Anti-microbial masterbatches based on MedX anti-microbial agents from SANITIZED® AG has been added by Clariant to its dedicated MEVOPUR® range, to support the development of medical devices with surfaces that are active against bacteria. Independent testing of the active ingredients by Sanitized has shown them to be effective against antibiotic resistant strains.
The development responds to the increased need for anti-microbials in applications such as surgical instruments, catheters, connectors for tubing, and in-line filters to help reduce the transmission of bacteria that are potential causes of secondary infection. It has been noted in publications that there is a serious risk of death from catheter-related nosocomial infection. There is also increasing interest in evaluating anti-microbials for pharmaceutical packaging, such as inhalers and ophthalmic solutions.
Clariant’s long-standing partnership with Sanitized benefits customers in a range of application sectors, including textiles and consumer goods. For the new MEVOPUR masterbatches, Sanitized manufactures the active MedX anti-microbial ingredient – silver (Ag+) on a glass carrier – according to the strict quality control and impurity check requirements stipulated by Clariant. Clariant then carries out biological evaluation based on the ISO10993 test protocols developed for medical raw materials. This includes ISO10993 part 18 material characterization at its ISO17025 certified laboratory in Singapore. The laboratory is fundamental to its global approach to raw material control and consistency within its medical and pharmaceutical segment, and played a key role in the development of the MEVOPUR products.
Taking these active ingredients, Clariant develops and proposes a masterbatch for evaluation according to the final customer requirements for a specific application, using grade polymers polyethylene (PE), polypropylene (PP) or polycarbonate (PC) proposed for medical applications, for example, by combining with pigments into the masterbatch to create a ‘combibatch’. Also, in the case of transparent / translucent applications Clariant selects an active ingredient with a similar refractive index to that of the host polymer to give the possibility of maintaining a level of transparency in the final application. The masterbatch offers a convenient form to deliver the active ingredient into the host polymer. The level of the MedX antimicrobial agent is selected according to the needs of the chosen polymer and device design, based on Sanitized’s recommendations. However there are a number of factors that influence performance of the agent; such as the device design, host polymer, type of bacteria, conditions under which the device is used etc. The initial recommendation is a starting point, and the medical device producer therefore needs to evaluate, and determine the level that meets the requirements.
As the anti-microbial agent is integrated into the polymer, it removes the need for device manufacturers to undertake a secondary antimicrobial coating operation on their medical device, with the associated cost and validation processes that are required.
“Offering antimicrobial masterbatches within the MEVOPUR brand means our customers can benefit from the Controlled, Consistent and Compliant conditions under which our masterbatches are produced,” comments Steve Duckworth, Head of Global Segment Medical and Pharmaceutical, Clariant. “To add to our customers’ peace of mind, Sanitized offers testing of the effectiveness of the antimicrobial agent in the finished article, and the opportunity of a brand license that enables device companies to use the internationally recognized Sanitized logo with their product.”