Contamination of rubber plungers in production

Many biotechnologically manufactured medications, highly viscous or low-dosage drug formulations, and a series of oncologic and ophthalmologic medications make high demands of primary packaging and drug delivery systems. Pharmaceutical companies need to make sure that they are essentially free of particulate contamination.

As regulatory expectations increase, elastomer component manufacturers face increased pressure to produce products free of defects.

Problems with rubber plungers
Defects in primary pharmaceutical packaging components can consist of:

  • Loose and embedded foreign contamination
  • Trimming defects
  • Moulding defects

Typical known defects are white spots, black spots, fibers, faulty dimensions, absence of coating and metal contamination.

100%  automated vison inspection in pharmaceutical component production will reduce significantly adhered and embedded particulates, trimming- and moulding defects, resulting in:

  • Increased product yield by reducing the number of drug product rejects
  • Minimized cost of poor quality, waste and re-work
  • Maximized quality of products and safety of patients.

At least the part of the plunger 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 plunger surfaces should be the target.

Because of the typical design of a pharmaceutical plunger, inside inspection of the surface that connects to the plunger rod is often the most challenging. Only high-end inspection systems with special machine vision technologies are capable of analyzing this plunger thread.

Another challenge can be the different color options of a pharmaceutical plungers. 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 can be a useful source for further process improvement. A database with a digital interface to process management software is to be preferred.

Machine vision integrator with expertise in the demanding life science industry will consult in an early stage of interest for automated inspection.