FCP

Cleanroom solutions

Fedegari Group has engineered a set of products specially designed for clean room applications and aseptic manufacturing:

FMF – Unidirectional Flow Fan Filters Modules

FMF is a modular unit which creates a vertical unidirectional airflow in Class ISO 5 according to ISO 14644-1 (“Grade A” EU GMP), protecting the critical area. The airflow maintains the clean room under a higher pressure than the surrounding environment, thus avoiding any contamination risk.

FMF modules can be combined together to create a tailor-made solution to assure the most cost-effective protection to critical areas inside pharmaceutical production sites.

Design & technical features

  • AISI 304 stainless steel casing
  • Suitable for different assembling solutions (suspended, fitted on false ceiling grids or on supporting legs)
  • G3/G4 efficiency disposable synthetic fibre pre-filters (according to EN 779) and H14 efficiency filters

FCP – Down Flow Booth (down cross workstation)

FCP – Down Flow Booth is a unidirectional vertical airflow unit, ISO 5 air cleanliness classification according to ISO 14644-1 (Grade A air supply and Class C according to EU GMP) designed to contain any kind of pharmaceutical powders or chemicals during sampling and dispensing operation. FCP has been designed according to the ISPE Good Practice Guide: “Assessing the Particulate Containment Performance of Pharmaceutical Equipment”.

The booth design adresses operation of sampling and dispensing and assures total protection of the operator, of the environment and of the product.

Fedegari has redesigned the workstation to reduce the electric power required to run the process by:

  • lowering by 50% HEPA filters’ pressure drop
  • resizing prefilter area: 50% extra capacity
  • installing more efficient fans
  • installing individual adjustable airflows

Thanks to this design and engineering improvement, FCP Down Flow Booth has lowered its total cost of ownership by 40%.

Design & technical features

  • Compact ceiling and rear plenum optimize usable work area while minimizing floor space
  • Three-stage filtration, G4, F9 and H14 can be accommodated (Bag-in, Bag- out pre-filter  replacement upon request)
  • Energy-efficient LED light fittings minimize airflow disruption
  • Removable bulkhead panels enable access to fans, cooling coil and fine dust filter for maintenace

 

 

FGW

FGW – Lab Glassware Washer

Fedegari Lab Division latest innovation is a Lab Glassware Washer that capitalizes the experience done with FOWS-series of washers in the pharmaceutical industry.

The power of steam: a cost-effective cleaning

 

The new FGW Lab Glassware Washer uses a steam generator to improve washing performances: steam has an optimized emollient effect on greasy and sticky dirt.

Moreover the use of steam can significantly reduces operating costs: this true eco-friendly solution allows to minimize the need of detergents as well as water consumption, lowering the running costs per cycle. In addition, steam is able to access hard-to-reach areas and therefore clean thoroughly. A conductivity meter placed on the FGW drain is capable to detect the water purity, helping to terminate the process as soon as the desired set-point is reached thus further reducing water and other utilities consumption of the washer.

The cleaning process is constantly supervised:

  • Dedicated probes monitoring the temperature of the air/water and of the steam in chamber
  • A dedicated trasducer controls the pressure of the circulating water.

Fedegari Glassware Washer has an internal LED lamp that remains operative during the whole cycle: in case of alarm evident signals are displayed by color change.

img_6050_led_per_sito_ex_fgw

 


 

Design and technical features

The piping, as any other equipment manufactured by Fedegari, has a rigorous sanitary finishing. The machine is loaded by a modular rack which could be standard or customized for adapting to all loads configurations and is directly connected to the piping. As all Fedegari laboratory process equipment, the FGW is easy to use specially thanks to ergonomic loading height, a friendly process controller and the interchangeable external trolleys compatible with Fedegari FOB5 lab sterilizers.

As all Fedegari lab equipment, the FGW series is compliant with cGLP standards.

The FGW series is equipped with Thema4lab process controller, engineered and pre-validated by Fedegari according to GAMP5. Thema4lab is the most advanced process controller for lab applications, based on a wide library of phase groups, developed by Fedegari thanks to its experience with the highest standards in the pharmaceutical industry.

30-process_summary_thema4lab

Thanks to the Thema4lab process controller you can manage both FGW and FOB5, creating a true Fedegari environment in your lab.

See how to integrate the FGW Lab Glassware Washer with your FOB5 Horizontal Steam Sterilizer:

 

 

FCIS

FCIS – Pharmaceutical isolator

The FCIS pharmaceutical isolator have been designed primarily for :

  • pharmaceutical dispensing/handling of API and High Potent Ingredients
  • to assure sterile continuity after unloading sterile process machines
  • to guarantee aseptic filling during manufacturing phase.

To achieve these goals, FCIS unit uses a barrier in order to separate the operator – working in C or D EU cGMP grade area (ISO7, ISO8 US cGMP) – from the working area – in A grade area EU cGMP (ISO5 US cGMP) – where all operations occur. The isolator meets all the requirements of the FDA, EMA, WHO and associated pharmacopoeia as well as all applicable EN standards and directives and international norms.

Fedegari’s pharmaceutical isolator can be integrated with a side transfer hatch designed to introduce/remove all the containers and material necessary for the process. 

Fedegari has developed for the pharmaceutical isolators the same solution standardized for its bio-decontamination pass-boxes, since the performances and reliability of third party H2O2 vaporizers were not satisfactory.  Moreover, the Fedegari Hydrogen Peroxide Vaporizer (FHPV) excludes the need of propietary consumables, reducing significantly operational costs.

Through H2O2 sensors and other devices, vapor concentration is directly monitored (over traditional estimated calculations) by process controller Thema4 and remains extremely constant (within ± 15 ppm) thus allowing process repeatability .

Design & Technical Features

  • Manufactured to the highest GMP quality standards, AISI stainless steel chambers with bright annealed surface finishing (Ra ≤ 0.4 μm).
  • Doors are protected with a double gaskets system to ensure the highest level of safety for the operators.
  • Integrated pressure decay leak test both for chambers  and gauntlets
  • Exhaust air from the isolator is filtered by a H14 HEPA filter before being expeled to outside environment.
  • Customizable and modular unit manufactured according to customers’ needs.
FSW it

FSW Eco-Steam Washer

FSW Eco-Steam Washer innovates the concept of GMP washing thanks to the use of steam in the washing cycle. 

Fedegari Eco-Steam Washers capitalize on the experience acquired with the FOWS-series of washer-sterilizers in the pharmaceutical market. FSW Eco-Steam Washer is the latest industrial innovation of Fedegari Group addressing pharma, food and cosmetic industries. These machines represent a cost-effective solution for the highest performances. Fedegari steam washers, in fact, use a built-in steam generator to optimize performances reducing operating costs, excluding the necessity of steam utility connection.

Steam works as cleaning agent and water heating. The direct injection of steam into the washer chamber avoids the need for additional heating elements and results in a cleaner in-chamber environment.

Due to its emollient effect on greasy and sticky dirt, the steam reduces the use of detergents and improves chamber and load sanification. During the washing cycle, the injection of clean compressed air filtered by the Pall vent filter (0.22 µm) increases the mechanical action of washing/rinsing through the chamber.

Final drying is performed with hot air filtered by Hepa filter H14 injected in chamber, in order to assure the total drying of the machine and of the load.

The FSW modular custom-made loading rack can be easily adapted to every specific load configuration.

 

Steam is a cost-effective and eco-friendly solution

– minimizes the use of detergents

– reduces energy and water consumption

– reduces operational costs

– improves washing performances

 

Design and technical features

  • Chamber and hydraulic components made of 316L stainless steel with sanitary finishing.
  • The door (hinged or sliding) is made of glass with the perimeter reinforcement made of 316L stainless steel.
  • Fully modular and customizable internal trolley: it can be designed according to the customer’s load.
  • Internal trolleys are designed to avoid any water stagnation thanks to dedicated draining points.
  • Thema4 process controller ensures a total control on washing performance, therefore a robust reliability during inspection and validation activities.
  • In case of emergency, alarms are audible and visible: an internal LED lamp is operative during the whole cycle and its alarms operates through LED color change.

An array of options

To meet even the most demanding requirements every FSW-Washer can be configured with various options like:
• Conductivity sensor installed on external water circulation circuit
• The additive is initially dosed up to a specific quantity (ml) selectable by a programmable parameter
• During the washing, a refilling of additive can be performed up to a specific conductivity value checked by the conductivity sensor
• A pressure transducer detects possible failures or malfunctions of the circulation pump or the spray nozzles.

FOB4

FOB4 – Stand-alone Lab Sterilizer

The FOB4 Stand-alone Lab Sterilizer is an autoclave that combines excellent performances with overall high quality materials and ease of use.

The FOB4 Lab Sterilizer is suitable for the use in laboratory for many different applications, such as:

  • Microbiology and analytical labs;
  • Research institutes and examination agencies;
  • Bio-Technologies and life sciences;
  • Animal facility and clinical diagnostic labs;
  • Pharmaceutical, food, chemistry industries, Q.C. labs;
  • Hospital operating theaters and medical care;
  • Agricultural, environmental and veterinary labs;

These sterilizers have been specially designed with ergonomical features for easy handling of higher volume sterilization materials and goods as: glassware, media preparation, liquids, in open and sealed containers, mixed regular and high risk waste, as well as surgery instruments, textiles, rubber articles for hospital use and packaged tools.

FOB4 Stand-alone Lab Sterilizer is easy to be configured, thanks to its conceptual design and modular construction with a convenient portfolio of optional kits.

In fact, all the models can be configured using various customized systems guaranteed by the wide range of processes, software options and an extensive choice of accessories.

Please, click on the link “suggested kits” on the right to check out all possible configurations referred to FOB4 series.

Design and Technical Features

FOB4 autoclave can be designed in two chamber dimensions: 147 liters (FOB4-TS) with single vertical sliding door or 210 liters (FOB4S-TS – FOB4/L TS) with double vertical sliding door for pass-through purposes. The vertically automatic sliding doors are pneumatically activated for space efficiency in laboratory and hospitals.

FOB4 autoclave has internal AISI 316 L stainless steel plates fed by steam used both as heat-exchanger system for steam pre-heating and to cool the chamber temperature by means of cold softened water. As an option these plates can be used for drying purposes at the end of the cycle.

Fedegari designs laboratory autoclaves combining operators’ safety as well as equipment performances. Hence temperature sensors and pressure transducers assure maximum precision and stability of the sterilization temperature, grant the highest level of safety and guarantee process reproducibility.

FOB4 Lab Sterilizers are equipped with DCS PLUS 10 process controller which is highly flexible: 30 cycles easy to customize in a multi-user environment with a large touch-screen color video-graphic display and interface for remote monitoring via Ethernet control. DCS PLUS 10 process controller is fully validated and documented.

 

FOB5

FOB5 – Stand-alone Lab Sterilizer

FOB5 Stand-alone Lab Sterilizer presents a great flexibility of use, ranging from quality assurance laboratories in pharmaceutical or food industries, to BSL3 – 4 laboratories in research centres and/or hospitals.

The possible application of FOB5 series of autoclaves can be:

  • Microbiology and analytical labs;
  • Research institutes and examination agencies;
  • Bio-technologies and life sciences;
  • Animal facility and clinical diagnostic labs;
  • Pharmaceutical, food, chemistry industries, Q.C. labs;
  • Hospital operating theaters and medical care;
  • Agricultural, environmental and veterinary labs;

As all the autoclaves of Fedegari Lab Division, FOB5 has a modular design which allows a high flexibility of use for different loads and treatments. Please, click on the link “suggested kits” on the right to check out all the possible configurations referred to FOB5 series.

Design and Technical Features

FOB5 autoclave series has a wide range of chamber volumes and come with both single and double vertical sliding door:

  • FOB5C-TS: 325 liters – single vertical sliding door
  • FOB5-TS: 456 liters – single vertical sliding door
  • FOB5S-TS: 481 liters – double vertical sliding door
  • FOB5SL-TS: 590 litres – double vertical sliding door
  • FOB5L-TS: 615 liters – single vertical sliding door
  • FOB5SXL-TS: 700 litres  – double vertical sliding door
  • FOB5XL-TS: 730 litres – single vertical sliding door

FOB5 series can be designed with a single or double stainless steel sealing flange (BIOSEAL), making it suitable for laboratory risk category L3 and L4 and operating theater. Thanks to its improved heating-exchange plates, this autoclave has a perfect temperature distribution in chamber, assuring the highest sterilization performance.

FOB5 autoclaves are made of AISI 316 L stainless steel as well as pneumatic valves and hydraulic components, all electropolished at sanitary grade. FOB5 lab sterilizers have two high-efficiency internal AISI 316 L stainless steel plates which can be used as heat-exchanger system for steam preheating, to cool the chamber temperature down by using cold water. Moreover – as an option – these plates can be used to perform final drying.

Full and easy accessibility to technical area from the front and lateral side allows service and regular maintenance. External trolleys are fully compatible with FGW Fedegari Glassware Washer Series to assure integration between cleaning and sterilization processes in your laboratory.

FOB5 is equipped with Thema4lab process controller, engineered and pre-validated by Fedegari according to GAMP5. Thema4lab is the most advanced process controller for lab applications. It is based on a wide library of phase groups developed by Fedegari thanks to its experience in the pharmaceutical industry across 60 years of history.

Thema4lab process controller is available for FGW Glassware Washers and FOB5 steam sterilizers, making training and maintenance easier for Fedegari machines.

FCTS isolatore test sterilità

FCTS – Sterility test isolator

The FCTS Sterility Test Isolator has been designed for pharmaceutical samples taken from manufactured drug batches and meets all the requirements of the FDA, EMA, WHO and associated pharmacopoeia as well as all applicable EN standards and directives and international norms.

Suitable for:

  • Injectable liquids
  • Ophthalmic ointments
  • Sterile antibiotic powders
  • Incoming raw materials
  • Freeze-dried drugs

 

When Fedegari started designing its first isolator, the goal was assuring customers the highest process reliability and repeatability possible.

FCTS sterility test isolator is equipped with the same solution that Fedegari has standardized in bio-decontamination pass-boxes, because the performances and the reliability of third party H2O2 vaporizers were not satisfactory. Moreover, with the FHPV there is no need of propietary consumables, reducing significantly operational costs.

This innovative design provides real time biocide concentration control (over traditional estimated calculations) and is totally managed by Thema4, assuring process reliability.

Through the H2O2 sensors and other devices, Thema4 assures that vapor concentration remains extremely constant (within ± 15 ppm) thus making process repeatability the logical consequence. The FCTS sterility test isolator is compliant with the most stringent cGMP guidelines of Pharmacopeia. It has been classified as ISO 5 FDA and Class A EU GMP.

Design and technical features

  • Working chamber has non-directional BA surface finishing (Ra ≤ 0.4 μm).
  • Air-tightness is 100% guaranteed by ultra-safe doors.
  • Equipped with an internal stainless steel trolley for material transfer from pass-box to working chamber assuring continuous loading of the isolator with materials.
  • Customizable internal storage and racks: can be designed according to customers’ needs.
  • Integrated pressure decay leak test both for chambers and gauntlets
  • FCTS is modular: customers can choose the positioning of the pass-box, the number of working chambers and gloves.
FVS

FVS – Vertical Lab Sterilizer

The FVS Vertical Lab Sterilizer is a compact, portable with very small overall dimensions for easy handling and use.

The FVS Vertical Lab Sterilizer controls the sterilization process adopting a close loop feedback system using PID algorithm. This solution permits a continuous and accurate control of chamber temperature and pressure with a significant energy saving, even in a so small autoclave.

The FVS series sterilizers are suitable for the use in many different applications in laboratory such as:

  • Empty glassware
  • Laboratories instruments
  • Small machine parts
  • Culture media/solution in small size open containers

 

Please, click on the link “suggested kits” on the right to check out all possible configurations referred to FVS series.

Design and Technical Features

With two chamber useful volumes ranging from 30 to 45 liters FVS series is the simplest choice for standard sterilization in the laboratory field. Both sterilizing chamber and lid are made with top-quality AISI 316 L stainless steel with  electropolished finishing.  FVS series is equipped with built-in AISI 304 stainless steel recovery tank for steam condensates and with a special profile high-resistant pneumatic gasket for automatic lid sealing, assuring maximum safety. A small air compressor with buffer assures pneumatic lid gasket closing and final drying.

FVS has a swing-top opening lid with quick closing and safety interlocks. The temperature ranges from 100 °C to 144 °C to cover wide spectrum of sterilization programs managed by TSC 09 microprocessor control system with graphic color LCD display and alphanumeric pad.

 

FVG

FVG – Vertical Lab Sterilizer

FVG Vertical Lab Sterilizer combines excellent performances with overall high quality materials, simplicity of use and optimal consumption.

All FVG series autoclaves are equipped with a built-in steam generator with automatic water feed pump. These autoclaves can treat a wide range of laboratory goods with reliable sterilization technology, such as: glassware and plastic articles, unwrapped instruments, machine parts and components, porous goods, culture media and liquids in open small size containers, laboratory regular waste in open bags.

The FVG series sterilizers are suitable for the sterilization and decontamination in many different laboratory sectors as:

  • Private and public microbiology labs
  • High schools and universities
  • Research institutes
  • Life science and biotech labs

Please, click on the link “suggested kits” on the right to check out all possible configurations referred to FVG series.

Design and Technical Features

FVG series can be provided in three different chamber useful volumes: 50 liters (FVG1) – 75 liters (FVG2) – 140 liters (FVG3).

Sterilization chamber and lid are made of AISI 316 L stainless steel, with mirror polished sanitary finishing. FVG  operates at high-pressure (3,5 bar g) and temperature (140 °C).

Exclusive horizontal swiveling lid with pneumatic gasket “rotate-and-seal”, for improved user safety. FVG is equipped with a heat recovering system for water preheating to steam generator, assuring utilities cost saving.

FVG has TSC 09 microprocessor control system with graphic color LCD display and an exclusive dual sensor system, by pressure and temperature, for double regulation and control of the sterilization process

 

FOD

FOD – Dry-heat sterilization

The perfect solution for dry-heat sterilization and depyrogenation needs. FOD ovens, such as autoclaves, run batch processes and are the ideal solution for the sterilization of all those production lines in which the variability of products, batches and formats do not allow the use of continuous sterilizers such as tunnels. FOD ovens main advantage lies on its particle contamination class assurance.

Fedegari guarantees the contamination level to remain under the established standards values for 100 class. This accuracy is verified also during the most critical phases such as heating and cooling, when the thermal expansion of the filters may release a great amount of particles.

Particulate contamination control originates from complex fluid dynamic studies and a close collaboration with Camfil, the world’s most respected filter manufacturer, with whom Fedegari works at the development of high-temperature filters.

The most peculiar features of the dry-heat sterilization and depyrogenation oven are extreme temperature uniformity – regardless of dimensional variables – and lowest particulate contamination. Temperature uniformity is the obvious consequence of Fedegari experience in thermal process control.

Design & technical feautures

  • Sterilizing chamber: sealed welding, made of AISI 304 stainless steel 1,5 mm thick.
  • Single-leaf flush door on both sides, internal surface in AISI 304 stainless steel.
  • 100 mm thick rock-wool panels guarantee perfect thermal insulation: average temperature of 40°C on the external surfaces at operating temperature of 250°C.
  • Electric heating through AISI 321 stainless steel heating elements, assembled on a sliding frame for easy removal and maintenance.
  • Cooling by AISI 304 stainless steel heat exchanger.
  • Continuous automatic control and regulation of pressurization of the sterilizing chamber.
  • Continuous filtering of air in the sterilizing chamber, thanks to a system composed by 4 HEPA filters.
  • 5 PT100 RTD probes.
  • Safety thermometer on Non Sterile front to prevent door opening if chamber temperature exceeds set value.
  • Stainless steel port for validation probe positioned on not sterile side.