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Pharmaceutical Inspection and Audit Trail through Industrial Vision

Pharmaceutical Inspection and Audit Trail

CIRA has developed vision systems compliant with CFR 21 Part 11 regulations, ensuring numerous checks for the pharmaceutical industry.

In the pharmaceutical industry, manufacturers and packagers face compliance challenges with global traceability regulations. They have had to transition to mass serialization of packaging to address these challenges. Mass serialization involves assigning a unique serial number to each medicine box to ensure complete traceability of health products and combat counterfeiting. Considering that 1 in 2 medicines sold online is counterfeit, control measures have been implemented at both national and international levels.


Whether packaged or not, a large amount of information is typically printed on the secondary container, including text, logos, and designs. Labeling and printing on these surfaces can be challenging due to packaging substrates and the size or font of the text, drawings, or codes to be applied. Some surfaces are reflective, curved, and difficult to mark.

Given the complexity of the visual appearance of packages, quality assurance usually involves comparing a sample of packages taken from the line to a reference model kept off-site. This process is complex and tedious.

Poorly printed, difficult-to-read, or defective codes, text, or designs can lead to customer dissatisfaction and sometimes even product recalls.

Verify that medical kits are complete and intact before their final shipment.

The completeness and integrity of the finished and packaged medical kits, consisting of multiple pieces, are verified using X-ray inspection just before they are shipped. Individual pieces have been inspected earlier, and this final check ensures that all pieces have been placed in the kit without any damage.

All components of the medical kit are essential for its use, so a missing or damaged component is enough to render it useless. Since the kits are sealed, the end-user can only verify the contents at the time of use, and other usable kits may not necessarily be available at that moment.

Due to flexible parts, such as tubes, and significant variations in the appearance of three-dimensional objects, it is practically impossible for conventional industrial vision to verify that medical kits are complete.

Opt for machine vision systems for effective pharmaceutical control

Opting for machine vision systems provides them with complete tracking of health products, from the identification of the unique serial numbers affixed to the labels until delivery.

Verification of the final assembly of drug administration devices.

During the final assembly and packaging processes, it often occurs that drug administration devices, such as auto-injectors, pens, cartridge systems, and pre-filled syringes, may become dislodged or misaligned. Even if sub-assemblies have been inspected and approved beforehand, damages inside sealed packages were previously challenging to detect. These devices are often used in emergency situations, and undetected damages can lead to malfunctions or injuries for patients. Additionally, packaging non-functional devices implies that the available stock is less than anticipated.

While X-rays of final packages can provide an image of the device assembly, the complexity of this image and the numerous possible defects make problem detection more difficult. However, advancements are underway in the field of medical device inspection, notably through industrial vision and machine learning technologies. These technologies enable the development of more sophisticated inspection systems capable of detecting internal defects and ensuring compliance with drug administration devices, thereby ensuring patient safety and product quality in packaging.

Inspection of package assembly and kitting

Cognex industrial vision systems simplify assembly and kitting applications by verifying the correct positioning of elements in medical or vaccine kits. They also confirm the presence of required elements and include implant cards, instructions, and patient warning documents. These automated systems overcome challenges posed by manual or automated visual inspections, such as visual variations, variable packing orientations, reflective surfaces, and complex geometries. With Cognex, medical device manufacturers enhance efficiency, accuracy, and regulatory compliance while reducing costs.

Inspection of Tablets and Pills

Automatically detect damaged pills and foreign bodies on a packaging conveyor.

Solid oral medications, such as tablets or pills, undergo visual inspection to detect defects before they are packaged in individual packaging such as bottles or blisters. This inspection aims to verify the dimensions, surface texture, shape, color, and integrity of the tablets, as well as the presence of any foreign bodies or defects that could contaminate the final packaging. Defective or contaminated tablets must be removed to prevent product recalls, sales losses, and damage to the brand's reputation.

Visual inspection of tablets is typically done manually, despite the limitations of the human eye in defect detection. This task is complex due to the variety of possible defects and types of foreign bodies. Additionally, reflective coatings can create illusions of damage. These factors make it challenging to use conventional industrial vision systems for effective inspection, justifying the persistent reliance on manual inspection.


Fast and precise barcode reading and vision-guided robotics.

During the shipment of medical device kits, they are grouped into boxes based on orders and arranged on pallets. Accurate verification of the box contents and detection of missing items require an extended field of vision to read codes and texts, along with advanced inspection tools. Industrial vision systems meet these needs by capturing a wide field of vision, reading codes, and verifying packaging compliance. This enhances the efficiency and accuracy of medical kit shipments while ensuring customer satisfaction.