Minebea Intec Combics® SPC Combics 3, Model CA...., Option H5 Owner's manual

Operating Instructions

Minebea Intec Combics®SPC

Combics 3, Model CA...., Option H5

Software for fill level control indicator according to finished packaging,

pharmacopeia and statistical process control regulations

98646-003-63

2 Combics SPC Indicator Operating Instructions

Table of Contents

Contents

Copyright .............................................................4

Symbols ................................................................4

Symbols and Signs ............................................4

Intended Usage ...................................................5

Safety Information .............................................6

Electromagnetic and Electrical Safety ............. 6

Notes on Using These Instructions ..................6

Damage ..............................................................6

National Regulations ........................................6

Notes on Installation ........................................6

Influences during Operation ............................6

IP Protection Rating .........................................6

Opening Devices ................................................ 6

Attaching Signs ..................................................7

Operating Design ................................................8

Data Interface .................................................... 8

Control Outputs ...............................................8

Saving Measured Values ...................................8

Key Description .................................................8

Soft Keys ........................................................... 9

Preparation ......................................................10

Product Data ................................................... 11

Product Handling ............................................11

Product Entry ..................................................11

Changing Product Data ..................................13

Deleting Products............................................13

Product Search ................................................14

Setting Application Parameters ..................... 14

Purpose ............................................................14

Configuration ..................................................14

Configuring Product-specific Data ................14

Sampling Process ............................................14

Measurement Result .......................................14

Statistics ...........................................................15

Miscellaneous ..................................................16

Factory Settings ..............................................17

Navigating the Setup Menu ........................... 18

Setup: Application parameters ...................... 21

Measurement.................................................... 25

Tare –> Gross (Variable Tare).........................25

Mean Tare Value .............................................25

Additive Weighing ...........................................25

Subtractive Weighing ......................................25

Sampling ..........................................................25

Alibi Memory ...................................................26

Port Lines .........................................................26

Displaying Evaluations..................................... 30

Measured Values .............................................. 31

Skipping Measured Values .............................31

Deleting Measured Values ..............................31

Confirming Limit Violators .............................31

Stopping Sampling Prematurely ....................31

Buffering Samples ...........................................31

Password Query ...............................................32

Tare Weighing .................................................32

Combics SPC Indicator Operating Instructions 3

Table of Contents

Data Output ...................................................... 35

Product Data Display ......................................35

Evaluation Data ...............................................35

- Favourites .....................................................37

- Print/Display .................................................37

Report Printout ................................................ 39

“Sample” Report ..............................................39

GMP Area, GMP Header .................................40

Statistic Report Printout .................................41

Product data memory printout: .....................42

Universal Gauge Interface .............................. 43

Error Messages ................................................. 45

4 Combics SPC Indicator Operating Instructions

Legal Information

Copyright

This documentation may not be reproduced or distributed either in whole or in

part without the explicit written permission of Minebea Intec.

This documentation is intended only for use by the buyer.

Transfer to third parties, whether free or in exchange for payment, is not

permitted.

The software included within the scope of delivery is the property of Minebea

Intec. The software may not be copied, changed, reverse engineered or modified

through assimilation.

The buyer may only use the software for his own purposes and may not make

the software available to third parties for use either for free or in exchange for

payment. If you encounter problems with the included software, please contact

the software distributor. Minebea Intec reserves the right to deliver updated

software for this product.

No liability is accepted for software installed before the purchase of this product.

The buyer is liable for any misuse of the product.

Symbols

Symbols and Signs

The following symbols are used in this manual:

2 Warning symbol for various types of dangers.

These symbols are explained in more detail in the “Safety Instructions” section.

h This symbol indicates useful information and tips.

e, 1, This and similar symbols mean that the respective key should be pressed.

T T ..., This means that this key must be pressed more than once.

t Indicates a required action

y Describes the result of an action

1. If a procedure has multiple steps...

2. ... the steps are numbered consecutively.

– indicates an item in a list

Applications Advice

E-mail : [email protected]

Combics SPC Indicator Operating Instructions 5

Intended Usage

The indicator is used for the automatic, computer-supported recording of

samples for finished packages and filling quantities. The results of the sample

analysis can be used to optimized the filling quantities and provide legal proof

of compliance with accuracy requirements.

The indicator has the following features:

– Manages up to 500 products (base data records)

– Up to 17 parameters can be set for each product

(e.g. product name, nominal filling quantity, -T2 limit, etc.)

– Comprehensive statistical evaluations for compliance with legal regulations,

long-term statistics for production verification

– Provides statistical types from which three can be activated simultaneously

– Simultaneous processing of up to 5 products with backweighing for each up to

125 measurements

– Sample measurement, tare weighing, test weighing

– Determines the tare weight, also for several packages in one step (multi-tare)

– Agency mode selection option for use with products with a k-factor, can only be

used by calibration officials

– Setting recommendation for filling machines to optimize product production

– Weight controls with symmetrical tolerance limits (SPC)

– Statistical process controls

– Testing of medicines for uniformity according to European pharmacopeia

– Data output via various interface types and protocols also Ethernet TCP/IP

– Graphical representation of the mean values of the last 20 samples for a max.

of 10 products.

– User-defined function keys

– LED display and port lines for sampling results

– Protection against unauthorized changes using versatile password protection

– Dosing using a control bar graph, LED display and switch outputs

– Connection of third-party measuring devices (scale, checkweigher, etc.) possible

via an ASCII interface

These operating instructions only describe the functions for finished packaging

control, pharmacopeia and statistical process control.

Information about installation, weighing-specific functions and device setup can

be found in the “Combics 3” operating instructions.

6 Combics SPC Indicator Operating Instructions

Safety Information

Electromagnetic and Electrical Safety

2 The Combics 3 with option H5 meets the requirements for electromagnetic

compatibility (EMC) and electrical safety; see the CE Declaration of Conformity.

Interference stronger than the maximum values specified in the standards

(seeSpecifications) should be avoided.

Notes on Using These Instructions

3 Please read all individual device instructions carefully and completely before

using this device. These instructions are part of the product. Keep them in a

safe and easily accessible location. These safety precautions and regulations

must always be accessible to the operator. If the instructions should be lost or

misplaced, please contact Minebea Intec for a replacement or download the

latest version from our website: www.minebea.com

Damage

3 The manufacturer is not responsible for any damage caused by improper

handling, improper use or non-compliance with warnings or safety instructions.

National Regulations

3 Existing national rules and regulations regarding accident prevention and any

internal company occupational, operational, and safety regulations must be

observed. All valid workplace health and safety regulations as well as all relevant

safety guidelines should be strictly adhered to when working on the device.

Notes on Installation

3 Conformance to the installation, operating, maintenance and repair instructions

in the operating instructions supplied with all devices is an absolute requirement.

Note the temperature ranges of the devices connected.

Influences during Operation

3 All components may only be operated under the ambient temperatures listed in

the Specifications. Do not expose the equipment to unacceptable sources of heat

or cold, direct sunlight, UV radiation, shocks or vibrations, and the installation

should ensure that heat can be properly dissipated and external heat sources are

kept at a sufficient distance. Drafts can cause measurement deviations, which

could cause inaccurate results.

IP Protection Rating

3 The equipment is only intended for indoor operation. The device is designed for

clean environments and should be handled according to its IP protection rating,

see Specifications in the associated documents.

Opening Devices

3 The device should only be opened by trained and qualified personnel.

Beforeopening the device:

Disconnect the device from the power supply.

Combics SPC Indicator Operating Instructions 7

Control Measurement Device Stickers

Attaching Signs

Placement of the “Control measurement device for packages” sign

If the scale is used in Germany for filling quantity control, the included sign

must be added as follows:

– Visible on the weighing platform or verification sign holder

– Near the ID label and the calibration labels

Example: Combics 3 ...

Control measurement device for packages WP 1

from 50 g to 12000 g

The sign lists the application range of the scale for packages from 50 g to

12,000 g according to the finished packaging regulation.

t Obtain the min. and max. loads according to the finished packaging regulation

from the respective operating instructions of the weighing platform and enter it

on the sign using permanent ink.

8 Combics SPC Indicator Operating Instructions

Operating Design

Products (records) can be entered via the device keypad. The data are saved to

the device memory that is protected against power failure.

Once sampling is complete, the measurement values are saved automatically to

the selected statistics and printed if necessary. The results can also be displayed

in various graphs.

The scale consists of a weighing platform and an indicator. In addition to the

socket for AC power (mains supply), it also has an interface port for connecting

peripheral devices, such as a barcode reader, universal keyboard, etc. Up to three

weighing encoders can be connected simultaneously.

Data Interface

The results of sampling or tare weighing can be output via the interface using

“SBI.” You can also control the scale or read weight values via other protocols

(XBPI, SMA, Profibus, Ethernet).

Control Outputs

The control output (TTL +5V or optional galvanically isolated) is linked to the

internal indicator light for the sampling interval and tolerance violations.

Assignment:

– Sample active (interval): SET output (always active) and info display

– Current weight under -T1: Output < and LED red

– Current weight between -T1 and +T: Output = and LED green

– Current weight over +T: Output > and LED yellow

Saving Measured Values

Sample measured values are saved to the selected statistics using power-failure-

proof memory.

Key Description

p Print report: This key is used to print a report. The type

of printout depends on the operating status of the Combics indicator.

D Switches to the 2nd key level. The soft keys of the key levels can be customized

via the »Soft key order« menu setting.

R Edit products (base data records). This setting allows you to copy, change and

delete products. The agency mode can be activated via a code word.

See the “Combics 3” operating instructions for information on other labeled

keys.

Operating Design

Combics SPC Indicator Operating Instructions 9

Operating Design

Soft Keys

The functions of active soft keys are indicated by symbols and abbreviations in

the last line on the display.

The current function of soft keys (function keys) are indicated in the bottom line

of the display (footer).

– Select and start program functions

– Navigation within application parameters, Fn key,

device parameters, info

– The sequence of these soft keys can be defined by the user via the menu.

Skip T For backweighing, tare –> gross or gross –> tare weighing, a tare/gross value can

be skipped.

Dens. Change the density

Sample This key is used to start the “Sample” function using one of the following

control modes (depending on the product setting):

Tare weight - tare –> gross - gross –> tare - Add. weighing - Substr. weighing

Pressing the “oo” soft key during sampling ends the sampling process before

reaching the sample size entered. The results are saved to the selected statistics.

Ta r e W This key is used to start the “Tare weighing” function. Weighing is stopped by

pressing the “oo” soft key. You can also enter the tare value via the keypad.

Theresult is saved to the protected product data memory.

Test W This key is used to start the “Test weighing” function using one of the following

control modes (depending on the product setting):

Tare weight - tare –> gross - gross –> tare - Add. weighing - Substr. weighing

Pressing the “oo” soft key during sampling ends the sampling process before

reaching the sample size entered.

Info This key, in connection to the other function keys, displays memory content

or the parameters currently being used.

DelS Deletes the last sample or tare weighing.

Save This opens additional selection options:

»Next« - »DelB«

For additional handling of backweighing

Eval. The following selection appears:

Print / View - Print+Delete - Favorites

For measurement results

10 Combics SPC Indicator Operating Instructions

Operating Design

Char t This displays the last 20 sample mean values of a max. of 10 products as a

chart or histogram. If more samples or products are being processed, the oldest

product or oldest samples are discarded.

Preparation

Display available application parameters:

t Select the Setup menu: Press the H key

y “SETUP” appears

t Select Application parameters: Press the “q” soft key several times and then the

“O” soft key if a password is required:

y The password prompt is displayed.

t If access is password protected: Enter the password using the alphanumeric keys.

t If the last character of the password is a letter: End alphabetic input by pressing

a

t Confirm the password and display the application parameters:

Press the “l” soft key

y The application parameters are displayed:

t To select the next group:

Press the “q” soft key (scroll down)

t To select the previous item in a group:

Press the “Q” soft key (scroll up)

t To select the next sub-item within a group:

Press the “O” soft key (scroll right)

t To select the previous group:

Press the “7” soft key (scroll left)

t To confirm the selected setup item: Press the “l” soft key

Combics SPC Indicator Operating Instructions 11

Conﬁguring Product Data

Product Data

Configuring Product Data

In the Application menu under:

Configuration

Product-specific settings

Operator ID

Batch ID

Unit base data

Machines

properties for product entry (base data records) are defined.

The indicator is used for fill level control. This control process is carried out

using samples. The data for a number of products and containers are required

for this. This data (base data records) should be entered before sampling takes

place.

Two locally saved data records have different product ID key fields.

Thecorresponding products must be entered before carrying out sampling,

testor tare weighings.

Product Handling

t Press the R key, the “Memory” opens and the first menu item is selected.

Products can be entered, copied, changed and deleted here.

You can password-protect product entry and deletion. You also have an overview

of the number of existing products. In this example, there are 7 products.

The Authority mode is activated via the “Code” soft key.

Product Entry

Product data (base data records) are only entered via the Combics indicator.

You can now enter a completely new product or copy an existing product.

Thenewly created or copied product can then be modified via “Change

product.”

t Press the “O” soft key.

y The overview will open.

t Press the “New” soft key.

t Enter the ID via the keypad and confirm using the “l” soft key

12 Combics SPC Indicator Operating Instructions

Entering the Product Name

y The input window will open.

t Enter the product name (max. 20 characters).

t Select a machine previously entered in the menu. (see Application parameters

page 14)

If the same products need to be run on different machines, then it makes sense

to link the product ID to the machine description.

Example: The product: cookies should run on machines A and B.

Suggestion: 1. Product ID: Cookies_A

2. Product ID: Cookies_B

t Adjustment step, smallest adjustment of a filling machine

t Select up to three statistics types (time periods)

Statistic type: „None“ may not be selected for the AWC tolerance system! For this

statistic type, the long-term values like the average values within the sampling

results are deleted when the day changes or when using batches for a batch

change.

t Select a tolerance system

AWC: for products that must comply with the finished packaging

regulation

USER DEF: User-defined

SPC: -T2 entry, suggestions can then be calculated for -T1, +T1, +T2,

canbe changed if required

PHARMA 1: for uncoated tablets

PHARMA 2: for capsules

PHARMA 3: for powder

PHARMA 4: for suppositories and vaginal balls

PH. US. DEF: user-defined with a suggestion according to Pharma 1

t Density of liquid products

t Number of samples: at least one

t Nominal filling quantity (select tolerance system USER DEF. if nominal filling

quantity is less than5 g)

t Mean tare value

t Limit for -T2, -T1, -T, +T or -T2, -T1, +T1, +T2

t Supplemental quantities for products whose weight decreases after filling,

e.g.due to evaporation.

t Sampling process with mean tare weight, with individual tare and gross

measurements, as additive weighing or subtractive weighing, with tablet

separator

t Tare when required after weight value is saved

t Date and time of the last modification

When sampling takes place, the number of decimal places shown on the display

and the printout depend on the scale being used for the sampling.

Combics SPC Indicator Operating Instructions 13

Changing Product Data

t Select “Change product.”

t Select product and confirm using “Change.”

t Parameters can now be changed.

If no sampling has yet taken place for this product and there are no statistics

saved, then you can change all parameters. If sampling has already taken place

for this product, then only the following can be changed: - Product name -

Adjust. Step* - Density (the density can only be changed if it previously did

not equal 0.) - No. Samples - Tare weight - Control system - Tare after save.

If the product is in buffer memory, then only - Product name - Adjust. Step -

Density - Tare after save can be changed.

t Confirm the changes with “Yes” or cancel with “No.”

Deleting Products

y Products can be deleted individually or all saved products can be deleted at the

same time. First, all existing statistics and buffer memories have to be deleted for

these products.

Otherwise, deletion would not be possible.

t Select the product to be deleted. Or select the “D el.All” soft key to delete all

products.

You are then prompted to confirm.

t “Yes” deletes the product. The statistics and buffer memory for the product

must be deleted first.

* Adjustment step: The smallest step that can be set for the filling machine and

is used for the adjustment recommendation in the sample evaluation.

14 Combics SPC Indicator Operating Instructions

Setting Application Parameters

Product Search

After accessing sampling, tare weighing, test weighing or density, you can page

through the saved product IDs like in a table of contents.

You can page through the list of product IDs using the “q Q” soft keys. Before

using the arrow keys, you can enter one or more initial characters: this will

display the first entry for these initial characters.

Setting Application Parameters

Purpose

The scale requires pre-set parameters for calculating weighing data and for

creating products. The Application menu is divided into the following menu

items: Configuration, Report and Code configuration.

Configuration

The product ID can be selected from the list of locally saved products before

every sampling, tare weighing, test weighing and density change. Then

additional information can be entered for the batch. These data are called

headerdata.

Configuring Product-specific Data

In Configuration in the Application menu, you can set:

– Whether the query for the operator ID should appear. If yes, also whether or

not the last entered operator ID should appear.

– Whether the batch ID must be entered.

– The definition of the weight unit for product creation, the info display, the

statistics and the printout.

– The machine IDs that can be selected for products.

Sampling Process

In Configuration, SPL PROC. in the Application menu, you can set:

– Whether there should be a prompt for information about the batch, if

available, every time sampling takes place

– Whether the measured value should be saved manually (press the “l” soft key)

or automatically

– Whether the scale is tared automatically before sampling takes place

– Whether the air buoyancy of products with a density greater than zero should

be taken into account

- Whether a signal for a tablet separator should be output and/or how long the

signal is.

The input takes place in 25 ms increments. The output for the tablet separator

is the SET port. This only has an effect when “Add. Feeder” was selected under

the sampling procedure during product configuration.

– Whether sampling should be carried out when manually pressing a key or

automatically after a time interval 0.0 - 240.0 min. The time interval “0.0”

means that the next sampling is started immediately after the end of the

previous sampling process.

Measurement Result

In Configuration, SPL RESULT in the Application menu, you can set:

– Whether a results printout takes place automatically or manually

– Whether measured values that are outside of the defined ranges (-T2, -T1, -T,

+T), so-called limit violators, have to be confirmed.

They are displayed as, e.g. “-T2 Err”. For the PHARMA tolerance system,

Combics SPC Indicator Operating Instructions 15

Setting Application Parameters

limit violators are always displayed at the end of sampling and must be

confirmed with the “l” soft key or you can set whether a mean that is less

than the nominal weight or nominal filling quantity must be confirmed.

- Whether a sample or cumulated mean value (long-term mean of the smallest

statistical time period selected)

– Whether for highly fluctuating measured values “too low” or “too

hig h ” is displayed when the measured value is outside of the plausible

limits. These plausibility limits are selected as a percentage deviation from

thenominal filling quantity or from the tare approximate value.

The following applies to gross measurements:

EPu Po

Standard 50 75 125

50 percent 30 50 150

75 percent 10 25 175

90 percent 510 190

95 percent 35 195

with: NZT: nominal filling quantity + supplement + tare mean [= 100%]

E: Unloading limit as a percent of NZT

Pu: Lower plausibility limit as a percent of NZT

Po: Upper plausibility limit as a percent of NZT

The following applies to tare measurements:

EPu Po

Standard 50 60 140

50 percent 30 50 150

75 percent 10 25 175

90 percent 510 190

95 percent 35 195

with: TN: Tare approximate value [= 100%]

E: Unloading limit as a percent of TN

Pu: Lower plausibility limit as a percent of TN

Po: Upper plausibility limit as a percent of TN

- When charts need to be deleted (time window):

Deleting the available data for the mean value charts after 0 or 1 to 255 hours.

The 0 hours setting means that the data are not deleted (a maximum of 20

sampling results are saved).

- Which value should be viewed as the lower good limit:

-T1 (standard) or -T.

This makes possible a more narrow control window.

Statistics

In Configuration, STATISTIC in the Application menu, you can set:

- Which of the following results should be displayed and in which sequence after

completing a sampling process:

– Average value

– Long-term mean

– Standard deviation

– Variation coefficient

– Lowest measured value (minimum)

– Highest measured value (maximum)

– Range (maximum – minimum)

– Process capacity index C p

– Process capacity index C pk

– Number of samples

16 Combics SPC Indicator Operating Instructions

Misc.

– Number of samples less than -T2

– Number of samples less than -T1

– Number of samples less than -T

– Number of samples greater than +T

– “n OK” in %

– Cumulated number of measurements less than -T2 in %

– Cumulated number of measurements less than -T1 in %

– Cumulated number of measurements less than -T or greater than +T1

in% (+T1 only for SPC and PHARMA)

– Cumulated number of measurements greater than +T or +T2 in %

(+T2only for PHARMA)

– Adjustment recommendation

The results are entered in the results list, which can also be empty under

certain circumstances. In this case, only the measured values are output

(see also example 2 on page 19).

– Whether an hourly statistics should also be provided with it. (The hourly

statistics are always available for the Dutch language)

– When the day change should take place for the statistics types. Enter using the

format: hour:minute (hh:mm). This entry refers to the daily, weekly, monthly

and yearly statistics. When shift statistics are being used, you can select the

times for the shift change here.

– The week day on which the change for the weekly statistics takes place

Miscellaneous

In Configuration, Miscellaneous in the Application menu, you can make

settings for:

- The soft key sequence at the 1st and 2nd key levels

- The functions protected by password:

- Entering products

- Deleting products

- Test weighing

- Tare weighing

- Density entry

- Deleting the last measured value via the “CF” key

- Deleting the last sample/initial weight via the “DelS” key

- Deleting statistics

Combics SPC Indicator Operating Instructions 17

Factory Settings

In Configuration, Factory settings in the Application menu you can:

– Reset all application parameters to factory settings

– Reset all existing passwords

- Delete all data for the mean value chart

- Set the soft key sequence to default settings

- Delete the weight values of the back and forth weighing

An additional menu item appears in Service mode in which

- All product data can be deleted and

- All statistics can be deleted

18 Combics SPC Indicator Operating Instructions

Navigating the Setup Menu

Example 1

Setting the “Save weight value” parameter to “manual”

Step Press key (or action) Display/Printout

1. Select the Setup menu H

2. Confirm “Application parameters” Soft key O

3. Confirm “Configuration” Soft key O

4. Select und Confirm Soft key q

“Sampling process” and then O

5. Select and confirm Soft key q once,

“Save weight value” then soft key O

6. Select and confirm “Manual” Soft key Q ,

then soft key l

7. If required, select Soft key o q Q O

further setup items

8. Save settings and Soft key oo

exit the menu

Combics SPC Indicator Operating Instructions 19

Navigating the Setup Menu

Example 2

Configuring Results Lists

Step Press key (or action) Display/Printout

1. Select the Setup menu H

2. Confirm “Application parameters” Soft key O

3. Confirm “Configuration” Soft key O

4. Select and Confirm “Statistics” Press soft key a

repeatedly

then Soft key >

5. Confirm “Parameters for

sample statistics” Soft key O

6. The results list appears Soft key O

(example: results list is empty),

Factory setting: the list contains

19 results

20 Combics SPC Indicator Operating Instructions

Navigating the Setup Menu

Step Press key (or action) Display/Printout

7. Add a result from the Soft key q Q

selection list to the results

list and confirm Soft key l

(example: add Range (max. - min.)

to the results “Mean,”

“Long-term mean,” “Minimum”

and “Maximum”)

8. If required, add additional Soft key q Q

results to the results list. Soft key l

9. If required, delete a result Soft key o

from the list: select the value Soft key q Q

to be deleted from results list

and delete Soft key Delete

10. If required, select further Soft key o q Q O

menu items

11. Save settings and Soft key oo

exit menu

Example 3

The sequence of soft keys in the Main menu

can be freely selected via a list similar to the

results list described above in the menu

(Miscellaneous, Soft key order).

The effect of the above change to the

soft key sequence is shown in the

picture on the right:

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Minebea Intec Combics® SPC Combics 3, Model CA...., Option H5 Owner's manual

Minebea Intec Combics® SPC Combics 3, Model CA...., Option H5 Owner's manual

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