The number of people living with diabetes is on the rise. The World Health Organization estimates approximately 60 million people are affected in Europe alone. In the USA the number is about 30 million and in China almost 110 million. In 2015, the International Diabetes Federation estimated over 415 million diabetics worldwide and anticipates 642 million by 2040. To make everyday life easier, diabetics use medical devices such as the insulin pen. They offer them a simple way to self-administer drugs.
To ensure that their products are safe and reliable, leading pharmaceutical manufacturers rely on automated optical inspection systems VINSPEC HEALTHCARE for their production lines. Only image-based inline inspections enable manufacturers to meet the strict quality requirements placed on cannula-based injection systems by industry standards (ISO 11608-1).
Insulin pens are produced in mass quantities; modern systems manufacture approximately 300 pens per minute. With such short cycle times, a thorough and reliable quality check is possible only with an automated optical inspection system. Furthermore, a 100% inspectionof critical assembly steps is an important prerequisite for the safe and reliable function of pens. A positive side effect is that the recall risk for drug manufacturers is reduced. That is why more and more insulin pens are being inspected by VITRONIC systems.
As the insulin pens are assembled, the system performs an automated inspection immediately after relevant assembly steps, to see if the individual components of the pens are correctly assembled. Even potential defects that could arise during assembly process are reliably detected by the image-based VITRONIC systems.
The VINSPEC HEALTHCARE solution for inspecting insulin pen dosing units consists of both high-performance components used in modern machine vision solutions as well as a special software package. Six parts are assembled and inspected per cycle, depending on the design of the system. Inspections are typically performed at eight inspection stations in the production cycle:
- Drive Sleeve, Metal Spring: Inspection of plastic sleeve, position and orientation of metal spring
- Grease Dot: Inspection of applied grease
- Dial grip, Number Sleeve: Dial function test, correct function unit display
- Dosage:correct assembly and position
- Lead Screw: Angle of rotation of lead screw
- Dosage knob and zero position
- Bearing: Inspection of position
- Body: 360° inspection of sleeve, e.g. for damages
The VINSPEC system is distinguished by its streamlined and modular setup. Thanks to fast and precise image capturing technologies, only one camera is needed to meet the inspection requirements of the individual stations – even with multiple workpiece carriers. A central computing unit pools the data from the stations and serves as an interface to the machine control unit. Depending on inspection results insulin pens are further processed or marked as rejects. Station- and track-related statistics are available, as well as a trend indicator, so countermeasures can be taken early on.