UDI labeling can establish healthcare equipment via their distribution and use. The deadline for labeling Class 1 and unclassified products is coming up.
Tim Kearns, Videojet Systems
Regardless of whether you are growing the manufacturing of professional medical units previously matter to Special System Identification (UDI) needs or ending your program to satisfy the FDA’s UDI prerequisites for Class I units, you’ll want to achieve higher-resolution printing of variable codes on units and their packaging.
UDI paves the way for traceability
To enhance professional medical unit traceability, the Fda recognized the UDI method and executed it in phases, starting in 2014. Whilst the company delayed UDI compliance for Class I and unclassified equipment until finally September 2022, comprehensive compliance for health care gadgets in Course II and III and implantable life-supporting and life-sustaining gadgets is presently necessary.
The UDI system necessitates labeling medical units with a exclusive product identifier in both of those a human-readable (plain-text) form and a equipment-readable sort that makes use of automated identification and knowledge capture (AIDC) technology. These identifiers ought to show up on labels and packaging, and occasionally on the equipment on their own.
UDI data is generally a combination of alphanumeric text and GS1 Knowledge Matrix or GS1 128 codes. The codes carry a one of a kind device identification number and generation information such as a batch code, whole lot quantity, expiration date or day of manufacture. The Food and drug administration defines the codes with two areas:
- Machine identifier (DI), a necessary, mounted portion that identifies the labeler and the specific machine version or design.
- Manufacturing identifier (PI), a conditional, variable part that identifies 1 or more of the next for every precise device:
- Large amount or batch selection
- Serial range in YYYY-MM-DD format
- Expiration day in YYYY-MM-DD format
- Date produced in YYYY-MM-DD structure
- Distinct identification code needed by §1271.290(c) for a human cell, tissue or mobile and tissue-based product (HCT/P) controlled as a gadget.
Laser marking systems are commonly employed to print and mark specifically on health care gadgets because of to their means to create lasting codes on quite a few difficult plastics, glass and metallic. The best printing and marking know-how for a supplied software depends on aspects which include the packaging substrate, products integration, creation speeds and code prerequisites.
How UDI can perform with Tyvek
Let’s choose a nearer appear at a common packaging selection for clinical products: DuPont Tyvek and very similar health-related papers.
Tyvek is built of really wonderful and continual filaments of virgin superior-density polyethylene (HDPE. It is a well-known healthcare device packaging material mainly because of its tear resistance, toughness, breathability, microbial barrier attributes and compatibility with sterilization solutions. Different Tyvek styles fulfill medical packaging functionality necessities for mechanical power and protection, with the product forming pouches, luggage and type-fill-seal lids.
Since of Tyvek’s texture and one of a kind homes, selecting a technologies to print UDI codes on it necessitates careful thing to consider. Dependent on the line setup, speed prerequisites and the type of Tyvek selected, 3 distinctive printing and marking technologies can give long lasting human- and machine-readable UDI-compliant codes.
Thermal inkjet is a non-contact printing technologies that enables high-pace, significant-resolution printing on Tyvek 1073B, 1059B, 2Fs and 40L with specific solvent-based mostly and h2o-based inks. The printer cartridge’s various nozzles propel ink drops to deliver the high-resolution codes.
Multiple thermal inkjet printheads can be mounted on the world wide web of thermoformers and positioned to print codes on a lidding world wide web just before warmth sealing. The printheads traverse the world wide web, coding several packages in a single pass when matching the index fee. These methods assist work details from an external database and from a hand-held bar code scanner.
With TTO technological know-how, a digitally managed printhead specifically melts ink from a ribbon instantly onto Tyvek to print significant-resolution codes and alphanumeric textual content. A company can integrate TTO printers on intermittent- or ongoing-movement adaptable packaging traces and ultrafast horizontal variety-fill-seal products. Particular ribbons designed with a blend of wax and resin deliver excellent adhesion, contrast, and light resistance on Tyvek 1059B, 2Fs and 40L.
UV lasers do the job by focusing and steering a beam of UV light with a collection of compact mirrors to deliver long lasting, significant-distinction marks, giving superb marks on Tyvek 2Fs. The laser’s UV wavelength produces a color change as a result of a photochemical response on the substance with out harming it. This laser technological know-how doesn’t call for materials like inks or ribbons.
Your operation’s throughput, utilization, financial investment and functioning fees are all things to consider when deciding on a printing or marking know-how to help satisfy UDI code prerequisites. Temperature and humidity can also impact a printer or laser’s effectiveness, so you must examination your packaging and goods in relation to your atmosphere to enable figure out the best option.
No matter whether choosing thermal inkjet, thermal transfer, or UV laser engineering, an experienced coding alternative service provider can tutorial you to the optimum engineering for UDI coding on Tyvek packaging. They can also determine and implement complicated info administration software to aid you meet up with the code and traceability demands of UDI.
Tim Kearns is profits supervisor for pharma and clinical devices for Videojet Systems.
The viewpoints expressed in this weblog submit are the author’s only and do not necessarily mirror those people of Healthcare Layout and Outsourcing or its staff members.