Sterilization > Industrial GMP Sterilization Autoclaves

Industrial GMP Sterilization Autoclaves

Industrial GMP Autoclave: Custom Performance & Reliability

An industrial GMP (Good Manufacturing Practice) autoclave is a sterilization system designed to meet the strict requirements of GMP standards in the pharmaceutical, biotechnology, and medical industries. It enables the saturated steam sterilization of equipment, containers, or products in direct contact with active substances, while ensuring complete cycle traceability and validated reproducibility.

Constructed from stainless steel and equipped with automated control systems, it guarantees regulatory compliance, product safety, and process reliability. Actini Group designs cGMP sterilization autoclaves, either standard or custom, built, and supports clients throughout all phases of their project, from design to equipment qualification.

With proven technology and robust engineering, these autoclaves ensure daily safety, compliance, and reliability. Suitable for the pharmaceutical, cosmetic, and food industries, our autoclaves combine high performance with ease of use to meet your most precise requirements.

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

GMP Equipment Perfectly Tailored to the Requirements of the Pharmaceutical Industry

The pharmaceutical sector is distinguished by particularly strict standards for quality, safety, and traceability. To meet these high requirements, often perceived as significant technical and regulatory challenges, Actini Group designs and manufactures a range of GMP autoclaves specifically developed for pharmaceutical industry applications.

Each pharmaceutical industry autoclave is engineered to ensure effective and uniform sterilization of products, instruments, and materials, while fully complying with Good Manufacturing Practices (GMP) and current international standards. With robust construction, precise control technology, and complete cycle traceability, Actini Group’s GMP autoclaves for the pharmaceutical sector deliver impeccable quality, optimal safety, and full compliance with industry standards.

Precise control of temperature, pressure, and critical process parameters makes every Actini Group GMP autoclave a benchmark piece of equipment for production environments that demand absolute reliability and full validation of sterilization 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

With our SoBatch supervision and programming, you can enjoy fully automated cycles with SCHNEIDER or SIEMENS. You can also centralize the management of your systems across multiple devices.

Developed on Wonderware, SoBatch meets the needs of the pharmaceutical industry and the requirements of 21 CFR Part 11. Beyond regulatory compliance for cGMP equipment, our program has features specifically developed to provide you with flexibility and ease of use in managing and monitoring your recipes and production cycles.

Native in autoclaves, washers, airlocks, and steam generators, SoBatch supervision can be installed independently on devices from other brands as part of an automation retrofit.

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

Features

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

Types of charges

Liquids, solids, porous materials

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

Steam vacuum autoclave

Autoclave technology, also known as saturated steam technology, used mainly for sterilizing items that come into contact with the final product.

They can handle a variety of loads, such as open vials, empty syringes, stoppers and caps, as well as instruments and component parts. Textiles, tools, equipment, and other solid items can also be sterilized at temperatures above 105 °C, ensuring effective and reliable sterilization.

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.

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

Tailored Support, from Standard Solutions to Complex Projects

Contact us to discuss your projects. Our teams of qualified professionals guide you through every step, from design to implementation, providing expert advice, technical expertise, and personalized support. With Actini Group, your projects are managed rigorously and safely, ensuring performance, quality, and success at every stage of your production.

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