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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.

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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.

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REPEATABLE MICROBIAL LETHALITY

Our patented injector architecture demonstrated lower variability, improved repeatability and up to 20% lower hydrogen peroxide consumption compared with conventional injection systems, without dependency on proprietary hydrogen peroxide formulations.

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EFFECTIVE STERILIZATION OF COMPLEX PRODUCTS

Deep vacuum conditions improve both penetration and aeration, supporting challenging products, packaging systems and load configurations.

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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.

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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.

PRESSURE CONTROL
In saturated steam sterilization, pressure governs steam conditions. Controlling pressure supports temperature uniformity and repeatable process behavior. 
±0.5°C UNIFORMITY
Temperature standard deviation is a key indicator of process behavior. The tighter the deviation, the greater the stability and repeatability across the entire load. 
DRY-LOADS
Critical components 
emerge sterile, dry and ready for immediate use. 
CANISTER PROVEN
We support advanced  canister-based transfer strategies while preserving filter integrity, drying performance and sterile transfer conditions.

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.

Proven by numbers

PROVEN BY NUMBERS

SAL ≤ 10⁻⁶
sterility assurance Level

0
quarantine

>40 m³
chamber capacity , effective volumes

- 70%
cycle time compared to EtO

WHEN SHOULD YOU CHOOSE OUR TECHNOLOGY

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.

FREQUENTLY ASKED QUESTIONS

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.

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