MEDICAL BACTIglas
testing data to avoid regulatory action. Global market access adds complexity, as EU
maintains the proximity of these points, but as a non-migratory additive, a substantial portion of the active remains in the body of the item, unavailable for antimicrobial effect and thus unused. Manufacturing solutions that could be considered at the project’s outset include active skin layers achieved through techniques such as twin-shot moulding or coextrusion, providing enhanced performance and cost-effectiveness.
How do you assess whether an antimicrobial material performs reliably over the expected lifetime of a medical product, especially when exposed to cleaning agents or sterilisation cycles? Establishing the desired performance is a critical step in the development journey. Key questions that should be addressed include: What is the function of the antimicrobial within the device? tested to demonstrate claimed functionality? Antimicrobials are incorporated into polymers
in tubing, control bacterial growth where condensate collects, such as in respiratory equipment, or maintain clean surfaces at frequent touchpoints like light switches. Each application faces vastly different cleaning protocols and functional lifespans—some devices are single-use building’s infrastructure. ISO 22196 serves as the primary test method
for measuring antibacterial activity on plastics and non-porous surfaces, providing quantitative applications often demand testing beyond standard ISO and ASTM methods. Bespoke elution tests may subject articles to repeated washing protocols using standardized cleaning the repeated microbial challenges faced by
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products like light switches or handrails. Thus durability testing can be designed to assess performance degradation over extended periods or multiple cleaning cycles. The key is working in partnership with customers to develop comprehensive testing environment and substantiate all proposed claims. This collaborative approach ensures that antimicrobial performance translates from laboratory results to real-world effectiveness, providing genuine value in the intended use case.
What testing standards or regulatory frameworks are most relevant for antimicrobial materials used in healthcare settings, and how do they shape product development? The development of antimicrobial materials for healthcare applications is governed by a complex regulatory landscape. In the European Union, antimicrobial materials fall under dual pathways: the Medical Device Regulation (MDR 2017/745) for medical products, and the Biocidal Products Regulation (BPR 528/2012) for antimicrobial claims. If antimicrobial function is the primary purpose, BPR applies; if it’s an ancillary feature, MDR may be primary, though BPR requirements for the active substance still apply. While in the United States, the FDA regulates antimicrobial medical devices under 21 CFR antimicrobial claims under FIFRA for public health products.
These regulatory frameworks directly impact
development decisions. Active substance selection is limited to those meeting the appropriate jurisdictional regulations, immediately reducing available options. Complete documentation of formulation, manufacturing processes, and supply chain traceability is essential, highlighting the critical importance of supplier selection from the outset. Furthermore, marketing claims must be carefully worded and may require substantiating
approvals may not translate to the US, Asia, or other regions, hence understanding of these different regulatory frameworks is crucial to The evolving landscape, with growing focus on antimicrobial resistance and environmental impact, continues to shape which technologies gain acceptance, making regulatory expertise essential for innovation in this sector. With the increasing focus on antimicrobial resistance, what considerations should manufacturers keep in mind when selecting or implementing antimicrobial technologies in medical applications? It must be remembered that the incorporation of an antimicrobial is not an alternative to appropriate cleaning regimes—it is a technology designed to complement good hygiene practices and assist in controlling microbial activity on a surface between cleaning cycles.
Selecting antimicrobial technologies that are
less likely to lead to antimicrobial resistance involves understanding their mechanism of action. Antimicrobials that operate through metabolic pathways or cellular structures. Single-target antimicrobials, including many enzymes, proteins, or cellular structures. Bacteria can develop resistance through mutations affecting the target site, production of enzymes that makes these agents effective also creates vulnerability—a single genetic change can confer resistance. Multi-target antimicrobials act through multiple
simultaneous mechanisms that would require numerous coordinated genetic changes to overcome. Metallic antimicrobials such as silver, copper, and zinc exemplify this approach. Silver ions disrupt multiple cellular processes: they bind to bacterial cell walls causing structural damage, interfere with cellular respiration by interacting with enzymes, generate reactive oxygen species that damage DNA and proteins, and disrupt cellular transport systems. The probability that a microorganism would simultaneously develop resistance to all these mechanisms remains extremely low, which explains why silver has been used for millennia without widespread resistance development. It is this multi-faceted mode of action that
makes silver-based systems particularly valuable in healthcare environments where antimicrobial resistance is a growing concern, offering effective protection while minimising the risk of contributing to resistance patterns.
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November/December 2025 Irish Manufacturing 37
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