The Falsified Medicines Directive (FMD) is a regulation that aims to prevent the entry of falsified products into the supply chain. This applies to pharmaceutical manufacturers, importers, contract packaging and wholesale drug distributors, as well as producers of active pharmaceutical ingredients, resulting in the requirement for a unique, legible item serialisation number machine, using a 2D barcode data matrix.
A unique device identification (UDI) is an alphanumeric code or a unique number that consists of two parts – a device identifier and a production identifier. The necessary information is presented in two formats, being human-readable and machine-readable. Although not stipulated by the legislation, the GS1 2D Data-Matrix is often selected as a machine-readable carrier for UDI data. As an example, the UDI could consist of GTIN, batch code and expiry date encrypted in a 2D code.
Code quality is important
Code quality is crucial for machine-readable codes. The variety of codes needs to be maintained from the day the code is applied to the day it is scanned by a patient or healthcare provider, which could be a year or two later. Data-matrix barcoding requires near-perfect presentation to achieve the highest verification grade.
When coding and marking pharmaceutical products, the identification of unsafe products through traceability must be guaranteed if needed, facilitating their speedy withdrawal from the market. It also helps in the fight against counterfeit pharmaceuticals, given the enormous consequences that these can cause to people’s health.
Laser coding technology
TracePack has all the solutions to help customers go beyond marking a product’s packaging to marking directly on pills and capsules. Laser coding can be carried out on a wide variety of materials within the pharmaceutical manufacturing chain, whether they are paper, cardboard, glass or plastic. It can also be done on the product itself, such as pills or tablets, blister packs, cases, medicine boxes and pallets.
Maximum control of both the marking characteristics and the properties obtained in the final product in a non-contact process, is ensured by the laser. This guarantees that the product is not subjected to mechanical stress – ensuring the hygiene and biological compatibility of the marking produced while keeping the medicine’s functionality intact.
Pills formed with a mixture of gelatine and titanium dioxide use different dyes for differentiation, resulting in the need for wide variety of colours which need to be marked. Using TracePack’ Macsa ID DPSS equipment with emission in green (532nm), a high definition and easily readable marking can be obtained in a whole range of colours. With a marking time of 150 milliseconds per capsule, high-speed marking ensures correct coding for high production situations in the laboratory.
Biodegradable single-dose capsules
Recyclable products with minimum environmental impact are continually developed in the packaging industry, offering new functional and attractive solutions for the consumer. Biodegradable single-dose capsules have been designed with this in mind, manufactured with a plastic substance and allowing different products to be encapsulated by vacuum to maintain all their characteristics.
Marking directly onto these capsules is done with TracePack’ Macsa ID CO2 laser marking system (with a 10.6 wavelength μm), leaving a high contrast whitish mark without damaging the package. There is also no risk of altering the characteristics of the product or breaking it. The fact that each capsule can be personalised with different complex information (such as logos, nutritional information etc.) implies a high cadence of laser marking, so an ultra-high-speed head is used allowing extreme marking speeds without losing definition in the result.
Secondary packaging requirements
The serial pharma technology from TracePack comprises several critical phases:
1. consultancy and advice regarding the choice of systems and equipment
2. control and management of marking machines
3. 2D code reading and print quality control
4. OCR/OCV viewing for validating humanly readable alphanumeric digits
5. PLC line communications.
It also offers database management for compliance with FMD. The main functions of serial pharma include management of packaging orders, serialisation in multiple lines, control and generation of serial numbers, coding in different formats, aggregation, rework management and user management in line with 21 CFR Part 11.
It also offers in-depth reporting and monitoring with historical query screen, storage registry of data in SQL database systems and integration with SAP and other ERPs. Visit the TracePack for more information on the range of coding lasers mentioned in this article. You can also call +27 (0)10 020 7221 or send an email to email@example.com.