GMP Sterilization Equipment > Industrial GMP Sterilization Autoclaves

Industrial GMP Sterilization Autoclaves

Industrial GMP autoclaves: Excellence in tailor-made sterilization

A specialist in high-performance sterilization, Actini Group designs custom cGMP industrial autoclaves that combine thermal performance, regulatory compliance, and industrial robustness. A true cornerstone of the pharmaceutical, biotechnology, and medical industries, the GMP autoclave ensures optimal saturated steam sterilization for equipment and products in direct contact with active substances. Constructed from stainless steel and equipped with advanced automated control systems, our equipment ensures complete cycle traceability and validated reproducibility, guaranteeing total process safety and absolute day-to-day reliability.

  • Capacity: From 30 to 24,000 liters per cycle
  • Industries served: pharmaceutical, biotechnology, food processing, cosmetic laboratories and industries.

Discover our GMP sterilization autoclaves

Industrial sterilization excellence made in France

Proud of its roots, Actini Group ensures 100% French design and manufacturing within its own workshops. This local expertise allows us to guarantee : impeccable finishing quality, rigorous control of every component and optimal technical responsiveness By choosing an Actini Group autoclave, you benefit from cutting-edge engineering expertise capable of handling the most complex projects, while ensuring local technical support and long-term durability aligned with French manufacturing standards.

cGMP Expertise at the Service of Your Production

A GMP industrial autoclave is not simply a sterilizer, it is critical equipment.At Actini Group, we transform regulatory constraints into performance drivers. Our equipment is designed to facilitate your qualification stages (IQ/OQ) and guarantee robust PQ (Performance Qualification) validation of sterilization cycles.

The Pillars of Actini Group Solutions

  • Total compliance : Equipment designed according to ISPE recommendations, GAMP 5 guidelines, and FDA standards (GMP regulations).
  • Ergonomics & HSE : Optimized access, loading heights, and reduced footprint.
  • Energy efficiency : Optimized cycles to reduce water and energy consumption.
  • Simplified maintenance : Optional remote technical skid to isolate maintenance areas from cleanrooms.

Designed for performance and its users

  • Reliability and traceability thanks to a cycle monitoring and management system tailored to your needs
  • Ergonomic design of access, height, and loading to meet your HSE requirements
  • Optimized cycles for maximum energy efficiency
  • Integrated clean steam production
  • Location of technical areas facilitating maintenance operations (remote skid option)
Autoclave de stérilisation industriel Actini Group

Selection guide: 3 technologies for 3 types of needs

Technology

Main Application

Key Advantage

Vacuum–Steam Porous loads (textiles, filters) and stainless steel Complete thermal penetration
Superheated Water Liquid loads in sealed containers Protection against container bursting
Ventilated (Air–Steam) Highly sensitive loads (filled syringes) Precise pressure control

cGMP solutions for pharmaceutical industry requirements

The pharmaceutical sector imposes critical standards in terms of quality, safety, and traceability. To transform these regulatory constraints into performance drivers, Actini Group designs autoclaves specifically adapted to the most sensitive applications.
Each system ensures: efficient and homogeneous sterilization, strict compliance with Good Manufacturing Practices (GMP), adherence to international standards (FDA) Thanks to a robust design and full control of critical parameters (temperature and pressure), our autoclaves provide absolute reliability for production environments requiring fully validated processes.

Actini Group autoclaves: industrial performance and optimal laboratory integration

Actini Group industrial autoclaves combine proven industrial performance and robustness with the ability to be integrated directly into laboratory environments.

These autoclaves offer several key advantages that make them a benchmark solution for laboratories:

  • cGMP Design: Specifically engineered for pharmaceutical, biotechnology, and research environments.
  • Wide Capacity Range: From 30 L to 24,000 L per cycle, suitable for both laboratory use and full-scale production lines.
  • Flexible Loading and Format Options: Sliding doors, trolleys, floor-mounted designs, and more, facilitating installation and operation in laboratory settings.
  • Automated Cycle Control and Data Traceability: Ensures safety, reproducibility, and compliance with international laboratory standards.
  • Made in France Manufacturing: Full control over components and control interfaces guarantees high-quality fabrication and technical support adapted to critical laboratory requirements.

In summary, thanks to their robust design, integration flexibility, and high compliance, Actini Group autoclaves are ideally suited for demanding laboratory environments.

SoBatch Supervision and Programming

Native to our autoclaves, the SoBatch supervision system (Schneider or Siemens) meets the requirements of 21 CFR Part 11.

  • Absolute traceability : Audit trail and batch reports exportable to your server.
  • Flexibility : Management of up to 5 user levels and centralized supervision.
  • Expert cycles : Leak test, Bowie-Dick cycle, Air filter SIP, Steam sampling

SoBatch features

  • Access to settings
  • Process curves
  • Export of raw data and batch reports
  • Communication with your computer server
  • Management of up to 5 user levels
  • Centralized supervision of up to 3 devices
  • Audit Trail
  • Adjustment of analog inputs

Cycles programmed natively with SoBatch

  • Sterilization cycle for solids and liquids
  • Sterilization cycle (SIP) for compressed air filters
  • WIT cycle for compressed air filters
  • Leak test
  • Bowie-Dick cycle
  • Steam sampling

Technical data

Icone conception

Features

Capacity: 500 liters Max. pressure: 3 barg Max. temperature: 143°C

Types of charges

Liquids, solids, porous materials

Icone ouverture

Opening

Single or crosswise Horizontal or vertical sliding opening, or hinged

Loading

Carrier trolley Modular shelf baskets Automatic loading Full-height loading (optional)

Our different sterilization autoclaves

Vacuum–Steam Autoclave

The saturated steam autoclave technology, also called a classical autoclave, is mainly used for sterilizing parts in contact with the final product.

It allows treatment of: open vials, empty syringes, stoppers and caps, instruments and format parts. Textiles, tools, equipment, and solid components can also be sterilized at temperatures above 105 °C, ensuring reliable sterilization.

Conception 3D d'un autoclave GMP sur mesure et intégration CAO dans une zone de production
Conception 3D d'un autoclave GMP sur mesure et intégration CAO dans une zone de production

Superheated water autoclave

Technology particularly suited to sterilizing liquid loads. Superheated water allows for better energy transfer and thorough sterilization.

It can process various types of loads, including sealed full vials, ampoules, solution bags, parenteral nutrition bags, and syringes, at temperatures above 105 °C.

Ventilated autoclave

Technology used for treating sensitive loads requiring pressure control and specifically adapted for sterilizing and cooling hermetically sealed containers.

This process allows for the sterilization of various types of loads, including sealed full vials, filled syringes, ampoules, and solution bags, at temperatures above 90 °C.

Modélisation 3D d'un autoclave industriel Actini Group avec skid technique déporté pour optimisation de l'espace en salle propre

Our parallelepiped autoclaves range

Ref.

Width (mm)

Height (mm)

Depth (mm)

Volume (liters)

P815 800 1.500 2.000 2.400
P912 900 1.200 1.500 1.620
P916 900 1.600 2.000 2.880
P1010 1.000 1.000 1.000 1.000
P1012 1.000 1.200 2.000 2.400
P1419 1.400 1.900 2.000 5.320
P1520 1.500 2.000 2.000 6.000

Our range of cylindrical autoclaves

Ref.

Width (mm)

Height (mm)

Depth (mm)

Volume (liters)

C70 700 700 From 1.000 to 3.700 From 5.000 to 1.800
C80 800 800 From 1.000 to 3.700 From 640 to 2.350
C90 900 900 From 1.000 to 3.700 From 810 to 3.000
C100 1.000 1.000 From 1.000 to 5.000 From 1.000 to 5.000
C120 1.200 1.200 From 1.000 to 9.900 From 1.440 to 14.520
C1520 1.500 2.000 From 2.000 to 11.500 From 6.000 to 34.500

Options

  • Integrity test
  • Vapor sampling
  • Remote connection
  • Traceability of materials outside the process
  • Containment by BioSeal
  • Remote technical skid
  • Soft WinCC pro

Studies of utility, connectivity, and scalability

  • Sizing of required utilities (electricity, steam, demineralized water, compressed air, N2, etc.) and drainage to be provided
  • Integration of a controlled steam generator if required
  • Sterilizing filtration of fluids with optional integrity testing in place
  • Possibility of relocating the technical skid for restricted environments

Tailor-made support, from project to implementation

Our teams support you at every stage: sizing of utilities (steam, demineralized water, N₂), integration of controlled generators, and sterilizing filtration with integrity testing.
From 30L to 24,000L, we adapt the thermal kinetics to the sensitivity of your active substances.

A complex GMP sterilization project?

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