Medical device manufacturers should ensure their packaging solutions exceed mandatory EU legislation to safeguard quality standards and maintain a contaminant-free environment, according to packaging machinery supplier ULMA.
The company is encouraging companies to go beyond current packing process standards – specifically urging companies to implement practices from Part 11 of Title 21 of the US Code of Federal Regulations to further bolster quality assurance.
Currently, medical device packaging processes must be compliant with ISO 11607, which is frequently updated to ensure maximum possible patient protection. Product safety has been further tightened through the introduction of the European Union’s new Falsified Medicines Directive (FMD) in February 2019, which enhances traceability and sterility through mandatory, unique product identifier barcodes and tamper evident features.
Part 11’s criteria aims ensure electronic records in the healthcare sector are as trustworthy as equivalent paper records through controls such as audits, system validations, audit trails, electronic signatures and the documentation for software and systems involved in processing electronic data. At the product packaging stage, this involves using innovative machinery compatible with a data-driven approach, to monitor performance metrics. By analysing areas such as machine packaging cycles, cycle numbers, specific analysis parameters and machinery operator identity, manufacturers can better evaluate performance data and enforce best possible practice.
Dave Berriman, technical manager at ULMA Packaging UK said: “While optional, Part 11 further highlights just how important the avoidance of spoiled products is in the medical sector. Where people’s safety is paramount all measures must be taken to boost quality control and minimise contamination risks.
“By utilising packaging machinery with software that can keep hold of important control system data, such as ULMA’s range of thermoforming machines, medical product manufacturers can enjoy peace of mind that their packages are sealed without leaks and can be opened without coming into contact with foreign particles.
“The risk of contamination in the healthcare sector cannot be overstated and any adverse effects caused by the packaging process could lead to potential fines, reputational damage, and, most seriously, jeopardise consumer health. By looking to packaging machinery that exceeds mandatory legislation and enables further control to be enacted, these issues are further negated.”