Quality Control in Primary Packaging for Pharmaceuticals
Simac Masic is a global supplier of machine vision systems to a wide range of industries including the implementation of fully automated inspection systems for the primary packaging of pharmaceuticals. In order to achieve 100% quality control in the inspection of pharmaceutical vials and syringes, the company commissioned the experts at STEMMER IMAGING to develop suitable high-speed vision systems.
The task
Component selection and design support for a fully automated inspection system from Simac Masic used to inspect pharmaceutical rubber stoppers and plungers.
The challenge
100% inspection of every single stopper and plunger at high operating speeds.
The solution
Through careful selection and configuration of optimally matched components, STEMMER IMAGING enabled the realisation of an optimised vision system for 100% reliable, automated inspection.
- Powerful cameras
- Matched illumination
- High processing speed
- Real-time control
- Over 99 % error detection
- Flexible handling of different product sizes
100% inspection for pharmaceutical primary packaging at high speeds
The pharmaceutical industry uses huge quantities of rubber stoppers and plungers made from many different elastomers. For example, special hollow plugs are used to seal pharmaceutical vials through which a syringe needle can be inserted to extract the medication. Plungers serve, among other things, as an airtight movable seal in the syringe body and allow liquids to be drawn into the syringe.
As primary packaging, both components must be free of any defect or contamination, as this could lead to costly rejects or, in the worst case, even compromise patient safety. Simac Masic has developed an inspection system specifically designed for the quality control of stoppers and plungers. The modular, fully automated iM series utilises customised multi-camera vision systems, developed in cooperation with the STEMMER IMAGING experts.
"We push STEMMER IMAGING and their suppliers to the limit. We make sure that we keep fully up to date with the exact performance levels of the components available. In some cases, for example with some of the lights used in our current system, we get the manufacturers to make us something special to meet our needs.“
Roberto Griguoli, Manager Engineering at Simac Masic
Simac Masic's customised solution for pharmaceutical packaging
To ensure 100% inspection of all surfaces on every single stopper and plunger, two vision stations with high-resolution colour cameras are integrated in addition to a metal detector to meet the highest quality requirements:
- High inspection accuracy and reproducibility
- Imaging the internal bore of stoppers and plungers
- High-speed and high-volume data handling
- Inspection of all surfaces
- Mechanical handling of different stopper and plunger sizes in the same machine
- Meeting all requirements for pharmaceutical packaging
- Ensuring the system can be used in an ISO Class 5 clean room environment
Vision station No. 1
In the first vision station, two high resolution cameras are used to inspect the top of the stopper and the steep internal sidewalls of the hollow plug for defects such as marks, cosmetic defects, inclusions, dents, particulate debris, fibres etc. Inspection of the cavity and inner walls of the stopper is particularly demanding, requiring precise positioning and careful attention to the lighting and lenses used.
A similar approach is used for the plungers, but as the cavities here are much smaller, a different camera with wide angle lensing is used.
Vision station No. 2
The second vision station consists of a compact camera aisle on which multiple cameras are mounted. Four of these cameras are arranged around the component to provide a full view of the entire side surfaces of the component. One of these cameras looks down to image the bottom surface of the top of the stopper. These inspections are triggered simultaneously. There is also space on this camera aisle to mount optional cameras for dimensional measurements and inert surface coating inspection.
The solution’s key success factors
As an independent technology provider, STEMMER IMAGING was able to select and optimally match the most suitable components for the application - without supplier lock-in. The implemented machine vision solution guarantees 100% reliable, fully automated inspection of rubber stoppers and plungers. In this way, Simac Masic can guarantee leading manufacturers of pharmaceutical components a flawless production of their primary packaging - free of quality defects and contamination.
High-performance cameras
The high sample throughput places high demands on image acquisition and processing. The high-resolution imaging system captures high-contrast images with low geometrical distortion to detect even the smallest defects.
Real-time control
A touch screen interface provides access to all machine functions and any changes and adjustments are displayed in ‘real-time’. Batch information can be entered and recipes can be selected for the particular components being inspected.
Optimally matched illumination
The individual lights used for each camera are run in pulsed overdrive mode, which both freezes the motion of the components to prevent image blur and delivers sufficient light intensity for the short shutter times used in the high-speed inspections.
Defect detection levels >99%
The imaging system developed by STEMMER IMAGING enables a defect detection rate of more than 99% at an inspection rate beyond the current machine speed, which is limited by the mechanical feeder system.
Maximum processing speeds
To capture the standard minimum of seven images per test object, powerful Windows-based industrial PCs are used, which reliably store and archive the huge amounts of data for each test object - and make it possible to conduct a full inspection audit trail for each component, in accordance with CFR21 Part 11 requirements.
Flexible handling of different product sizes
Stoppers and plungers are produced in a wide variety of sizes and shapes. The whole system has been designed so that no mechanical adjustment of any of the cameras is needed after product changeover.
“We exchange ideas with STEMMER IMAGING and we have worked together on feasibility studies carried out on site at their offices in The Netherlands. They are always happy to let us borrow components for evaluation in our laboratories, so all cameras, lenses and lighting are fully tested in our laboratory before being used on a machine.”
Roberto Griguoli, Manager Engineering at Simac Masic
Other successful projects from the packaging industry
Reliable quality control of aluminium trays
Aluminium trays are used worldwide in a wide range of shapes for packaging food. Novelis Deutschland GmbH, with the help of the system integrator, Industrielle Sensorsysteme Wichmann GmbH (ISW), has produced a two-stage inspection system to check the quality of the trays - equipped with high-quality, perfectly matched machine vision components from STEMMER IMAGING.
Benefit from our industry expertise when it comes to the quality control of your primary packaging
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