+ 39 011 9621221 PROCESS VALIDATION 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. 100 % IPC dimensional controls. Advanced 100% controls system for: Colour ID band check. Glass Integrity (breakages, cracks). Internal siliconization conformity. No-contact glass thickness/concavity control devices. Breaking force control devices. 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*

+ 39 011 9621221 PRIVACY POLICY 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 HIGHLIGHTS GMP Soffieria Bertolini has been registered on 01/03/07 by BSI against ISO 15378 (GMP standard for design, manufacture and supply of Primary Packaging Materials to Pharmaceutical industries). ENVIRONMENTAL CONTROLS Airborne particles count (manufacturing depts Class ISO 9; clean room Class ISO 8). Air microbial contamination. Surfaces microbial contamination. QUALITY LEVELS SOFFIERIA BERTOLINI is now offering two different quality levels. STANDARD QUALITY ZENITH QUALITY Product Quality characteristics designed according to specific customer requirements. The last development is the FORTIS VIAL (high durability). GMP TRAINING Our personnel is trained and audited on a regular basis according with the quality management system procedures certified through the ISO NORM 9001 and ISO NORM 15378. Breaking and code rings color conformity detection. Our lines are equipped with cameras capable to detect the rings color in order to prevent any customer’s ampoules mixing. 100% detection of bottom concavity and thickness 100% bottom thickness and concavity profile. The bottom of the vials are scanned by an optical probe. The bottom profile, the bottom concavity and the bottom glass thickness is detected at 100% in line. Screw Neck 100% controls Each parameter is checked at 100% in order to guarantee the perfect match between the vial and the cap. 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*