Medical devices are becoming more sophisticated, with embedded electronics, multi-material assemblies and miniaturisation. Not only this, but manufacturers are experiencing the rising pressure of both UK and global regulatory framework under UKCA marking, MDR principles, ISO sterilisation compliance, FDA and MDSAP requirements. The drive to reduce environmental impact, energy consumption and improve chemical safety also plays a significant role in the entire process.
Therefore, the challenge of sterilising medical devices safely and consistently grows alongside this. Traditional EO sterilisation remains widely used, alongside gamma and steam, but these are affected by different supply chain threats or material suitability issues, so alternative technologies are more in demand than ever.
Although BDK is not a sterilisation house, our ISO 13485 certification includes sterilisation so we are able to take on the responsibility for sterilisation and work with subcontract sterilisation service providers. Also, we develop medical device and dressing products where design choices must take sterilisation compatibility into account. As new sterilisation methods emerge, understanding material interactions is increasingly important.
Emerging Sterilisation Technologies
It’s important to note that while many new innovations in medical device sterilisation technology show strong potential, regulatory acceptance for terminal sterilisation varies significantly by modality. Manufacturers must carefully assess regulatory expectations, validation pathways and intended use when considering alternative approaches.
Cold Plasma Sterilisation
Both atmospheric and low-pressure cold plasma sterilisation deliver rapid, chemical-free, low-temperature surface sterilisation. These systems generate reactive species that inactivate microorganisms without heat damage. This makes them ideal for sensitive polymeric components and precision assemblies.
Plasma exposure can alter surface energy which can potentially affect bond stability and long-term tack. Therefore, stability testing is essential to confirm whether surface oxidisation is caused or adhesive chemistry is compromised.
Low-Temperature Hydrogen Peroxide Vapour (VHP) Sterilisation
Already well-established in some medical device categories, particularly those containing electronics or microfluidic components, VHP sterilisation is a low-temperature solution for those that cannot tolerate steam or dry heat.
However, adhesives and tapes with moisture sensitivity may swell or soften during this process. Residual hydrogen peroxide can interact with certain chemistries resulting in reduced adhesive clarity, bond strength or polymer backings. As a result, manufacturers require more adhesive materials specifically formulated for vapour compatibility.
Supercritical CO₂ Sterilisation
Supercritical CO₂ offers a low-thermal and low-oxidative alternative, ideal for biological components and delicate materials. Because it penetrates without leaving toxic residues, it is gaining traction in high-value device applications.
From an adhesive perspective, supercritical CO₂ can cause temporary swelling or residue which may weaken bonds or alter mechanical properties. Careful adhesive selection and cycle testing are needed to ensure that assembly integrity is maintained.
X-ray & Electron-Beam (E-Beam)
One of the most active areas for innovation is radiation sterilisation. Both X-ray and E-beam methods demonstrate improved dose control, better uniformity and enhanced penetration modelling. However, radiation remains as one of the most challenging environments for adhesives.
Some common material degradation risks for polymers and adhesives systems include chain scission, colour changes and loss of cohesive strength. Many adhesives show adverse performance after exposure, limiting their use in certain bonded assemblies. Even though E-beam has been positioned as “the next major sterilisation technology” for over a decade, widespread adoption has been gradual because of this.
Ozone & UV-C Hybrid Systems
Ozone and UV-C hybrid systems are emerging as potential point-of-use or decentralised solutions as they offer rapid sterilisation without thermal or chemical stress. This is particularly true for devices requiring surface-level decontamination.
Light-sensitive adhesives, however, may degrade under this exposure and ozone technology can react with elastomers or pressure-sensitive adhesives. These considerations must be factored into design decisions long before production scaling.
Improvements in Existing Sterilisation Validation Approaches
ISO Sterilisation Standards
Standards such as ISO 11135 (ethylene oxide), ISO 17665 (steam), and ISO 11137 (radiation) continue to develop. For manufacturers preparing for UKCA and MDR compliance, there is greater emphasis on traceability and risk-based validation for the documentation. It’s important to note that adhesive components can complicate validation cycles as they may hold moisture, ethylene oxide (EO) residues or behave differently under load or temperature shifts.
Data-Driven Validation & Cycle Optimisation
Manufacturers are now using digital twins, computational modelling and sensor monitoring to predict sterilisation effects on device assemblies. This is particularly useful for multi-layered adhesive structures or bonded components where airflow or vapour penetration is not uniform. By understanding adhesive behaviour across varying temperature and humidity cycles supports accurate validation and less rework.
Reduced EO Residuals
As a whole, the medical device manufacturing industry is moving towards lower EO dependency and shorter aeration requirements. This shift affects barrier materials, coatings and adhesive layers that must resist EO absorption whilst still allowing diffusion.
Material Considerations for Innovative Sterilisation Technology
Adhesive Stability Across Sterilisation Modalities
Different sterilisation methods expose adhesives to different conditions, for example:
- Heat can cause softening, outgassing, or loss of cohesion
- Radiation may cause brittleness or chemical degradation
- Oxidation affects ageing, tack, and long-term flexibility
Therefore, selecting the right sterilisation method for the right materials is fundamental.
Device Assembly Impacts
Post-sterilisation bond strength can vary significantly; however, adhesives influence more than just bonding. Outgassing can affect sensitive diagnostic surfaces and adhesive migration under heat or vapour can compromise tolerances. Designing medical devices with sterilisation in mind encourages early planning for adhesive placement, joint geometry and multi-material layering.
Adhesive Innovations Supporting New Sterilisation Technologies
As new sterilisation technologies develop, so do adhesive innovations to further support this. Emerging adhesive formulations now aim to resist degradation under plasma or vapour sterilisation, reduce residue formation and enable antimicrobial or indicator properties within the adhesive layer.
Role of Packaging in Sterilisation Selection
Common medical packaging materials, such as Tyvek®, polymer films, and seal adhesives, each present different characteristics that can enable or restrict specific sterilisation modalities, such as permeability, thermal, and chemical resistance.
For example, plasma and vapour-based systems may have limited compatibility with certain films or seal layers, while radiation-based methods can impact package integrity or seal strength. Dose mapping and penetration effectiveness are also dependent on packaging and material selection.
As a result, packaging design and sterilisation must be developed in parallel from the earliest stages of product development.
R&D Challenges When Adopting New Sterilisation Technologies
Polymer & Adhesive Compatibility Testing
Chemical interaction risks may increase with newer modalities; issues to be aware of include:
- Oxidation or chain scission under radiation
- Moisture absorption during vapour cycles
- Polymer softening under CO₂ plasticisation
It’s important to conduct thorough testing, such as delamination checks, tack evaluations, colour stability, and adhesive ageing studies, to reduce the risks and correct any problems early on in the manufacturing process.
Ensuring Biocompatibility Post-Sterilisation
Sterilisation can change surface energy, alter adhesive chemistry or trigger formation of by-products. Cytotoxicity, extractables and leachables studies must confirm that adhesives remain biocompatible post-sterilisation, especially for skin-contact or implantable devices.
Durability & Multi-Material Assembly Performance
Complex assemblies mixing different material interfaces, like metals, TPEs, silicones, and films, can react differently under sterilisation. Bonded flexible components used in wearables or sensors require especially careful testing.
Accelerated Development Timelines
R&D teams face pressure to choose a sterilisation pathway earlier in development cycles. Adhesive compatibility data must be gathered early to avoid costly design delays, adjustments or regulatory documentation corrections.
Procurement Considerations for New Sterilisation Tech
Cost Implications
New sterilisation technologies may reduce per-cycle energy use but often require higher upfront investment. Switching adhesives or materials to achieve compatibility also impacts the cost of materials.
Supply Chain Stability
Procurement teams must verify that adhesive suppliers and component manufacturers meet UK regulatory requirements and can support the chosen sterilisation pathway.
Long-Term Scalability & Outsourcing
For many manufacturers, outsourcing sterilisation remains essential. Ensuring compatibility between adhesives and third-party sterilisation methods is critical, particularly when using newer or less standardised modalities.
How BDK Helps with Sterilisation
As the industry explores new sterilisation technologies, material compatibility becomes even more essential. As one of the most sensitive components in this process, it’s vital to choose the right method for the adhesives early on to ensure devices remain stable, compliant and high performing.
While BDK is not a sterilisation provider, we have a deep understanding of adhesive behaviour across multiple sterilisation environments. As part of our ISO 13485 accreditation, we can help control and manage the sterilisation of your product with accurate validation methods and packaging of sterile medical devices in our cleanroom environment.
We are your valuable partner during design, material selection and manufacturing processes, helping take your product from conception through to market. Contact us today to discuss your next project.