Reducing the risk of mix-ups and improving processes with smart track and trace solutions for pharmaceutical drug containers

Pharmaceutical track and trace Solutions

The advance of traceability of raw materials, parts, and finished products has been shaped by highly regulated industry sectors whose compliance is legally required, such as the pharmaceutical, aerospace, and automotive sectors. Although traceability has always been a vital aspect of pharmaceutical production, few drug container manufacturers have taken on the challenge of providing traceability along the supply chain. SCHOTT Pharma sets new standards.

The challenge

Reducing the risk of mix-ups with smart pharmaceutical track and trace solutions for drug containers 

Regulations at the national and international level require all pharmaceutical containers to have labels on their secondary packaging. However, current requirements fall short of ensuring full traceability for pharmaceutical products along the entire value chain.

The absence of unique identification on primary packaging containers leads to increased risk and inefficient processes. One example is the risk of mix-ups, typically circumvented by using different colour rings for syringes, or coloured caps for vials. This process, however, has its limits, is inflexible, and prone to error.

Schott Pharma’s pharmaceutical glass vial with smart code for track and trace
The solution

Track and trace your drug container from production to the end user

By using a laser to melt a unique data matrix code onto the container the moment it is manufactured, SCHOTT Pharma containers are permanently labelled. The code is inextricably linked to the container at the earliest possible step in the entire value chain.

This offers a great advantages compared with systems wherein the code is only attached at a later stage. The code is also stable during washing, autoclaving and depyrogenation up to a temperature of 600 °C. It resists abrasion, avoiding the risk of particle contamination compared with solutions that require additional substances for the application of the code. The data matrix code can be as small as 1 x 1 mm, which equals 14 x 14 dots.

Pharmaceutical glass vial with data matrix code for track and trace
With syriQ® smart and EVERIC® smart, SCHOTT Pharma brings Industry 4.0 to pharmaceutical fill-and-finish operations, offering the ability to track and trace individual primary packaging containers from production all the way to the end user. Mix-up risks are minimized, recalls quicker and easier, line clearance becomes more efficient, and lyophilization process development is simplified.
smart container solution track and trace.JPG
FAQ

Frequently asked questions about pharmaceutical track and trace solutions

The absence of unique identification on primary packaging containers leads to increased risk and inefficient processes. One example is the risk of mix-ups, typically circumvented by using different colour rings for syringes, or coloured caps for vials. This process, however, has its limits, is inflexible, and prone to error.
SCHOTT Pharma uses laser-marking to inextricably link the code to the container at the earliest possible stage. No additional material is introduced. It is scratch-resistant and as studies have shown, the container's strength is kept in a standard range. Tests have proven its readability at high speed, even with non-transparent fillings.
The positioning of the code on the bottom of the vial (EVERIC® smart) makes it unnecessary to turn the container or install multiple cameras. In addition, the code can even be read when the container is nested in the adaptiQ® ready to use configurations and there is no overlap with the applied label. The position of the code on the flange for syringes (syriQ® smart) prevents interferences with camera inspection, or drug product and graduation/ dose mark visbility. The code can be read even when nested in RTU.

Smart containers for smart fill-and-finish

SCHOTT Smart Containers set the stage for Industry 4.0. The highly discrete, robust and durable code solution is inextricably linked to the container and therefore ensures traceability along the entire value chain.

Schott Smart Containers ensure traceability along the entire value chain.

Get in touch

Diana Löber

Diana Löber

Product Manager Bulk & Sterile Solutions

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