When standard off-the-shelf equipment cannot meet your facility’s complex piping, strict safety containment, or unique automation architecture, the Steril’Flex range provides the ultimate solution. Engineered specifically around your process boundaries, Steril’Flex skids are fully customized continuous liquid sterilization systems designed for high-stakes biopharmaceutical and advanced biotech environments.
From custom 3D physical modeling and advanced metallurgy to safety-rated PLC automation, Steril’Flex seamlessly integrates into your existing plant infrastructure while guaranteeing 100% thermal reliability, maximum nutrient preservation, and complete regulatory peace of mind.
Full regulatory compliance (FDA & cGMP): pre-validated skids designed for seamless IQ/OQ/PQ qualification. Integrated automation guarantees data integrity with strict FDA 21 CFR Part 11 electronic record compliance.
Risk mitigation: eliminate batch-to-batch contamination risks. Precise, millisecond thermal kinetic control protects heat-sensitive proteins, mRNA components, and cell culture media from thermal degradation.
OPEX & sustainability optimization: features a high-efficiency heat recovery section that reclaims up to 90% of thermal energy, drastically reducing utility demands and carbon footprint.
Built to handle aggressive chemical CIP regimes, challenging media formulations, and strict cleanroom environments:
Custom product-contact metallurgy: Options for 316L Stainless Steel, AL6XN, or Hastelloy C22 for high-corrosion or high-chloride environments.
Premium surface finishes: Internal surface roughness executed down to Ra ≤ 32 µin (0.8 µm) or Ra ≤ 20 µin (0.5 µm) upon request.
High-grade welding: Executed under stringent hygienic welding procedures to ensure complete sterility barriers.
Rigid holding section piping: Constructed with rigid stainless steel piping for maximum durability and thermal integrity.
Sanitary heat recovery options: 316L custom plates or Compabloc titanium heat exchangers delivering up to 95% heat recovery efficiency.
Automatic internal piping disconnection: Drainable internal skid piping with automated disconnection (in 316L or Hastelloy).
Accommodates production scales from 528 gal/h to 10,560 gal/h (2,000 to 40,000 L/h or ~2.3 to 46.5 GPM). This broad operational window allows seamless throughput scaling from pilot-scale optimization to high-volume commercial manufacturing.
Flawless handling of challenging fluids, including cell culture media (agar, glucose, salted solutions), high-yield fermentation broths, active pharmaceutical ingredients (peptides, insulin), plant extracts, and concentrated flavor formulas.
Features highly configurable temperature programs ranging from 194°F to 302°F (90°C to 150°C). This allows precise control over thermal hold times to achieve exact target kill-steps and required F0 values without degrading active nutrients.
Maintains a positive pressure differential on the sterile side within the heat recovery exchanger. This creates a physical containment barrier that prevents cross-contamination in the event of unexpected pressure fluctuations or micro-leaks.
Integrates optional SIL-rated Safety PLCs directly into the automation architecture. This ensures full alignment with your plant's risk management matrix and emergency shut-off protocols.
Control cabinets are available with heavy-duty NEMA 4X ratings. This guarantees complete corrosion protection and washdown resistance for aggressive cleanroom or harsh processing environments.
Built fully configurable to meet cGMP, ASME BPE, and 21 CFR Part 11 requirements for electronic records and signatures. Every unit includes a turnkey Traceability Matrix package for effortless FDA and site validation audits.
Maximum energy efficiency: integrated aseptic tubular heat exchangers feature ultra-performing recovery systems that reclaim up to 90% of thermal energy, drastically lowering your facility’s utility costs and carbon footprint.
Total automation & recipe repeatability: equipped with advanced PLC control, the system delivers 100% automated production, monitoring, and cycle logging. Automated CIP/SIP cycles ensure perfect process asepsis and eliminate human error.
North American regulatory readiness: Built to meet the strictest standards. Available in full cGMP design, ensuring complete FDA CFR compliance, adherence to ASME-BPE guidelines, and supplied with a comprehensive traceability matrix for fast validation.
Production flexibility means being able to run simple or multi-product configurations without changing your hardware. To secure your process parameters before capital expenditure, Actini offers specialized pilot testing.
Pilot Rental Program: Evaluate product behavior and validate your thermal kinetics in real-world conditions. Pilot units are available for rent and can be deployed directly at your facility or tested within Actini’s laboratory.
The Steril’Flex platform delivers a fully customized, continuous inline sterilization solution engineered to balance high performance, process safety, and operational flexibility. Every system is delivered as a turnkey, custom-modeled modular skid, tailored from initial 3D hydraulic design to metallurgy and surface finishes. Engineered for seamless integration, each unique Steril’Flex skid is optimized to fit perfectly within your facility’s footprint and classified cleanroom requirements.
Partner with Actini North America to de-risk your scale-up and ensure absolute process compliance. Our biopharma engineers custom-model your exact thermal kinetics and validate critical parameters under real-world conditions prior to fabrication. From engineering design through full IQ/OQ/PQ qualification, we ensure your system meets the industry’s most stringent FDA and cGMP standards.
