In part 1 of this 2-part series, we discussed some of the challenges involved in producing labels for use in clinical trials — many of which can contribute to costly delays and other issues that affect clinical trial outcomes. In this blog, we look at one of the solutions that can overcome these challenges and help reduce errors, equipment expenses, and overall costs —The T11 Manual Mark & Verify, one of the solutions in Systech’s PCE Track and Trace line. 

The T11 Manual Mark & Verify is an integrated solution for printing and visually inspecting labels. Its inherent flexibility makes it well suited for producing labels for investigational medicinal products (IMPs) used in clinical trials. Its benefits include: 

• All-in-One Label Printing and Verification: Because the T11 can handle the two disparate functions, it can reduce the purchase, insurance, and maintenance costs of two separate pieces of equipment. Combined with Systech’s PCE Line Manager software, it can also be used for label serialization to track and trace IMPs throughout the clinical trial lifecycle, increasing its usage potential and return on investment. 

• Space-saving Design: Featuring an ergonomic, compact design, the T11 can be used in small, confined environments. It fits on a tabletop or cart, so it can easily be moved to different sites as needed.   

• Dual-mode Printing: The T11 offers two modes for printing: reel-to-reel and peel off. With rewind mode, labels can be printed and verified in batches and rewound reel-to-reel for later use. Because print runs for labels used in clinical trials are typically small, especially in the initial phases, the T11 offers a quicker, more cost-effective solution that sending labels to a third-party company for printing. It also keeps label verification in-house, so organizations are better positioned to ensure label accuracy. Peel-off mode supports just-in-time printing. Once initial or revised label content is approved, labels can immediately be printed and applied. This is particularly useful in helping to reduce potential delays due to labelling issues. Label content for the IMPs used in clinical trials can change frequently between and during phases. When last-minute label changes occur and relabeling is required, the T11 enables on-demand production. By not having to send the revised labels out for printing, disruptions to production timelines are minimized.  

• Variable Format Capability: The T11 can handle variable label formats. This enables it to accommodate new or changing regulatory requirements for label content, as well as country-specific language requirements. 

• Assured Accuracy and Compliance: The T11’s production process requires approved label content and design to start. This helps ensure that EU CTR or EU CTD regulations and other requirements are met before label printing proceeds. An integrated vision inspection system provides further assurance of accuracy by making sure all approved content appears on each label.  

How the T11 Works 

Setting up label takes only minutes. Once the approved IMP label design and content are provided, the information is input manually or via software that links the company’s data source to the T11. The data is then dynamically assigned to a PDF template to create a label proof.    

As labels are printed, they are visually inspected by the T11’s integrated camera. Two options are available to provide optimal verification of label information — a smart camera or a high-resolution camera.  

Both camera types can conduct three types of verification: presence check, quality check and reference check. The choice of camera depends on label size, print resolution, and whether inspection is required for all components of the label or just a couple of them.  

The label content is compared against the approved PDF. If any errors or omissions are found, the operator is immediately notified, and the production process stops. Verification of the faulty label’s removed is required before the system will continue production. This helps ensure that erroneous labels do not get used.  

When the T11 is used with Systech’s PCE Line Manager track and trace software, additional capabilities are available. Among them: reporting on the origin of label errors so they can be mitigated.     

See the T11 in Action 

Any organization involved in running clinical trials can benefit from using the T11. Its features are particularly beneficial for cost-sensitive emerging companies and startups, as well as companies running clinical trials in multiple countries and sites.  

The best way to see how the T11 can benefit your organization is to see it in action. Schedule a free, no obligation on-site demo today.