In the pharmaceutical industry, product labeling is not merely a process; it is a crucial regulatory requirement. Inkjet printers used to print batch codes, expiration dates and unique identifiers on primary and secondary packaging of drugs play a crucial role in ensuring patient safety and meeting global regulatory standards. Selecting the appropriate inkjet coding technology and effectively implementing it is a fundamental link in the quality system of pharmaceutical enterprises.

Regulatory environment and requirements

Global regulatory authorities, such as the FDA in the United States and the EMA in the European Union, all mandate strict drug traceability. This usually includes clearly and indelible batch codes and expiration dates marked on the smallest sales unit. In addition, many regions are implementing serialization requirements, which assign a unique serial number to each individual product unit. These codes must be 100% accurate, easy to read and remain intact throughout the entire validity period of the product. Any coding error or ambiguity may lead to serious batch recalls, regulatory penalties, and ultimately endanger patient safety.

Inkjet coding technology suitable for pharmaceutical applications

1.Continuous inkjet technology: This technology is renowned for its reliability on high-speed production lines, long-distance coding capability, and adaptability to various porous and non-porous materials. CIJ is usually a robust choice for printing batch codes on secondary packaging, such as outer boxes.

2.Thermal inkjet technology: TIJ technology stands out for its high resolution, excellent print quality and precise character formation capability. This makes it particularly suitable for printing clear and easily readable QR codes, data matrix codes and expiration dates on primary packaging such as vials, ampoules or blister packaging. Its non-contact printing process also minimizes the risk of product contamination.

The key considerations for successful implementation

1.compatibility and adhesion: The ink used must be compatible with packaging materials such as glass, plastic, and aluminum foil, and be able to form a strong adhesion to resist friction, condensation, and possible sterilization processes. The ink itself should not have any interaction with the medicine.

2.Integration and data integrity: Inkjet printers must be capable of seamless integration with the enterprise's serialization and production line control systems. It should receive print information from a trusted database and ensure the integrity and accuracy of the data to prevent human input errors.

3.Verification and Documentation: Pharmaceutical applications require that the inkjet coding system undergo strict installation confirmation, operation confirmation, and performance confirmation. Complete documentation must be provided to prove that the system operates reliably and consistently in the verification state.

When choosing a coding solution for a pharmaceutical production line, it is necessary to have a comprehensive understanding of regulatory requirements, the product life cycle and technical capabilities. Investing in a reliable inkjet coding system specifically designed for the strict standards of the pharmaceutical industry is not only a necessary step to meet compliance requirements, but also an active strategy to protect brand reputation and safeguard the health of patients worldwide.