Europe's largest hygiene research center opens
A research centre for hygiene and infection prevention has relaunched in the north of France, with double the size and capacity to develop initiatives to combat infection.
Ecolab, a provider of water, hygiene and infection prevention services and its subsidiary Laboratoires Anios, inaugurated the expansion of the Luce Letartre Research Center in Sainghin-en-Mélantois, near Lille.
It now has 2,000 square metres and dual GLP and ISO 17025 certifications. Equipped with the latest technology, the research center will be able to develop hygiene and infection prevention products to fight infections in a healthcare setting and demonstrate the effectiveness of all types of bacteria, viruses, fungi, yeasts and other emerging microorganisms that could be present in a hospital environment.
Additionally, the Ecolab-Anios facility is the only research center in Europe to integrate dedicated labs for chemistry formulation, microbiology, analytical chemistry and virology, the latest addition to the group’s capabilities.
Among the high profile guests at the opening were French Minister for Foreign Trade and Economic Attractiveness Franck Riester, and Minister for Industry Agnès Pannier-Runacher.
"Ecolab has a longlasting and widespread presence in France, and this investment shows that its confidence in the French economy remains very high" Riester said. "International investors trust in France, because our pro-business agenda is clear, and remains so. The France Relance recovery plan supports this strategy, supporting and transforming our economy towards a green, competitive and sustainable model."
First built in 2012, the newly expanded centre aims to develop and test the effectiveness of new disinfectant formulations on infection-causing microorganisms. With its increased capacity, the 37 employees at the facility will be able to conduct more than 22,000 tests per year and provide robust data as companies pursue product registrations in multiple countries.
The centre's expansion comes at a time when COVID-19 has highlighted the importance of effective hygiene measures. To support healthcare facilities in their fight against the virus, Ecolab and Anios have significantly increased the production of infection prevention products, such as the alcohol-based hand rub Aniosgel. The site has been operating 24 hours a day, seven days a week since February 2020, doubling output of the hand gel to supply the French market and other areas throughout the world.
Chafik Hilal, general manager of Ecolab Europe’s Healthcare division, added: "This Center of Excellence has capacity and capabilities that are unmatched in Europe. This expansion supports our growth ambitions combining the scientific and commercial expertise of Ecolab and Anios to help hospitals eradicate healthcare-acquired-infections (HAIs) and protect public health. HAIs are responsible for 37,000 deaths each year in Europe.
A guide to labelling compliance for medical devices
Small medical device manufacturers often find themselves scrambling to achieve the necessary compliance and validation, risking costly mistakes.
Validating systems and processes including labelling, to ensure they are compliant with stringent regulatory standards is tough and can be expensive. Indeed, compliance with the EU’s Medical Device Regulation (MDR) will cost more than 5% of annual sales, according to 48% of 101 companies polled by the German company Climedo Health, in July and August 2020 about their MDR-readiness.
But if companies bungle the software validation process or put incorrect and uncompliant data on the labels themselves, the penalties are likely to be more severe than just making corrections. Health and safety may be put at risk and fines imposed for failing to comply. When it comes to compliance, they may become overwhelmed with regulations in other geographic regions that focus on device traceability, each with a unique device identifier (UDI-like) component to it.
On the validation front, companies may not be familiar with the software validation process and the multiple tests and documentation necessary for validation are demanding if companies only have a small IT team that is very busy.
Putting a plan in place
MDR-compliant labelling, however, brings with it certain requirements which differ from what is demanded under the FDA’s Unique Device Identification (UDI) system rules. Under MDR, for example, manufacturers must ensure the label specifically states the device is a medical one using an MD symbol in a box. This is only one of many stipulations that usually require redesigned labels.
Small medical device manufacturers who rely on time-consuming and error-prone manual or legacy labelling processes to facilitate these label updates run the risk of mislabelling which can lead to non-compliance. They may have limited staff and no structured processes around roles and responsibilities when it comes to label design, changes and approval. As project leads work toward a compliant labelling process, it is therefore important to establish defined roles and access for each stage of the process.
When dealing with a compliance initiative, up to date, correct and compliant labelling is imperative. This involves having all the relevant label design elements in place to comply with the EU MDR or FDA regulations. Many times, label templates are hard coded, meaning IT must be involved in making changes. And with IT staff often being tasked with multiple mission-critical projects in the organisation, labelling projects can be delayed. For many small medical device manufacturers who have limited resources, finding a solution can be a challenge.
Why labelling in the cloud offers a roadmap forward
Validation-ready cloud labelling solutions have now emerged to ease compliance with regulations and time-consuming validation requirements. These solutions, built with the needs of regulated companies in mind, digitise the quality control processes and facilitate compliant labelling with role-based access, approval workflows and electronic signatures. Outside of compliance, carrying out labelling in the cloud drives scalability and productivity for small medical device manufacturers and boosts overall efficiency.
The latest cloud labelling solutions integrate with other cloud solutions, allowing for seamless functionality and minimising the need for local infrastructure resources and cost.
When it comes to validation, as with many labelling systems, those hosted in the cloud have vendor-supplied documentation that streamlines the process and significantly eases the burden when it comes to installation qualification (IQ). The manufacturer itself has a much lighter burden and a streamlined path to a validated system and process.
A more relaxed software release schedule eases the validation burden on life sciences companies because the software is updated once a year rather than multiple times. This gives them a continuously updated and maintained labelling solution without increasing the validation workload on their IT staff.
The manufacturer would of course need to work closely alongside the vendor and review the documentation, but, if needed, the vendor is able to do much of the work for them, providing not only the full validation acceleration pack but also professional services to assist with the validation process.
While some medical device manufacturers choose to tackle validation on their own, the vendor supplied validation acceleration pack or documentation helps to simplify the process. Consultancy and advice around validation is usually available from the vendor, tailored to the business’s specific needs.
Given the immense hassles of compliance for small device manufacturers, cloud-based labelling systems offer the benefits of a full label management system while easing compliance and validation. This is a future-proof technology. With a cloud-based labelling system, medical device manufacturers can be confident that they are running the most up-to-date software, enabling them to address the fast-changing new regulations and cope with whatever comes their way. And especially in the current pandemic, when face-to-face meetings are still problematic, it is a perfect way to keep labelling operations moving forward.