High Temperature
for Porous loads

Manufacturing components such as stoppers, filters, garments and silicone tubing requires more than achieving sterility. Manufacturers must be able to consistently demonstrate that every critical surface has been effectively sterilized, batch after batch, providing objective evidence for process validation and regulatory confidence.

Residual air can prevent saturated steam from reaching every critical surface. For this reason EU GMP Annex 1 and EN ISO 17665 require validated assurance of air removal whenever porous-load sterilization relies on air purging, ensuring validation is supported by objective process evidence rather than assumptions.

Request more information

VALIDATED AIR REMOVAL IS MORE THAN A PROCESS PHASE. IT IS THE CONDITION THAT MAKES POROUS-LOAD STERILIZATION POSSIBLE.

Fedegari doesn't simply expose porous loads to saturated steam. We demonstrate, on every production cycle, that the physical conditions required for effective steam penetration have been achieved before sterilization begins..

This is why Fedegari governs air removal, steam penetration and drying as one continuous process, transforming regulatory expectations into objective process evidence for every production cycle.

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.

Fedegari's Process Control architecture integrates dedicated functions specifically developed for porous-load sterilization:

Integrated Air Detector
Fast, slow and modulated vacuum pulse strategies
F₀ calculation
Sterilization Time (ts) calculation
Continuous recording of temperatures, pressures and phase transitions

Together, these functions provide objective evidence that air removal, steam penetration and drying have been performed under validated process conditions throughout every production cycle.

BETABAG STOPPER STERILIZATION

Sterilization of stoppers within BetaBags requires dedicated air removal, controlled steam penetration and optimized drying to achieve exceptionally low residual humidity while preserving packaging integrity and supporting immediate aseptic use.

Why isn't F₀ sufficient for porous-load sterilization?

Unlike liquid loads, porous-load sterilization also requires saturated steam to reach every critical surface. Effective air removal is therefore essential to establish the conditions required for sterilization. This distinction is reflected in EU GMP Annex 1 (§§8.57–8.59), where F₀ is recognized as a validation parameter for aqueous solutions, while porous loads require effective steam penetration.

Why is validated air removal required?

Residual air and non-condensable gases can prevent direct steam contact within porous materials. EU GMP Annex 1 (§8.61) and EN ISO 17665:2024 require validated assurance of air removal whenever porous-load sterilization relies on air purging, making validated air removal a prerequisite for demonstrating effective steam penetration.

Why are different vacuum pulse strategies required?

Different porous materials and packaging configurations retain air differently. Fast, slow and modulated vacuum pulse strategies are selected according to the physical behaviour of each load, ensuring repeatable air removal, steam penetration and drying across different porous applications.

How does the integrated air detector support process control?

The integrated air detector verifies that effective air removal has been achieved before the sterilization phase begins, providing continuous in-process evidence on every production cycle. This approach is recognized by EN ISO 17665:2024, EN 285:2015, PDA Technical Report No. 1 and EU GMP Annex 1 (§8.61) as a validated means of providing assurance of air removal.

How is low residual humidity achieved?

Dedicated drying phases remove residual moisture while preserving the integrity of both the load and its packaging.

Which applications is this technology designed for?

Typical applications include sterilizing filters, stoppers in bags, garments, silicone tubing, canisters and other porous loads used in pharmaceutical and biotechnology manufacturing.

What's the difference between a pressure-based and a temperature-based air detector?

Temperature-based air detectors infer the presence of residual air from temperature measurements. Pressure-based systems assess whether chamber conditions correspond to saturated steam conditions, allowing the presence of residual non-condensable gases to be identified using a different physical principle. Both approaches support air removal monitoring, but they rely on different methods of detection.