Low temperature sterilization
Many products cannot tolerate the temperatures and humidity associated with moist heat sterilization. At the same time, increasing regulatory and environmental pressure is accelerating the search for alternatives to Ethylene Oxide (EtO), particularly in medical device manufacturing.
Hydrogen peroxide sterilization provides an effective alternative for heat-sensitive products. The challenge is achieving microbial lethality without condensation, material damage, excessive hydrogen peroxide consumption or prolonged aeration times.
ANYONE CAN INTRODUCE HYDROGEN INTO A CHAMBER. EFFECTIVE STERILIZATION BEGINS WHEN YOU CAN CONTROL WHAT HAPPENS NEXT.
The challenge is ensuring that every surface receives the right concentration, for the right time, without condensation and without compromising the product.
This is where our expertise resides.
Predictable sterilization performance across sensitive products, complex geometries and industrial-scale loads.
Through control of hydrogen peroxide generation, distribution, penetration and aeration, we enable low-temperature sterilization where process complexity would otherwise limit performance.
EFFECTIVE STERILIZATION OF COMPLEX PRODUCTS
Deep vacuum conditions improve both penetration and aeration, supporting challenging products, packaging systems and load configurations.
INDUSTRIAL-SCALE LOW-TEMPERATURE STERILIZATION
Maintaining process control becomes increasingly complex as chamber volume increases.
We support effective chamber volumes exceeding 40 m³ while maintaining the process conditions required for low-temperature sterilization.
ONE PLATFORM, MULTIPLE STERILIZATION STRATEGIES
Different products often require different sterilization principles.
Moist heat and hydrogen peroxide sterilization capabilities can be combined within the same platform according to process requirements.
emerge sterile, dry and ready for immediate use.
DEDICATED PROCESS CONTROL FUNCTIONS
Low-temperature sterilization depends on the ability to govern and document critical process conditions throughout the entire cycle.
Our Process Control architecture includes:
- Parametric Release
- Audit Trail
- Continuous process monitoring
- Configurable vacuum, injection and aeration parameters
Together, these functions provide objective evidence of process performance, support validation activities and ensure complete process traceability.
MEDICAL DEVICE ASSEMBLIES
Tubing sets, blood lines and disposable assemblies requiring validated microbial lethality without thermal damage.
EtO REPLACEMENT
As manufacturers move away from Ethylene Oxide, hydrogen peroxide sterilization provides an alternative for products requiring validated sterility assurance without the operational constraints associated with EtO processing.
COMPLEX PRODUCTS AND PACKAGING SYSTEMS
Combination products, challenging geometries, multiple layers of packaging or difficult-to-access surfaces require effective sterilant penetration together with controlled aeration and residual removal.
INDUSTRIAL-SCALE PRODUCTION
Large-scale manufacturing environments require process consistency across increasing load sizes while preserving product integrity and sterilization performance.
Why is hydrogen peroxide distribution important?
Uniform sterilant distribution is essential to achieve repeatable microbial lethality across the entire load.
Can any hydrogen peroxide formulation be used?
Yes. The process can be developed using any hydrogen peroxide supplier and concentration without dependency on proprietary formulations.
What role does deep vacuum play?
Deep vacuum improves sterilant penetration while supporting efficient aeration and residual removal.
How are compliance and traceability supported?
Parametric Release and Audit Trail provide process evaluation, traceability and documentation throughout the sterilization lifecycle.
ARTIFICIAL VALVES
Artificial valves combine long-term implant performance with exceptional material and geometrical complexity. Biological tissues or collagen-based components may coexist with implantable textiles, polymeric films, metallic structures and surface treatments. The sterilization process must reach external surfaces, internal cavities, layered structures and interfaces between dissimilar materials without altering mechanical response, dimensional stability, biocompatibility or haemodynamic function.
PACKAGED SURGICAL SUTURES
Packaged surgical sutures combine variables that respond differently to sterilization: absorbable or non-absorbable polymers, braided or monofilament structures, functional coatings and multilayer barrier systems. The combinations to be treated may span Polyglactin 910, Polydioxanone, Polyester, Polyamide, Polypropylene and Polyethylene, together with aluminium pouches, paper–plastic laminates, Tyvek® sterile-barrier systems and more complex polymeric assemblies. Sterilization must therefore do more than achieve microbial inactivation.
COMBINATION PRODUCTS
Drug-device combination products can bring together a thermosensitive drug, a complex delivery system and a protective package within a single sterilization challenge. For blistered prefilled syringes, the process must reach external surfaces, recessed areas and partially enclosed geometries without exposing the filled product to damaging temperatures. Sterilant penetration through the Tyvek® layer must therefore be demonstrated, together with microbial effectiveness inside the blister and around critical syringe components.
RTU CARTRIDGES
RTU manufacturing carries more value - and more responsibility.
Ready-to-use cartridge manufacturers are taking on a critical role in biopharmaceutical supply chains. By supplying cartridges already washed, depyrogenated, siliconized, assembled, packaged and sterile, they enable pharma companies to outsource container preparation and the associated validation burden.
RTU VIALS
Ready-to-fill vial manufacturers supply pharmaceutical companies with primary containers that are already washed, depyrogenated, packaged and sterile, transferring container preparation and part of its qualification burden upstream. Growing demand for injectable biologics is increasing production volumes while making conventional sterilization routes more difficult to sustain. Steam may exceed the thermal limits of some packaging materials, while EtO introduces toxic-residue concerns and extended degassing times.
GLASS VIALS
The rapid growth of biologics, nanoparticle-based medicines and Advanced Therapy Medicinal Products (ATMPs) is redefining the relationship between pharmaceutical formulations and primary packaging.
Interactions between proteins such as insulin, nanoparticles and container surfaces are well-recognised phenomena that can influence product stability, efficacy and patient safety. As these therapies become increasingly sensitive, material compatibility can no longer be considered an intrinsic property of the container alone.
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