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98646-001-25

Sartorius
ial ogy
isi30-000Q (SartoPac 85) Industring Technol
Weigh

Sampling and Evaluation Program for Average Weight Control, Statistical Process
Control and Weight Controls in Accordance with Pharmacopoeia Regulations
Operating Instructions

1
Intended Use Contents Getting Started

The isi30-000Q Applications Intended Use ............................ 2 Affix the “Equipment for Prepackage
Package is designed for use in Control” label to the scale.
Contents .................................. 2
automatic, computer-controlled
If you use the scale in Germany for
sampling for evaluation of Getting Started ......................... 2
average weight control, the enclosed
prepackaged products and fill Operating Design ...................... 3 label must be affixed as follows:
quantities.
Application Setup – Clearly visible on the weighing
You can use the results of sampling Configuring the Applications ..... 6 platform or the verification tag
evaluations to optimize the filling Menu Structure Diagram ........... 7
process and for official – Near the manufacturer’s label and
List of Parameters..................... 9
documentation to show that the the verification mark
process meets prepackage Configuring the Program
requirements for precision in filling. Base Data ........................... 13
Example: IS12CCE-I0CE
Configuration ....................... 14
The isi30-000Q Applications Formatting the Printout ............ 16
Package offers the following Equipment for Prepackage Control
features: Sampling
from 50 g to 12,000 g
Sampling ............................. 19
– 100 product-memory modules Tare Weighing ..................... 22
available for managing product Test Weighing ...................... 24
information This label indicates the range of use
Evaluation for the scale in controlling packages
– Up to 15 parameters can be set Display ................................ 25 weighing from 50 to 12,000 g in
for each product (e.g., name, Print .................................... 26 accordance with prepackaging
nominal quantity, – T2 tolerance Print and Delete .................... 27 regulations.
limit, etc.) Display Current Product .......... 27
● Refer to the instruction manual
– Sampling evaluation, tare Product List ........................... 28
for your weighing platform
weighing and test weighing Data Output Functions to determine the minimum and
– Automatic or manual storing Application Line .................... 30 maximum capacities; enter
of weight values Standard Printout ................... 30 these values on the label with
Printing a Sample Evaluation ... 31 a permanent felt marker.
– Statistical evaluation to meet legal
Printing Tare Weighing Data ... 31
requirements, long-term statistics
Printing Test Weighing Data .... 32
for monitoring production
Printing a List of Products ........ 32
– Adjustment step indicated for Printing Base Data ................. 32
optimizing the packaging process Printing Statistics.................... 32
Communications Port ............. 33
– Weight controls with symmetrical
Digital Input/Output
tolerance limits – statistical process
Interface Port ........................ 33
controls (SPC)
Error Codes ............................ 34
– Test for consistency of medicinal
preparations in accordance Overview
with European pharmacopoeia Description of the Keys ........... 35
regulations Parameter Settings ................. 37
Abbreviations ....................... 38
These operating instructions contain
only descriptions of the functions
for checkweighing prepackaged
products, statistical process control
and weight controls in accordance
with European pharmacopoeia
regulations. Installation instructions,
scale-specific functions and instruc-
tions for device setup are contained
in the “Installation and Operating
Instructions“ for the isi10, 20 and 30
industrial terminals.

2
Operating Design

Operating Design Data Input Scale Function Keys


These keys are blue color-coded,
Dialog Type and are assigned normal scale
To configure the scale for check- functions. They are described in the
weighing prepackaged products, Data is entered in the isi30-000Q “Installation and Operating
you need to set certain parameters in application through the keys or using Instructions“ for the “isi“ terminals.
the application setup menu (e.g., a bar code scanner, mainly in dialog
base data, configuration, printout form. There are two types of dialog:
format). Then you can begin Application Function Keys
– Select dialog
weighing. The description of the – Input dialog These keys have light-emitting diodes
operating design is divided into the (LEDs) that light up during operation.
following sections: They are used to start application
Select Dialog functions (e.g., sampling or evaluation).
– Data Input
The selection text is displayed When a function key is pressed:
– Display Modes in the weight display line or in the
– Error Codes application line (bottom line). – the corresponding LED lights up
Use the UP and DOWN arrow keys and a single beep tone (acoustic
– Storing Data (Y and y) to select an option; signal) is sounded; or
– Deleting Data then press ENTER (L) to confirm – two beeps are sounded, indicating
your selection. that the key has no function or is
– Data Output
blocked in the current operational
Input Dialog status.
The parameter to be defined is This provides for easy operation,
displayed in the weight display line requiring few keys to be pressed.
or the application line; enter a value For most keys, the symbol
here (name or number). indicating the function is not on
the key itself, but located
Bar Code Scanner above the key.

All the data that you can input using


Numeric Keys
the keypad can also be entered
via bar code scanner. The numeric keypad can be used
to enter both positive and negative
numbers, with decimal places.
Keys
Each key is described in detail in
the chapter entitled “Overview;“ only Keys for Alphabetic Input
the basic concept is described here. Press the a key before entering
All data entered are displayed in letters. The LED lights up; now you
the application line at the bottom of can enter letters.
the display (20 characters max.).
The keys are divided into 4 groups: Correcting Data Input

– Scale function keys You can interrupt and cancel data


(tare, gross, etc.) (blue keys) input by pressing C.
– Application function keys You can also use the j c x
– Numeric keys and X keys to change or correct
– Keys for alphabetic characters the character string during input.
as well as correction and arrow keys
(cursor keys).

3
Display Modes Display During Operation (Example)

There is one display mode for 1 1 1 1


operation and another for
application setup. Information on the
application status or the selected 16 5 1 0.1
function is given in the bottom line of 1
the display (application line).
NNNN0000
Display Mode During Operation

This display mode is described in


detail in the “Installation and
Operating Instructions” for the “isi”
text
industrial terminals.
2 3 4 5 6 7 8

Display Mode During 1: Weighing platform specifications 5: For zeroing the weighing platform
Application Setup 2: Application line 6: + /– sign for value displayed
3: Symbol for the function 7: Weighed value
You can set the desired weighing in progress 8: Weight unit of displayed value
parameters by selecting the 4: Weighing platform number
corresponding menu items. The
menus have a hierarchical structure
comprising several levels. The
“Application” menu item is displayed
at the highest level. There are
several submenus under this menu
item; “Base Dat.”, for example, is a Display During Configuration (Example)
submenu of the “Application” menu,
and is at the second menu level.
In the sample display at the right,
“Enter” is displayed as the last menu
item selected from the fourth level.
When a parameter has been
selected from a list of parameter
options, a small circle (6) is
displayed to the right of that
parameter option, and it is moved
to the top of the list.
When you select a submenu, the
level just above it is displayed
(abbreviated) in the upper line; e.g.,
in the example at the right:
application –> app.
configuration –> conf. 1: Symbol for the routine 5: Last (sub)menu (item) selected
password –> passw. in progress (in this case, 6: Indicates that this is the currently
“Configuration”) selected setting
2-4: Menu levels above the 7: Indicates that additional
displayed menu item, submenus/menu items exist
“Password required to enter 8: Application line
base data – Yes/no”

4
Operating Design

Error Codes Storing Data Data Output

When a key is pressed which has no Saving Configuration Settings You can choose from 3 forms
function or is blocked at a certain of data output:
point in an application program, the The application data are stored – Display in the application line
error is indicated as follows: in RAM which has backup battery – Printout on the YDP01IS-0CE
– the display shows an error power, which means your printer
message for 2 seconds; then settings are not lost in the case – Output to the YDO01IS
returns to the previous display; of a power outage. COM port
When you turn on the isi30-000Q,
– a double-beep is sounded as an the most recent configuration settings
acoustic signal. are active. Application Line
This process is the same for all
operating modes (setup, application This line displays the following
Blocking Access to Configurations
program routines). data after a sampling:
Error codes and messages are You can block access to the setup – Average value of samples
described in detail in the section menu by assigning a password. – Long-term average
entitled “Error Codes.” – Standard deviation
You can also block access to each of
the following areas separately: – Variance coefficient
– Sample size
– Enter base data – Number of values < –T2
– Delete base data – Number of values < –T1
– Perform test weighing – Number of values < –T
– Delete statistics – Number of values > +T
– Delete individual values – Individual values
during sampling – Machine adjustment instruction
– Delete entire sampling series

Saving a Sampling Series Printer

A sampling series may be interrupted You can connect a printer to the


before it is completed. When isi30-000Q. In addition to the
this is the case, a printout is standard printout, you can also
generated automatically which generate separate printouts of
includes the error message a specific sampling series, product
“Sampling aborted.” lists, base data or statistics.
In the setup menu, you can configure
whether the printout includes a GMP
Deleting Data header and a GMP footer (space for
operator‘s signature). GMP stands
Deleting Characters for Good Manufacturing Practice.

You can delete an incorrect


character by pressing the c key. Communications Interface to an
External Computer
Interrupt/Cancel Data Input The isi30-000Q is equipped with an
SBI interface for data communication.
You can cancel input by pressing C, This is a simple ASCII interface.
as long as you have not yet The functions available through this
pressed L. interface are described in the
respective “Interface Description.”

5
Application Setup Configuring the Applications Example

The application menu has a Let us assume you want to set the
You need to define certain para- hierarchical structure with several “Print individual values” parameter
meters in the isi30-000Q so that the levels. Select the corresponding [46] to “all,” and the scale is
program can calculate weighing menu items to access the individual currently in the operating mode.
data according to your requirements. parameter options.
The procedure is as follows:
Access the application setup menu
Press L to select a menu item.
to set these parameters. 1. Access the application setup menu:
Press Y or y to move from one
Press [SETUP]: Base Dat.
Application setup is a part of the item to another within a menu level.
is displayed
general device setup (see the Press x or C to return to the level
“Installation and Operating above the current menu level. 2. Access the printout parameter:
Instructions” for the “isi” industrial Press Y Y: printout
terminal). The applications that is displayed
you select in application setup will Diagram
3. Select printout parameter:
refer to these general configurations
The menu structure is illustrated on Press L: machine
in some cases to “decide” on
pages 7–8. is displayed
certain actions.
Descriptions of individual menu items 4. Activate the individual values
The application setup menu is
are listed by the numbers in square parameter:
divided into 4 parts: Base Data,
brackets in this diagram, starting Press Y Y: ind. val.
Configuration, Printout and
on page 9. These descriptions are is displayed
Password.
presented in the following format: 5. Select individual values
There are two ways to access the
parameter:
application setup menu:
[46] Press L: the most recently
– from within the general device Print individual values ind. val. set parameter
setup menu, by selecting the No ind. values printed none is displayed
“Application Setup” menu item, or Print fill quantity only fill amt. o 6. Display all:
– from the operating mode, by Print tare and fill amt. all Press Y or y until all appears
pressing the respective function
7. Select all:
key [Setup]. o indicates currently active setting o
Press L: all
is displayed
o indicates that “all” is the selected
parameter
8. Exit application setup:
Press x 3 times
or press C 3 times

6
Application Setup

Menu Structure Diagram (Part 1)

1 2 3 4 5 Parameter described
el el el el el
Lev Lev Lev Lev Lev under no.:

Application Base Data Enter Product name [1]


Setup
Machine designation [2]
Tolerance system [3]
Density [4]
Adjustment step [5]
Sample size [6]
Nominal fill quantity [7]
Average tare [8]
–T1 limit [9]
–T2 limit [10]
–T limit [11]
+T limit [12]
Supplement amount [13]
Control mode [14]
Tare automatically after values stored [15]
Save data entered [16]
Delete [17]
Memory data [18]
Display [19]
Delete all [20]

Configuration Operator [21]


Batch [22]
Average tare [23]
Density [24]
Always enter [25]
Require Enter/change base data [26]
password
Delete base data [27]
(Code) to:
Perform test weighing [28]
Delete statistics [29]
Delete individual values [30]
Delete entire sampling run [31]
Take over values [32]
Weight unit for base data [33]
Tare before beginning sampling [34]
Print evaluation [35]
Delete statistics list [36]
First statistics value displayed [37]

Printout see next page

Password see next page

7
Menu Structure Diagram (Part 2)

1 2 3 4 5 Parameter described
el el el el el
Lev Lev Lev Lev Lev under no.:

Application Base Data see previous page


Setup

Configuration see previous page

Confirm outliers Limit 1 [38]


Limit 2 [39]
Limit 3 [40]
Limit 4 [41]

Plausibility Gross [42]


Tare [43]

Printout Print machine designation [44]


Print base data [45]
Print individual values [46]
GMP header/footer [47]
Output to COM port [48]
Print histogram [49]

Password Old password New password New password [50]

8
Application Setup

List of Parameters

Parameters Under the “Base Data”


Menu Item

[1] SPC: The machine adjustment step is the


Product name prd. The –T1, +T1 and +T2 limits are smallest step of the filling machine.
Max. 16 characters for calculated from the value entered for The adjustment instruction is always
product name –T2. All limits are displayed and calculated as a whole-number multiple
can be changed. Tolerance violations of this step. If the adjustment step = 0,
[2] are as for the PHARMA setting. no adjustment instruction is output.
Machine name machine
Max. 16 characters for machine PHARMA 1 through 4 [6]
designation All tolerance limits are calculated Sample size number
automatically, none are displayed. Max. 125 individual samples
[3] Deviations are calculated from the per series
Tolerance system tol.sys. mean value (average weight) Default setting for PHARMA: 20
Acc. to prepackage of the sample and not from the
regulations REG nominal quantity. [7]
User defined user def. –T2 violations are not –T1 violations. Nominal fill quantity nom.Fill.
SPC spc +T2 violations are not +T1 violations. 2 decimal places; unit as selected
Pharma 1 pharma 1 under [33] or in “ml“, if [4] ≠ 0.000
Pharma 2 pharma 2 Mean Limits [in %]
Pharma 3 pharma 3 [in mg] –T2 –T1 +T1 +T2 [8]
Pharma 4 pharma 4 Average tare tare wt.
PHARMA 1: 2 decimal places; unit as selected
REG SPC Non-coated tablets under [33]
User def. Pharma 1 thru 4 <= 80 80 90 110 120
Limit 1 –T2 –T2 80 – 250 85 92.5 107.5 115
>= 250 90 95 105 110 [9]
Limit 2 –T1 –T1
–T2 tolerance limit -t2
Limit 3 –T +T1
PHARMA 2: 2 decimal places; unit as selected
Limit 4 +T +T2
Capsules under [33] or in “ml”, if [4] ≠ 0.000
The following applies in all cases < 300 80 90 110 120 If you select the “User def.” or the
(N = nominal fill qty): >= 300 85 92.5 107.5 115 “SPC” tolerance system, you can
–T2 ≤ –T1 ≤ –T ≤ –T ≤ N ≤ +T or define the –T2 limit.
–T2 ≤ –T1 ≤ N ≤ +T1 ≤ +T2 PHARMA 3:
Powders –T2 must always be ≤ –T1.
REG: > 40 80 90 110 120
–T2 and –T1 limits are calculated
[10]
automatically from the nominal fill PHARMA 4:
–T2 tolerance limit -t2
quantity but not displayed. Suppositories and pessaries
All 90 95 105 110 2 decimal places; unit as selected
–T2 violations are also –T1 violations.
under [33] or in “ml“, if [4] ≠ 0.000
–T1 violations are also –T violations.
[4] If you select the “User def.” system,
User Defined: Density density you can define –T1.
All the tolerance limits can be defined
4 decimal places; unit is g/ml If you select the “SPC” system,
and are displayed. None of the limits
you can change –T1.
are calculated automatically. Select
[5]
this tolerance system if the products –T1 must always be the nominal fill
Machine adjustment step adj.step.
tested are < 5 g/ml. Tolerance quantity.
2 decimal places; unit as selected
violations are as for the AWC setting.
under [33] or in “ml“, if [4] ≠ 0.000

9
Parameters Under the
“Configuration” Menu Item

[11] [14] [21]


–T tolerance limit for REG and Control mode control Operator designation operator
User. def. tolerance systems -t Average tare avg.tare Display default
2 decimal places; unit as selected Tare, then gross tare->gross operator des. with def o
under [33] or in “ml“, if [4] ≠ 0.000 Gross, then tare gross->tare No default op. des. no def.
Additive weighing add. whg. Do not enter operator des. no
You can define the –T limit.
–T must be ≥ –T1. [15] [22]
Automatic taring after weight Batch designation batch
+T1 tolerance limit for SPC and value stored tar.a.val. Enter batch number Yes
PHARMA tolerance systems +t1 Yes Yes Do not enter number no o
2 decimal places; unit as selected No no
under [33] or in “ml”, if [4] ≠ 0.000 [23]
If you select the “SPC” system, you [16] Average tare tare wt.
can change the +T1 limit. Save data entered save Enter a value Yes
Yes Yes Do not enter a value no o
+T1 must be ≥ the nominal quantity. No no
[24]
[12] [17] Density density
+T tolerance limit for REG and Delete a product delete Enter a value Yes
User def. tolerance systems +t Yes Yes Do not enter a value no o
2 decimal places; unit as selected No no
under [33] or in “ml“, if [4] ≠ 0.000 [25]
The +T limit can be defined. [18] Always enter operator, batch,
Show data in memory mem.data tare & density data ent.alwys.
+T must ≥ the nominal quantity. To display a list of product names; Always enter Yes o
press p to print Enter only at start no
+T2 tolerance limit for SPC and of sampling series
PHARMA tolerance systems +t2 [19]
2 decimal places; unit as selected Display display Restrict access to functions: Passw.
under [33] or in “ml”, if [4] ≠ 0.000 To display the base data for the
If you select the “SPC” system, you current product; press p to print [26]
can change the +T2 limit. Enter/change base data ent.b.dat.
[20] Password required* Yes o
+T2 must be ≥ the +T1 limit. Delete all base data del.all No password required no
Yes Yes
[13] No no
Supplement amount suppl. [27]
! Important Note: Delete base data del.b.dat.
2 decimal places; unit as selected
under [33] or in “ml“, if [4] ≠ 0.000 Only select “yes” here if you Password required* Yes o
are sure that you want to delete all No password required no
This is an “evaporating supplement” base data.
which is subtracted from the [28]
gross value when a measured value Perform test weigh test wgh.
is taken over. Password required* Yes o
Fill quantity = No password required no
(gross – tare)/density – supplement

* = Password required to access


this function

10
Application Setup

[29] [37] With a PHARMA tolerance system,


Delete statistics del.stat. First value displayed of out-of-tolerance values are displayed
Password required* Yes o sampling statistics dis.stat. at the end of sampling and must
No password required no Sampling average mean o be confirmed by pressing L.
Long-term mean l-mean
[30] Standard deviation s [41]
Delete ind. values del.val. Variation coefficient V Limit 4 (+T or +T2) limit 4
Password required* Yes o Sample size n Out-of-tolerance value
No password required no Number < limit –T1 n<-t1 must be confirmed Yes
Number < limit –T2 n<-t2 Confirmation not required no o
[31] Number < limit –T n<-t
If you select the REG tolerance
Delete last measurement del.meas. Number > limit +T n>+t
system, out-of-tolerance values must
Password required* Yes o Adj. instruction adjust.
be confirmed.
No password required no With a PHARMA tolerance system,
[38]
out-of-tolerance values are displayed
[32] Limit 1 (–T2) limit 1
at the end of sampling and must
Take over values take val. Out-of-tolerance value be confirmed by pressing L.
Manually manual must be confirmed Yes o
Automatically autom. o Confirmation not required no [42]
If you select the REG tolerance Plausibility limit for gross weight gross
[33] Standard standard o
system, out-of-tolerance values must
Unit for base data Unit Up to 50% error
be confirmed. 50 pct
Grams g o With a PHARMA tolerance system, Up to 75% error 75 pct
Kilograms kg out-of-tolerance values are displayed Up to 90% error 90 pct
at the end of sampling and must
[34] You can adapt your “User def.” or
be confirmed by pressing L.
Tare before “SPC” tolerance system for use with
beginning sampling tar.b.sam. products of widely varying weights.
[39]
Yes Yes Select the standard setting (± 25%)
Limit 2 (–T1) limit 2
No no o for all other tolerance systems.
Out-of-tolerance value
must be confirmed Yes [43]
[35] Confirmation not required no o
Print evaluation prt.eval. Plausibility limit for tare weight Tare
Manually manual o If you select the REG tolerance Standard standard o
Automatically autom. system, out-of-tolerance values must Up to 50% error 50 pct
be confirmed. Up to 75% error 75 pct
[36] With a PHARMA tolerance system, Up to 90% error 90 pct
Delete statistics for out-of-tolerance values are displayed
You can adapt your “User def.” or
products weighed del.list at the end of sampling and must
“SPC” tolerance system for use with
Manually manual o be confirmed by pressing L.
products of widely varying weights.
Automatically autom. Select the standard setting (± 40%)
[40]
for all other tolerance systems.
Limit 3 (–T or +T1) limit 3
Out-of-tolerance value
must be confirmed Yes
Confirmation not required no o
If you select the REG tolerance
system, out-of-tolerance values must
be confirmed.

11
Parameters Under the “Printout” Save Parameter Settings
Menu Item

[44] You can protect your parameter


Print machine designation machine settings from unauthorized changes
Yes Yes o by assigning a password.
No no The password you enter is hidden
(only asterisks (*) are displayed).
[45]
Print base data base dat. [50]
Yes Yes o Password [Example] passw.
No no Old password [BLUE] ****
Enter new
[46] password [RED] ****
Print individual values ind. val. Confirm new
No indiv. values printed none password [RED] ****
Print fill quantities only fill amt. o
Print tare and fill quantities all

[47]
Print GMP header/footer gmp
Yes Yes
No no o

[48]
Output ind. values to
COM port com
No ind. values none o
Fill amounts only fill amt.
Tare and fill amts. all
Can only be output if the
corresponding parameters under
menu item [46] are set.

[49]
Histogram Histogr.
Print Yes
Do not print no o

12
Configuring the Program

Configuring the Program – Density for liquid products Displaying Product Data
– Adjustment step You can have the data on a specific
– Sample size product displayed if you want to
Base Data check it.
– Nominal quantity (Select the
The isi30-000Q Application “User def.” tolerance system if this Select the menu path: Base Data/
Package is designed for use in quantity is less than 5 g) Display. Enter the product name
average weight control of or scroll through the product list (see
– Average tare above) until you find the desired
prepackaged products. Average
weight control is performed by – –T2, –T1, –T and +T limits, or product; then confirm by pressing
evaluating samples of the products. –T2, –T1, +T1 and +T2 limits L. Use the Y y keys to scroll
There are large amounts of data to through the product data. See
– Supplement amount for products
be managed and processed relating above under “Entering Product Data”
that decrease in weight after
to the products and their containers regarding the number of decimals.
filling, due to evaporation
or packaging. The isi30-000Q has Press C if you want to exit the
memory locations for up to 100 Supplement =
application setup menu.
products, allowing easy access to Gross – supplement – tare
all required data. – Control mode
Printing Product Data
with average tare weight, with
individual tare and gross measure- You can print out product data for
Product Memory
ments, or additive weighing documentation purposes.
When you access product memory, Select the menu path: Base Data/
– Taring
the amount of memory available Display. Then enter the product
if you want the weighing
is displayed for 2 seconds in the name or select it from the list (see
equipment to tare automatically
application line. above) and confirm by pressing L.
after a weight value is stored
Press p to generate a printout.
When you enter the base data for a
Entering Product Data See above under “Entering Product
product, the number of decimals for
Data” regarding the number of
You can manage data, including the the weight value is set to 2. The value
decimals.
following information, on 100 is stored, however, with the full
accuracy indicated. Press C if you want to exit the
different products. Each of the 100
application setup menu.
product memory locations can The first time sampling is performed
contain the following data: with this product, the number of
– Product name/number decimals on the display and the Changing Product Data
(designation for ID) printout is determined by the scale
used. In subsequent sampling the You can make changes in the data
– Machine designation (remark) number of decimals is set to the on any product.
– Tolerance system (menu item [3]) accuracy of the last scale used. Select the menu path: Base Data/
Enter. Use the Y y keys to scroll
REG: For products subject to
through the list of parameters; press
prepackage regulations Product Data Search
L to select the desired parameter.
User Tolerance limits can You can scroll through a list of Enter new values for the parameter.
def.: be defined product names in the application Press C if you want to exit the
menu and after starting the sampling application setup menu.
SPC: You enter the –T2 limit; the
routine, tare weighing or test
–T1, +T1 and +T2 values
weighing.
are calculated based on this
value. You can also chan- Select the menu path: Base Data/
ge the values calculated. Memory Data in the application
setup menu. Then use the up/down
PHARMA 1: For non-coated
arrow keys (Y y) to scroll through
tablets
the list of products. You can also
PHARMA 2: For capsules enter a letter before scrolling to move
PHARMA 3: For powders to the first product that begins with
that letter.
PHARMA 4: For suppositories/
pessaries Press C if you want to exit the
application menu.

13
The following data cannot be Configuration Blocking Access to Functions
changed if long-term statistics exist
on the product in question: You need to select the product name Select the menu path: Application
– Tolerance system from the list of products before each Setup/Configuration/Password
– Nominal quantity sampling series, tare weighing or test to configure:
– Tolerance limits weighing. – whether a password must be
Once you have selected the product, entered before base data can be
Deleting Product Data you can enter additional data entered or changed in the Setup
concerning the machine operator, menu (menu item [26]),
You can delete a product from
batch, tare weight and density. – whether a password must be
the list.
These data comprise the header entered before base data can be
Select the menu path: Base Data / data. deleted from the Setup menu
Delete (or: Delete All). Enter the (menu item [27]),
password, if necessary, and confirm
by pressing L. Then enter the – whether a password must be
Configuring Header Data
product name or select it from the list entered before test weighing can
(see above) and press L to confirm. be performed (menu item [28]),
Select the menu path: Application
Press L again to delete the Setup/Configuration to configure: – whether a password must be
product(s). entered before statistics can be
– whether a prompt is displayed deleted (menu item [29]),
Press C if you want to exit the for input of the operator data and,
application setup menu. if so, whether the last operator – whether a password must be
designation entered should appear entered before an individual
as a default (menu item [21]), measured value can be deleted
(menu item [30]), and
– whether the batch designation
must be entered (menu item [22], – whether a password must be
entered before an entire sampling
– whether the tare weight can be series can be deleted (menu item
changed (menu item [23]), [31]).
– whether the density value can be
changed (menu item [24]), and
– whether input of operator, batch, Measured Data
tare weight and density data
should be prompted for each Select the menu path: Application
sample (“Enter always”) or Setup/Configuration to configure:
whether these data are entered – whether measured values are
once for the entire series (menu stored manually (by pressing L)
item [25]). or automatically (menu item [32]),
– the weight unit used for statistics
and base data (menu item [33]),
– whether the weighing instrument
is automatically tared before each
sample (menu item [34]),
– whether the evaluation of sample
data is printed manually (by
pressing p) or automatically
(menu item [35]).

14
Configuring the Program

– whether out-of-tolerance values – to have an error message (“Too


must be confirmed before the low” or “Too high”) displayed
program can continue. An out-of- when a measured value exceeds
tolerance value is displayed, for plausible limits. You can set these
example, as “–T2 ERROR”. “plausibility limits” by selecting
the percentage of deviation from
With the “REG” tolerance system,
the nominal fill quantity or from the
–T2 violations must always be
tare approximation value.
confirmed.
For gross measurements:
With a “PHARMA” tolerance
system, out-of-tolerance values are E –P +P
calculated based on the average
Standard 50 75 125
weight in the sampling run,
not on the nominal fill quantity. 50 percent 30 50 150
This is why violations can only be
75 percent 10 25 175
displayed at the end of sampling.
The out-of-tolerance values must be 90 percent 5 10 190
confirmed. where:
(See menu items [38] NST: Nominal fill quantity +
through [41].) supplement + average tare
[= 100%]
U: Unloaded scale limit as
a percentage of NST
–P: Lower plausibility limit as
a percentage of NST
+P: Upper plausibility limit as
a percentage of NST
(See menu item [42].)

For tare measurements:


E –P +P
Standard 50 60 140
50 percent 30 50 150
75 percent 10 25 175
90 percent 5 10 190
where:
TA: Tare approximation
[= 100%]
U: Unloaded scale limit as
a percentage of TA
–P: Lower plausibility limit as
a percentage of TA
+P: Upper plausibility limit as
a percentage of TA
(See menu item [43].)

15
Formatting the Printout Example: Designation of Printed Lines
Printout of a Sampling Evaluation (Described on page 18)
The isi30-000Q can print out
7 different types of data records:
1. -------------------- GMP-Dotted line
12.03.1998 16:00 GMP-Date/time
– Standard printout (net, tare 2, Type ISI30 GMP-Terminal type
tare 1, gross) Ver. S1.1020.03.7 GMP-isi30-000Q software version
– Printout of sampling evaluation ID 2.2.1 GMP-Cust./system/code/workst. no.
Type IS34EDE GMP-Weighing platform type
– Printout of tare weighing Ser. no. 51106279 GMP-Weighing platform serial no.
– Printout of test weighing -------------------- GMP-Dotted line
2.
Sample from: Header line
– List of products 12.03.1998 16:00 Date/time of sampling
– Base data for a product Blank line
3.
Prod. CHOC.COOKIES Product name
– Statistics
Contr. Avg.tare Control mode
Mach. MACHINE 1 Machine designation
Batch ABC456 Batch designation
You can configure how the sample
data, tare weighing and test
Tol.S. REG Tolerance system
weighing printouts are triggered as
Nominal 100.0 g Nominal quantity
well as their formats.
Density 0.0000 Density in g/ml
In the application setup menu, you -T2 91.0 g –T2 limit
can configure whether a printout -T1 95.5 g –T1 limit
is generated manually (by pressing -T 98.0 g –T limit
p) or automatically after each +T 103.0 g +T limit
sample, tare weighing or test Suppl. 1.0 g Supplement amount
weighing. Tare 10.0 g Average tare
4.
[35] Fill amount: Explanatory text
Print sampling evaluation prt.eval. 001 * 96.9 g Individual value (* = out-of-tolerance)
Manually manual o 002 99.3 g Individual value
Automatically autom. 003 99.5 g Individual value
004 103.0 g Individual value
5.
The sampling evaluation printout Evaluation: Explanatory text
consists of 9 sections (see “Example: Mean 99.7 g Sample mean
Printout of a Sampling Evaluation): L-Mean 99.7 g Long-term mean
s 2.5 g Standard deviation
– 1. GMP header
V 2.51 % Variance coefficient
– 2. Identification section n 4 Sample size
– 3. Base data n<-T2 0 No. of values < –T2
n<-T1 0 No. of values < –T1
– 4. Individual values n<-T 1 No. of values < –T
– 5. Evaluation n>+T 0 No. of values > +T

– 6. Histogram continued on next page


– 7. Adjustment instruction
– 8. Operator
– 9. GMP footer

16
Configuring the Program

6.
The sections for GMP header and Histogram: Explanatory text
footer, machine designation, base
data, individual values and <-T2 Values < –T2
histogram are optional. Select the
menu path: Application Setup/ <-T1 Values from
Printout to define which of these –T2 to –T2 + (–T1 – –T2)/2
sections should be printed (menu <-T1 Values from
items [44] through [49]). See above –T2 + (–T1 – –T2)/2 to –T1
under “Entering Product Data” <-T Values from
regarding the number of decimals. –T1 to –T1 + (–T – –T1)/2
<-T Values from –T1 + (–T – –T1)/2
In a sampling run using a PHARMA
to –T1 + (–T – –T1)
tolerance system, N is the sample
-2: Values from –T1 + (–T – –T1)
average and –T1/2 or +T1/2
to –T1+ (N – –T)/2
values are calculated in the
-1: Values from –T + (N – –T)/2 to N
sampling run.
In the long-term statistics using +1: Values from N to N + (+T – N)/2
a PHARMA tolerance system, N,
–T1/2 and +T1/2 values are set in +2: Values from N + (+-t – N)/2 to + T
the base data. In this case, numeric
values from –7 to +7 are included >+T Values from +T to ((+T – N)*2)/2
on the printout as indicators.
>+T Values from ((+T – N)*2/2 to
(+T – N)*2
>+T Values from (+T – N)*2 to
((+T – N)*4)/2
>+T Values from ((+T – N)*4)/2 to
(+T – N*4
>+T Values > (+T – N)*4

<-T2 0 0.0 % Absolute and relative numbers of


<-T1 0 0.0 % measured values per category
<-T1 0 0.0 %
<-T 0 0.0 %
<-T 1 25.0 %
-2: 0 0.0 %
-1: 2 50.0 %
+1: 0 0.0 %
+2: 1 25.0 %
>+T 0 0.0 %
>+T 0 0.0 %
>+T 0 0.0 %
>+T 0 0.0 %
>+T 0 0.0 %

7.
Adj. + 6.23 g Adjustment instruction
8.
Oper. AB12 Operator designation
9. --------------------
12.03.1998 16:03 GMP-Date/time
Name: GMP-Field for signature
GMP-Blank line
-------------------- GMP-Dotted line

several blank lines

17
GMP Sections Batch Designation SPC:
The –T1, +T1 and +T2 limits are
GMP Header If the batch designation is too long calculated from the value entered for
to be printed on the “Batch” line, –T2. All limits are displayed and
GMP stands for Good Manufac- can be changed. Tolerance violations
the remaining characters are printed
turing Practice. The information in are as for the PHARMA setting.
right-justified on the next line
this section documents the date and
(16 characters max.).
time the measurement was made, PHARMA 1 through 4
as well as the equipment used. All tolerance limits are calculated
automatically, none are displayed.
Control Mode
Deviations are calculated from the
GMP Footer mean value (average weight) of the
The other possible control modes
This section contains a field for the sample and not from the nominal
are “Tare –> gross”, “Gross –>
operator‘s signature under the text: quantity.
tare”, “Add. Whg.” and “Tare
“Name:”. The operator documents –T2 violations are not –T1 violations.
cont.”.
the measurements made by signing +T2 violations are not +T1 violations.
the printout here.
Mean Limits [in %]
Tolerance System [in mg] –T2 –T1 +T1 +T2
You can configure whether these two
sections are printed or not. If you set Any of the following designations PHARMA 1:
the GMP menu item to “NO” during may appear to indicate the tolerance Non-coated tablets
a sampling series, the header/footer system used: ≤ 80 80 90 110 120
will not be included on the printout. 80 – 250 85 92.5 107.5 115
– REG
– User def. ≥ 250 90 95 105 110
Formatting a GMP Printout: – SPC
– Pharma 1 PHARMA 2:
– Pharma 2 Capsules
[47] – Pharma 3 < 300 80 90 110 120
GMP header/footer gmp – Pharma 4 > 300 85 92.5 107.5 115
Yes Yes
No no o REG SPC PHARMA 3:
User def. Pharma 1 – 4 Powders
> 40 80 90 110 120
Limit 1 –T2 –T2
Limit 2 –T1 –T1 PHARMA 4:
Product Name Limit 3 –T +T1 Suppositories and pessaries
Limit 4 +T +T2 All 90 95 105 110
If the product name is too long
to be printed on the “Prod.” line, the The following applies in all cases
remaining characters are printed (N = nominal fill qty):
right-justified on the next line Explanatory Text
–T2 ≤ –T1 ≤ –T ≤ –T ≤ N ≤ +T or
(16 characters max.). –T2 ≤ –T1 ≤ N ≤ +T1 ≤ +T2
In tare weighing, the explanatory
text would indicate “Tare values”
REG:
Machine Designation rather than “Fill amount.”
T2 and –T1 limits are calculated
automatically from the nominal fill
If the machine designation is too quantity but not displayed.
long to be printed on the “Mach.” –T2 violations are also –T1 violations. Adjustment Step
line, the remaining characters are –T1 violations are also –T violations.
printed right-justified on the next line In tare weighing, the explanatory text
(16 characters max.). User Defined: would indicate “Average Tare
All the tolerance limits can be defined Allowed” or “Indiv. Tare Required”
and are displayed. None of the limits rather than “Adj.”
are calculated automatically. Select
this tolerance system if the products
tested are < 5 g/ml. Tolerance
violations are as for the AWC setting.

18
Sampling

Sampling Performing a Sampling Routine Entering Header Data (Overview)

Regulations affecting prepackaged ● Select sampling function


When you turn on the isi30-000Q: products require that the weight or
● Enter or select a product name
– The display segments are tested volume of package contents must not
go below certain ‘tolerable negative $ Enter operator data
(all segments light up)
error’ limits at the time of manufacture. $ Enter batch designation
– a self-test of the weighing range This limit is called –T1/–T2.
is run $ Enter average tare
No more than 2% of the packages
– the software version is displayed are allowed to exceed the specified $ Enter density value
for 2 seconds negative error.
The isi30-000Q is then ready to Prepackages having a negative error The prompt for entering a density
operate. The measured value line greater than twice the tolerable value only appears if a value greater
shows the weight of the load on the negative error are not allowed to be or less than 0 has been entered in
weighing platform, and the prompt placed on the market; i.e., sold to the base data.
Please press a key appears the public. This lowest limit is known
in the application line. as –T2.
You can also configure a more The prompts for entering
Sampling results can be calculated stringent in-house limit, “–T,” as well as – operator data,
as average tare values, tare –> an in-house upper limit, “+T,” both
gross values, gross –> tare values, independent of the above limits. – batch designation,
or as additive weighing, depending – average tare, and
By sampling the products you can
on the “Control mode” setting.
determine whether the fill quantities – density
meet specified limits. For statistical
Tare –> Gross determination of these values, only appear if configured in the
In sampling, the tare values must first the following must be entered in Setup menu.
be determined individually; then the program:
the containers are filled and weighed
in the same order, this time calculated – the tare weight, In the application setup menu, you
as gross values. – the nominal quantity, can configure that the header data
input is not prompted before you
– for liquid products, the density exit the sampling mode.
Gross –> Tare
so the weight can be converted to
If the filled containers are sealed a volume value, and The values entered for
when they come from the filling
– if necessary, the supplement – average tare
machine (e.g., bottles), the gross
weight is measured first. Containers amount for products that decrease – density
are then opened, emptied (destructive in weight after filling.
are stored as new values in the
testing) and the weighed in the If you have selected the “REG” product base data after sampling
same order as tare values. tolerance system, the –T1 and –T2 is concluded.
limits are calculated automatically;
Additive Weighing with a “PHARMA” system, all limits
For additive weighing, the equipment are calculated automatically.
is automatically tared after the When you use the “User def.”
measured value is stored. For tolerance system, you can enter
sampling, you can place the samples products with weights lower
on the weighing platform one after than 5 g.
another without having to remove the
previous sample (e.g., tablets). Performing a sampling series consists
of the following steps:
Average Tare – Entering header data
Select this mode for determining the – Determining weights of the
nominal fill quantity with a given tare samples
value that applies to all packages. – Creating statistics and, if desired,
The average tare can be determined printing data
during sampling.

19
Collecting sample data (product in this example: chocolate cookies)

Enter header data:


– Product name: choc.cookies
– Operator designation: DEFAULT: U.Mueller
– Batch designation: ABC123
Enter density: not prompted, because the configured value is 0.0000
Always enter these values: yes
Control mode: average tare
Sample size: 3
Store values: automatically
Print report: manually
Tare weight: 20 g

Step Key(s) (or instruction) Display/Output

Initial status please press a key

1. Select sampling function [SAMPLE] prod.=<1st product>

2. Enter product name [letters or numeric keys] prod.=Choc.cookies


or select from list
Yy prod.=Choc.cookies

3. Confirm product name


L Oper.=u.Mueller

4. Change operator designation [letters or numeric keys]


if desired

5. Confirm operator designation


L batch=

6. Enter batch designation [letters or numeric keys] Batch=ABC123

7. Confirm batch designation


L G 1/3 load

8. Remove load from scale; Unload scale 0.00 g


if the readout is ≠ 0.00
N or T
9. Load scale Place filled container 1 on pan G ---/3 < 299.0 g>

10. Unload scale Remove container G 2/3 load

11. Load scale Place filled container 2 on pan G ---/3 < 301.8 g>

12. Unload scale Remove container G 3/3 load

13. Load scale Place filled container 3 on pan G ---/3 < 300.4 g>

14. Unload scale Remove container mean=+ 300.4 g


(You can define which of
the results will be displayed
first after sampling; see the
section entitled
(Application Setup”)

20
Sampling

Displaying and Printing the Evaluation

Print evaluation: manually


Print individual values: all (tare and fill quantities)

Step Key(s) (or instruction) Display/Output

Collect sample data as mean =+ 300.4 g


described above

1. Display resulting values (repeatedly if necessary)


Yy l-mean =+ 300.4 g

2. Print evaluation
(no machine adjustment
p ---------------------
Sample from:
necessary) 12.03.1998 14.23

Prod. CHOC.COOKIES
Contr. Avg.tare

Tol.S. REG
Nominal 300.0 g
Density 0.0000
-T2 282.0 g
-T1 291.0 g
-T 295.0 g
+T 330.0 g
Suppl. 0.0 g
Tare 20.0 g

Fill amount:
001 21.4 g1)
299.0 g2)
002 20.5 g1)
301.8 g2)
003 18.0 g1)
* 294.4 g3)

Evaluation:
Mean 300.4 g
L-Mean 300.4 g
s 1.4 g
V 0.47 %
n 3
n <-T2 0
n <-T1 0
n <-T 1
n >+T 0

1) Adj. + 0.0 g
= Tare
2) ---------------------
= Fill amount
3) = Limit exceeded

21
Skipping Measured Values Interrupting a Sample Series Tare Weighing

In the Tare –> gross control mode, In the Tare –> gross and Gross –> When you are working with an
you can skip a gross value, for tare control modes, you can interrupt average tare weight for
example if the tare container is sampling by pressing f (the containers in sampling, the tare
defective. To do this, press the series is “parked” in memory). You weight must remain within
[SKIP TARE] key instead of the gross can then process a new sample. defined limits.
measurement. The same applies You can only interrupt one sample
With the tare weighing function
when working in the Gross –> at a time.
you can determine whether the
tare mode.
Press , when you want to resume “average tare” control mode is
the interrupted series. allowable (configured in the
Confirming Out-of-Tolerance Values Setup menu for each product).
A “parked” sample remains in
memory even after the equipment is There must be at least 25 tare
When a value exceeds a tolerance turned off, either until you resume values collected for tare
limit (–T2, –T1, etc.), an error the series (starting from the basic weighing. The resulting calcu-
message is displayed (–T2 ERROR, weighing mode) or until you delete lated average value is auto-
–T1 ERROR, etc.). You can it by pressing c f. An LED lights matically stored for the selected
configure whether this message must up on the f key to indicate that product. The previously stored
be confirmed (see menu items [38] there is data in the “parking” tare weight for that product
to [41]). memory. is overwritten.
When you select the REG tolerance The printout will include an
system, out-of-tolerance values must indication as to whether the
be confirmed. Ending a Sampling Routine setting
Before Completion
With a “PHARMA” tolerance system, – “Average tare” is allowed, or
out-of-tolerance values are calculated – “Individual tare” is required.
Press the [SAMPLE] key to end a
based on the average weight in
sampling routine before it has been (See the example on the
the sampling run, not on the nominal
completed. The data collected following page)
quantity. This is why violations
are stored. The data collected up to
can only be displayed at the end In a histogram of tare weights,
that point will be included in the
of sampling. The out-of-tolerance the range from 50% to 150% of
evaluation.
values must be confirmed. the tare weight is divided into
categories of equal width.
Canceling a Sample

You can cancel the last sample


completely by pressing c and
[SAMPLE].

Assigning a Password

You can block access to the “Cancel


Sample” function by assigning a
password. The password you enter
is hidden (only asterisks (*) are
displayed). See the menu item
“Password” in the section entitled
“Application Setup” for details
on assigning passwords.

22
Sampling

Example: Tare Weighing to Determine Whether Individual Tare Values are Required

with the settings:


Product name: Choc.cookies
Mean tare weight: 20.00 g
Number of samples: 25
Values taken over: automatically
Print evaluation: manually
Printout: without machine designation, base data and individual values

Step Key(s) (or instruction) Display/Output

Initial status please press a key

1. Select tare weighing [TARE WEIGH.] prod.=<1st product>

2. Enter product name [letter or numeric keys] prod.=Choc.cookies


or select from list
Yy prod.=Choc.cookies

3. Confirm product name


L T 1 load

4. Load scale Place 1st empty container on pan t --- < 19.7 g>

5. Unload scale Remove container T 2 load

6. Repeat steps 3 through 5


for 24 more containers

7. End tare weighing [TARE WEIGH.] average tare allowed

8. Print evaluation
(Example; result is “Average tare
p ---------------------
Sample from:
allowed;” individual values are 12.03.1998 14.23
not required)
Prod. CHOC.COOKIES
Contr. Avg.tare
Batch 5

Nominal 250.00 g
Tare 20.00 g

Evaluation:
Mean 20.07 g
s 0.53 g
V 3.48 %
n 25

Average tare allowed

Oper. 3
---------------------

23
Test Weighing

The test weighing routine is identical


to the sampling routine with the
exception that the results cannot be
taken over in the long-term statistics.
Test weighing is performed to
determine the optimal filling machine
settings for the production process.
● Start test weighing:
Press [TEST-WEIGH.]
● Continue as with sampling

24
Evaluation

Evaluation You can also have a list of the The program outputs the number
products already weighed (DISPLAY out-of-tolerance values with the
WEIGHED PROD.) displayed and/ percentage value by which the limits
Select the Evaluation function to have or printed, and generate a list of are exceeded.
the weight values collected in sam- products for evaluation (PRODUCT
pling displayed or printed as statistics. LIST). The DISPLAY WEIGHED
Statistics are compiled for three PRODUCTS function offers an
Select the time period for the desired
different time periods. overview of the products for which
statistics (1ST PERIOD, 2ND PERIOD,
statistics are available.
Press [EVAL.] to access the evaluation 3RD PERIOD). The following data
function; then select one are then displayed or printed:
With the PRODUCT LIST function,
of the following: – Date and time of the first and you can define which products
– PRINT last samples in the series should be included in a printout of
– Target weight statistics. With this function you
– DISPLAY – Mean value can have an evaluation limited to
– PRT.+DEL. – Standard deviation certain products.
– Averaged standard deviation
– Number of packages
– Number of samples < –T2, < –T1,
< –T and > +T

DISPLAY Evaluation

Step Key(s) (or instruction) Display/Output


1. Select the evaluation function [EVAL.] prt.+del.
2. Select the display function
yL 1st Period

3. Select the time period


of the evaluation
yY 1st Period
2ND Period
3RD Period
and confirm
L L Prod.=

4. Enter the product designation


(here: 1234)
1234 1234

or select it from the list


yY 1234

and confirm
L From 12.02.1998 11.55
To 12.03.1998 12.22
5. Display statistics (repeatedly, if nec.)
yY targ.
-mean
=+ 2000 .0 G
=+ 2002 .8 g
6. Print statistics
p s
s-avg
=+
=+
13 .2 g
14 .0 g
n-ent. = 6
n-samp. = 2
n <- t2 = 0
n < -t2 =+ 0 .0 Pct
n < -t1 = 0
n < -t1 =+ 0 .0 Pct
n < -t = 1
n < -t =+ 16 .7 Pct
n > +t = 1
n > +t =+ 16 .7 Pct

25
PRINT Evaluation

Step Key(s) (or instruction) Display/Output


1. Select the evaluation function [EVAL.] prt.+del.
2. Select the print function
yyL 1st Period

3. Select the time period


of the evaluation
yY 1st Period
2ND Period
3RD Period
and confirm
L Weighed Prod.

4. Select the type of product


– weighed product
yY Weighed Prod.
– selected product Selected Prod.
– all products All Prod.
– individual product Product
and confirm
L Weighed Prod.

The evaluation is now printed. --------------------


Statistics Print at:
12.03.1998 14:23

Prod. CHOC.COOKIES
Mach. 111
Oper. 1
(If this is a printout of statistics Batch ABC123
from the 1st period, the batch
designation is printed here, if you Stat. period 1
are working with batches. from: 01.03.98 07:42
This means you can use the to: 12.03.98 14:22
Period 1 statistics as batch
statistics by printing and deleting Tol.S. REG
the evaluation after each batch.) Nominal 18.5 g
Density 0.0000
-T2 15.1 g
-T1 16.8 g
-T 17.6 g
+T 19.4 g
Suppl. 0.0 g
Tare 0.0 g

Evaluation:
Targ. 18.9 g
L-Mean 18.6 g
s 1.0 g
s-Avg. 1.0 g
n-ent. 10
n-samp. 2
n <-T2 0 0.0 %
When you select WEIGHED PROD.(ucts), n <-T1 0 0.0 %
you will be prompted to define whether n <-T 1 10.0 %
the list should be deleted after printing: n >+T 2 20.0 %

Select
or
yY DELETE LIST
DELETE LIST
No
Yes
and confirm
L weighed prod. 0

26
Evaluation

PRINT AND DELETE Evaluation

Step Key(s) (or instruction) Display/Output


1. Select the evaluation function [EVAL.] prt.+del.
2. Confirm “Print and delete”
L 1st Period

3. Enter the password alphanumeric keys ******


and confirm
L 1st Period

4. Select the time period


of the evaluation
yY 1st Period
2nd Period
3rd Period
and confirm
L Weighed Prod.

5. Select the type of product


– weighed product
yY Weighed Prod.
– selected product Selected Prod.
– all products All Prod.
– individual product Product
and confirm
L Weighed Prod.

The evaluation is now printed


and deleted.
6. “Repeat print?” prompt is
displayed Repeat (1 = Yes)
7. Repeat printout if desired Repeat (1 = Yes) 1
or
1L
Quit function
L

Evaluation: Display Weighed Products

Step Key(s) (or instruction) Display/Output


1. Select the evaluation function [EVAL.] prt.+del.
2. Select “Display weighed products”
YL Prod. = 111

Display next product


designation
Y Prod. = 666

Display previous product


designation
y Prod. = 111

3. Print report while displayed


p --------------------
Weighed products:
4. Quit function
C CHOC.COOKIES
12.03.1998 09:13
--------------------

27
Evaluation PRODUCT LIST

LIST=MEMORY DATA
Step Key(s) (or instruction) Display/Output
1. Select the evaluation function [EVAL.] prt.+del.
2. Select “Product list”
and confirm
YYL List=Mem.Data

3. Select “List = Mem.data” (example)


and confirm
L Prod. = 111

Display next product


designation
Y Prod. = 666

Display previous product


designation
y Prod. = 111

4. Print report while displayed


p --------------------
Selected products:
5. Quit function
C CHOC.COOKIES
12.03.1998 09:13
--------------------

LIST=INSERT PRODUCT
Step Key(s) (or instruction) Display/Output
1. Select the evaluation function [EVAL.] prt.+del.
2. Select “Product list”
and confirm
YYL List=Mem. Dat.

3. Select “List=Insert Prod.”


and confirm
YL Ins. =

4. Enter a product designation


to be added to the list
111L Ins. =

(for example, 111)


and confirm
5. Enter and confirm the
next product designation to be
666L Ins. =

added to the list


6. Quit function
C

28
Evaluation

LIST=DELETE PRODUCT
Step Key(s) (or instruction) Display/Output
1. Select the evaluation function [EVAL.] prt.+del.
2. Select “Product list”
and confirm
YYL List=Mem.Data

3. Select “List=Delete Prod.”


and confirm
YYL Del. =

4. Enter product designation


to be deleted from the list
111L Del. =

and confirm
5. Enter and confirm the
next product designation to be
666L Del. =

deleted and confirm


6. Quit function
C

LIST=DELETE ALL
Step Key(s) (or instruction) Display/Output
1. Select the evaluation function [EVAL.] prt.+del.
2. Select “Product list”
and confirm L
YYL List=Mem.Data

3. Select “List=Delete All”


and confirm L
YYYL Del. Prod. List no

4. Select the “Delete product list”


function
y Del. Prod. List yes

5. Confirm function and quit


C

29
Data Output Functions You can enter up to 16 characters Standard Printout
in this line. If you enter more than
16 characters, an arrow pointing to The standard printout contains the
You can choose from the following the left or right indicates that there following data:
forms of data output: are more characters.
– Net weight
– Application line Data that was already input appears
in the application line as a default – Tare2 weight
– Standard printout value. You can either confirm or – Tare1 weight
– Printout of sample data overwrite this value. For the “Opera-
tor designation” field, the default- – Gross weight
– Printout of tare weighing data input function can be configured in
– Printout of test weighing data the application setup menu.
When you press p, the standard
– Printout of product list printout is generated, except in the
Sampling Evaluation Data following cases:
– Printout of base data
– after completion of sampling,
– Printout of statistics After completing a sampling series tare weighing or test weighing
– Output to COM port (or tare weighing or test weighing), (> sampling evaluation printed)
you can have the statistics displayed
in the application line: – while the product list is displayed
(> product list printed)
Application Line ● Display evaluation data:
Press Y y – while base data are displayed
Initial Display (> base data printed)
● Print evaluation data: Press p
– when statistics are printed
After you turn on the isi30-000Q the
With the “Standard” printout, blank
software version is displayed in the Statistics
lines are not added at the end.
application line, in the following format:
Blank lines are added at the end of
The weight values collected in
Sx.xxdd.mm.y all other types of printout so you
sampling are displayed or printed
do not need to press the “Form feed”
where: as statistics when you select the
key on the YDP01-IS and YDP03-
x.xx Software version Evaluation function. Statistics
0CE printers.
dd.mm.y Date software created are compiled for three different
(only the last digit of the time periods.
year included) Press the [EVAL.] key to have statistics
compiled; then select either PRINT,
DISPLAY or PRINT AND DELETE.
Base Data You can also choose to have a list of
the products already weighed
You can have the base data for displayed (DISPLAY WEIGHED
any product displayed in the PROD.) displayed or printed, as well
application line as defining a list of products for
During sampling or Setup: evaluation.
● Press the [INFO] [SAMPLE] keys
(or [INFO] [TARE WEIGH.] or
[INFO] [TEST-WEIGH.])
● To display base data:
Press Y y
● To print base data: Press p
● To exit this display:
Press x or C

30
Data Output Functions

Printing a Sampling Evaluation Printing Tare Weighing Data Example:


Printout of Tare Weighing Data
You can have this printout generated This printout is similar to the sampling
automatically or manually after printout, with the following – with base data
completion of a sampling run. You differences: – with machine designation
can also configure this printout in the – with individual values
– “Tare values:” is displayed rather
application setup menu to suppress
than “Fill amount:” --------------------
certain sections.
– Either “Average tare allowed” or Sample from:
With a “PHARMA” tolerance system, 12.03.1998 10:07
“Indiv. tare required” is displayed
the –T2, –T1, –+T1 and +T2 limits
rather than “Adj. +”
are determined at the end of Prod. 01
sampling. This is why they appear Contr. Tare cont.
under “Evaluation” on the printout. When you delete a tare weighing Mach. MACHINE 1
When you press the [SAMPLE] key to by pressing c [TARE WEIGH.], the Batch 5
stop a sampling series before it is following printout is generated:
completed, a printout is generated Tol.S. REG
automatically which includes the Example: Printout when a Nominal 100.00 g
error message “Sampling Tare Weighing is Deleted Density 0.0000
aborted.” -------------------- -T2 91.00 g
Sample from: -T1 95.50 g
12.03.1998 16:00 -T 98.00 g
When you delete a completed +T 110.00 g
sample by pressing c [SAMPLE], Prod. 01 Suppl. 0.00 g
the following printout is generated: Contr. Tare cont. Tare 10.30 g
deleted
-------------------- Tare values:
Example The difference between this printout 001 10.0 g
and the printout from a deleted 002 10.0 g
-------------------- sample is that this contains the “Tare 003 10.6 g
Sample from: cont.” line. 004 10.6 g
22.03.1998 16:00
Evaluation:
Prod. 01 Example:
Mean 10.3 g
Contr. Avg.tare Printout of Tare Weighing Data
s 0.3 g
deleted – without base data
V 3.36 %
-------------------- – without machine designation
n 4
– without individual values
--------------------
Indiv. tare required
Sample from:
12.03.1998 10:04
Oper. 3
--------------------
Prod. 01
Contr. Tare cont.
Batch 5

Nominal 100.00 g
Tare 10.00 g

Evaluation:
Mean 10.0 g
s 0.0 g
V 0.00 %
n 4

Indiv. tare required

Oper. 3
--------------------

31
Printing Test Weighing Data Printing Base Data Printing Statistics

This printout is similar to the sample You can print out the base data You can have statistics displayed and
data printout, with the following for a product when they are printed. You can have the statistics
difference: displayed in the application line. on a single product printed while they
are displayed (press p).
– “Test weigh from:” is displayed ● To print base data: Press p
rather than “Sample from:”. --------------------
Example of a Printout of Base Data Statistics Print at:
18.03.1998 14:23
Printing a List of Products --------------------
Product data: Prod. CHOC.COOKIES
Mach. 111
You can print out a list of all products Oper. 1
Prod. CHOC.COOKIES
when it is displayed in the Stat. period
Mach. MACHINE 1
application line. The list contains from: 17.03.98 07:42
Ad.Step. 1.00 g
up to 100 products, listed in to: 17.03.98 13:30
Tol.S. REG
alphabetical order.
Density 0.0000 Tol.S. REG
● To print a list of products: Number 10 Nominal 300.0 g
Press p Nominal 100.00 g Density 0.0000
Tare 10.00 g -T2 282.0 g
-T2 91.00 g -T1 291.0 g
Example of a List Containing -T1 95.50 g -T 295.0 g
-T 98.00 g +T 330.0 g
3 Products
+T 103.00 g Suppl. 0.0 g
Suppl. 1.00 g Tare 20.0 g
--------------------
List of Products: Contr. AVG.TARE
Evaluation:
Tar. NO Targ. 300.4 g
Butter cookies L-Mean 300.4 g
Nougat rolls Created on: s 1.4 g
Choc. cookies 12.03.1998 16:03 s-Avg. 0.47 %
-------------------- n-ent. 3
12.03.1998 16:00 n-samp. 1
-------------------- <-T2 0 0.0 %
<-T1 0 0.0 %
<-T 0 0.0 %
<+T 0 0.0 %
--------------------

Additional Printouts:
--------------------
Weighed products:

Butter cookies
Nougat rolls
Choc. cookies

12.03.1998 16:22
--------------------

--------------------
Selected products:

Choc. cookies

12.03.1998 16:21
--------------------

32
Data Output Functions

Communications Port Digital Input/


Output Interface Port
The isi30-000Q has an SBI interface
for communication with an external You can trigger the following
computer system. This is a simple functions via the YDO 03 IS digital
ASCII interface. I/O port:
In general, all data output to the Port 1: Store weight on scale during
printer are also passed to the sampling: L key
communications port (SBI) if there is
one installed and configured. Port 2: Generate printout: p key

The settings under the menu item Port 3: Tare: T key


“Output to COM port” [48] only
offer the option of having individual
values output to this port even when
they are not included in the printout.

Ind. values output dependent on


the settings for the printer [46] and
the COM port [48]

Setting COM [48]


None Fill amt. All
Printer [46]
None – Fill amt. All
Fill amt. Fill amt. Fill amt. All
All All All All

33
Error Codes

Error Codes

Display/Printout Cause Solution


Entry error Product name entered Enter correct product name;
does not exist in base data if necessary, create new product
Blocked Printer error Error message displayed for
2 seconds, then the message
Printer (1=stop) is displayed.
● Press 1 to interrupt printing
● Install printer correctly
VIOLATION Value(s) exceed the preset ● Press L to confirm
tolerance limits when using
the “PHARMA” tolerance system
no product No product in base data ● Create a base data record
n<2 Not enough samples measured ● Continue measuring samples
stat. not printed Statistics not printed None
because no data exist
+T error +T limit exceeded ● Press L to confirm value
+T1 error +T1 limit exceeded ● Press L to confirm value
+T2 error +T2 limit exceeded ● Press L to confirm value
-T error –T limit exceeded ● Press L to confirm value
-T1 error –T1 limit exceeded ● Press L to confirm value
-T2 error –T2 limit exceeded ● Press L to confirm value
too low Weight is less than the lower ● Unload the weighing platform
plausibility limit (see [42] and [43])
too high Weight is more than the upper ● Unload the weighing platform
plausibility limit (see [42] and [43])
--------- IThe display of long-term statistics None
(on the printout) is limited to 9 digits (highest
value: 999 999 999). A higher
number is indicated by dashes
(as shown at left). Corresponding
percentages and histogram
bars are invalid.

34
Overview

Overview Standard Function Keys


L Key
C Key
Press this key to:
Description of the Keys This key is used to cancel functions: – conclude input in the application
press this key to interrupt data input; menu,
Weighing Platform Function Keys the program returns to the previous – store a measured value while in
status. You can also stop a program the weighing mode,
These keys are blue color-coded and routine by pressing this key. – toggle between weight units in the
are assigned normal scale functions. weighing mode (press and hold
They are described in the “Installa- key for more than 2 seconds), or
c Key
tion and Operatin2g Instructions” for – confirm notice of an out-of-tolerance
This key is used to delete input data value (such as ”–T2 ERROR”)
the “isi” terminal. The symbols on
and memory contents. When
these keys have the following
entering data, press this key to delete
meanings: x and X Keys
the character to the left of the cursor.
e Toggle the weighing platform To delete memory contents, use this Use these keys to move the cursor
M Display metrological specifi- key in combination with other when entering characters. In the
cations – with “MultiRange” function keys: application setup menu, the x key
weighing range structure has the same function as the C key.

t ISO test c + [SAMPLE]:


Y and y Keys
h High resolution Press this key combination to delete
the last sample measured. A printout Use these keys to select menu items
b Gross display is generated to document this in the application setup menu and
N Zero the weighing platform function (see “Printing Sample during sample evaluation. When
Data”). you access the sampling, tare or test
T Tare weighing functions, you can use
P Preset tare these keys to scroll through the
c + [TARE WEIGH.]:
product list.
Press this key combination to delete
p Print the last tare weighing. A printout is
f Key
generated to document this function.
Press this key to generate a printout (see “Printing Tare Weighing Data”). If you wish to interrupt a sampling
of statistics or a product list. The type series while working in the Tare –>
of printout will depend on the gross or Gross –> tare control mode;
operating status of the isi30-000Q c + L:
for example, in order to test a sample
(see also “Standard Printout,” in Press this key combination to delete of another product with an average
the section entitled “Data Output the last weight value stored during tare value, press this key to interrupt the
Functions”). a sample run. series and “park” (store) the series in
memory. You can then recall the
c + f: “parked” series, when in the basic
operating mode, by pressing ,.
Press this key combination to delete The LED on the f key lights up to
a “parked” sample. indicate when there is a parked series
stored here.
j Key
This key toggles between the “insert” , Key
and “overwrite” modes when you Resume a “parked” sample series;
are entering letters or numbers. see also “f Key.”

a Key
Press this key to enter letters and
special characters (*, /, space).
The corresponding LED lights up to
indicate that this key is active.

35
isi30-000Q Function Keys [SKIP TARE] [INFO] + [SETUP]
Press this key to skip a measurement Press this key combination to display
When you press a function key, value during Tare –> gross or Gross the current program version, in the
the corresponding LED lights up to –> tare weighing. following format:
indicate the active function. Sx.xxdd.mm.y
Measured values that were skipped
are displayed with the remark: “Tare Sx.xx Software version
[SAMPLE] skipped” rather than suppressed. dd Day the software was
created
Press this key to start sampling in one mm Month the software
of the following control modes: [EVAL.] was created
– Average tare Press this key to display the y Year the software was
evaluation options: created (only the last digit of
– Tare –> gross the year included)
– Gross –> tare – print
– display Example:
– Additive weighing – prt.+del. S1.1020.03.7
– display weighed prod. = Version 1.10 from 20 March 1997
Press this key again during sampling if
you want to end the series before it is – product list
completed. The data collected up to
this point are stored. The report is [SETUP]
printed. “Sample aborted” is
displayed at the bottom of the printout. Press this key to access the
application setup menu in order to
configure base data, parameter
[TARE WEIGH.] options, printout formats or
passwords.
Press this key to start the tare
weighing function. Press this key
again during tare weighing to end [INFO]
the series.
Press this key in combination with
one of the function keys ([SAMPLE],
[TEST WEIGH.] [TARE WEIGH.], [TEST WEIGH.]),
to display the memory contents or
Press this key to start test weighing in current parameter settings for that
one of the following control modes: function.
– Average tare When you press this key, the word
– Tare –> gross “Info” is displayed to indicate that
this function is active.
– Gross –> tare
– Additive weighing
Press this key again during test
weighing if you want to end the run
before it is completed. The data
collected up to this point are not
stored, but the evaluation data is
output as with the [SAMPLE] function.

36
Parameter Settings (photocopy this page and use this form to keep track of current settings)

Base Data
Product name
Machine designation
Tolerance system
Density compensation value
Adjustment step
Sample size
Nominal fill quantity
Average tare weight
–T2 limit
–T1 limit
–T or +T1 limit
+T or +T2 limit
Supplement
Control mode
Tare after values taken over

Product name
Machine designation
Tolerance system
Density compensation value
Adjustment step
Sample size
Nominal fill quantity
Average tare weight
–T2 limit
–T1 limit
–T or +T1 limit
+T or +T2 limit
Supplement
Control mode
Tare after values taken over

Product name
Machine designation
Tolerance system
Density compensation value
Adjustment step
Sample size
Nominal fill quantity
Average tare weight
–T2 limit
–T1 limit
–T or +T1 limit
+T or +T2 limit
Supplement
Control mode
Tare after values taken over

37
Overview

Abbreviations In the Evaluation Data Display nom. Nominal fill quantity


Adj. Adjustment step Number Sample size
l-mean Long-term mean (no. of samples)
In the Base Data Display
Mean Mean value for sample operator Enter operator designation
add. Additive n-Ent. No. of packages in Prod. Product(s)
Cont. Control mode entire sampling run prt.+del. Print and then delete
Date Date and time n-Samp. No. of samples in prt.eval. Print evaluation
Dens. Density this evaluation reg Tolerance limits according
MA. Machine designation n Sample size to legal regulations
nom. Nominal quantity n<-T No. of values < –T limit suppl. Supplement amount
num. Number of samples n<-T1 No. of values take val. Take over values
Prd. Product name < –T1 limit tar. Tare
step. Adjustment step n<-T2 No. of values tar.a.val. Tare automatically after
sup. Supplement amount < –T2 limit values taken over
-T In-house tolerance n>+T No. of values > +T limit tar.b.sam. Tare before sampling
limit –T From Beg. of stat. period Tare wt. Tare weight
-T1 –T1 To End of stat. period test wgh. Start test weighing
-T2 -–T2 perm. permissible Tol.sys. Tolerance system
+T In-house tolerance req. required Unit Weight unit
limit +T s Standard deviation user def. User-defined tolerance
Tare Average tare weight V Variation coefficient limits
Tar. A. Val. Tare automatically after Targ. Target weight with def. Default value displayed
values taken over S-Avg Averaged standard
tol.s. Tolerance system deviation On Printouts
-2 Histogram category
For Header Data Input In the Application Setup Menu (–7 to +7)
Batch Batch designation -T –T limit Add.Whg.
Density Density value -T1 –T1 limit Additive weighing
oper. Operator designation -T2 –T2 limit Adj. Adjustment step
Prod. Product name +T +T limit Contr. Control mode
Tare Average tare add. wgh. Additive weighing DensityDensity value
Adj.step Adjustment step G Gross value
In the Weighing Mode: autom. Automatic(ally) L-Mean Long-term mean
Sampling, Test Weighing avg. tare Average tare value Mach. Machine designation
G ---/20 After one of 20 weight Base dat. Base data Mean Sampling average
values is taken over BaTCH Batch designation N Net value
G 1/20 1st of 20 gross Passw. Password n Sample size
measurements (gross Com COM data port NominalNominal quantity
individual measurement Config. Set configurations Oper. Operator name
tare –> gross or gross control Control mode perm. Permissible
–> tare) (sampling order) Prod. Product name
f ---/20 After one of 20 weight dat. Data req. Required
values is taken over del. all Delete all s Standard deviation
f 1/20 1st of 20 measurements del.b.dat. Delete base data S-Avg. Averaged standard
with fixed tare weight del.list Delete statistics list deviation
T ---/20 After one of 20 weight del.meas. Delete last sample Suppl. Supplement amount
values is taken over measurement +T In-house tolerance limit
T 1/20 1st of 20 tare del.stat. Delete statistics -T In-house tolerance limit
measurements (tare del.val. Delete value T1 Tare1 weight
individual measurement density Density value T2 Tare2 weight
tare –> gross or gross dis.stat. 1st value displayed <-T No. of values < –T limit
–> tare) in statistics <-T1 No. of values < –T1 limit
ent.alwys. Always enter header data <-T2 No. of values < –T2 limit
In the Weighing Mode: ent.b.dat. Enter base data >+T No. of values > +T limit
Tare Weighing Fill amt. Fill amount (quantity) -T1 –T1
T 5 5th measurement gmp Good Manufacturing -T2 –T2
when checking weight Practice Tare Average tare weight
of empty container ind.val. Individual value(s) Targ. Target value
Mem.data Memory data Tol.S. Tolerance system
38 no def. No default value V Variance coefficient
39
Sartorius AG
b 37070 Goettingen, Germany
p Weender Landstrasse 94–108, 37075 Goettingen, Germany
t (551) 308-0, f (551) 308-289

Copyright by Sartorius AG, Goettingen, Germany.


All rights reserved. No part of this publication
may be reprinted or translated in any form or by any means
without the prior written permission of Sartorius AG.
The status of the information, specifications and
illustrations in this manual is indicated by the date
given below. Sartorius AG reserves the right to
make changes to the technology, features,
specifications, and design of the equipment
without notice.
Status: April 1998, Sartorius AG, Goettingen, Germany

Printed in Germany on paper that has been bleached without any use of chlorine . W398-A00.isi 30-000Q e (SartoPac 85) . DP
Publication No.: WIS6010-e98042

40

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