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.

Quality Soffieria Bertolini, ampoules and vials for the pharmaceutical industry

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.

Quality Soffieria Bertolini

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.

Quality Soffieria Bertolini

Screw Neck 100% controls

Each parameter is checked at 100% in order to guarantee the perfect match between the vial and the cap.

Screw Neck controls Soffieria Bertolini

DMF 14744 TYPE III FDA USA

DMF-2005-010 HEALTH CANADA

DMF CHINA ONGOING

at Aenean commodo ipsum elit. lectus consectetur