The new CVB2000 process controller has been specially developed for automatic operation of the most recent FVA/A1 series and the new FOB serie TS of Fedegari sterilizers.
The system is based on a PLC integrated with the operator panel. It is extremely easy to use, and allows the automatic start-up and management of all configurated sterilization cycles, with control of parameters and checking of process safety devices.
All the information regarding the sterilisation cycles can also printed out by a small thermal paper printer (optional) positioned under the panel monitor mounted on the front of the machine and equipped with an adjustable display.
A Flash Memory card where programme software is housed and a Memory recipe are available for automatic storage of cycle data, with 32 kb Ram capacity.
In addition, two RS232 serial ports for printer and remote PC connection and N°.1 auxiliary port for Ethernet communication are located on the back of the panel.
The panel is also equipped with a buffer battery for Back-Up saving of all data.
Man-machine communication is conducted through a multilingual operator interface (standard languages: English, Italian, German, French) consisting of a spacious active-matrix video graphic LCD STN colour touch screen with 40 columns x 16 lines (5.7 inches high resolution 320x240 pixels).
The management software is able to memorize up to 15 (fifteen) standard programmes, 6 of which are pre-set as routine Test programmes (vacuum, pressure, B&D, decontamination, etc.) while the remainder are totally configurable and personalizable by the user. All operations are password-protected to prevent access by unauthorised personnel: the access management system foresees seven different password-protection levels to enable access to the various functions.
During the execution of a programme the operator interface enables the operator to view the following on the monitor screen:
Main menus
• Cycle libraries
• Calibration and setting data and self-diagnosis values with analog and digital IN/OUT lists
• The data and parameters relative to the phase being executed (programme number,
phase name, values set, current temperature, time and pressure data and
accumulated sterilisation time, Fo, etc.)
• Real-time graphs of process variables
• Machine synoptic chart, including indication of activations
• All alarms, acoustic warning signals, auxiliary messages, language selection
• Information pages on the machine’s configuration, software version, number of
cycles executed etc..
All the pressure and temperature sensors can be calibrated through the operator interface in a simple, clear and secure manner (access to this operation is password-protected).
STANDARD AND OPTIONAL CONTROLLER FUNCTIONS
The following are amongst the standard and optional functions that can be activated by the operator as password-protected parameters:
Automatic “Stand By” function for energy saving.
Delayed process start-up
(with insertion of desired start-up date and time).
• Step-by-step function
This function can be activated on the process currently under way by pressing the appropriate icon displayed on the touch-screen, and makes the cycle pass on directly to the next phase by disactivating the commands and end checks for the current phase.
• Stop-cycle function
This function can be activated by the operator but in emergencies only and not during all cycle phases.
F0 calculation and control fuction (option SWX1):
the system proceeds to calculate the special mathematical function F0 on the basis of the values measured by the temperature probles during the execution of all the phases in the cycle. The Fo value is then indicated in the cycle print-out together with the main parameters and is used particularly in pharmaceutical contexts.
CVB2000 Link software for connection to external PC and remote supervision
(option SWX2):
at the back of the panel there is a RS232 serial port that can be used for transmission of data to a remote system and cycle data storage; it allows full supervision of the machine and also makes it possible to print out the complete cycle and relative diagram in A4 format.
Cycle repetition (option SWX3):
for automatic repetition of the last cycle selected (for a selectable number of times) even when no operator is present. This function is particularly useful in the case of special repetitive tests on long-term production which apply to many industrial products.
Special kit for conformity with FDA CFR21 Part11 and Ethernet protocol
(option SWX6):
a Fedegari exclusive optional, available also for laboratory autoclaves, consisting of:
Ethernet Protocol
Ethernet connection hardware installed on board the operator panel, consisting of:
special CPU with integrated Ethernet port
• Ethernet Port adapter
• CVB Logger data monitoring collecting and printing software,to be installed on an
extermal PC belonging to the customer
This protocol allows:
Complete remote supervision of the sterilizer with monitoring of graphic data – Temperature
and Pressure trends and current programme activations and phases status.
• Data Log: filing and storage on external PC of the process reports regarding all
cycles executed, with possibility of calling up for viewing.
• A4 printing: printing out the filed reports on an A4 printer connected to the PC.
• supervision of several sterilisers from a single PC (by enabling several licenses)
CFR21 Part 11 conformity
This software adds to the functions described above the full conformity of the CVB Logger data monitoring collecting and printing software with all aspects of CFR21 part 11 specifications: password access management, electronic data filing and audi trail recording in compliance with the strictest pharmaceutical standards.
Automatic Pharmacopea cycle (option SWX8)
Special automatic cycle (configurable as programme 15 on the controller) in accordance with the European Pharmacopea Standards for electrolyte release testing of glass containers for pharmaceutical use.
For further particulars, please ask the Fedegari Technical Service.
