According to GMP Annex 1, during the filling process of pharmaceutical goods into vials, the correct position of the plug needs to be inspected by adequate means before the cap of the vial is applied, to minimize possible microbiological impurities.
Due to geometrical tolerances of vials and plugs as well as due to position tolerances and vibrations caused by the transport system, simple height measurement sensors proved to be unreliable for this task.
For an inspection which is not influenced by these conditions, the gap between plug and vial needs to be measured. In the pharmaceutical industry the maximum gap allowed is 1mm which needs to be inspected at line speeds of up to 40m/min and throughputs of 30.000 vials/hour.
Furthermore at this stage the vial is considered open and in the isolator area. This leads to special demands regarding the surface quality and chemical resistance of the inspection equipment used.
OCTUM Solution –compact design, fast and reliable inspection.
The OCTUM machine vision systems for plug gap control fulfill all these customer requirements. The inspection is performed with two cameras arranged in an angle of about 90° between the cameras. The gap of the plug is measured in four points on the vial circumference with an accuracy of ±0,05 mm. Cameras and the optical equipment are mounted in a stainless steel housing suitable for use in the isolator area. This compact housing allows easy integration of the inspection system in the filling line both for linear and circular transport of the vials.
The system software used for plug inspection is available also as 21 CFR Part 11 conform version. OCTUM delivers with these machine vision systems all documentation and services needed for system validation.
The OCTUM plug gap inspection system provides reliable detection of missing or wrong inserted plugs on the vials. Due to the compact stainless steel housing integration on the filling line is easy.
Additional inspections may be integrated in the same or similar compact stainless steel housing ( border cap inspection, filling level inspection, label inspection, code reading for track & trace…) providing a standard design and look & feel for all the systems on the line. Furthermore the operator could supervise control and configure all systems on the line from a single point of interaction.