Products
Washers & Sterilizers
We offer a complete line of turn-key solutions for washing and sterilization in the pharmaceutical sector, and the ability to undertake all stages of a project from concept to completion that exceed customer expectations. Washing, sterilization, and drying solutions for laboratories and production lines are just some of the available technologies offered by our partners. Every piece of equipment is designed and built in compliance with cGMP, GAMP, and international pharmaceutical standards and regulations. We also provide depyrogenation tunnels and custom automation solutions.
Product Lines
Washing Machines
Depyrogenation Tunnels
Saturated Steam Sterilizer
Superheated Water Sterilizer
Washer-Sterilization
Elastomeric Closures Treatment
Bio-Decontamination Unit
Washing Machines
Our washing machines are designed for cleaning (internally & externally) and drying both glass and plastic pharmaceutical containers.
Our washing machines are available in custom dimensions and with different types of gripping systems. The washing machines can be integrated with sterilization tunnels and packaging lines for a complete modular processing line.
- Customized layout according to end-user’s requirements
- GMP conforming design
- Flexible system that can handle multiple container types
- Easy cleaning of all working surfaces
- Container feeding can be via rotary or bi-flow table, or unscrambling unit and inline conveyor.
- Multiple washing and drying stations that are programmable to meet specific recipe requirements
- Integrated water recirculation system
- CIP/SIP
- Direct connection to sterilization tunnel
- Integrated siliconization stations (upon request)
- User friendly touch screen operator interface (HMI)
- 21 CFR Part 11 compliant
- Vials
- Syringes
- Ampoules
- Cartridges
- Custom container types
Depyrogenation Tunnels
The process of hot air sterilization and depyrogenation tunnels involves the removal of pyrogens from solutions or surfaces by means of controlled exposure of glass containers to high temperatures. Our tunnels are equipped with convection heat transfer and provide high production output with evenly and precise distribution of heat over glass vials, cartridges, syringes, and infusion containers.
Our depyrogenation tunnels are specially designed to be installed between a washing and a filling or packaging system (dependent on end user requirements). These high output tunnels count on precise temperature control and heat distribution to ensure full sterilization of glass containers before they are aseptically filled.
Sterilization is achieved in accordance with ISO 14644-1 requirements, by a laminar flow of filtered hot air, within an ISO 5 environment, throughout the complete tunnel length.
The tunnels are composed of three main chambers: inlet chamber, hot chamber, and cooling chamber, with the possibility to add a fourth chamber for further cooling.
The perfect balance flow of airflow conditions ensures the stability and uniform distribution of temperature offering safe and reproducible operations, with continuous in-process control and validation of the system.
All our equipment is fully compliant with strict pharmaceutical standards including cGMP and ISO.
- Possibility of using air for the Inlet Chamber from either the room or from an external environment via a duct
- Heating Chamber composed of two insulated stainless steel shells
- A maximum hot air temperature of 350°C for energy-saving and glass overheating prevention
- Ability to process each container type with suitable time and temperature to ensure correct depyrogenation cycle
- An additional dedicated fan provides the pressure control for the airflow balance in the Cooling Chamber
- Inline connection to upstream and downstream equipment
- Additional cooling chamber
- Sterilization cooling section
- Particle measuring inside the chamber
- A continuous airglow measuring system
- An automatic air pressure balance inside the tunnel for consistent positive pressure to avoid backflow
- Air speed monitoring and automatic adjustment by means of anemometric systems in all chambers
- Automatic vial discharge at batch end
- Remote assistance
- Printer and SCADA interface for production data recording and management
- Document packages for complete system validation
- Vials
- Syringes
- Ampoules
- Cartridges
- Custom container types
Saturated Steam Sterilizer
Intended for multi-purpose sterilization in bio-pharma industries. From solids and porous to liquids in open or non-hermetically sealed containers. Fedegari’s saturated steam sterilizer is suitable for tyndallization, pastorization and inactivation.
- 316Ti (316L upon request) stainless steel chamber, which can have a circular or square section, according to customer’s or process’ need.
- Chamber range from 200 to 6,800 liters, but loading capacity is fully customizable, according to customer’s need.
- Chamber internal surface is mechanically polished and complies with rigorous pharmaceutical standards, with a roughness Ra <0.4 μm.
- One or two doors in automatic sliding version (vertical or horizontal movement) or semi-automatic hinged version.
- 4 RTD PT100 temperature probes per chamber to monitor chamber and product temperature.
- Fedegari exclusive patented door gaskets that assure 100% tightness. These gaskets are FDA compliant and optionally also USP Class VI compliant.
Benefits:
- Innovation: control through pressure (less than 0.5 °C variation).
- Total control: 4 RTD PT100 temperature probes per chamber, up to 200 alarms and monitoring messages.
- Easy validation & integration: pre-validated Thema4 process controller standardized.
- Complete flexibility: custom designed chambers are easily provided.
- Cost-effectiveness: smart maintenance and process optimization.
- European directives: 2014/30/EU – Electromagnetic compatibility (EMC), 2014/35/EU – Low tension equipment (LVD), 2006/95/EC – Safety of machinery (MD)
- European standards: EN ISO 12100, EN ISO 13857, EN ISO 13849-1, EN IEC 60204-1, EN 61326-1, EN 61010-1, EN 61010-2-040, EN 4126-1, EN 12953-9
- USA electrical standards: NFPA 70 – National electrical code, UL 61010-1 – Safety requirement for electrical equipmentfor measurement, control and laboratory use – Part 1: general requirements
- Pressure vessel and electrical steam generator compliant to: 2014/68/EU – Pressure equipment directive (PED)
Superheated Water Sterilizer
In compliance with cGMP and FDA standards for LVP products, the superheated water sterilizers are suitable for treating loads in containers that may be deformed due to the difference in pressure between the chamber and the container itself.
Where the product is liable to separation or for accelerating thermal transition phases, the whole load can be rotated during the entire sterilization process.
- Sterilization of parenteral solutions, liquids in sealed containers not deformable (eg. glass vials) and liquids in heat sensitive sealed containers (eg. plastic bags or bottles).
- Terminal sterilization of pre-filled syringes (PFSs)
Rotating Load
The load is held in rotation thanks to a special rotating drum inside the chamber. The rotation drum has a magnetic coupling and is adjustable in speed, direction of rotation and intermittently. This system finds application in the treatment of suspensions and emulsions and ensures a better performance of the tightness tests for ampoules under vacuum and a more homogeneous heat transmission in the load.
Washer-Sterilization
The washer sterilizer is an absolutely unique and original solution, designed for improving and simplifying all cleaning requirements when the loads need to enter a controlled-contamination environment. The washer sterilizer is a hybrid solution suitable for washing, decontaminating, sterilizing, and drying various types of loads as no traditional machine can ever do.
These multipurpose machines, totally managed by Thema4 process controller, represent the most cost-effective solution in terms of CAPEX as well as operating costs while combining the high-performance of a steam sterilizer into a jet washer.
This new concept presents many advantages when compared with a traditional solution of two different machines (washer + steam sterilizer): FOWS requires less space in a plant, less time to complete the process, less training, and reduced maintenance and validation costs.
To carry on the washing cycle, FOWS washer sterilizer benefits from the emollient effect of steam on greasy and sticky dirt such as ointment, cream, gel, etc. Thanks to this, the consumption of detergents, water, and energy is significantly reduced presenting a truly eco-friendly solution. Additionally, vacuum can be used for drying loads, reducing process duration with lower operating costs.
- FOWS steam sterilizer is equipped with a AISI 316L stainless steel chamber.
- Chamber’s inner surface mechanically polished until a roughness of less than Ra <0,4 μm, in order to avoid any water stagnation.
- 6 RTD PT100 probes positioned in chamber for constant monitoring and immediate of washing and sterilization cycles. The probes are located in some critical points of the chamber, such as the interspaces of the door and water drain, in order to have the assurance of the uniformity of temperature.
- Additional space for two validation probes, to ensure greater ease of data checking.
- The hydraulic system and the valves are made of AISI 316L steel with sanitary finishing.
- Chamber 100% air-tight guaranteed by two inflatable gaskets, with an original solution patented by Fedegari.
- Food, Bio-pharmaceutical, Cosmetics
- Sealed & unsealed containers, Filters, Machine parts, Tools, Wrapped tools, Garments, Glassware
Elastomeric Closures Treatment
ELASTOMERIC STOPPERS TREATMENT
Applications: bio/pharmaceuticals
Loads: Stoppers
Processes: Stopper washing, siliconizing, and sterilizing
Thanks to a wide experience in the pharmaceutical industry, Fedegari has developed a special sterilizer addressed to elastomeric closures treatment. This process equipment can perform washing, rinsing, siliconizing, sterilizing, drying and automatic unloading of stoppers in a sterile area. All these processes are managed by Thema4 process controller.
The stopper treatment autoclave uses a drum with a special magnetic coupling, which guarantees more space in the chamber.
As for Fedegari washer sterilizer (FOWS) this is a dual-purpose unit: when is not running as a stopper treatment it can be used as a normal moist-heat sterilizer.
- Dual-purpose unit: saturated steam sterilizer or elastomeric stopper processing.
- Double option for unloading in sterile area.
- Rotating drum with magnetic coupling: no obstruction in the chamber.
Basket:
Thanks to a special engineering, rotating AISI 316L stainless steel drum guarantees the best performance when running washing, siliconizing and drying cycles. The automatic unloading phase is performed by inverting the rotating way and due to the auto-sterilizing chute, positioned on unloading door.
Unloading in heat-sealed bags: the autoclave is equipped with an auto-sterilizing chute on the unloading side and with an external trolley for the weighing and heat-sealing of the bags. Operators action is limited to putting on the bags on the chute and to switching on the heat-sealing system. Customers can configure the desired bags weight, so that the machine can regulate the amount of the unloaded stoppers.
Unloading in stainless steel tanks: the stoppers treatment autoclave is equipped with a rotating auto-sterilizing chute connected with a stainless steel tank, which is sterilized thanks to the direct link with the chamber. Operators action is limited to external clamp removal. The tank is linked to the chamber thanks to a special lifting column, or in alternative with a lifting trolley.
- Internal and external trolleys
- Cassettes for vials and bottles
- Built-in electric steam generator
- Suitable filter on industrial steam line
- Condensate drain cooler
- Vortex breaker
- Second filter in series on compressed air line
- “Air detector” system
- Steam sampling system
- Hot air drying
- Specific decontamination cycles
- Additional HMI panels
- Graphic User Interface (GUI) for remote control
- Thema4 external recorder
Bio-Decontamination Unit
With the bio-decontamination unit you can bring inside the clean rooms all those products and instruments that cannot be thermally sterilized. Surface bio-decontamination of the load is carried out with vaporized hydrogen peroxide – H2O2.
Among the most reliable sporicidal agents, vaporized hydrogen peroxide (H2O2) is nowadays one of the most popular: its antibacterial, antimycotic and antiviral properties are well known and scientifically documented.
This solution is becoming increasingly relevant as the regulators shift their focus away from traditional moist- and dry-heat sterilization processes to address all other bioburden risks. This innovative process equipment meets the current approach required by the EMA and FDA.
- Stainless steel AISI 316L chamber, polished to strict sanitary standards (Ra <0.4 μm).
- Doors are made of AISI 316L stainless steel with a central glass panel
- 100% air-tight guaranteed: thanks to two separate inflatable gaskets seating in two slots mechanically machined all around the door with an additional leak-monitoring system.
- Direct control of hydrogen peroxide in the chamber.
- Optimized process: surface bio decontamination is achieved in 30 minutes.
- Fedegari hydrogen peroxide vaporizer with control loop (PID based), which provides superior reliability and repeatability for easier validation.
- Great flexibility: FCDV can be used as a pass-through hatch aired with synchronized doors and pressure control.
- Process optimization: surface bio-decontamination in 30 min.
- Reliability: FHPV hydrogen peroxide vaporizer totally engineered and manufactured by Fedegari.
- Flexibility: the unit can be used as a pass-through hatch aired with synchronized doors and pressure control.
- Easy validation & integration: all processes managed by Thema4 process controller.
