Position inspection solutions for vial stoppers – according to GMP Annex 1 / 121

Pharmaceutical products need to comply to the highest standards. The stopper positioning therefore becomes a critical inspection point. To prevent microbial contamination, the Annex 1 of the Good Manufacturing Practice (GMP) requires the inspection of the stopper position to be made with an adequate solution.

Omron offers a range of proven technology solutions that have been developed together with leading producers of pharmaceutical products.

The GMP annex 1 paragraph 121 requires that: ‘Vials with missing or displaced stoppers should be rejected prior to capping. Where human intervention is required at the capping station, appropriate technology should be used to prevent direct contact with the vials to minimise microbial contamination.‘

A solution with high process reliability for single or multiple vial lines can be provided by the ZX-GT laser measurement system.

The solution, developed by Omron‘s swiss application engineering organisation for a 2 line vial filling station, was initially chosen because background lighting for a vision system could not be mounted between the production lines. Finally with the ZX-GT, they had a solution that provided high process reliability and the best value for money. A theoretical measurement accuracy of 5-10µm can be achieved with the system, but taking the vibration of spiral conveyors, starwheels or conveyor belts and vial position tolerances into consideration, a specified requirement of +/- 0.3mm could be easily achieved by the complete system.

Our vision sensors and systems provide a flexible and easy to operate solution range for:

• stopper position inspections for standard and higher position variations (stronger vibrations or material tolerances)
• combined fill level, stopper and vial inspections
• CFR 21 part 11 compliance functions (audit trail, user access administration, etc)
• integration into standard or customer specific production and machine environments