GMP Sterilization Equipment

GMP Sterilization Equipment

Expertise in thermal GMP sterilization for industries and laboratories.

A leader in thermal treatment for over 70 years, Actini Group designs high-tech sterilization and decontamination solutions. Aware of the critical challenges related to product quality, we offer standard or custom equipment tailored to your specific products and strictest requirements. Our autoclaves and continuous GMP sterilizers guarantee an optimal Sterility Assurance Level (SAL).

Sterilization Autoclaves (Superheated water, steam, or air-steam): 30 to 24,000 L/cycle.
Continuous Sterilizers (Steril’Flex, Steril’One): 100 to 40,000 L/h.
Continuous Sterilizer Rental (Steril’Rent): 100 to 500 L/h.
Sectors: Pharmaceutical, biotechnology, cosmetics, food processing, and laboratories.

Discover our sterilization equipment

Continuous sterilizers

Sterilisation autoclaves

Sterilizer rental

Mastering Sterilization to GMP Standards

Sterilization is a critical process aimed at eliminating all forms of microorganisms (bacteria, viruses, heat-resistant spores, and fungi). Beyond biological elimination, our equipment guarantees cycle reproducibility and regulatory compliance (GMP, ISO, FDA).

Our solutions treat everything from small volumes in Quality Control labs to large-scale industrial production. Whether using steam, superheated water, or continuous processes, we adapt to your specific load.

Autoclave de stérilisation GMP Actini Group

What is a GMP sterilizer used for?

An industrial sterilizer allows products, equipment, or medical devices to undergo controlled thermal treatment.
This process eliminates all microorganisms, including spores.

It ensures sterility while preserving the quality, integrity, and physical and chemical characteristics of the products.

Depending on the sterilization type (steam, overheated water, or hot air), it guarantees microbiological safety of media, containers, solutions, and finished products.

It is essential to prevent contamination, protect patients, consumers, or users, and ensure reliability of industrial processes.

Moreover, it ensures compliance with strict regulations in the pharmaceutical, biotechnology, and food sectors.
It also provides effective and reproducible sterilization, suitable for autoclaves, continuous autoclaves, or custom sterilization systems.

How does a sterilizer work?

Depending on the sterilization method, the process can use:

Pressurized steam (steam autoclave): for resistant products and medical instruments.
Overheated water: for sterilizing heat-sensitive solutions.
Hot air (ventilated): for dry items sensitive to humidity.

The sterilizer follows a precise cycle, controlled for temperature, pressure, and duration, ensuring complete sterilization while preserving quality, integrity, and chemical/physical characteristics of the products.
In pharmaceutical, biotechnology, and food sectors, these cycles are often validated according to GMP, ISO, or FDA standards.
This ensures reproducible sterility and microbiological safety.
Some installations also allow continuous sterilization for industrial production lines or quality control laboratories, offering flexibility and efficiency.

Regulatory compliance challenges: a strict normative framework

In the healthcare and biotechnology sectors, compliance is not an option—it is a prerequisite for market access. Our equipment is designed to meet the most rigorous standards of the global industrial landscape:

Good Manufacturing Practices (cGMP): Strict adherence to protocols to ensure consistent and safe quality.
International Health Standards: Full alignment with FDA (USA), USP, MHRA (UK) directives, and ISPE baseline guides.
Electrical and Mechanical Safety: Compliance with IEC 60204 standards and the 2006/42/EC Machinery Directive.
Pressure Equipment: Designed according to the European Pressure Equipment Directive (PED 2014/68/EU).
Quality Assurance: Risk assessment according to EN 12100, Machinery Directive 2006/42/EC, and Low Voltage Directive 2014/35/EU.
Data Integrity and Digitalization: Cycle control via GAMP 5 validated systems, in compliance with FDA 21 CFR Part 11 (electronic signatures and records) and Parts 211 and 212 for finished and radiopharmaceutical products.

This normative rigor ensures seamless IQ/OQ/PQ qualification stages and guarantees the success of your most complex regulatory audits.

Microbiological safety: meeting GMP, ISO, and FDA standards

GMP (Good Manufacturing Practices): The benchmark for operational quality. These standards ensure that products are consistently manufactured and controlled according to strict quality requirements, minimizing risks such as contamination and dosage errors inherent in pharmaceutical and food production.
FDA (Food and Drug Administration): The “passport” to the U.S. market. Its requirements—specifically 21 CFR Part 11 for data integrity—mandate rigorous traceability and scientific validation of processes. FDA compliance is globally recognized as a gold standard for quality.
ISO (International Organization for Standardization): Standards for management and safety.
ISO 9001: Guarantees quality management and the reliability of our equipment, from design to manufacturing.
ISO 14001: Certifies our environmental commitment through solutions optimized for water and energy consumption.

In short, GMP dictates how to produce correctly, the FDA requires data-driven proof of compliance, and ISO provides the organizational structure to guarantee global safety.

Microbiological Safety and Active Ingredient Integrity

In high-tech industries, sterilization presents a dual challenge: achieving absolute sterility while preventing the thermal degradation of sensitive components. Excessive exposure or poorly controlled temperatures can denature complex proteins or alter the vitamins in food products.

Our systems address this challenge through advanced control of the Sterilization Value ( $F_0$ ):

Precision Control: Through fine regulation of the time/temperature ratio, our equipment applies the exact dose of thermal energy required to destroy the most resistant microorganisms (spores) without “overcooking” the product.
Protection of Active Ingredients: For thermolabile molecules or complex culture media, the use of short High-Temperature (UHT) cycles or controlled back-pressure guarantees the chemical stability and efficacy of your active ingredients.
Organoleptic Qualities: In the food and cosmetic sectors, our processes preserve texture, color, and nutritional properties, ensuring a safe, premium-quality finished product.

This approach guarantees a maximum Sterility Assurance Level (SAL) while optimizing your production yields.

Innovative thermal treatmentequipment rooted in french expertise

Autoclave polyvalent à eau surchauffée Actini Group pour charges mixtes (solides et liquides).

Manufactured in France using high-quality components, Actini Group sterilizers offer full traceability and optimal precision for all cycle parameters. Our systems can be tailored to the specific nature of your products and unique customer requirements, providing a reliable, durable, and high-performance solution for both industrial sites and laboratories.

Always at the forefront of innovation, Actini Group develops modular and custom sterilization solutions designed to adapt to your diverse needs in terms of capacity, footprint, and process requirements.

Models	Hourly Capacity	Technology	Applications
Testing Pilot	20 to 500 Liters	Electric heating - Actijoule (single pass) - Aseptic tubular design - Cooling heat exchanger - Pumps (centrifugal and positive displacement)	Product testing - Product characterization - Sterilization validation - Shelf-life testing - Product launches - Multi-product small batches - SHORT OR LONG-TERM RENTAL AVAILABLE
Industrial Pilot	500 to 1,000 Liters	Electric or steam heating - 100% tubular or hybrid technology (tubular/plates)	Small series production - Contract manufacturing - Product launches
Production Sterilizer	2,000 to 40,000 Liters	Steam heating - Tubular design for heating and holding, hybrid tubular/plate technology for heat recovery and cooling	Industrial production applications

Our sterilization autoclaves: find the right solution for your process

Every product has a unique thermal kinetic profile. Actini Group offers three heat transfer methods to suit the nature of your loads:

Saturated Steam Sterilization (Vacuum-Steam) The standard for porous loads (textiles, filters) and stainless steel equipment. The use of fractional vacuum guarantees instantaneous thermal penetration to the core of the materials.
Superheated Water Sterilization (Water Spray) Ideal for liquids in sealed containers (bags, vials). This technology prevents sudden thermal shocks and protects the physical integrity of your packaging through controlled back-pressure.
Air-Steam Sterilization (Ventilated) The high-precision solution for the most sensitive products, such as pre-filled syringes. It allows for pinpoint pressure control and perfect drying.

Continuous sterilization: performance and productivity

For large volumes or complex media (culture media, nutrient solutions), continuous sterilization offers major advantages over batch processing:

Increased Productivity Constant flow rates of up to 20,000 L/h, ideal for high-speed production lines.
Active Ingredient Preservation Reduced residence time at high temperatures (UHT) to minimize the degradation of thermolabile components.
Energy Efficiency Optimized heat recovery via high-performance tubular heat exchangers.

Equipment for food, cosmetic, biotechnology, and pharmaceutical sectors

Actini Group offers a comprehensive range of industrial sterilization equipment designed to meet every requirement:

Autoclaves: Available in superheated water, vacuum-steam, or ventilated versions. They can process volumes ranging from 30 to 24,000 L per cycle, making them ideal for laboratories as well as pharmaceutical and food industries.
Continuous Sterilizers: Featuring the Steril’Flex and Steril’One models, these units are capable of sterilizing from 100 to 20,000 L per hour—perfect for industrial production lines and large-scale sterilization processes.
Continuous Sterilizer Rental (Steril’Rent): A flexible solution for temporary or occasional needs, requiring no permanent capital investment while guaranteeing reliable sterilization in compliance with GMP and ISO standards.

Each piece of equipment is engineered to provide efficient, reproducible sterilization tailored to the specific nature of the product, whether for medical devices, pharmaceutical solutions, or food products.

Sterilize Your Complex Media with Our Continuous Sterilizers

At Actini Group, we support you at every stage, from design to industrialization.
We guarantee reliable sterilization of your most complex media.

Our expertise applies to nutrient solutions, culture media, and sensitive pharmaceutical products.
We ensure processes that are adapted, reproducible, and secure.
We also provide maintenance of your equipment to ensure performance and reliability of your industrial processes.

Our continuous sterilizers are available for purchase or rental.
They exist in standard or custom versions.
They are designed to meet your exact technical, regulatory, and GMP/ISO quality requirements.

Sterilize Your Solid Products with Our Industrial Autoclaves

With our industrial sterilization autoclaves, Actini Group guarantees effective and safe treatment.
This applies to solid products, such as syringes, bags, vials, or medical devices.

This process ensures optimal sterilization while preserving the quality, integrity, and physical and chemical characteristics of your products.

Our solutions provide maximum safety and strict compliance with the most demanding standards.
This is essential for pharmaceutical, biotechnology, and food sectors.

Thanks to our equipment, you benefit from total reliability for critical industrial processes.
They ensure microbiological safety and product quality.

Why Choose Actini Group Engineering?

“Made in France” Expertise: All our equipment is designed and manufactured in our French workshops, guaranteeing full traceability and responsive support.
Proven Track Record: With over 130 projects completed worldwide every year, we have mastered the constraints of the most demanding environments (BSL-3/BSL-4 laboratories, biopharma sites).
Customized Support: From thermal kinetic analysis to fleet maintenance, our engineers optimize your operating costs (OPEX) and process safety.