Project
From the left: Expertise Director in NIRAS Life Science, Jesper Wagner and Vice President of Contura International, Morten Vestergaard
In the manufacturing of medical devices, it's crucial that every product meets specifications and that the production process enables this. Ultimately, reliable and robust processes safeguard the products, making them safe for use and ensuring that they function as intended.
To achieve this constant and reliable flow, regulations are in place to ensure validation of the processes. Validation entails a structured approach aimed at reducing variability in the processes, ensuring consistency, documenting, and thorough testing.
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In 2022, NIRAS was approached by Contura International regarding the expansion of their production of long-lasting, biocompatible, non-degradable hydrogel. This hydrogel has proven to be a blockbuster product, benefiting both humans and animals worldwide suffering from osteoarthritis of the knee as well as stress urinary incontinence.
Contura is also on the verge of tripling its organisation, making it all the more important that growth happens in a structured way. At the same time, it’s crucial for the success of the project that this structure has the flexibility to evolve alongside changing project needs.
“The success of the products and the growth of the company comes with a lot of opportunities but also a need for making sure that we grow in a structured and controlled manner so that we can continue to deliver products of the highest quality. Validation is an important part of this work.” Vice President of Contura International, Morten Vestergaard explains.
“The success of the products and the growth of the company comes with a lot of opportunities but also a need for making sure that we grow in a structured and controlled manner so that we can continue to deliver products of the highest quality. Validation is an important part of this work.” Vice President of Contura International, Morten Vestergaard explains.
Contura’s existing factory was built nearly 20 years ago. Since then, significant regulatory changes regarding validation have been implemented For the new factory, the focus has shifted to a risk-based approach to validation which prioritises critical factors that pose the highest risk to patients.
NIRAS was asked to handle the risk-based validation in this new factory; the key goal was to ensure that process knowledge obtained during validation remained within the company, and that internal knowledge and quality systems were updated alongside the factory's construction phase. Effective management of suppliers would ensure timely delivery and the reuse of test documents during qualification activities is crucial to avoid redundant tests.
“The challenge doesn’t lie in approaching validation, which was relatively straightforward in the case of this new factory, but in understanding Contura's specific needs and uncertainties regarding the process. What initially appeared as a routine task turned out to encompass many more elements which requires a partnership built on trust and mutual respect between the client and NIRAS as a vendor,” Expertise Director in NIRAS Life Science, Jesper Wagner, explains.
Fast-forward 1½ years, Contura’s factory is nearing completion, with ongoing progress in finalising the facility and documentation. Key lessons have been learned, particularly in regard to optimising the risk-based validation approach. This has equipped Contura with enhanced process knowledge and a solid foundation for addressing future challenges. The risk-based approach has been a key element of the validation approach facilitated by NIRAS, and the system was created alongside Contura.
NIRAS is proud of the cooperation and partnership with Contura in the creation of a successful new facility ready to impact patients worldwide.
Contura develops and manufactures innovative medical products in orthopaedics and stress incontinence using its unique, patented hydrogel technology. Their state-of-the-art production facility in Denmark produces products that make a difference to the lives of patients all over the world.
Read more about Contura at https://contura.com/
