We are seeing the world respond in ways we have never seen before to help defend the world against COVID-19. From social distancing and wearing personal protective equipment in our daily lives to global and local health care companies manufacturing new products and ramping up to meet exponential demand, we are witnessing a worldwide effort.
There has been a common theme to beat the virus, mainly through three measures: diagnostics, prevention, and protection. Manufacturers are responding by shifting technologies and resources to meet the need for COVID-related products. Whether producing PPE, hand sanitizer, test kits or any of the other products and devices currently in high demand, manufacturers must code their products and packaging for supply chain traceability and to meet any government regulations that may apply to their products. Coding, printing, and marking experts are working with manufactures to match the ideal printing and serialization technologies to these various in-demand diagnostic, preventive and protective products and their packaging.
For the diagnostic countermeasure, several printing and marking technologies support producers of critical diagnostic kits and testing kits for sample collection. Continuous inkjet (CIJ) printing, for instance, is often selected for simple coding of primary packaging, like for nasal swabs. CIJ’s ease of integration allows for a smooth and consistent traversing system to print lot numbers and expiration dates directly on the packaging.
Other materials used in testing and diagnostic kits, like Tyvek® and medical paper, can be marked directly with both thermal inkjet printers and UV laser marking systems to produce high-resolution codes, including unique serial codes, to help with supply chain traceability.
Diagnostics manufacturers are finding that many coding solutions can go beyond printing to also manage variable data, verify the code, and utilize traceability software to support regulation and patient identification.
In a recent example, a manufacturer of COVID-19 diagnostic kits worked with a coding solutions company to modify their packaging operations at multiple sites to include variable data coding on cartons. The manufacturer worked with coding experts to identify a thermal inkjet printer and software to help achieve unique product coding while keeping up with increased production. The manufacturer’s white, varnished cartons are now printed with fast drying, solvent-based inks. High-resolution variable data and machine-readable Data Matrix codes are printed to meet regulatory requirements and patient identification needs. The manufacturer is also relying on this complete solution’s code management and vision inspection tools across several packaging lines.
Prevention and coding
Pharmaceutical companies are now planning production for COVID-19 vaccines. Printing and marking technologies not only code the critical serialized data onto unit cartons, but also traceability information onto the vials and syringes.
Vial coding has unique challenges due to internal processes like bright-stocking, sterilization, and refrigerated storage. To help, vials can be directly coded with either a permanent laser-marked code or an invisible UV-ink code printed with a continuous inkjet printer or thermal inkjet printer. In this application, a GS1 Data Matrix code is typically applied to the vial cap, allowing for internal traceability without the code visible at the point of use.
To achieve a permanent laser code on a vial, fiber lasers mark the side of the aluminum closure. New, streamlined fiber laser marking heads allow for ease of integration into most filling and capping equipment while still providing the power and precision to mark small Data Matrix codes at high speeds.
Coding protective devices
Companies must code their critical products in many places, including directly onto the product itself; onto the primary packaging, such as a carton, with laser or thermal inkjet; and onto the shipping case with a label printer applicator or case printer.
High resolution capabilities and advanced inks make thermal inkjet a good fit for printing on a mask manufacturing line. It allows for angled print which is especially helpful in printing logos on the unique geometry of a mask.
Medical masks are considered personal protective equipment (PPE) and are therefore classified as medical devices. They are subject to local regulations such as the UDI system or the European Medical Device Regulation (MDR), and must be labeled accordingly.
Medical masks that comply with FFP2, FFP3, N95 or KN95 standards are generally required to be labeled directly. Typical coding requirements include:
- Manufacturer’s business name, a registered trademark, or an easily understood abbreviation of manufacturer’s business name, e.g. company logo
- Testing and certification approval number, e.g. EN 149:2001
- Filter series and filter efficiency level, e.g. N95, FFP2 or KN95
- The model number or part number, represented by a series of numbers or alphanumeric markings, e.g. 9455 or 9455A
- Lot number
- Date of production
Packaging cartons of medical masks as well as their shipping cartons may require labeling information including:
- Global Trade Item Number (GTIN)
- Lot or batch number
- Date of production
- Quantity per packaging unit
Generally, this information must be provided in both a human-readable (plain-text) form and a machine-readable form, e.g. a Data Matrix code.
With the significantly increased demand for PPE and testing kits, the health care industry is doing everything they can to keep pace. Furthermore, coding, printing and marking companies are helping health care manufacturers meet the increased production of test kits and PPE, while gearing up for the mass production of coding and traceability for a COVID-19 vaccine.