Pharmaceutical products and medical devices require the heighest level of packing, labelling and marking.
This industry and market is very challenging due to advanced logistics, variable data (LOT, EXP, 1D-2D Codes) are being scanned with high speeds on many stages of distribution. The need to meet industry standards (GMP, GAMP5, 21 CFR Part 11) and legal requirements (EU FMD, US DQSA, UDI), often become quite a revolution and enforce a change in the approach to marking, coding, labelling.
Blister packaging is a term for many types of pre-formed plastic packaging, comprised of PET (polyethylene terephtalate) or PVC (polyvinyl chloride) plastic, with a thermo-formed cavity or pocket, created to protect a variety of consumer goods in industries such as pharmaceuticals.
There are very noticable trends like short batches, short production runs, customization which force customers to print and code varable data during the packaging stage. The best technology for this job is TTO (thermal transfer overprint) . Thermal transfer printers are designed for printing on flexible materials such as foil, Tyvek and labels. These are reliable devices enabling operation in continuous and start-stop traffic.
Intrex has designed LSC-100 labelling system to handle various blister sizes in terms of marking and personalizing according to current needs. Additionally modular device construction allows to expand capabilities and cover different formats and products. User friendly software KUP Vision manage the entire unit. It is also equipped with communication ports to integrate with existing ERP systems.
Printing on pharmaceutical cartons
The information printed on a carton can be just as important as the contents contained within. Without readable product data, it is impossible to guarantee legislative compliance, eliminate costly supply chain errors, or ensure the safety of users. For example: Serialisation requirements are the single greatest challenge the printing industry has faced in recent decades. High-quality, cost-effective laser and thermal inkjet printers offer fast, accurate marking of cartons – helping to ensure compliance and maximise uptime. Especially, Thermal-ink jet became leading technology witch guarnatees high constrast 2D codes meeting all indutry standards.
Labelling and marking on bottles/ cylindrical containers
Pharmaceuticals and supplements are packaged in cylindrical containers as a very convenient form of product storage. This trend can be observed for many years in the United States, where e.g. blister packing is becoming less and less popular. An integral part of the packaging process is the application of a self-adhesive label as well as application of variable data. Labelling systems are based on various modules responsible for rotating products and their o positioning during label application. Very often, the label applicator head is integrated with a variable data printing device, the ideal technology for is thermal transfer technology, which applies the data to the label before it is applied on the product. For full control of the process, cameras and vision systems are used to detect faulty labelling, labelling errors and to allow rejection of non-conforming products.
Face mask printing
Masks are products that have direct contact with facial skin, therefore they require special ink with appropriate certification. Two technologies are most often used: small character inkjet printers – Domino Ax series and cartridge printers – Domino Thermal – ink jet. Fast drying high contrast inks used ensure the highest quality of marking and meeting the requirements and regulations of the medical devices industry.
Case printing, coding and labelling
One of the last stages of the confectioning process is packing the products, most often primary cartons, into cases that must be labelled, usually with barcodes, 2D codes and other information required in the logistics process. In many cases, the printed data comes from production management systems. Equipment designed for applying labels to unit packing, bulk and pallets. Possibility of thermal transfer module operation, application of thermal labels and labelling function.
Ensuring patient safety with vision systems inspection of printing and labelling
Packaging is the final step in the manufacturing process of pharmaceuticals and it is extremely important for maintaining the highest quality and patient safety to ensure that all products are correctly and legibly labeled and coded. For this purpose, vision sensors and cameras are used; they detect erroneous products e.g. with illegible print, print with low contrast, incorrect data. In case of detection, they are removed from production line at the reject station. As a result, only products verified as good leave the machine responsible for marking and labelling. The whole process is supervised and managed by software, which has funcionalities to generate production reports and statistics after the batch is completed and production ended.
Pharma industry trends
With ongoing global pandemic, this is even more pronounced. The needs of continuous development in the field of paharmaceticals packaging, marking and labelling. The specifics of the pharmaceutical industry have changed considerably in recent years. We can observe a significant increase in production focused on short batches and readiness to quickly respond to changing needs and demand for pharmaceticals. This requires more flexibility of the whole process of marking and labeling, as a consequence implementation of machines designed for this type of operation, adapted to quick changeovers and production on demand also personalisation. Parallel importers and contract manufacturers have significantly increased their market share, and this type of business particularly needs off-line equipment focused on short production batches.
Printing and labelling technologies
Printing and labelling of medicines requires a very individual approach, choosing the optimal technology (e.g. inkjet, high resolution inkjet (TIJ), thermal transfer, or laser) tailored to achieve the highest quality print on a given type of substrate and material. An integral part of the process is to perform test printing / marking on the customer’s product.
Many technologies are available:
Laser marking involves discoloration of the outer shell of the material to obtain a durable, high-quality marking on its surface. Depending on the customer’s requirements and the substrate, it can take various forms, including ablation, engraving, discoloration, foaming or annealing. In pharma industry very often used for blister marking as well as label marking. High speed and very reliable technology.
High-resolution printers are ideal where high print quality must go hand in hand with high line speeds. Excellent adhesion and lightfastness are achieved thanks to fast drying inks. We offer this solution where cleanliness, efficiency and reliability are important. This is best technology for carton marking, ensures high quality prints and meets all pharma industry standards – especially serialisations and track&trace application.
Thermal transfer printing technology is designed for printing on flexible materials such as foil, Tyvek and self-adhesive labels. The devices enable continuous and start-stop operation. The dyeing process is based on a dye ribbon and a print head, otherwise known as a heater. The heated ribbon transfers ink – in a selected form of characters and shapes to the product – in high resolution. Thermal transfer printers are often integrated with packaging machines as well as and labeling systems.
As a machine bulider and a provider of complete solutions for the pharmaceutical industry, we have many years of experience allowing us to deeply understand and analyze custmer’s needs in order to offer you the best possible solution. In many cases, our equipment inegrates both variable data marking, labeling and vision control technologies, all managed by a dedicated vision control system.