The medical and pharmaceutical industry is highly regulated in terms of product safety, anti-counterfeiting and supply chain management. Effective product traceability is critical to improve patient safety and comply with regulatory requirements. Here, coding and marking solutions play a vital role in ensuring traceability for medicine boxes, medical devices and packaged healthcare products.
In this article, coding systems used for product tracking in the medical and pharmaceutical industry, regulatory compliance and best solutions will be discussed.
The Importance of Product Tracking in the Medical and Pharmaceutical Industry
1. Patient Safety and Anti-Fraud
Counterfeiting of pharmaceuticals and medical products poses a major threat. According to the World Health Organization (WHO), the rate of counterfeit medicines worldwide can be as high as 10%. Coding and traceability solutions increase patient safety by preventing counterfeit products from entering the supply chain.
2. Regulatory Compliance and Digital Tracking Systems
Regulations such as the European Union Falsified Medicines Directive (FMD) and the US Drug Supply Chain Security Act (DSCSA) require pharmaceutical manufacturers to mark each product with a unique code. In Turkey, the Pharmaceutical Tracking System (ITS) enables products to be tracked on a box-by-box basis.
To comply with these regulations, pharmaceutical companies and medical device manufacturers must use Direct Part Marking (DPM), Data Matrix, QR code, barcode and RFID technologies to track products.
Coding Solutions Used in the Medical and Pharmaceutical Industry
1. Inkjet Coding Technology
Inkjet coding is a method that can print at high speed on products such as medicine boxes, ampoules and bottles. Thermal Inkjet (TIJ) and Continuous Inkjet (CIJ) systems are frequently preferred in the pharmaceutical industry.
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Advantages:
- Suitable for fast production lines.
- Can create small and clear codes.
- Water-based, solvent-based or UV ink options are available.
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Disadvantages:
- Ink consumption can be costly.
- Print quality may vary on some surfaces.
2. Laser Marking Technology
Laser coding is ideal for permanent and high-resolution markings. In particular, it gives excellent results on glass, plastic and metal surfaces.
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Advantages:
- No consumables required (no ink or labels).
- Provides indelible and abrasion resistant marking.
- Environmentally friendly.
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Disadvantages:
- The investment cost is higher compared to inkjet systems.
- Some surfaces may require special laser types to achieve significant results.
3. Thermal Transfer Printing (TTO) and Labeling Systems
Especially for sterile packaging and flexible packaged products, thermal transfer printing (TTO) technology is used. These systems can print clear and legible codes directly onto plastic packaging.
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Advantages:
- High print quality.
- It can process critical information such as barcode, QR code and lot number.
- Works well on plastic and foil surfaces.
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Disadvantages:
- There may be operating costs due to the use of a thermal ribbon.
4. RFID and Smart Labeling Systems
RFID technology is increasingly being used to improve the traceability of pharmaceuticals and medical devices. These radio frequency tags enable contactless data transfer and facilitate logistics processes.
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Advantages:
- It offers wide traceability.
- Increases efficiency in warehouse and logistics operations.
- Allows simultaneous scanning of a large number of products.
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Disadvantages:
- RFID label costs are higher than barcode systems.
- Integration in small medical products can be difficult.
Considerations in Coding and Tracking Systems
The following factors should be considered for the effective use of coding systems:
- Legal Compliance: The coding system used must comply with regulations such as ITS, FMD and DSCSA.
- Durability: Marked codes must remain clear and legible from production to the patient.
- Integration: It should be compatible with production lines and work integrated with systems such as ERP/SAP.
- Verification and Quality Control: It should be supported by automated validation systems that test readability.
Ensuring product traceability in the medical and pharmaceutical industry is critical for patient safety and anti-counterfeiting. Coding solutions such as inkjet, laser, thermal transfer and RFID offer different advantages according to the needs of the industry. A reliable and compliant coding system provides great convenience to manufacturers and supply chain stakeholders.
By choosing the right coding technology, you can improve the traceability of pharmaceuticals and medical devices, comply with regulatory requirements and increase your operational efficiency.
