Addressing future regulations with quality coding


Code quality is an increasingly critical issue in unique device identification (UDI), as ineffective codes can result in supply chain failure

Efficient coding onto medical devices and packaging ensures more efficient recall procedures, reduced medical errors, increased inventory visibility and improved supply chain security. The UDI code applied to each item provides the supply chain management system with key information, such as what the product is and where and when it was produced. Should a recall be necessary, owing to a product being faulty, the code is critical to the item in question being traced back to its origin.

The technology to assign, apply and verify UDI codes to a wide range of products and packaging surfaces is an invaluable asset. However, if the code is not appropriately applied for any reason, it could become unreadable, making it difficult or impossible to locate the product’s source. It is therefore essential that the correct coding and marking technologies are installed at each level of the manufacturing and packaging process.

Coding and marking solutions

There are a number of key considerations that need to be assessed before investing in a coding and marking solution. This is because of the variety of substrates and materials involved at each stage of the supply chain, which include primary packaging (blister foils, flexible packs and carton boxes), secondary packaging (plastic trays and lids), tertiary packaging (pallets and large containers) and direct part marking (pacemakers and surgery equipment).

At the primary packaging level, thermal transfer overprinting (TTO) and thermal inkjet (TIJ) systems provide the best serialisation solutions. TTO systems are capable of printing high resolution (300 DPI) crisp, clean human- and machine-readable codes along with graphics, logos and other variable text fields on large areas.

TIJ is another ideal solution for coding and marking at the primary packaging stage and for multi-substrate packaging lines. Using solvent and water-based ink, it is capable of printing high resolution, complex, durable codes at a fast repeat rate onto all cartons and certain foils.

At the secondary and tertiary packaging stage, when larger label information needs to be printed and applied onto cases, print and apply labelling machines (PALM) can deliver full GSI codes (used to encode product, serial and batch numbers) and multiple applicator options. PALM can also print label information onto packaging types that TIJ and TTO otherwise could not, such as challenging substrates or product shapes.

Being able to permanently mark a variety of materials with the utmost precision, fibre lasers are the most prominent technologies found in direct part marking. A fibre laser solution can produce unlimited lines of distinguished, sharp text, graphics or even 2D data matrix codes. Laser-applied codes are indelible and, because they require no inks or fluids, they are cost-efficient and environmentally friendly.

Challenges ahead

Market research conducted by Domino revealed that code quality is the key challenge for SMEs. When asked to rate the significance of coding-related issues compared with other production issues, more than half of respondents said that coding issues were of the highest importance.

For the medical and pharmaceutical sector, there is a legal requirement to adhere to the EU Medical Device Regulation 2017/745. European manufacturers of medical devices will face even tougher regulations to ensure that their products are safe to use under the new EU laws, which are scheduled to come into effect from 26 May 2020 onwards.

Manufacturers now face a responsibility to familiarise themselves with the exact requirements of this legislation. By taking action ahead of the deadline and partnering with a reliable supplier, the ideal coding and marking solution can be integrated and compliance successfully achieved.