Alastair Cook, product manager at ULMA Packaging UK, explores the benefits of thermoforming technology to ensure the highest safety standards are upheld.
Credit: ULMA Packaging
The medical industry requires fully reliable packaging that offers maximum possible protection for products designed to care for patients and preserve their health. Consequently, packaging solutions in this sector must meet the strictest possible regulations.
These criteria include ISO 11607 for the packaging of medical products. This is extremely stringent, and frequently updated as part of ongoing efforts to protect product integrity and the safety of patients.
Exceed standards
Alongside adhering to ISO 11607:2019, further legislation has been introduced to heighten supply chain product safety. The European Union introduced the Falsified Medicines Directive (FMD) in February 2019, and the UK government has confirmed it will be in effect after Brexit.
Designed to improve protection and preserve tough sterilisation conditions, the legislation established two mandatory safety demands on packs of medical products. These include unique identifier barcodes to ensure full traceability, and tamper-evident features to assure patients their medicines have not been interfered with.
Many medical product manufacturers exceed the heightened scrutiny of current legislation to provide quality control assurance, achieving compliance with regulations such as Part 11 of Title 21 of the Code of Federal Regulations, otherwise known as Title 21 CFR Part 11, or Part 11 for short.
Though part of the USA’s Food and Drug Administration (FDA) regulations, some UK organisations have implemented practices set down in Part 11 to further bolster quality control. Its criteria look to ensure electronic records in the healthcare, biotech and biologic fields can be considered as trustworthy as their equivalent paper records. This involves implementing controls like audits, system validations, audit trails, electronic signatures, and documentation for software and systems involved in processing electronic data.
Application of regulations
For medical manufacturers, practices from Part 11 are applied at the product packaging stage. By retaining important control system data, manufacturers can pinpoint metrics such as individual machine packaging cycles, cycle numbers, parameters monitored, and even machine operator identity. This thoroughly forensic process reinforces quality control, allowing close evaluation of detailed machine data to better inform and ensure best possible practice. Again, while optional, Part 11 further highlights just how important the avoidance of spoiled products is in the medical sector.
So, when specifying appropriate product packaging solutions in the medical industry, it is vital the integrity of packaged medical devices remain uncompromised. Though factors that could induce product spoilage should be a concern regardless, maintaining contaminant-free packaging processes is paramount for medical manufacturers. Failure to adhere to safety protocol could result in impaired packaging processes, potential fines, reputational damage, and, most gravely, jeopardised consumer health.
Better materials
Multiple materials can be used to package medical products, including plastic films, medical-grade paper, synthetic materials such as Tyvek flash spun high-density polyethylene, or aluminised materials, such as steel. Although they all protect packaged products, their effectiveness is amplified by how they are applied. Consequently, choosing appropriate machinery to eliminate the damage of products and maintain a sterile packaging barrier is of vital importance.
Of all the packaging technologies and lines available, thermoforming is most ideally suited to mass medical device packaging. Naturally versatile, robust and reliable - thermoform machines can use multiple rigid and flexible packaging materials to create dependable, protective packaging.
How thermoforming works
Thermoform machines for the medical sector produce trays on a horizontal packaging line. This is done through the use of two film coils, which are usually composed of different rollstock materials. These differing materials are unwound from their respective reels and fed through a pre-heating station. This station, which contains a lower and upper plate, softens the material to enhance its pliability.
As part of this process, the bottom film is heated and negatively formed into a cavity via the use of a vacuum or, on occasion, highly-filtered compressed air. The film is then cooled, making the plastic more rigid when it is removed from the mould. For difficult shapes such as blister packaging, where cavity shapes can exceed the size of small medical devices, a ‘plug assist’ feature partially pushes plastic into the cavity to create more even and uniform wall distribution.
After this cavity is created, the product is loaded into it using automated product filling. When the product is in place, the top film layer is then rolled over the mould and heated to create a hermetic, airtight seal between the product and the surrounding environment. This thermoforming fill seal process, which all takes place on the same piece of equipment, provides an extremely effective level of protection against external contaminants and the possibility of tampering. As well as being extremely durable, the high-quality seal also keeps the packaged product in place, minimising the risk of damage that can be incurred during transportation to distributors and finally the end user.
Following the sealing process, the packaging is cut into its final shape from a larger tray and ejected from the thermoform machine. These finished medical devices can then be sterilised through varying means, including steam-heat treatments, radiation, or gases such as ethylene oxide. Crucially, these processes ensure contaminants are minimised without compromising the packaging integrity mandated by medical packaging manufacturers.
Data-driven approach
Thermoform machinery provided by leading packaging machinery suppliers, such as ULMA, can also provide fixed and variable data printing and labelling, before or after sealing. To further ensure products are being packaged to the relevant standard, this can also occur before the cutting stages.
Medical manufacturers can enjoy peace of mind, knowing that all stages of the packaging process are being closely monitored to maintain the highest possible product standards. Furthermore, because of the modular design of thermoform machines, it is easier to add monitors to view the entire packaging line for heightened visibility and closer control of consistency at each stage of the process.
Examples of parameters that can be monitored are: Forming time, homogenous temperature across the packaging, and guaranteeing that the forming process remains at optimum temperature. If there is a deviation from the criteria specified by the standard or the manufacturer, any faulty product can be sealed and ejected from the packaging line without coding.
Overall, thermoform machines are extremely well-positioned to adhere to the rigorous demands required by legislation governing the medical sector. By investing in this packaging technology, the medical sector can continue to provide the best in product safety and consumer health satisfaction.