Benutzerhandbuch "CELSIUS 2007 FDA-Edition" USER MANUAL CELSIUS 10 Control software for MEMMERT appliances – FDA Edition Validatable in according to 21 CFR Part 11 U. S.
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CELSIUS 10 FDA-Edition About this manual Intended use and target group This user manual describes the installation and use of the MEMMERT control software CELSIUS 10 FDA Edition. It is intended for use by trained personnel of the operating company, who have the task of programming/operating MEMMERT ovens. If you intend to work with the software, please read this manual carefully before starting. Familiarise yourself with the programme and run several tests before actually controlling an oven.
CELSIUS 10 FDA-Edition Other documents that you must read: Please also read the user manual for the respective oven to be operated with the software and familiarise yourself with it. Storage and forwarding This manual should always be kept in a place where those working with the software have access to it. It is the responsibility of the operator to ensure that persons who work with or will work with the software are informed as to the whereabouts of this user manual.
CELSIUS 10 FDA-Edition Content 1. End user licence agreement 7 2. Introduction 9 2.1 2.1.1 2.1.2 2.2 2.3 Description........................................................................................................................... 9 Basic programme functions .............................................................................................. 9 Advanced FDA Edition functions ....................................................................................
CELSIUS 10 FDA-Edition 8.2 8.2.1 8.2.2 8.2.3 8.2.4 8.2.5 8.2.6 8.3 Protocol ............................................................................................................................. 43 Types of Protocols ........................................................................................................... 43 Recording the actual progression ................................................................................... 44 Saving and loading protocol data (*.pro) ...............
CELSIUS 10 FDA-Edition 1. End user licence agreement NOTE - IMPORTANT - PLEASE READ THE FOLLOWING AGREEMENT TEXT CAREFULLY This end user licence agreement forms a legally binding agreement between you, whether a natural or a legal person, and MEMMERT GmbH & Co.KG. This licence agreement bindingly regulates the use of software licences of MEMMERT GmbH & Co.KG. The software licence may include also pertinent media and printed material as well as in online or electronic format (“software licence“).
CELSIUS 10 FDA-Edition MEMMERT GmbH & Co.KG accepts no responsibility for errors, faults or damage which result from incorrect operation, use of unsuitable operating material, or unusual operating conditions. The user must employ the SOFTWARE PRODUCT only for his own purpose unless expressly agreed otherwise. The user must notify MEMMERT GmbH & Co.KG without delay of any faults which occur, together with a brief description of the fault. §4 - RESTRICTED WARRANTY MEMMERT GmbH & Co.
CELSIUS 10 FDA-Edition §8 - CHOICE OF LAW All legal relations between the parties, including delict law, are subject to the law of the German Republic. The legal domicile is Schwabach, Germany. §9 - FINAL CLAUSE 1) Supplements to this agreement, including this clause, have to be produced in writing. 2) If one or several of the above terms should be or become invalid, this does not affect the effectiveness of the other terms.
CELSIUS 10 FDA-Edition 2.1.2 Advanced FDA Edition functions Within a closed system this specially developed software meets the FDA requirements. The Food and Drug Administration as the USA regulatory authority is responsible for monitoring manufacturing processes in the food, chemical and pharmaceutical industries.
CELSIUS 10 FDA-Edition 2.
CELSIUS 10 FDA-Edition 2.
CELSIUS 10 FDA-Edition 3. Preparation and installation Always first install CELSIUS before you connect an oven to your computer. The installation of CELSIUS FDA-Edition must be performed by the Windows system administrator. 3.1 Establishing Windows users and assigning user rights All users of CELSIUS FDA-Edition must be established by the system administrator as Windows users with their own user passwords. 1.
CELSIUS 10 FDA-Edition 6. You are shown the License conditions for the use of the software in German and English. You must accept the license conditions before you can continue with the installation. If you reject the license agreement, the installation procedure is terminated; but it can be restarted at any time. Click on "I accept the terms of the License Agreement" if you agree with the terms of the license, and then click on "Next". 7.
CELSIUS 10 FDA-Edition 9. In the next window, select the programme components/drivers that should be installed: ► Select "CELSIUS 10.0" if you only want to install the programme itself. ► Also select "USB Device Driver" if you want to connect ovens via the USB interface. ► In addition, you should select "Chipcard Driver" if you want to use a MEMoryCard XL in an external card reader device (see page 24). You can also install USB and chip card drivers later on.
CELSIUS 10 FDA-Edition 12. Click on "Finish" to complete the installation. CELSIUS 10.0 and the selected drivers are now installed on your PC/laptop and can be used. 4. Programme description 4.1 Starting CELSIUS CELSIUS can be started in three ways: ► by double-clicking on the shortcut created on the desktop: ► by going to the Start menu: Programs Documents Settings Search Help and Support Run Shut down ► by double-clicking on a profile file generated by CELSIUS (*.cel) or log file (*.
CELSIUS 10 FDA-Edition 4.2 Start screen and licence file CELSIUS FDA Version can be started only with a valid licence file containing a list of equipment serial numbers which can be accessed with this version. The licence file called “LICENSE.XML“ is located in the CELSIUS folder and carries a digital signature; it is thus protected against any alteration. The licence file contains also a licence number and optionally an entity name which is included in the GLP data.
CELSIUS 10 FDA-Edition 4.2.1 Language Programme interface and menus can be displayed in five languages (German, English, Spanish, French and Italian). If you want to use a different language than the one currently set, you can change the language via the menu bar: Preset language Can be changed via ...
CELSIUS 10 FDA-Edition "File" menu Menu item Submenu items New Profile Load Tempering Profile ► Save Tempering Profile ► – Description See page Creates a new tempering profile. A possible existing profile will be deleted. Deleting a profile that has not yet been saved must be confirmed.
CELSIUS 10 FDA-Edition Menu item Submenu items Quick call via Description See page From External MemoryCard Loads log files from the MEMoryCard in the external card reader To File (*.pro) If no log file was specified when a tempering profile was started, the log file can be generated with this after the sequence has been completed. 39 Print log data as a spreadsheet or save as Excel® format (.xls) 41 Print Profile The tempering profile in the active window is printed.
CELSIUS 10 FDA-Edition Menu item Submenu items Quick call via Exit Description See page Ends CELSIUS. If the function "Save Settings on Exit" is activated (see page ), the assignment of the interfaces to the ovens and their configurations are saved for the next programme start. Other basic settings are always saved when the programme is terminated. If some ovens are still active or if tempering profiles have not yet been saved a prompt appears for security reasons.
CELSIUS 10 FDA-Edition Menu item Quick call via Description Zoom Out Zooms out of the time range displayed in the graphical view. The largest time unit is 10 000 h. Zoom all Displays the standard time range in the graphical view so that all data are displayed See page Menu "Run" Menu item Quick call via Description Start Starts the tempering profile displayed in the current window Stop Ends the sequence of a started tempering profile prematurely. Continuation not possible.
CELSIUS 10 FDA-Edition Menu item Quick access via Description See page Save Settings on Exit When this function is enabled, the allocation of interfaces to ovens and their configurations is automatically saved when the programme ends. The next time the programme starts, CELSIUS tries to log on the ovens exactly as before. If an oven that was previously logged on online is no longer available, it is not logged on again.
CELSIUS 10 FDA-Edition "Window" menu Menu item Description Cascade Arranges windows in overlapping form Tile Arranges windows next to each other Arrange Icons Re-arranges iconified windows 1, 2 ... Moves to the corresponding device window Menu "?" Menu item Description User Manual Opens this manual in PDF format Info about CELSIUS Information on the programme version and registration 4.2.
CELSIUS 10 FDA-Edition Item Function Description See page 5 Save tempering profile to file Saves the current tempering profile to a file 35 6 Save tempering profile to oven Saves the current tempering profile to the internal memory of the oven 35 7 Save tempering profile to MEMoryCard Saves a tempering profile on the MEMoryCard in the oven or in an external card reader, if connected 35 8 Graphical View Displays the opened tempering profile in graphical form 29 9 Tabular View Displays t
CELSIUS 10 FDA-Edition 5. Establish CELSIUS users and manage user rights The FDA version of CELSIUS has its own user management. CELSIUS users must however already be Windows users. After the installation of CELSIUS-FDA the standard procedure is to designate the installing operator as the CELSIUS administrator. He then has the authority to designate other users and to assign to them CELSIUS-specific rights.
CELSIUS 10 FDA-Edition Every user can have individual rights assigned to him for the use of CELSIUS FDA Edition: User right Description Run CELSIUS FDA This authorization permits a Windows user to start the CELSIUS programme. Open device If this field is marked, the user is authorized to connect up the equipment via the PC port and to exercise control and produce protocols. Open profile If this field is marked, the user is authorized to load an existing thermostating profile.
CELSIUS 10 FDA-Edition 6. Connect ovens and external devices Always install the software and necessary drivers (e.g. USB) first before connecting an oven to the computer. Only ovens that are listed in the license file and license box (see page 17) can be connected. When connecting an oven, read the information and notes concerning this in the oven's user manual.
CELSIUS 10 FDA-Edition 6.2 Connect ovens with an RS-232 interface To connect an oven with an RS-232 interface, a twisted RS-232 connection cable in accordance with DIN 12900 part 1 is required (see also page 48). If the computer has no nine-pin RS-232 interface, then a USB–RS-232 adapter is additionally required (available in specialist shops, see figure on the right).
CELSIUS 10 FDA-Edition 6.3.1 Setting the IP address of the oven with XTADMIN 1. Connect the oven whose IP address you want to change with a standard network cable to a free network socket and switch it on. 2. Install and run the programme XTADMIN on the installation CD. The main programme window of XTADMIN appears. 3. Click on "SET IP" (1), a new "XTIP" window opens 4.
CELSIUS 10 FDA-Edition 6.4 Connecting an external card reader If you want to connect an external card reader (can be acquired separately as an accessory) to your computer so that you can store data on a MEMoryCard, the card reader must first be logged on. 1. Connect the card reader to a USB or COM interface of the computer. 2. In the "Settings" menu, click on the menu item "Options". 3.
CELSIUS 10 FDA-Edition 7.2 Logging on an oven 1. In the "Settings" menu, select the menu item "Log-on Device" or click in the toolbar on the icon. The dialog box "Log-on Device" appears: 2. Each oven by default is given a device address. What device address is preset can be found out in the setup menu for the oven (see accompanying user manual). The device address can also be changed there. Every oven that is or is going to be connected must have its own distinctive device address.
CELSIUS 10 FDA-Edition For ovens logged on offline, the desired device configuration must be specified in another dialog. The configuration dialog appears automatically if an oven was logged on offline. Select from the list the oven type that you want to simulate or to which you want to transfer a tempering profile, and confirm this with "OK". With optional extras (e.g. additional switching contacts), these must be activated manually for them to be used later on.
CELSIUS 10 FDA-Edition What setting options are available depends on what oven type is used for a tempering profile. The setting options for individual oven types are listed from page 7. With "Edit"→"Undo" or , the last performed entry / change can be revoked. 8.1.3 Device status line The device status line is visible at the top of the graphical and tabular views while a tempering profile is being created or run. It shows the following information: Controller active COM3 IST: 24.1 °C 40.
CELSIUS 10 FDA-Edition Depending on the oven type, additional oven-specific functions are available at the bottom of the graphics window, such as for adjusting the flaps, controlling the fan speed or for programming the switching contacts (3). They can be enabled and disabled via mouse click or adjusted via drop-down menus. These functions are shown in the tabular view as additional table columns (see page 34).
CELSIUS 10 FDA-Edition If a coordinate is created in a prohibited area or you want to move it to such an area, the mouse cursor turns into a no-entry sign. The coordinate jumps automatically back to its previous position when you let go. Changes to the graphical view are automatically updated when you switch to the tabular view, and vice versa. Ramp close statements Each segment (ramp) of a tempering profile must end with a close statement and be linked to the next segment.
CELSIUS 10 FDA-Edition ► loop: The tempering profile is repeated endlessly from the beginning, until the user ends the tempering profile. This command can only be applied for the final ramp segment of a tempering profile. ► LOOP(n) The tempering profile is repeated from the beginning n-times (n: 1 ... 99): ► HOLD At the end of the tempering profile, the parameters of the last ramp segment are retained until the user ends the tempering profile.
CELSIUS 10 FDA-Edition ► Move the mouse cursor over the vertical axis in the temperature, humidity, pressure, CO2 or O2 windows. The mouse cursor turns into a magnifying glass.
CELSIUS 10 FDA-Edition Working with vacuum ovens VO in the graphical view With vacuum ovens VO, the temperature and vacuum profiles are displayed in the graphical window simultaneously. The switching output A of the CELSIUS software offers a choice between IN1 (fresh air) and IN2 (inert gas). To switch over to the respective ramp segment, click on line a: Switch contact a off: IN1 (fresh air) Switch contact a on: IN2 (inert gas) 8.1.
CELSIUS 10 FDA-Edition 1 2 Edit Profile Time hh:mm 3 Period hh:mm 4 5 6 7 Type Flap Fan 8 9 Tabular View (example) 1 Ramp segment No. ... 2 Beginning of ramp segment after programme start 3 Duration of the ramp segment 4 Temperature in the ramp segment 5 Ramp close statement (see page 30) 6 Flap position 7 Fan speed 8 Position of switching contact a 9 Position of switching contact b In addition to the ramp segments entered, the table always shows an empty line (in the example: line 8).
CELSIUS 10 FDA-Edition 8.1.6 Executing a tempering profile Before a tempering profile is started, disable the screen saver and the energy-saving mode of your computer, as these could interfere with the programme sequence. For a tempering profile to be started, ► it must have previously been saved (see page 36) ► the relevant oven must be connected and logged on to the computer and be in operating mode "I". If this is not the case, an error message will be displayed.
CELSIUS 10 FDA-Edition 8.1.7 Saving and loading tempering profiles In order to prevent any alteration of files, CELSIUS FDA encrypts all profile and protocol files. Encryption employs a key which is specified in the licence file. Existing files from a previous CELSIUS version can not be read or exported. If an encrypted file has been altered (except through CELSIUS), access to the data is no longer possible, even for the producer of the software.
CELSIUS 10 FDA-Edition 8.1.8 Printing a tempering profile In order to print a tempering profile, Print click on or select "File→Print "File Printer Profile". The Windows print dialog appears. The default setting is the standard printer set for Windows. You may Location select a different printer that is conComment nected. Print Range The print command prints out the All content of the active window. The Pages time range displayed on the screen is printed, with or without GLP header Selection data.
CELSIUS 10 FDA-Edition 8.2.2 Recording the actual progression When a tempering profile is run, the actual values of the oven are displayed in the graphical view as colour curves (1) which follow the tempering profile (2). Each colour represents a different value (e.g. temperature, humidity), explained in a colour legend at the top right of the window: Temp. Set Temperature 2 1 The display of the colour legend can be switched on and off in the in the menu via "Settings"→"Show Color Legends".
CELSIUS 10 FDA-Edition Logging with vacuum ovens VO The logged measured values for temperature and vacuum for vacuum ovens VO are entered as a red curve. In online operation (oven must be registered), the actual temperatures of a maximum of two heating levels are logged by CELSIUS. If there are more than two shelves, only the temperatures of the two lowest heating levels are logged. In operation with a chip card, the value of the lowest heating level is logged.
CELSIUS 10 FDA-Edition 8.2.3 Saving and loading protocol data (*.pro) If the option "Create Log File" is enabled when a tempering profile is run (see page 35), the protocol values are saved to the protocol file (*.pro) selected. You may also write the actual value curve with the corresponding tempering profile later on to a protocol file if the protocol option is not enabled in the start dialog of the temperature programme.
CELSIUS 10 FDA-Edition After data have been read in, a selection dialog appears. Here you can select the period of time for which you would like to display a protocol. The protocol is read from the bin file that was previously transferred by the oven, and which is displayed in the entry field "Ring Protocol File". If the protocol data for the selected period of time need more main memory than is made available by the computer, a warning appears. In this case, you should make the period of time shorter.
CELSIUS 10 FDA-Edition 8.2.6 Export log data in tabular form (Report) With the report function, it is possible to print log data in tabular form or save them as Excel® format (.xls) for processing in a spreadsheet programme and graphically enhance them, for example. This way, ring protocol data can be processed, as well as log data resulting from running a temperature-control profile (see Chapter “Types of Protocols” on page 38).
CELSIUS 10 FDA-Edition A dialog window appears in which you can specify what is to be included in the report: 1 2 3 5 6 4 7 Report options and presentation as spreadsheet 1 Period presented in protocol window (can be changed by zooming [see page 32] and/or the horizontal scroll bar) 2 Period to be included in the report 3 Interval of individual datasets, recordings are taken at one-minute intervals. To reduce the amount of datasets, a larger interval (e.g. 5 minutes) may be chosen.
CELSIUS 10 FDA-Edition 8.3 Ending work with CELSIUS You can end work with CELSIUS ► via "File"→"Exit" ► by closing the programme window ► with the key combination Alt + F4 If an oven is stilll logged on or an opened tempering profile has not Yes No been saved, a warning will appear: If you confirm the prompt with Yes, open tempering profiles will be closed and not saved. If you want to cancel this, click No.
CELSIUS 10 FDA-Edition Typical arrangement of an entry in the audit trail file: Type Time stamp User name Device adress Device number Filename Forms of audit trail entries: Report type Description Audit OK General audit trail entries, e.g. during storing OK Fehler Audit trail entries of authority tests: User authorized for this action User not authorized for this action Info Notes, e.g. on electronic signing of a profile or protocol file.
CELSIUS 10 FDA-Edition Examples of successful authorization tests: Examples of denied authorization test and error entries: 9.2 Electronic signature Using the electronic signature, the user of a tempering profile or a protocol file can sign it digitally. The digital signature is saved and encrypted in the particular file. The signature function is called via the menu entry „Security“→“Signatures“.
CELSIUS 10 FDA-Edition Electronic signatures can not be deleted or overwritten as long as the file has not been altered. If a signed profile is altered (menu: Wrap-Up profile) or an existing profile is saved under a different name (menu: save as …), all digital signatures are deleted. 9.
CELSIUS 10 FDA-Edition 10.3 Backup Folder If you want verification of all changes to the temperature profiles and protocol files, it is possible to create backup copies with time and date stamp when any change is made and store these in a separate, write-protected backup folder. The backup function can be enabled via "Settings"→"Backup Folder". If the checkmark "Use backup folder" is set, an existing directory can be entered, or an existing backup directory can be selected via the button.
CELSIUS 10 FDA-Edition 10.3.1 Automatic backup of versions in the backup folder As evidence for all alterations of temperature profiles and protocol data, CELSIUS FDA-Edition prepares backup copies for each alteration, with date and time stamp, which are saved in a separate backup folder. A separate folder, marked with the date, is produced for each date. The folder contains all backup copies of a day. The filename is extended by the current clock time.
CELSIUS 10 FDA-Edition 10.6 Working with MEMoryCard MEMMERT ovens with P fittings are equipped with an integrated card reader for MEMoryCard XL (32 kB). On each MEMoryCard, a tempering profile with up to 40 ramps can be stored. This tempering profile is then processed by the oven on its own, i.e. without a PC connection. During the profile sequence, the MEMoryCard saves the actual data that are accumulated in electronic form.
CELSIUS 10 FDA-Edition 10.8 Programme language The programme and the menus can be displayed in five different languages. How you can change the languages is described on page 13. 10.9 Connection details 10.9.
CELSIUS 10 FDA-Edition 10.10 Deinstalling CELSIUS You must have administrator rights to be able to deinstall CELSIUS.
CELSIUS 10 FDA-Edition 11. Index 21 CFR Part 11 10 *.bin file 19, 47, 54 *.cel file 54 *.
CELSIUS 10 FDA-Edition Programme shortcuts 14 Protocol 23, 25, 43, 46, 47 Protocol file 16, 19, 20, 25, 41, 46, 47, 56 Protocol files 47, 54 R Ramp close statement 36 Ramp segment 35, 40 Report function 48 Ring protocol memory 19, 42, 46, 47 RS-232 interface 29, 32 S Save protocol data 20, 46 Save settings 22, 55 Save settings when ending 23 Save tempering profile 19, 42 Save tempering profile to file 25 Save tempering profile to MEMoryCard 25 Save tempering profile to oven 25 Saving and loading protocol
Memmert GmbH + Co KG | PO Box 1720 | D-91107 Schwabach, Germany | Tel. +49 (0) 9122-925-0 | Fax +49 (0) 9122-145-85 | Email: service@memmert.com | www.memmert.com 18.09.
