Sartorius isi30-000q (SartoPac 85)

Transcription

1 Sartorius isi30-000q (SartoPac 85) Industrial Weighing Technology Sampling and Evaluation Program for Average Weight Control, Statistical Process Control and Weight Controls in Accordance with Pharmacopoeia Regulations Operating Instructions 1

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

3 Operating Design Operating Design To configure the scale for checkweighing prepackaged products, you need to set certain parameters in the application setup menu (e.g., base data, configuration, printout format). Then you can begin weighing. The description of the operating design is divided into the following sections: Data Input Display Modes Error Codes Storing Data Deleting Data Data Output Data Input Dialog Type Data is entered in the isi30-000q application through the keys or using a bar code scanner, mainly in dialog form. There are two types of dialog: Select dialog Input dialog Select Dialog The selection text is displayed in the weight display line or in the application line (bottom line). Use the UP and DOWN arrow keys (Y and y) to select an option; then press ENTER (L) to confirm your selection. Input Dialog The parameter to be defined is displayed in the weight display line or the application line; enter a value here (name or number). Bar Code Scanner All the data that you can input using the keypad can also be entered via bar code scanner. Keys Each key is described in detail in the chapter entitled Overview; only the basic concept is described here. All data entered are displayed in the application line at the bottom of the display (20 characters max.). The keys are divided into 4 groups: Scale function keys (tare, gross, etc.) (blue keys) Application function keys Numeric keys Keys for alphabetic characters as well as correction and arrow keys (cursor keys). Scale Function Keys These keys are blue color-coded, and are assigned normal scale functions. They are described in the Installation and Operating Instructions for the isi terminals. Application Function Keys These keys have light-emitting diodes (LEDs) that light up during operation. They are used to start application functions (e.g., sampling or evaluation). When a function key is pressed: the corresponding LED lights up and a single beep tone (acoustic signal) is sounded; or two beeps are sounded, indicating that the key has no function or is blocked in the current operational status. This provides for easy operation, requiring few keys to be pressed. For most keys, the symbol indicating the function is not on the key itself, but located above the key. Numeric Keys The numeric keypad can be used to enter both positive and negative numbers, with decimal places. Keys for Alphabetic Input Press the a key before entering letters. The LED lights up; now you can enter letters. Correcting Data Input You can interrupt and cancel data input by pressing C. You can also use the j c x and X keys to change or correct the character string during input. 3

4 Display Modes Display During Operation (Example) There is one display mode for operation and another for application setup. Information on the application status or the selected function is given in the bottom line of the display (application line) NNNN Display Mode During Operation This display mode is described in detail in the Installation and Operating Instructions for the isi industrial terminals. text Display Mode During Application Setup You can set the desired weighing parameters by selecting the 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 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. password > passw. 1: Weighing platform specifications 2: Application line 3: Symbol for the function in progress 4: Weighing platform number Display During Configuration (Example) 1: Symbol for the routine in progress (in this case, Configuration ) 2-4: Menu levels above the displayed menu item, Password required to enter base data /no 5: For zeroing the weighing platform 6: + / sign for value displayed 7: Weighed value 8: Weight unit of displayed value 5: Last (sub)menu (item) selected 6: Indicates that this is the currently selected setting 7: Indicates that additional submenus/menu items exist 8: Application line 4

5 Operating Design Error Codes When a key is pressed which has no function or is blocked at a certain point in an application program, the error is indicated as follows: the display shows an error message for 2 seconds; then returns to the previous display; a double-beep is sounded as an acoustic signal. This process is the same for all operating modes (setup, application program routines). Error codes and messages are described in detail in the section entitled Error Codes. Storing Data Saving Configuration Settings The application data are stored in RAM which has backup battery power, which means your settings are not lost in the case of a power outage. When you turn on the isi30-000q, the most recent configuration settings are active. Blocking Access to Configurations You can block access to the setup menu by assigning a password. You can also block access to each of the following areas separately: Enter base data Delete base data Perform test weighing Delete statistics Delete individual values during sampling Delete entire sampling series Saving a Sampling Series A sampling series may be interrupted before it is completed. When this is the case, a printout is generated automatically which includes the error message Sampling aborted. Deleting Data Deleting Characters You can delete an incorrect character by pressing the c key. Interrupt/Cancel Data Input You can cancel input by pressing C, as long as you have not yet pressed L. Data Output You can choose from 3 forms of data output: Display in the application line Printout on the YDP01IS-0CE printer Output to the YDO01IS COM port Application Line This line displays the following data after a sampling: Average value of samples Long-term average Standard deviation Variance coefficient Sample size Number of values < T2 Number of values < T1 Number of values < T Number of values > +T Individual values Machine adjustment instruction Printer You can connect a printer to the isi30-000q. In addition to the standard printout, you can also generate separate printouts of a specific sampling series, product lists, base data or statistics. In the setup menu, you can configure whether the printout includes a GMP header and a GMP footer (space for operator s signature). GMP stands for Good Manufacturing Practice. Communications Interface to an External Computer The isi30-000q is equipped with an SBI interface for data communication. This is a simple ASCII interface. The functions available through this interface are described in the respective Interface Description. 5

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

7 Application Setup Menu Structure Diagram (Part 1) Level 1 Level 2 Level 3 Level 4 Level 5 Parameter described under no.: Application Setup Base Data Enter Product name [1] 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 (Code) to: Delete base data [27] 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

8 Menu Structure Diagram (Part 2) Level 1 Level 2 Level 3 Level 4 Level 5 Parameter described under no.: Application Setup Base Data see previous page 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

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

10 Parameters Under the Configuration Menu Item [11] T tolerance limit for REG and User. def. tolerance systems -t 2 decimal places; unit as selected under [33] or in ml, if [4] You can define the T limit. T must be T1. +T1 tolerance limit for SPC and PHARMA tolerance systems +t1 2 decimal places; unit as selected under [33] or in ml, if [4] If you select the SPC system, you can change the +T1 limit. +T1 must be the nominal quantity. [12] +T tolerance limit for REG and User def. tolerance systems +t 2 decimal places; unit as selected under [33] or in ml, if [4] The +T limit can be defined. +T must the nominal quantity. +T2 tolerance limit for SPC and PHARMA tolerance systems +t2 2 decimal places; unit as selected under [33] or in ml, if [4] If you select the SPC system, you can change the +T2 limit. +T2 must be the +T1 limit. [13] Supplement amount suppl. 2 decimal places; unit as selected under [33] or in ml, if [4] This is an evaporating supplement which is subtracted from the gross value when a measured value is taken over. Fill quantity = (gross tare)/density supplement [14] Control mode Average tare Tare, then gross Gross, then tare Additive weighing control avg.tare tare->gross gross->tare add. whg. [15] Automatic taring after weight value stored tar.a.val. No no [16] Save data entered No [17] Delete a product No save no delete no [18] Show data in memory mem.data To display a list of product names; press p to print [19] Display display To display the base data for the current product; press p to print [20] Delete all base data del.all No no! Important Note: Only select yes here if you are sure that you want to delete all base data. [21] Operator designation operator Display default operator des. with def o No default op. des. no def. Do not enter operator des. no [22] Batch designation Enter batch number Do not enter number [23] Average tare Enter a value Do not enter a value [24] Density Enter a value Do not enter a value batch no o tare wt. no o density no o [25] Always enter operator, batch, tare & density data ent.alwys. Always enter o Enter only at start no of sampling series Restrict access to functions: Passw. [26] Enter/change base data Password required* No password required [27] Delete base data Password required* No password required [28] Perform test weigh Password required* No password required ent.b.dat. o no del.b.dat. o no test wgh. o no * = Password required to access this function 10

11 Application Setup [29] Delete statistics Password required* No password required [30] Delete ind. values Password required* No password required [31] Delete last measurement Password required* No password required [32] Take over values Manually Automatically [33] Unit for base data Grams Kilograms [34] Tare before beginning sampling No [35] Print evaluation Manually Automatically [36] Delete statistics for products weighed Manually Automatically del.stat. o no del.val. o no del.meas. o no take val. manual autom. o Unit g o kg tar.b.sam. no o prt.eval. manual o autom. del.list manual o autom. [37] First value displayed of sampling statistics Sampling average Long-term mean Standard deviation Variation coefficient Sample size Number < limit T1 Number < limit T2 Number < limit T Number > limit +T Adj. instruction dis.stat. mean o l-mean s V n n<-t1 n<-t2 n<-t n>+t adjust. [38] Limit 1 ( T2) limit 1 Out-of-tolerance value must be confirmed o Confirmation not required no If you select the REG tolerance system, out-of-tolerance values must be confirmed. With a PHARMA tolerance system, out-of-tolerance values are displayed at the end of sampling and must be confirmed by pressing L. [39] Limit 2 ( T1) limit 2 Out-of-tolerance value must be confirmed Confirmation not required no o If you select the REG tolerance system, out-of-tolerance values must be confirmed. With a PHARMA tolerance system, out-of-tolerance values are displayed at the end of sampling and must be confirmed by pressing L. [40] Limit 3 ( T or +T1) limit 3 Out-of-tolerance value must be confirmed Confirmation not required no o With a PHARMA tolerance system, out-of-tolerance values are displayed at the end of sampling and must be confirmed by pressing L. [41] Limit 4 (+T or +T2) limit 4 Out-of-tolerance value must be confirmed Confirmation not required no o If you select the REG tolerance system, out-of-tolerance values must be confirmed. With a PHARMA tolerance system, out-of-tolerance values are displayed at the end of sampling and must be confirmed by pressing L. [42] Plausibility limit for gross weight gross Standard standard o Up to 50% error 50 pct Up to 75% error 75 pct Up to 90% error 90 pct You can adapt your User def. or SPC tolerance system for use with products of widely varying weights. Select the standard setting (± 25%) for all other tolerance systems. [43] Plausibility limit for tare weight Tare Standard standard o Up to 50% error 50 pct Up to 75% error 75 pct Up to 90% error 90 pct You can adapt your User def. or SPC tolerance system for use with products of widely varying weights. Select the standard setting (± 40%) for all other tolerance systems. If you select the REG tolerance system, out-of-tolerance values must be confirmed. 11

12 Parameters Under the Printout Menu Item Save Parameter Settings [44] Print machine designation machine o No no [45] Print base data base dat. o No no [46] Print individual values ind. val. No indiv. values printed none Print fill quantities only fill amt. o Print tare and fill quantities all You can protect your parameter settings from unauthorized changes by assigning a password. The password you enter is hidden (only asterisks (*) are displayed). [50] Password [Example] passw. Old password [BLUE] **** Enter new password [RED] **** Confirm new password [RED] **** [47] Print GMP header/footer No gmp 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 Print Do not print Histogr. no o 12

13 Configuring the Program Configuring the Program Base Data The isi30-000q Application Package is designed for use in average weight control of prepackaged products. Average weight control is performed by evaluating samples of the products. There are large amounts of data to be managed and processed relating to the products and their containers or packaging. The isi30-000q has memory locations for up to 100 products, allowing easy access to all required data. Product Memory When you access product memory, the amount of memory available is displayed for 2 seconds in the application line. Entering Product Data You can manage data, including the following information, on 100 different products. Each of the 100 product memory locations can contain the following data: Product name/number (designation for ID) Machine designation (remark) Tolerance system (menu item [3]) REG: For products subject to prepackage regulations User Tolerance limits can def.: be defined SPC: You enter the T2 limit; the T1, +T1 and +T2 values are calculated based on this value. You can also change the values calculated. PHARMA 1: For non-coated tablets PHARMA 2: For capsules PHARMA 3: For powders PHARMA 4: For suppositories/ pessaries Density for liquid products Adjustment step Sample size Nominal quantity (Select the User def. tolerance system if this quantity is less than 5 g) Average tare T2, T1, T and +T limits, or T2, T1, +T1 and +T2 limits Supplement amount for products that decrease in weight after filling, due to evaporation Supplement = Gross supplement tare Control mode with average tare weight, with individual tare and gross measurements, or additive weighing Taring if you want the weighing equipment to tare automatically after a weight value is stored When you enter the base data for a product, the number of decimals for the weight value is set to 2. The value is stored, however, with the full accuracy indicated. The first time sampling is performed with this product, the number of decimals on the display and the printout is determined by the scale used. In subsequent sampling the number of decimals is set to the accuracy of the last scale used. Product Data Search You can scroll through a list of product names in the application menu and after starting the sampling routine, tare weighing or test weighing. Select the menu path: Base Data/ Memory Data in the application setup menu. Then use the up/down arrow keys (Y y) to scroll through the list of products. You can also enter a letter before scrolling to move to the first product that begins with that letter. Press C if you want to exit the application menu. Displaying Product Data You can have the data on a specific product displayed if you want to check it. Select the menu path: Base Data/ Display. Enter the product name or scroll through the product list (see above) until you find the desired product; then confirm by pressing L. Use the Y y keys to scroll through the product data. See above under Entering Product Data regarding the number of decimals. Press C if you want to exit the application setup menu. Printing Product Data You can print out product data for documentation purposes. Select the menu path: Base Data/ Display. Then enter the product name or select it from the list (see above) and confirm by pressing L. Press p to generate a printout. See above under Entering Product Data regarding the number of decimals. Press C if you want to exit the application setup menu. Changing Product Data You can make changes in the data on any product. Select the menu path: Base Data/ Enter. Use the Y y keys to scroll through the list of parameters; press L to select the desired parameter. Enter new values for the parameter. Press C if you want to exit the application setup menu. 13

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

15 Configuring the Program whether out-of-tolerance values must be confirmed before the program can continue. An out-oftolerance value is displayed, for example, as T2 ERROR. With the REG tolerance system, T2 violations must always be confirmed. With a PHARMA tolerance system, out-of-tolerance values are calculated based on the average weight in the sampling run, not on the nominal fill quantity. This is why violations can only be displayed at the end of sampling. The out-of-tolerance values must be confirmed. (See menu items [38] through [41].) to have an error message ( Too low or Too high ) displayed when a measured value exceeds plausible limits. You can set these plausibility limits by selecting the percentage of deviation from the nominal fill quantity or from the tare approximation value. For gross measurements: E P +P Standard percent percent percent where: NST: Nominal fill quantity + 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 percent percent percent 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

16 Formatting the Printout The isi30-000q can print out 7 different types of data records: Standard printout (net, tare 2, tare 1, gross) Printout of sampling evaluation Printout of tare weighing Printout of test weighing List of products Base data for a product Statistics You can configure how the sample data, tare weighing and test weighing printouts are triggered as well as their formats. In the application setup menu, you can configure whether a printout is generated manually (by pressing p) or automatically after each sample, tare weighing or test weighing Example: Printout of a Sampling Evaluation :00 Type ISI30 Ver. S ID Type IS34EDE Ser. no Sample from: :00 Prod. CHOC.COOKIES Contr. Avg.tare Mach. MACHINE 1 Batch ABC456 Tol.S. REG Nominal g Density T g -T g -T 98.0 g +T g Suppl. 1.0 g Tare 10.0 g Designation of Printed Lines (Described on page 18) GMP-Dotted line GMP-Date/time GMP-Terminal type GMP-isi30-000Q software version GMP-Cust./system/code/workst. no. GMP-Weighing platform type GMP-Weighing platform serial no. GMP-Dotted line Header line Date/time of sampling Blank line Product name Control mode Machine designation Batch designation Tolerance system Nominal quantity Density in g/ml T2 limit T1 limit T limit +T limit Supplement amount Average tare [35] Print sampling evaluation Manually Automatically prt.eval. manual o autom. 4. Fill amount: 001 * 96.9 g g g g Explanatory text Individual value (* = out-of-tolerance) Individual value Individual value Individual value The sampling evaluation printout consists of 9 sections (see Example: Printout of a Sampling Evaluation): 1. GMP header 2. Identification section 3. Base data 4. Individual values 5. Evaluation 5. Evaluation: Mean 99.7 g L-Mean 99.7 g s 2.5 g V 2.51 % n 4 n<-t2 0 n<-t1 0 n<-t 1 n>+t 0 Explanatory text Sample mean Long-term mean Standard deviation Variance coefficient Sample size No. of values < T2 No. of values < T1 No. of values < T No. of values > +T 6. Histogram 7. Adjustment instruction continued on next page 8. Operator 9. GMP footer 16

17 Configuring the Program The sections for GMP header and footer, machine designation, base data, individual values and histogram are optional. Select the menu path: Application Setup/ Printout to define which of these sections should be printed (menu items [44] through [49]). See above under Entering Product Data regarding the number of decimals. In a sampling run using a PHARMA tolerance system, N is the sample average and T1/2 or +T1/2 values are calculated in the sampling run. In the long-term statistics using a PHARMA tolerance system, N, T1/2 and +T1/2 values are set in the base data. In this case, numeric values from 7 to +7 are included on the printout as indicators. 6. Histogram: <-T2 <-T1 <-T1 <-T <-T -2: -1: +1: +2: >+T >+T >+T >+T >+T <-T % <-T % <-T % <-T % <-T % -2: % -1: % +1: % +2: % >+T % >+T % >+T % >+T % >+T % Explanatory text Values < T2 Values from T2 to T2 + ( T1 T2)/2 Values from T2 + ( T1 T2)/2 to T1 Values from T1 to T1 + ( T T1)/2 Values from T1 + ( T T1)/2 to T1 + ( T T1) Values from T1 + ( T T1) to T1+ (N T)/2 Values from T + (N T)/2 to N Values from N to N + (+T N)/2 Values from N + (+-t N)/2 to + T Values from +T to ((+T N)*2)/2 Values from ((+T N)*2/2 to (+T N)*2 Values from (+T N)*2 to ((+T N)*4)/2 Values from ((+T N)*4)/2 to (+T N*4 Values > (+T N)*4 Absolute and relative numbers of measured values per category Adj g Oper. AB :03 Name: Adjustment instruction Operator designation GMP-Date/time GMP-Field for signature GMP-Blank line GMP-Dotted line several blank lines 17

18 GMP Sections GMP Header GMP stands for Good Manufacturing Practice. The information in this section documents the date and time the measurement was made, as well as the equipment used. GMP Footer This section contains a field for the operator s signature under the text: Name:. The operator documents the measurements made by signing the printout here. You can configure whether these two sections are printed or not. If you set the GMP menu item to NO during a sampling series, the header/footer will not be included on the printout. Formatting a GMP Printout: [47] GMP header/footer No Product Name gmp no o If the product name is too long to be printed on the Prod. line, the remaining characters are printed right-justified on the next line (16 characters max.). Machine Designation If the machine designation is too long to be printed on the Mach. line, the remaining characters are printed right-justified on the next line (16 characters max.). Batch Designation If the batch designation is too long to be printed on the Batch line, the remaining characters are printed right-justified on the next line (16 characters max.). Control Mode The other possible control modes are Tare > gross, Gross > tare, Add. Whg. and Tare cont.. Tolerance System Any of the following designations may appear to indicate the tolerance system used: REG User def. SPC Pharma 1 Pharma 2 Pharma 3 Pharma 4 REG SPC User def. Pharma 1 4 Limit 1 T2 T2 Limit 2 T1 T1 Limit 3 T +T1 Limit 4 +T +T2 The following applies in all cases (N = nominal fill qty): T2 T1 T T N +T or T2 T1 N +T1 +T2 REG: T2 and T1 limits are calculated automatically from the nominal fill quantity but not displayed. T2 violations are also T1 violations. T1 violations are also T violations. User Defined: All the tolerance limits can be defined and are displayed. None of the limits are calculated automatically. Select this tolerance system if the products tested are < 5 g/ml. Tolerance violations are as for the AWC setting. SPC: The T1, +T1 and +T2 limits are calculated from the value entered for T2. All limits are displayed and can be changed. Tolerance violations are as for the PHARMA setting. PHARMA 1 through 4 All tolerance limits are calculated automatically, none are displayed. Deviations are calculated from the mean value (average weight) of the sample and not from the nominal quantity. T2 violations are not T1 violations. +T2 violations are not +T1 violations. Mean Limits [in %] [in mg] T2 T1 +T1 +T2 PHARMA 1: Non-coated tablets PHARMA 2: Capsules < > PHARMA 3: Powders > PHARMA 4: Suppositories and pessaries All Explanatory Text In tare weighing, the explanatory text would indicate Tare values rather than Fill amount. Adjustment Step In tare weighing, the explanatory text would indicate Average Tare Allowed or Indiv. Tare Required rather than Adj. 18

19 Sampling Sampling When you turn on the isi30-000q: The display segments are tested (all segments light up) a self-test of the weighing range is run the software version is displayed for 2 seconds The isi30-000q is then ready to operate. The measured value line shows the weight of the load on the weighing platform, and the prompt Please press a key appears in the application line. Sampling results can be calculated as average tare values, tare > gross values, gross > tare values, or as additive weighing, depending on the Control mode setting. Tare > Gross In sampling, the tare values must first be determined individually; then the containers are filled and weighed in the same order, this time calculated as gross values. Gross > Tare If the filled containers are sealed when they come from the filling machine (e.g., bottles), the gross weight is measured first. Containers are then opened, emptied (destructive testing) and the weighed in the same order as tare values. Additive Weighing For additive weighing, the equipment is automatically tared after the measured value is stored. For sampling, you can place the samples on the weighing platform one after another without having to remove the previous sample (e.g., tablets). Average Tare Select this mode for determining the nominal fill quantity with a given tare value that applies to all packages. The average tare can be determined during sampling. Performing a Sampling Routine Regulations affecting prepackaged products require that the weight or volume of package contents must not go below certain tolerable negative error limits at the time of manufacture. This limit is called T1/ T2. No more than 2% of the packages are allowed to exceed the specified negative error. Prepackages having a negative error greater than twice the tolerable negative error are not allowed to be placed on the market; i.e., sold to the public. This lowest limit is known as T2. You can also configure a more stringent in-house limit, T, as well as an in-house upper limit, +T, both independent of the above limits. By sampling the products you can determine whether the fill quantities meet specified limits. For statistical determination of these values, the following must be entered in the program: the tare weight, the nominal quantity, for liquid products, the density so the weight can be converted to a volume value, and if necessary, the supplement amount for products that decrease in weight after filling. If you have selected the REG tolerance system, the T1 and T2 limits are calculated automatically; with a PHARMA system, all limits are calculated automatically. When you use the User def. tolerance system, you can enter products with weights lower than 5 g. Performing a sampling series consists of the following steps: Entering header data Determining weights of the samples Creating statistics and, if desired, printing data Entering Header Data (Overview) Select sampling function Enter or select a product name $ Enter operator data $ Enter batch designation $ Enter average tare $ Enter density value The prompt for entering a density value only appears if a value greater or less than 0 has been entered in the base data. The prompts for entering operator data, batch designation, average tare, and density only appear if configured in the Setup menu. In the application setup menu, you can configure that the header data input is not prompted before you exit the sampling mode. The values entered for average tare density are stored as new values in the product base data after sampling is concluded. 19

20 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 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 Y y 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=ABC 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 < g> 10. Unload scale Remove container G 2/3 load 11. Load scale Place filled container 2 on pan G ---/3 < g> 12. Unload scale Remove container G 3/3 load 13. Load scale Place filled container 3 on pan G ---/3 < g> 14. Unload scale Remove container mean= g (You can define which of the results will be displayed first after sampling; see the section entitled (Application Setup ) 20

21 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 = g described above 1. Display resulting values Y y (repeatedly if necessary) l-mean = g 2. Print evaluation - p (no machine adjustment Sample from: necessary) Prod. CHOC.COOKIES Contr. Avg.tare Tol.S. REG Nominal g Density T g -T g -T g +T g Suppl. 0.0 g Tare 20.0 g Fill amount: g 1) g 2) g 1) g 2) g 1) * g 3) Evaluation: Mean g L-Mean g s 1.4 g V 0.47 % n 3 n <-T2 0 n <-T1 0 n <-T 1 n >+T 0 1) = Tare 2) = Fill amount 3) = Limit exceeded Adj g - 21

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

23 Sampling Example: Tare Weighing to Determine Whether Individual Tare Values are Required with the settings: Product name: Choc.cookies Mean tare weight: 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 Y y 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 - p (Example; result is Average tare Sample from: allowed; individual values are not required) Prod. CHOC.COOKIES Contr. Avg.tare Batch 5 Nominal Tare g g Evaluation: Mean g s 0.53 g V 3.48 % n 25 Average tare allowed Oper. 3-23

24 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

25 Evaluation Evaluation Select the Evaluation function to have the weight values collected in sampling displayed or printed as statistics. Statistics are compiled for three different time periods. Press [EVAL.] to access the evaluation function; then select one of the following: PRINT DISPLAY PRT.+DEL. You can also have a list of the products already weighed (DISPLAY WEIGHED PROD.) displayed and/ or printed, and generate a list of products for evaluation (PRODUCT LIST). Select the time period for the desired statistics (1ST PERIOD, 2ND PERIOD, 3RD PERIOD). The following data are then displayed or printed: Date and time of the first and last samples in the series Target weight Mean value Standard deviation Averaged standard deviation Number of packages Number of samples < T2, < T1, < T and > +T The program outputs the number out-of-tolerance values with the percentage value by which the limits are exceeded. The DISPLAY WEIGHED PRODUCTS function offers an overview of the products for which statistics are available. With the PRODUCT LIST function, you can define which products should be included in a printout of statistics. With this function you can have an evaluation limited to certain products. DISPLAY Evaluation Step Key(s) (or instruction) Display/Output 1. Select the evaluation function [EVAL.] prt.+del. 2. Select the display function y L 1st Period 3. Select the time period y Y 1st Period of the evaluation 2ND Period 3RD Period and confirm L L Prod.= 4. Enter the product designation (here: 1234) or select it from the list y Y 1234 and confirm From L To Display statistics (repeatedly, if nec.) targ. = G y Y -mean = g 6. Print statistics s = g p s-avg = 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 = Pct n > +t = 1 n > +t = Pct 25

26 PRINT Evaluation Step Key(s) (or instruction) Display/Output 1. Select the evaluation function [EVAL.] prt.+del. 2. Select the print function y y L 1st Period 3. Select the time period y Y 1st Period of the evaluation 2ND Period 3RD Period and confirm L Weighed Prod. 4. Select the type of product y Y weighed product 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: :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: :42 This means you can use the to: :22 Period 1 statistics as batch statistics by printing and deleting Tol.S. REG the evaluation after each batch.) Nominal 18.5 g Density T g -T g -T 17.6 g +T 19.4 g Suppl. 0.0 g Tare 0.0 g Evaluation: Targ g L-Mean 18.6 g s 1.0 g s-avg. 1.0 g n-ent. 10 n-samp. 2 n <-T % When you select WEIGHED PROD.(ucts), n <-T % you will be prompted to define whether n <-T % the list should be deleted after printing: n >+T % Select y Y DELETE LIST No or DELETE LIST and confirm L weighed prod. 0 26