Regulations, laws and directives from public authorities and monitoring organisations mean manufacturers of medical products have to integrate ever more comprehensive monitoring mechanisms into their production processes. This leads to even more intensive inspection during the manufacturing process and certainly in the downstream packaging procedure. The complexity of products and their degree of sensitivity are also increasing: highly-sensitive medical systems, combination packs of devices, activation systems and biological components all have an influence on the type of packaging, the shape of the pack and the entire packaging procedure. Shorter product life cycles and increasing individualisation, as well as statutory regulations at all levels, have an impact on the size of production batches, which are becoming ever smaller. As a result of these developments, one sees constantly rising demands for greater product safety as well as precision and reproducibility in the packaging procedure.
The complexity of products has a direct effect on the complexity of the packs. These have to be created in such a way that products are protected to the optimum degree against mechanical effects, or that the individual product components are prevented from becoming mixed up in the pack. Packs often have to be produced with several cavities, which are precisely matched in shape to the individual product. Such a pack however imposes specific demands on the particular packaging solution as regards forming technology, product loading and pack sealing.
The increasing level of sensitivity with many products places particularly high demands on the packaging materials that are used to produce the pack. Such products are often sensitive to oxygen or other environmental influences such as moisture, UV radiation, heat or cold. Sensitive substances must often also be prevented from being activated during transport.
This means the packaging materials used have to meet a wide range of requirements. Composite films with peel systems for example make it easier to open the pack, so the product is not damaged when it is removed. Depending on the particular requirement, films can be used, which have a high degree of transparency or good barrier properties, or which can withstand different types of sterilisation such as gamma sterilisation for example.
Suppliers of packaging solutions react to current market developments by providing machine concepts that meet particular needs. There is an ever increasing use of a wide range of systems for automation, batch management, line documentation, and linking to higher-level ERP systems.
There is also rising demand for suitable inspection systems for monitoring product presence and quality, as well as for the presence and legibility of codes and labels on packs.
In addition to the demands of complex and sensitive products, smaller batch sizes and the need for quick format change also make the packaging procedure in the medical products industry particularly challenging. It is here that a high level of flexibility is demanded of the packaging machine. This can include the use of suitable die changing systems for reducing set-up time, as well as improved line clearance to prevent the cross contamination of products. This makes it easier to convert machines to the next production batch, with the result that security and efficiency in the packaging procedure are increased.
The aim is a fully monitored packaging procedure, which meets all the hygiene requirements, and which can also be tracked, reproduced and above all validated. The proportion of manual operations when packing medical products continues to decline – the packing of complex and sensitive products is increasingly being automated. A packaging process, which can be validated, is designed to ensure critical process parameters are routinely documented, and the integrity of the packaging system is maintained throughout the process.
When it comes to the marking and identification of medical products, the standardised global UDI system (Unique Device Identification) currently imposes many obligations, which go far beyond previous requirements, on all manufacturers of medical products. They compel manufacturers to provide unique marking for all products and packs, using both clear text and machine-readable codes, allowing seamless traceability throughout the entire process chain to be assured at all times. UDI also serves as the key to a worldwide database, in which all the information about the products is managed. In conjunction with suitable communication systems, the quality controls at individual pack level, for example for product monitoring, label presence or code legibility, ensure only faultless products in undamaged packs with clear markings get into circulation, and that the right data is correctly stored in the appropriate IT systems. Labellers and printers as well as vision systems can also be used to support compliance with the UDI requirements. RFID monitoring also enables the correct pack parameters for the particular product to be identified.
Particularly in the case of products in the pharmaceutical industry, the identification of products with regard to serialisation and the track-and-trace requirements plays a very significant role.
The ease of operation of a packaging machine and its machine control is also critical to other possible applications. Batch management has to be simple and visible, while the overall packaging procedure must be reproducible. The packaging machine and integrated line modules must be convenient to control via its HMI terminal, so that process reliability is always maintained. Thanks to higher-level recipe management, it is possible to manage labellers, inspection systems and handling modules simply and quickly via the HMI of the packaging machine.