Produits > GMP Sterilization Equipment > Ventilated Autoclave (Air-Steam Technology)

Ventilated Autoclave (Air-Steam Technology)

Air-steam autoclave: high-precision retort sterilization

As a major player in thermal processing, Actini Group designs advanced sterilization solutions that meet the strictest cGMP requirements. Our ventilated autoclaves guarantee product integrity through absolute control of the Air-Steam mixture.

Category: Sterilization
Capacity: 30 to 24,000 liters per cycle
Technology: Air-Steam (Ventilated)

Vue de face d'un autoclave ventilé en acier inoxydable avec interface de contrôle tactile et colonne lumineuse de statut.

What is an air-steam ventilated autoclave?

Fluid Control:
Why opt for forced ventilation?

The ventilated autoclave relies on dynamic fluid management. Unlike standard models, it utilizes an internal ventilation system coupled with precise steam injection. This technology is crucial for:

Temperature Homogenization: Continuous stirring guarantees optimal thermal uniformity, even for dense loads.
Overpressure Control: Prevents bursting or deformation of airtight containers (bags, sealed vials, syringes) by balancing internal and external pressures.
Cycle Acceleration: Forced circulation allows for rapid cooling, significantly reducing overall process time.

Sterilization Cycle:
Safety and Traceability

Air Removal
Elimination of residual air pockets to ensure direct steam contact with the load.
Sterilization Plateau
Rigorous maintenance of temperature (121°C or higher) and pressure.
Secured Cooling
Controlled pressure reduction phase, making products immediately handleable without risk of recontamination.

Autoclave ventilé Actini Group pour stérilisation de poches de solutés pharmaceutiques

Advantages of air-steam technology for industry

Choosing an Actini Group ventilated autoclave means opting for enhanced process safety:

Biological Versatility: Effective against the most resistant pathogens (Prions, heat-resistant spores).
Load Protection: Ideal for sensitive loads (IV bags, pre-filled syringes) thanks to precise pressure kinetics control.
Productivity: Faster cycles and integrated drying, limiting additional handling.
Compliance: Equipment designed according to cGMP standards, suitable for BSL-3 and BSL-4 (P3/P4) environments.

Fields of application: multi-sector expertise

Pharma & Biotech: Terminal sterilization of filled vials, ampoules, pre-filled syringes, and IV bags.
High-Security Laboratories: Secure decontamination in BSL-3 or BSL-4 confinement (glassware, culture media).
Food Industry: Precision thermal processing for canned goods and flexible packaging.

Secteurs d'application de l'autoclave ventilé : industries pharmaceutique, biotechnologique et agroalimentaire.

Secure Your Processes with High-Precision Sterilization

Because sensitive loads cannot tolerate pressure fluctuations, Actini Group has developed a technology capable of maintaining the total integrity of your vials, bags, or syringes. From the initial temperature ramp-up to the final cooling phase, every step is optimized to combine biological safety with the preservation of your products’ physicochemical properties.

Étude et design 3D d'un autoclave industriel sur mesure avec technologie Air-Vapeur pour intégration en zone stérile.

Critical applications: focus on hermetic containers

Our Air-Steam expertise provides the technological answer to the challenges posed by containers exposed to biological contaminants. It allows for safely exceeding the 90°C threshold, ensuring perfect sterility while stabilizing the internal pressure of the vessels.

This solution is specifically recommended for:

Filling Units: Sealed filled vials and glass ampoules.
Ready-to-Use Devices: Pre-filled syringes (terminal sterilization).
Parenteral Solutions: Flexible or semi-rigid IV bags.
Research & Production: Any hermetic container sensitive to sudden pressure differentials.

Product Highlights

Design

Rectangular or Cylindrical, compliant with cGMP standards.

Opening

Single or Pass-through (Full SAS), sliding or hinged doors.

Loading

Manual, adjustable trolley, automatic conveying, or floor-level loading.

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Control

Full automation with exportable batch reports (21 CFR Part 11 compliant).

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Custom autoclave design & engineering

Analysis of Loads to be Sterilized

Type of loads: solid and/or liquid
Quantity per batch and per day, weight
Preliminary and/or final sterilization
Type of loading/unloading required (trolley, floor-level, etc.)
Collection tanks
Associated treatments: pre-sterilization washing, H₂O₂ cycle, etc.

Control, Automation & Traceability

Sterile fluid filtration with optional in-place integrity testing
Recipe management and data recording system: batch reports, raw data, exportable to the client’s server

Installation & Environment Study

Containment requirements (P3/P4)
cGMP environment
Choice of single- or double-door autoclave
Adaptation of door opening directions: lateral, vertical, hinged

Sizing & Utilities

Studies of utilities, connectivity, and scalability
Sizing of required utilities: electricity, steam, demineralized water, compressed air, N₂, etc.
Planning of necessary drainage systems
Integration of a controlled steam generator if required

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Sterilization technology comparison

Load Type	Saturated Steam	Superheated Water	Air-Steam (Ventilated)
Porous loads & Stainless steel	Excellence standard	Suitable (spray)	High performance
Sealed liquids	Risk of overpressure	Maximum safety	Precise control
Mixed loads	Long cycles	Excellent homogeneity	Very good distribution
Fragile objects	Direct thermal shock	Thermal progressivity	Rapid cooling

Why entrust your custom autoclave project to Actini Group?

With decades of expertise in heat transfer, Actini Group does more than manufacture machines: we develop integrated engineering solutions. Every project undergoes a thorough analysis of your constraints (fluid types, cooling kinetics, BSL-3/BSL-4 requirements). Our mastery of cGMP and FDA standards, coupled with automation allowing full traceability (Audit Trail 21 CFR Part 11), makes us the preferred partner for the most demanding pharmaceutical and biotech industries.