The Steril’Flex range is the leading solution for industrial continuous sterilization (UHT) of high-value liquids. Specifically designed for cGMP environments, it addresses the technical challenges of high-viscosity products, heat-sensitive active ingredients, and multi-recipe productions requiring total flexibility.
The Steril’Flex goes beyond the concept of simple equipment: it is an advanced engineering platform designed to integrate into the most complex production architectures. Whether your processes involve cell culture media, sterile injectables, or biotechnological ingredients from fermentation, our technology guarantees a Sterility Assurance Level (SAL) compliant with the strictest standards without compromising the integrity of your molecules.
Preservation of thermolabile actives: Thanks to perfectly controlled thermal kinetics, we prevent any degradation of sensitive active ingredients.
Management of complex fluids: A specific design for high-viscosity products, protein-rich solutions, or media loaded with particles.
Aseptic Design: Every component is selected to eliminate dead zones and guarantee total efficiency of cleaning cycles.
Advanced metallurgy: Use of high-end alloys (316L Stainless Steel, Hastelloy, AL6XN) to resist corrosive fluids and guarantee maximum skid longevity.
Controlled surface finishes: Electropolished interior finishes with a roughness (Ra) of less than 0.4 µm to meet the requirements of classified areas.
Digital traceability: Integrated supervision allowing data recording compliant with FDA 21 CFR Part 11 requirements, ensuring the integrity of your batch reports.
Mastery of fluids from 1 to 2,000 cP (nutrient media, agar, glucose solutions, proteins, loaded fermentation broths, active ingredients, peptides, insulin, plant extracts, molasses, flavors...)
Ultra-high performance thermal recovery section (up to 90% energy savings).
Programmable treatment temperature from 80°C to 140°C with millimetric regulation.
Powered by electricity (Actijoule®) or industrial steam.
The Steril’Flex is an industrial sterilizer designed to offer a customized continuous sterilization solution, combining performance, safety, and adaptability. Each installation can be personalized according to your specific needs, from modeling and design to materials, equipment, and finishes. Every Steril’Flex skid is unique. We model your installation to integrate it perfectly into your classified production zones.
Discover the main technical characteristics below:
3D & Hydraulic Design: Custom modeling according to your layout constraints.
Intelligent Control: Advanced automation with safety PLC and 21 CFR Part 11 compliant supervision.
Process Options: Sterilization of fermentation lines, aseptic booster pumps, and IP65 stainless steel cabinets.
Industrial sterilization of fermentation lines: Yes, optional
Booster pump: Yes, optional
Auxiliary equipment:
Electrical cabinet: IP54 / IP65 – stainless steel, optional
Advanced metallurgy: Parts in contact with the product in 316L Stainless Steel, Hastelloy, AL6XN, or SAF2507 for maximum corrosion resistance.
Recovery section: Custom plates in 316L or titanium Compabloc.
Connection to holding cell: Stainless steel piping.
Hygienic Design: Fully drainable piping, high-quality orbital welds, and surface finish ($Ra$) up to 0.65 μm.
Weld coloration: High quality
Interior finish: 0.8 / 0.65 μm
Compliance & traceability: Our systems guarantee a GMP-validated sterility level and complete traceability, meeting FDA requirements.
Reliability & availability: Proven technology designed to minimize production downtime and reduce costs related to contamination.
Easy integration: Compatibility with your existing processes, plug-and-play solutions, limiting interruptions and additional CAPEX.
Risk reduction: Our systems minimize the risk of quality deviations, preventing significant financial losses and protecting your reputation.
Productivity: Long production times and high energy efficiency, limiting utility needs and energy consumption (recovery exceeding 90%), thereby reducing the environmental footprint of the installations.
Regulatory Compliance: Systems validated according to GMP and FDA standards, including total batch traceability.
Increased Productivity: Extended cycle times and reduced maintenance thanks to a robust, self-cleaning design (CIP/SIP).
CAPEX Reduction: Easy integration into your existing processes in “Plug-and-Play” mode, limiting installation costs.
Environmental Footprint: Heat recovery exceeding 90% for sustainable and carbon-free production.
Entrust your projects to Actini Group to secure your processes and guarantee the compliance of your facilities.
Our experts design your custom thermal path and validate your parameters under real conditions before industrialization.
We support you through IQ/OQ/PQ qualification to meet the strictest requirements.
