetic Defects Control In order to check 100% cosmetic defects (scratches, cracks, spots, etc.) we use the dedicated camera installed on the manufacturing line, just before final packaging Printing Control We check the printing area assuring the positioning and completeness of text and variable data, by means a dedicated camera. Automatic Packaging To further reduce cosmetic defects. ISO 9001 ISO 15378 ISO 45001 ISO 14001 DMF 14744 TYPE III FDA USA DMF-2005-010 HEALTH CANADA DMF B20190001816 NMPE CHINA SOFFIERIA BERTOLINI S.p.A. Via Sestriere, 7 10060 Candiolo (TO) Italy Ph + 39 011 9621221 Fax + 39 011 9625516 info@soffieriabertolini.it VAT Number: IT00456600014 Capitale sociale 1.034.000 int. vers. C.C.I.A.A. Torino 00456600014 REA 176465 HOME COMPANY AMPOULES VIALS TECHNOLOGY R & D QUALITY CONTACT Cookies • Privacy • Credits dpsonline*