Batch Coding Machine for Pharmaceutical Serialization of Data

Regulatory Requirements for Serialization

Governments worldwide have implemented strict serialization regulations to prevent counterfeit pharmaceuticals from entering the market. Key regulations include the Drug Supply Chain Security Act (DSCSA) in the United States and the EU Falsified Medicines Directive (EU-FMD) in Europe. These regulations mandate serialization to improve traceability and patient safety by ensuring that each pharmaceutical product can be tracked back to its origin.

Importance of Serialization in the Pharmaceutical Industry

In the pharmaceutical industry, coding and marking are critical for ensuring product traceability, compliance, and safety. The importance of coding and marking cannot be overstated, as it plays a crucial role in safeguarding public health, ensuring regulatory compliance, and maintaining the credibility of pharmaceutical brands.

Moreover, advanced coding technologies such as inkjet printing allow pharmaceutical manufacturers to print high-quality, durable marks on a wide range of packaging materials, including glass, plastic, and blister packs. These markings are designed to withstand harsh conditions, ensuring that critical information remains legible throughout the product’s lifecycle. For pharmaceutical companies, investing in robust and reliable coding and marking systems is essential for maintaining product integrity, building consumer trust, and avoiding costly compliance issues.

Overview of Batch Coding in Pharmaceutical Packaging

What is Batch Coding?

Batch coding refers to the process of marking or printing a unique identifier on a product or packaging that signifies a specific batch of goods produced within a manufacturing run. This code typically includes important information such as:

• Batch number: A unique number or code identifying a particular batch of products.

• Manufacturing date: The date when the batch was produced.

• Expiration date: The date after which the product should not be used or sold.

• Lot number: A reference number used to track the product’s production, often linked to the raw materials used in the batch.

Batch coding is essential for product traceability, allowing manufacturers, distributors, and consumers to track the origin, production timeline, and quality of a product. It is particularly crucial in industries like pharmaceuticals, food and beverage, and cosmetics, where safety and regulatory compliance are paramount. Batch coding helps ensure that products can be recalled quickly if issues are detected, and it supports compliance with legal standards.

Role of Batch Coding in Pharmaceutical Traceability

Batch coding plays a pivotal role in pharmaceutical traceability, ensuring the safe and efficient tracking of pharmaceutical products from production to distribution. A batch code is a unique identifier assigned to a specific group of products produced under similar conditions, typically including the manufacturing date, expiration date, and lot number. This system allows both manufacturers and regulatory bodies to track the journey of each product, ensuring its authenticity and quality throughout the supply chain.

Batch Coder RNJet H1

• Thermal HP TIJ 2.5 print-head
• Max. Print Speed: up to 180 m/min (150 dpi) or up to  90 m/min (300 dpi)
• Max. Print Height:12.7 mm (0.5″)
• Max. Print Length: 5500 mm
• Throw Distance: Up to 8 mm
• Resolution: 300 dpi
• Ink Types: Solvent & water based
• Ink Drying Time: 1 to 3 seconds, depending on substrate
• Ink Colors: Black, Pigmented White, Pigmented Yellow, Red, Blue, FDG Blue, FDG Dark Pink, UV, UV White (ask us for more)
• Print Orientation: Side-printing, Downwards
• I/O Ports: Photocell, Shaft-Encoder, USB, Ethernet, RS 232
• Display: 7″ Touch screen Stainless Steel Case
• Power: 12V – 5.0A
• No. of Print Heads: 1
• Ink Management: Ink Percentage Indicator on the screen & Ink consumption calculator
• Operating Temperature: 0°C to 45°C, Relative humidity: 20% – 80%
• Storage Temperature: -5°C to 50°C
• Connectivity: USB, RS-232, Ethernet

How RNJet H1 Optimizes Pharmaceutical Coding and Marking

The RNJet H1 enhances pharmaceutical coding and marking by improving efficiency, accuracy, and compliance with industry regulations. Here’s how:

1. Improved Compliance and Traceability: The RNJet H1 ensures compliance with regulatory requirements by printing clear and legible batch codes, expiration dates, and lot numbers. This facilitates traceability and helps manage product recalls effectively, ensuring quick identification of affected products.

2. Increased Efficiency: With print speeds of up to 90 meters per minute, the RNJet H1 keeps production lines running at optimal speed without compromising quality. This makes it ideal for high-volume pharmaceutical environments where time-sensitive tasks must be completed quickly.

3. No Maintenance: The RNJet H1 batch coding machine is a completely maintenance-free coding and marking solution, manufactured in Canada.

4. Cost-Effective Operation: The RNJet H1’s versatile ink compatibility and low maintenance design keep operating costs down. Its reliable performance and reduced downtime help pharmaceutical companies save on service costs and increase overall productivity.

5. Flexibility Across Packaging Types: Whether it’s plastic, glass, or metal, the RNJet H1 can print on a variety of materials, providing the flexibility needed to handle diverse pharmaceutical packaging types, such as vials, bottles, small boxes and cartons.

Conclusion: The Impact of Efficient Serialization on Pharmaceutical Safety

In the fast-paced and highly regulated pharmaceutical industry, reliable and efficient coding and marking solutions are crucial for maintaining product quality, ensuring compliance, and optimizing production processes. The RNJet H1 offers an advanced, maintenance-free solution that streamlines batch coding, improves traceability, and ensures accurate labeling on a wide range of packaging materials. With its high-speed printing, versatile ink compatibility, and user-friendly design, the RNJet H1 empowers pharmaceutical manufacturers to meet stringent industry standards while minimizing operational costs. By integrating the RNJet H1 into their production lines, pharmaceutical companies can enhance efficiency, reduce errors, and safeguard product integrity, ultimately leading to greater consumer trust and regulatory compliance.

For more information or to optimize your pharmaceutical coding and marking solutions, contact us or call us at +1(905) 597-4978 today!