Mix-up prevention and Track & Trace is of the highest concern in the pharmaceutical environment. Some drug products are shipped throughout the world prior to being labelled which happens at its final destination. Tamperproof codes provide a legitimate supply chain for patient safety.

Some drug product containers are not individually coded or labeled at the production site and only the lot code on the final bulk package and not on the individual units. There are, however multiple reasons to do so, as for example the fact that the individual unit receive their label in the country where the dosages are finally sold.

There is only limited control over cross-contamination, mislabeling and manipulative interference. Furthermore, regulatory requirements are asking for enhanced traceability in support of the logistics distribution and to prevent counterfeiting.

• Our customer approached us for a development of an itemized and tamperproof code on small glass vials. With years of experience in sophisticated handling of pharmaceutical containers, WILCO qualified as the development partner.
• Firstly, the code had to be applied reliably at a high throughput rate of 420 vials per minute. Based on this code information and quality requirements the sorting into different categories had to be realized. Highest efficacy was asked for, since every miscoding would result in direct product loss.
• Feasibility studies allowed the analysis of product positioning (by means of the container tolerance incorporation) as well as the movements during coding (vibrations at high production speed). The material handling was designed for low-vibration operation to ensure the highest accuracy and precision. Non-accepted codes occurred due to shades in the aluminum crimp cap or due to a polluted surface caused by dust or condensation.

• Our coding platform provided the base for high precision cap coding to fulfill mix-up prevention and track and trace requirements. By means of a laser coding system a small 2D data matrix was etched onto the aluminum cap. The ECC 200 code consisted of dot sizes of about 100 µm (approx. ⁴/_1’000”) and is practically tamperproof. The 12 x 12 data matrix allows data in form of 10 numerical and 6 alphanumerical figures.
• The integrated vision system verifies the correctness and quality of the data matrix. Later in the process the code is read by use of a dome camera for tracking and verification. Products with non-accepted codes are tracked and separated at the reject station. This physical removal is confirmed in a fail-safe manner.
• The products are fed onto a rotary star equipped with smooth and precise holding devices. A mechanically driven lifting mechanism moves the products up into reference position, which ensures the high precision of the marking location on the container.