Terminal sterilization
for liquids

Small molecules continue to account for the majority of sterile pharmaceutical products worldwide. For these formulations, terminal sterilization remains the preferred approach to sterility assurance because it allows the final packaged product to be sterilized after filling.

Yet, sterilizing liquids in closed containers is not simply a question of lethality. Thermal expansion, vapor generation and pressure build-up continuously affect the product-container system throughout the cycle. The challenge is therefore twofold: achieving the required sterility while preserving the integrity of the container, closure system and product itself.

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ACHIEVING MICROBIAL LETHALITY IS ONLY ONE PART OF THE CHALLENGE.

PRESSURE, HEAT TRANSFER AND PACKAGE INTEGRITY MUST BE GOVERNED TOGETHER THROUGHOUT THE ENTIRE CYCLE.

Our approach is built on decades of sterilization expertise, including the contribution of V. Mascherpa and D. Pistolesi to the understanding and industrial application of F₀ sterilization.

Delivering lethality while preserving product-container integrity.

For heat-stable sterile pharmaceuticals, we enable terminal sterilization by governing lethality, pressure, heat transfer and package integrity as a single process, ensuring that sterility and product-container integrity are achieved together.

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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.

Why use steam-air instead of pure steam?

Steam-air technology allows chamber pressure to be controlled independently from temperature. This capability is essential when sterilizing liquids in closed containers where package integrity depends on maintaining a controlled pressure balance.

How are containers protected during sterilization?

Controlled counterpressure is applied throughout the cycle to balance the pressure generated inside the container. This reduces the risk of deformation, rupture and closure-system failures.

Why is pressure control critical for prefilled syringes?

During sterilization, thermal expansion and pressure build-up can cause plunger movement and affect closure-system integrity. Carefully designed pressure profiles help control these phenomena and preserve the product-container system.

How is temperature uniformity achieved?

Forced circulation of the steam-air mixture through magnetically coupled fans and dedicated airflow management devices prevents stratification and promotes homogeneous heat distribution throughout the chamber.

How is sterilization performance demonstrated?

Sterilization performance is demonstrated through integrated lethality calculations, including F₀, Lethality Factor (Lf) and sterilization time calculations, combined with continuous process monitoring and recording.

Is this technology suitable for plastic and flexible containers?

Yes. The ability to control pressure independently from temperature allows pressure-sensitive packaging systems to be sterilized and cooled while reducing the risk of deformation and package damage.