Code breaker

According to Colin Morgan, Videojet Technologies, improving the coding process can increase productivity for pharmaceutical manufacturers

Product coding during the packaging process is a vital part of pharmaceutical manufacturing. Perhaps to a greater degree than in any other industries, pharmaceutical packaging demands the highest quality variable coding. Legibility and contrast are a pre-requisite when it comes to regulatory and traceability codes and yet, coding solutions must also facilitate line productivity and seamless integration for today’s competitive environment.

The coding and marking of pharmaceutical products are key to reliable product identification which helps companies fight counterfeiting and help prevent errors in administering drugs to patients. As pharmaceutical product coding regulations change, so does the threat of coding errors which may necessitate costly re-work and material waste. The reallocation of valuable time and resources to rework products directly affects the ability of a 24/7 manufacturing facility to run effectively, reducing throughput and profits.

According to a Videojet survey, up to 70% of coding errors are caused by operator error, with approximately half of these caused by mistakes during manual data entry. In addition, it was discovered that coding errors are not the deviation, but the norm. 

Message selection can take place centrally, at one coder or through a barcode scanner. But typically an operator has to select a job at one location unless extensive integration to manufacturing systems has occurred. While manufacturers can typically put additional checks in place during packaging to address coding errors, this does not necessarily handle the issue effectively or efficiently. By working with an experienced printing partner with extensive printing capabilities and system design know-how, they can create and implement a coding process with built-in code assurance elements that limit the potential for user error. Simplifying the process of message selection and entry through the use of automation and software tools can greatly prevent coding errors, increasing productivity, reducing waste, and minimising operational costs and risk management.  

Automated code assurance

“Poka-yoke” is a Japanese term that can be translated as “mistake-proofing”. When applied to manufacturing operations, a poka-yoke is any measure put into place during the manufacturing process designed to prevent human errors before they occur. The right printing partner can help a pharmaceutical manufacturer design a comprehensive system that implements various poka-yoke principles through advances in printing technology, eliminating coding and marking errors. 

Intelligent user interface

Using an operator interface designed with existing code assurance tools can simplify message selection, restrict operator input and automate messages. For example, the printer’s user interface can include features such as separate user authorisation for code creation and job selection, restricted and pre-approved coding parameters, and job storage under intuitive names that speak directly to the product being coded.

Software and network message control

Implementing Windows-based software can provide additional support, isolating code design from the production floor and eliminating the need to load individual message onto each printer interface. This PC-based message creation and management tool serves to remove human error from the coding equation.

Regulatory Concerns

In addition to the costs associated with rework and scrapped printing jobs, coding mistakes can result in fines and penalties. Regulations on drug product coding are driven by security and emerging technologies. Medication dispensing errors, the proliferation of easily available drug products via the internet and the emergence of false or incorrectly labelled products are all key concerns in the healthcare industry. In the United States, manufacturers are legally required to correctly display product information, such as ingredient or nutritional data mandated by the Nutrition Labelling and Education act and the Federal Food, Drugs and Cosmetics. The introduction of safety features (mandatory seals and unique pack identification) on packaging for certain medicines will provide assurance to patients of the authenticity of medicines they receive through healthcare systems where these medicines are at risk of counterfeiting.

There are different coding technologies suitable for packaging types for example, cartons are the most common packaging formats for the pharmaceutical industry and must be marked with the highest quality human readable and machine readable codes to ensure the product’s traceability. Bottle coding is also extremely common and they can be coded in numerous places like the bottle side, underside, label or cap.  Vial marking and eye dropper bottle marking are challenging because of their small size and the complex sequence of packaging operations. Coding these packaging types is best achieved when the coder is integrated into an original equipment manufacturer (OEM) packaging specifically designed as high quality codes require precise material handling and rigid vibration-free coder mounting. Failure to comply with these standards can bring fines and even product recall – both costly and extremely damaging to any brand.

By working with an experienced printing partner to design a coding process with built-in code assurance elements (also known as poka-yoke principles), pharmaceutical manufacturers can eliminate errors before the label is even applied to the product. Utilising the latest in manufacturing automation and software tools can prevent coding errors, enhancing productivity and increasing the bottom line.