Manufacturers of medical technology products worldwide must meet ever higher demands and stricter regulatory requirements of the FDA and MDR.
Since the introduction of the MDR final cleaning and packaging have been critical elements of the product. This leads to a considerable economical effort for medical technology companies.
To optimally support and relieve companies in these processes, the SBS Ecoclean Group, global provider of turnkey cleaning solutions for medical technology, and the globally active VC999 Medical, business unit specialising in packaging machines and pre-validated materials of VC999 Verpackungssysteme AG, entered into a close cooperation. It enables the planning and worldwide delivery of complete turnkey solutions for cleaning and sterile packaging, including packaging validation, from a single source.
The SBS Ecoclean Group and VC999 Medical have concluded a worldwide sales and service cooperation with the aim of minimising both the time and financial effort involved in certifying and validating the cleaning and sterile packaging of medical technology products. Ecoclean supplements its turnkey range for medical technology with the MDR and GMP-compliant packaging systems of VC999 Medical, which, depending on the application, already contain pre-validated packaging materials (PAPE, Tyvek and paper/foil).
Fabio Cordaro, global business development CLP and expert for parts cleaning in medical technology at Ecoclean, said: "The packaging machines and materials from VC999 Medical have been established on the global market for decades and ideally complete our portfolio.
"This enables us to plan and supply manufacturers of medical technology products, such as implants and instruments, with complete turnkey solutions, from preliminary and intermediate cleaning during production to final cleaning and transfer to the cleanroom to sterile packaging."
VC999 Medical is a business unit of the Swiss VC999 Verpackungssysteme AG that specialises in packaging. The has its own packaging validation with a shelf life of ten years.
Jürgen Klein, who is responsible for product management at VC999 Medical, said: “On the one hand, the fact that it is also a global player in the medical technology market spoke in favour of the cooperation with Ecoclean. On the other hand, we got a partner on board who covers the process immediately before packaging.
"This enables us to offer customers quick and effective cleaning and packaging of their products, which contributes to a more efficient production."
The added value that results for customers from the close cooperation includes, on the one hand, increased safety for the processes of professional cleaning and sterile packaging, taking current legislation into account. On the other hand, the effort for certifications and validations is minimised so that they can be used quickly. Added to this is the simple adaptation of the solutions for production sites in different countries and across continents.
For optimal process design and coordination, the partners have mapped a complete process chain from preliminary, intermediate, and final cleaning, including cleanroom and packaging at Ecoclean's Center of Competence in Monschau (Germany). Corresponding trials with original products can be carried out and analysed in laboratories.
