Contamination of rubber stoppers in production


Rubber stoppers with no defects
Pharmaceutical companies need to make sure that they are essentially free of particulate contamination. As regulatory expectations increase, drug product manufacturers face increased pressure to produce products free of defects and minimize rejects of finished drug products. Particulate matter in finished pharmaceuticals can come from a number of sources, including the container closure system. Elastomeric closures are an essential packaging for parenteral drug products, and they represent a possible source of particulate matter.


No more contamination and imperfections

Contamination and imperfections associated with elastomer components are a source of risk, especially for areas that are not visible when the component is positioned in the container. Possible causes for end-of-line rejects:

  • loose and embedded particles
  • defects caused by trimming and molding
  • functionality issues, such as container closure integrity and leakage

Spots in different colors, hairlines, fibers, faulty dimensions, absence of coating and metal contamination are typical defects.

Elastomer components that are 100% automatically vision verified are free of visible defects and contamination, reduce end-of-line rejects and enhance product quality and patient safety.

At least the part of the stopper that is in contact with the medicine should be free of defects. During product handling however, loose contamination on non-contact surfaces can also travel to more critical segments of the product. This is why a 100% inspection of all rubber stopper surfaces should be the target.

The inside inspection of the stopper, be it for lyophilization, injection of infusion, is the most critical Only high-end inspection systems with special machine vision technologies are capable of analyzing this segment of the product.

Another challenge can be the different color options of a pharmaceutical stoppers. Light colored defects on light product compounds the need for specific machine vision with color cameras.

The data that is gathered by the inspection system should be a useful source for process improvement.

Consult a machine vision integrator with expertise in the demanding life science industry for automated inspection.