Designed to meet the strict validation criteria of Health Canada and the FDA, ACTINI Inc.’s Steril’Flex line of industrial skids provides continuous-flow (UHT) thermal treatment for critical, high-value-added fluids. From pilot-scale R&D laboratories to large-scale industrial volumes, our software and mechanical engineering safeguards your production lines against the risk of thermal deviation. This approach guarantees absolute repeatability of your process cycles.
Ensuring the safety of your raw materials and process fluids is the cornerstone of industrial productivity. Steril’Flex has established itself as the leading solution for the continuous sterilization of cell culture media (agar, glucose, saline solutions, yeast) and fermentation wort.
Unlike traditional batch systems, our continuous-flow thermal processing technology eliminates the risk of overheating. It offers precise temperature control to prevent component degradation. This system thus preserves the complete integrity of heat-sensitive active ingredients, such as peptides, insulin, plant extracts, sugar solutions, and flavorings.
Steril’Flex’s advanced engineering allows you to configure the skid’s thermal profile and metallurgy to meet the specific requirements of a wide range of industries:
A safety controller with SIL certification automatically manages production and cleaning cycles for complete multi-product flexibility. In addition, pilot units are available for rent so you can conduct feasibility tests directly at your site or at Actini’s facilities.
Efficient processing of emulsions, gels, and high-viscosity fluids requiring a strictly aseptic design to avoid excessive use of preservatives.
Pasteurization and sterilization of complex solutions, plant extracts, flavorings, syrups, or molasses, with maximum energy efficiency.
This system ensures the thermal stabilization and sterilization of chemical baths, process fluids, and rinse water. It eliminates all bacterial contamination without altering the physicochemical properties of the solutions.
Process parameters |
Standard specifications & options for the Steril’Flex Line |
Impact & role of Engineering |
|---|---|---|
| Flow rate range | Available Configurations: • 2,000 L/h (8.8 gpm) • 5,000 L/h (22 gpm) • 15,000 L/h (66 gpm) • 20,000 L/h (88 gpm) • 40,000 L/h (176 gpm) | Full scalability, from pilot validation phases to mass production volumes. |
| Viscosity range | Handles fluids from 1 to 1,000 cP (media, agar, proteins, automotive formulations, emulsions) | Capable of running multi-product campaigns without risk of critical pressure drop or line clogging. |
| Temperature precision | Adjustable processing temperature from 90°C to 150°C (194°F to 302°F) | Precise control via PID loops to ensure safe thermal kinetics and prevent overheating of heat-sensitive ingredients. |
| Energy Recovery | Custom-designed plate heat exchangers | Up to 95% heat recovery efficiency, drastically reducing the plant’s OPEX and carbon footprint. |
Engineering component |
Features of the Steril’Flex line |
Impact & role of engineering |
|---|---|---|
| Hot zone metallurgy | Product-contact parts made of 316L stainless steel, AL6XN, or Hastelloy/C22 | Maximum resistance to corrosive process fluids, halogenated solutions, and chemical sanitizing agents. |
| Piping & connections | Rigid stainless steel support line; 316L and/or Hastelloy pipes that are fully automatically drainable | Guaranteed aseptic design with no dead zones, facilitating complete gravity drainage to prevent cross-contamination. |
| Weld quality | High-quality orbital welds with full traceability | Absolute mechanical integrity under pressure and hygienic geometric compliance to prevent biofilm adhesion. |
| Surface finishes | Standard: Ra < 0.8 µm / 32 µin - High-performance option: Ra < 0.5 µm / 20 µin (Electropolishing) | Drastic reduction in surface roughness to meet ASME BPE criteria requirements in classified areas. |
| Automation & data | Safety controller with SIL rating, automated management of SIP/CIP cycles | Support for 21 CFR Part 11, cGMP compliance, and a traceability matrix for the digital integrity of batch reports. |
An optional overpressure system can be integrated into the heat recovery section. This configuration eliminates any risk of cross-contamination between the treated fluid and the cold fluid.
This system is natively equipped for in-line sterilization of feed streams. It therefore interfaces directly with the feed ports on your bioreactors.
The IQ/OQ/PQ qualification protocols are structured to support your compliance efforts. They thus facilitate your validation processes with Health Canada, the FDA, and during industrial quality audits.
Let our specialists handle your hydraulic and thermal challenges. Our Canada-based application engineers will analyze your P&ID diagrams to configure a custom platform, validate your scale-up parameters, and ensure your regulatory compliance.
