The Sofinn Group is comprised of companies that offer state-of-the-art equipment for the pharmaceutical and biotech industries, including turnkey solutions for distillation, sterilisation, lyophilisation, effluent decontamination, washing, and filling. We manufacture and deliver water-for-injection (WFI) stills, pure steam generators, decontamination stations, and killtanks.
Since 1976, Sofinn has delivered equipment and turnkey systems for numerous local and international clients. We also represent world-leading manufacturers of dry heat sterilisers, depyrogenation ovens, tray dryers, and autoclaves.
Sofinn provides service for all stages of our equipment’s lifetime, keeping clients’ apparatus in good working order and prolonging its lifespan. All maintenance tasks are carried out by well-trained staff who have extensive experience in the pharmaceutical industry.
AQUA-NOVA® 3rd generation multiple effect stills
Sofinn’s AQUA-NOVA® water stills and pure steam generators represent more than 30 years of experience in WFI production and clean water systems. Our third-generation multi-effect and single-effect stills are characterised by flexible operations and a safe distillate quality that exceeds the specifications of US Pharmacopoeia (USP), European Pharmacopoeia (EP), and Japanese Pharmacopoeia for WFI.
Our original ‘float’ type design from 1981 heat exchangers and low steam velocities combined with cyclone separation and proportional media regulation, is still the most reliable way of producing Water For Injection (WFI) and Pure Steam (PS) as per the latest, international pharmacopoeias.
User advantages of Aqua-Nova stills:
- The most reliable WFI still on the market
- No feed water tank necessary
- Extremely simple heat exchanger leak test without counter pressure
- True cyclone separation of particles with direct discharge to drain
- Easy service and maintenance due to simple and effective design
AQUA-NOVA® Pure Steam Generators (PSG)
Sofinn’s AQUA-NOVA® pure steam generators use the same solid-column design as our water stills, with low steam velocities and extremely efficient particle separation using our step-based technique. Their robust and reliable designs include modulating control valves for all utilities and ensure the devices can operate securely in all conditions.
Our generators have capacities ranging from 100kg to 5,000kg an hour, as well as output pressures of between one and six bars. The quality of the steam they produce meets European steam quality acceptance criteria as outlined in EN 285, while the generators’ internal surfaces are electropolished as with a WFI still.
AQUA-NOVA® Two in one Simultaneous WFI and PS production
Sofinn’s two-in-one AQUA-NOVA WFI still and pure steam generator allows pure steam and WFI to be produced at the same time with one system. Its innovative column design, including low steam velocities, creates major savings in terms of investment, space usage, validation effort, and maintenance.
The generator’s hourly capacity ranges from 100l to 2,000l of WFI and 100kg to 2,000kg of pure steam when these are produced simultaneously. Its customisation options include water pre-treatment and skid-mounted WFI storage tanks, pumps, and outlet valves.
Pharmtec® Effluent Decontamination units and kill tanks for wastewater treatment
Sofinn portfolio company Pharmtec has developed a patented technology for decontaminating effluents without a pump or heat exchanger, meeting Bio Safety Level (BSL) 1-4 requirements with superior resistance to clogging.
The vacuum treatment ensures better temperature homogeneity and easy process validation. With an hourly processing capacity of 50-5,000l, the systems are available in several models for research and development (R&D), clinical batches, and industrial production.
Pharmtec’s compact, robust treatment module starts automatically and self-decontaminates at the end of treatment. An intuitive control panel allows the user to adjust operating parameters and record treatment data, including good automated manufacturing practice (GAMP) standards, 21 CFR 11 criteria, and audit trails.
Several configuration options are available, including:
- Plastic or stainless-steel collection tanks with absolute vent filters (0.01µm)
- Steam barriers between the contaminated effluents and the exterior
- Construction using corrosion-resistant special materials such as Incoloy and Uranus
- Heat recovery and cooling of treated effluents
- Double safety barriers
- Safety integrity level (SIL) II safety automation and integrated clean-in-place capabilities
- Dry heat sterilisers and tray dryers for pharmaceutical production
LYTZEN® GMP dry heat sterilisers and tray dryers from Denmark
Sofinn subsidiary LYTZEN has specialised in depyrogenation ovens and tray dryers for more than 50 years, leveraging its knowledge of vial batch depyrogenation. LYTZEN chambers range from 590l to 7,000l in size and are designed to meet exact specifications for airflows, temperature distribution, and ISO 5 particle classifications.
LYTZEN depyrogenation ovens are designed to minimise particle generation and thereby prevent particles from being released onto the product. Each of the company’s ovens is tested at the factory during a full cycle run before delivery.
During cooling, a small vacuum builds up inside the vial and draws particles into the vial. The Siemens control system is well-structured and offers a range of cooling, instrumentation, and documentation options to meet the customer’s exact needs.