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VENTICELL IL - detailed description

General and actively provable quality

A faktory acceptance test (FAT) is taken for granted; a site acceptance test (SAT) can also be performed upon the user's request and in his presence. 27-point measurement according to DIN 12880 can also be performed during the output control. To prove the sustained sterilization quality by the manufacturer (importer) in accordance with the declared device parameters, VENTICELL IL hot-air sterilizer users are provided with appropriate documents:

  • IQ - Installation Qualification
  • OQ - Operational Qualification
  • PQ - Performance Qualification (validation)
  • The testing and validations are performed by our accredited testing laboratory according to the standards.

 

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Hot-air Sterilization and depyrogenation

Sterilization )is validated process used to render a product free from viable microorganisms. According to EN 285.

The sterilization effect in hot-air sterilizers is reached by the sterilized material heating to high temperatures (160—180°C).

 

Depyrogenation is a procedure reducing the number of bacterial endotoxins (pyrogens) by three orders at least by high temperature (250—300 °C) acting for a given period of time.

There are the following important parameters of the mentioned processes:

  • accurate profile thanks to a well-designed hot air flow system and perfect construction design of the sterilization chamber
  • quick temperature rise and cooling
  • compliance with the regulations on clean premises

 

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VENTICELL IL, ISO class 5

  • complies with regulations on clean rooms according to ISO 14644-1
  • external HEPA filters at the input and special internal HEPA filters for high temperature
  • sophisticated construction of the sterilization chamber
  • loading equipment
  • guarantee of compliance with ISO Class 5 in all the sterilization chamber zones
  • working temperature up to 300°C
  • various sterilization chamber volumes – see table
  • one-door and passthrough models
  • stainless steel fascia panels of the device with possibility of individual installation into a clean room

 

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VENTICELL IL, ISO class 7

  • complies with regulations on clean rooms according to ISO 14644-1
  • external HEPA filters at the input
  • sophisticated construction of the sterilization chamber
  • loading equipment
  • guarantee of compliance with ISO Class 7 in all the sterilization chamber zones
  • working temperature up to 300°C
  • various sterilization chamber volumes – see table
  • one-door and passthrough models
  • stainless steel fascia panels of the device with possibility of individual installation into a clean room

 

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High standard of manufacture

  • robust structure, valuable inner space
  • stainless steel sterilization chamber DIN 1.4301 (AISI 304) or DIN 1.4404 (AISI 316L)
  • sectional stainless steel device frame for easy device installation
  • stainless steel outer jacket made of high-strength, chemically resistant, polished steel
  • AISI 304 for easy maintenance and long service life
  • removable inner stainless steel sheets for easy maintenance of the working chamber
  • well-organized and ergonomic control panels
  • easy intuitive control and service
  • semi-automatic controlled stainless steel door with mechanical opening
  • HEPA filters for the working chamber aeration
  • internal HEPA filters for high temperature
  • internal overpressure blower with sealed shaft
  • temperature sensors PT100 for accurate temperature keeping (4 pieces as a standard)
  • optional flexible PT 100 sensors
  • digital- or analogue-display pressure sensors for pressure measurement and regulation in the sterilization chamber and for ambient pressure comparison
  • “Emergency stop” function - under emergency conditions it allows for the device to come to a standstill
  • strengthened water cooling by means of a cooling exchanger inside the chamber
  • possibility of use of the transport and loading system in all device types
  • individual adjustment of service space
  • input and output flanges facilitating the device connection at the installation site
  • wide range of optional equipment

 

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Sterilization chamber

  • the sterilization chamber is made of chemically resistant stainless steel DIN 1.4301 (AISI 304) or DIN 1.4404 (AISI 316 L)
  • precise and tight sealing welds of the sterilization chamber, tested by capillary method during the manufacturing process
  • highly polished sterilization chamber surface minimizes particles deposition and makes cleaning easy
  • easily removable inner stainless steel sheets for easy maintenance of the operation chamber
  • sophisticated construction of the chamber and door to maximize the dilatation stability of the chamber during the working cycle, which eliminates the particles release and increases the temperature homogeneity in the sterilization chamber
  • high-quality, 15 cm thick Superwool insulation and third outer insulation jacket
  • dimension-optimised rectangular chamber ensures maximum volume usability for standardized containers placement
  • for the possibility of the device validation, the sterilization chamber is equipped with an access port with the diameter of 30 mm

 

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Device door

  • double automatic door lock for maximal process safety
  • semi-automatic controlled stainless steel door with mechanical opening equipped with a two-stage hinge allowing easy door opening and reliable closing
  • welded door construction has a double, heat-resistant, silicone shaped sealing, fully eliminating any contact of the inner environment with the outer one during the work cycle
  • door sealing easy to replace
  • stainless steel electromotive door lock using significant door weight, ensuring reliable door closing
  • ergonomically positioned handles for easy door handling
  • emergency door opening allowed by independently supplied electromotors, or by manual drive in case of power supply failure
  • one- or passthrough models available

 

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Unique heat transfer inside the working chamber

  • The activity is based on horizontal air flow through air ducts in the back and side device walls by means of a blower in an electrically heated chamber. Thus the spatial air temperature deviation and accurate temperature profile are ensured.
  • Sophisticated placement of the ventilation air ducts, heating elements, internal blower and adjustable air suction flap and discharge allow fast temperature rise and accurate cycle course in the sterilization chamber.
  • Forced air cooling by an overpressure blower during the final cycle phase ensures the resulting reduction of necessary working cycle duration (e.g. 320 bottles ROUXE 1000 ml, sterilization 250°C / 30 minutes, cooling by air to 90°C, cycle duration 4 – 6,3 hours depending on the flow intensity).
  • Temperature range up to 300°C allows the device use in the whole spectrum of industrial applications including the hot-air sterilization and depyrogenation.
  • Inner blower with frequency control using a frequency convertor for air flow optimization in the chamber

 

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Filters, overpressure, particles

  • Thanks to special two-stage HEPA filters of class H 11 and H 14 placed at the air inlet into the device, the requirements of the standard EN 14644, ISO Class 5 and 7, have been met.
  • The use of thermally resistant internal HEPA filters H 13 and fluent air flow regulation allow arrangement of perfect continuous cleaning of the inner chamber, thus reducing the particles occurrence during all the cycle phases (only VENTICELL® IL, ISO Class 5), which means compliance with EN 14644, ISO Class 5.
  • The additional overpressure blower ensures overpressure in the chamber 0,45 - 1,5 mbar.
  • Door sealing and special sealing of the blower axis eliminates any contact with the outer atmosphere during and after the sterilization cycle.
  • The output device pipes can be equipped with additional H 13 filters.

 

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Transporting and loading system

The sterilized material handling is facilitated by a loading system consisting of a transporting and loading cart. The transport cart construction has been designed to ensure a very stable load handling, even if it is quite heavy.

The loading cart with shelves of optimized size for standardized containers loading is equipped with wheels with special thermally resistant bearings, which guarantees the load placement into the device without any risk of particles release from the cart. The loading device construction allows continuous air flow in the chamber, thus contributing to the working cycle duration shortening and temperature homogeneity increase in the sterilization chamber.

 

 

 

 

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Environmental awareness

Both the device production and the devices as such comply with the strictest ecological criteria. They do not burden the working and living environment. Multi-stage controlled cycle and continuous regulation of the revolutions rise and run-out prevent useless power surges in the customer's power supply mains.

The design of the device construction, e.g. an effective flow in the chamber, perfect and extremely thick outer insulation of the sterilization chamber by the rock wool, ventilator axis sealing, or settable suction an exhaust flaps not only optimize the cycle parameters, but also minimize energy consumption and protect the user's premises from uselessly radiated heat. The heat insulation keeps its perfect insulating properties even in high temperatures when it retains low temperature absorption. During operation, it does not release any smell or smoke emission because it contains neither binders, nor lubricants.

The device does not produce any harmful by-products. Ecological processing methods are used during its production. More than 90 % of the device and its pack are recyclable. The device contains neither any harmful substances nor heavy metals and complies with the directive on the restriction of the use of hazardous substances and wastes no. 2002/95/EC and 2002/96/EC.

 

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Unique properties, safe working operations

  • high operational safety, doubled system of collection and evaluation of process information and its continuous comparing and evaluating
  • any deviation greater than the approved one causes an error message announcement
  • control by an industrial PLC system with own control software

 

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Control system PLC – Siemens S7-1500

  • basic device functions on both device sides (in a two-door model) and extended user functions offered on the main panel
  • main comfortable color 12,1" touch panel ensures a clear and simple operation, diagnostics and service at the loading side
  • color 7" touch display on the unloading (clean) side (in a two-door model) informs also about the process state and allows the basic device control to the operator
  • visual and acoustic states and processes signaling (during the process, the display shows the process course and time till the working cycle end in both digital and analogue form) – optional accessory
  • visually and acoustically settable alarms and a number of individual configuration settings (ventilator, air flaps, communication language, print or data output, flexible PT 100 sensors control etc.) are a common part of the device
  • clock – indicator of the time remaining till the program end; real time indicator
  • after the cycle ends, the automatics confirms the correct course, offers a protocol print for the given cycle and allows the device door opening
  • the "delayed start" function allows the device switch-on in a pre-defined time without the operator's presence
  • the diagnostic section allows an easy service diagnostics and very quick service intervention

 

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Batch documenting

In addition to both the local and remote checking of the working processes, the working cycle documenting is required in certified operations. It is ensured by:

  • independent documentation allowing saving of several protocols in the panel memory
  • integrated thermal printer (optional equipment)
  • connection of PC (Ethernet) for data exchange or remote diagnostics and protocols saving in the computer memory by means of the Printer Archiv software (optional equipment)
  • WIFI module for wireless connection to the computer allowing actual data transfer

 

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Optional equipment

  • one-door or passthrough model
  • use of better-quality stainless steel 316 L
  • surface treatment Ra=0,4 µm
  • surface treatment “mirror polish” Ra=0,125 µm
  • water cooling – it increases the efficiency of work with the device and shortens the cooling duration up to a half
  • output HEPA filter including a special output neck
  • input/output HEPA filter assembled out of the clean room
  • transport and loading cart made of stainless steel AISI 304 or 316L, provided with special resistant wheels without particles release and high-temperature bearings, the loading cart is optimized for usual material container sizes, or it can be adjusted according to user’s requirements
  • access port with diameter according to user’s requirements
  • fluently adjustable output flap
  • additional validation access port
  • integrated thermal printer with 10-year guarantee of the printing permanence and print width of 113/104 mm
  • additional flexible temperature sensors PT 100
  • additional optional pressure sensors with digital or analogue displaying
  • flexible temperature sensor PT100 for the process control and check at the given point of the chamber
  • data outputs Wifi or USB for external data loggers and printers connection
  • special software WarmComm 4.0 for data saving and management in a PC
  • with 21 CRF part 11 and GAMP5 with outputs to the touch display or SW Warmcomm 4.0
  • air-tight model “Bio-Seal”
  • customized covering strips for device integration into pharma partition walls and ceilings
  • basic IQ, OQ, and PQ documentation for validation
  • FAT, SAT

 

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VENTICELL IL Easy

The economical hot-air sterilizer variant VENTICELL®IL EASY complies with the requirements for installation in clean rooms as well. It complies with the requirements of EU Directives 2004/108/EC and 2006/95/EC. The device construction is based on the established and well-proved MMM heating technology devices (COMFORT line) intended for long-term use in hot-air sterilization and depyrogenation processes with the following necessary technical adjustments:

  • sealed chamber and door for installation in clean rooms
  • separated control panels on both device sides
  • power electronics separated from the basic device body
  • reinforced device door for lesser thermal dilatation and better sealing
  • levelling legs for stable installation
  • modified control SW for the temperature heating up time minimization
  • sealed exhaust extension and sealed access port for validation
  • varnished or stainless steel covering strips for device installation into the wall.

 

VENTICELL IL Easy

  • Volume: 55, 111, 222, 404, 707 litres
  • Working temperature: up to 250/300 °C
  • Interior: stainless steel, mat. No. 1.4301 (AISI 304)

 

Microprocessor control unit

  • 6 programs
  • chip card system for individual program storage
  • RS 232 – interface for printer or PCcommunication
  • delayed heating start and stop function
  • acoustic and visual alarm of error state
  • time range 0–40 years with 1 min-intervals
  • digital safety thermostat
  • real time
  • programming temperature ramps
  • heating sequences
  • programme cycles
  • adjustable ventilation rate 10 to 100 %
  • manual control of the air exhaust flap
  • keyboard blocking
  • door opening control

 

Options VENTICELL IL Easy

  • door with window and interior lighting
  • access ports diam. 25, 50, 100 mm
  • door locking
  • left door versions (except for the 707 litres volume)
  • special software WarmComm 4.0
  • HEPA-filter (air filter integration)
  • potential-free contact for alarm messages
  • flexible PT100 sensor
  • passthrough version
  • operation temperature range extension up to 300 °C, only in combination with stainless steel shell of the device
  • stainless steel shell of the device
  • automatic door lock
  • contact for external flaps control
  • inner chamber design AISI 316 L for higher chemical resistance and strength

 

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