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STERIL'ONE - Standard industrial media sterilization

cGMP continuous thermal sterilization units

Streamlined, fast-deploy thermal treatment for industrial liquids

In liquid production environments, scaling up sterilization capacity should not require months of complex custom engineering. The STERIL’ONE range delivers a standardized, turnkey solution designed for continuous thermal treatment of liquid products. Engineered on pre-validated 3D modeling, standard hydraulic design, and standard electrical layouts, STERIL’ONE offers fast lead times and plug-and-play simplicity without compromising thermal accuracy or product quality.

Whether processing culture media prior to fermentation, active ingredients, or complex industrial liquids, STERIL’ONE provides exact temperature control, high-efficiency heat recovery, and automated operation—ensuring consistent, repeatable batch quality every single run.

Engineered to protect your yield, brand, and bottom line

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 for hygienic performance and mechanical reliability

Every STERIL’ONE skid is constructed to meet rigorous sanitary requirements and operational stability:

Product-contact metallurgy: Hot sections built from premium 316L stainless steel.
Flexible holding connection: Equipped with FDA-approved silicone hoses for holding section connections.
Sanitary heat recovery: Utilizes a 316L simple plate sanitary heat exchanger for thermal exchange.
Precision surface finish: Standard internal surface finish of Ra ≤ 40 µin (1.0 µm), with options available down to Ra ≤ 32 µin (0.8 µm) or Ra ≤ 20 µin (0.5 µm) upon request.
Electrical protection: Control cabinet rated NEMA 12 / IP54 with standard automation.
Internal skid piping: Drainable via manual disconnection using 316L and flexible silicone hose.

Available flow rates & capacities

Model range	Capacity in US Gallons per Hour (gal/h)	Flow rate range in GPM (US)	Metric flow rate range (L/h)
Steril’One 500	~132 gal/h	~0.58 GPM	500 L/h
Steril’One 2,000	~132 to 528 gal/h	~0.58 to 2.3 GPM	500 to 2,000 L/h
Steril’One 6,000	~528 to 1,585 gal/h	~2.3 to 7.0 GPM	2,000 to 6,000 L/h
Steril’One 20,000	~1,585 to 5,280 gal/h	~7.0 to 23.2 GPM	6,000 to 20,000 L/h

Product-centric engineering & cGMP integrity

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.

Scalability & de-risked testing options

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.

Operational capabilities & fluid diagnostics

Flow rates

From 0.44 gpm to 176 gpm (100 to 40,000 L/h) customizable modular skids.

Viscosity Range (1 to 1,000 cP)

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.

Thermal accuracy

Fully adjustable processing temperatures ranging from 194°F to 302°F (90°C to 150°C) with precise holding times configurable via an integrated bridge board system.

Custom options & available configurations

Tailor your Steril’One skid to your exact plant automation, process piping, and documentation requirements:

Process & Sanitary Hardware Options:

Sampling Valve: Hygienic sampling valve for in-line quality checks.
Configurable Holding Tube: Standard 1-minute holding section (std) / Optional 2-minute holding section (opt).
Upstream & Downstream CIP/SIP: Optional downstream SIP/CIP or upstream valve SIP/CIP modules for complete process aseptic control.
Mass Flow Meter: Precision inline flow monitoring.
Advanced Pumping Solutions:
- Centrifugal pump with mechanical seal flushing (product with high sugar content).
- Centrifugal booster pump.
- Twin-screw positive displacement pump (Pompe volumétrique double vis).
- Twin-screw positive displacement pump with seal flushing.
Rinsing Verification: Conductivity meter for automated machine rinse validation.

Automation, Communication & Documentation Options:

Advanced Documentation Package: Turnkey validation protocols and traceability package for US regulatory compliance.
Remote Access: Remote monitoring and troubleshooting capabilities.
Flexible Communication Protocols:
- HMI screen only (IHM uniquement).
- Standard dry contact communication (Contact sec).
- Standard Profinet communication.
- Custom ProFINET integration tailored to your DCS/PLC network.

Facing a complex sterilization challenge?

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.