Introduction The Dispensing functionality is essentially pre-weighing ingredients before they are issued for consumption in a Batch.

This functionality is available from the new moduleMES Process perations. The main areas in this module are ! perator "or#bench Dispensing $ Pre-"eigh Electronic Master and %ontrol Batch &ecord 'onconformance Management (abelling)Device *ntegration This note provides an overview and some functional highlights of the Dispensing function in &+,- as well as- the basic setup and process needed for Dispensing. Functional Overview The Dispensing function .also #nown as pre-weigh/ in the MES Process peration module is a #ey re0uirement in many process industries- including pharmaceuticalbiotechnology- food and beverage and chemical manufacturing. This function controls the measurement- containeri1ation and labeling of precise 0uantities of specific materials to the right batch steps prior to- or during the manufacturing process. 2ll the stages are trac#ed- including- material identification from the point of issue in *nventory to the point of delivery in the Batch manufacturing process. This trac#ing is especially critical when wor#ing with the active pharmaceutical ingredients .2P*s/ in a drug product formulation .per FDA Code of Federal Regulations Title 21 Part 211.10/ with pigments when formulating paints and when wor#ing with materials that may become e3plosive or otherwise ha1ardous when not blended in precise ratios in chemical processing. The production batch process for such materials re0uires the right materials to be dispensed to production batch steps with specific 0uality parameters and in right 0uantities to ensure safe manufacturing process and a consistent 0uality product. Since the formulation 0uantities may run into decimals- the accuracy of the 0uantities is critical. Thus- standard weigh-scale integration has been provided to minimi1e the ris# of data entry error. racle MES for Process Manufacturing also provides configurable container and dispensed material holding cage label printing- which may be automatic or userinitiated and includes details such as ! ingredient- lot no.- 0ty- batch no. and the step in the batch operation - for full traceability throughout the manufacturing process. 2 user friendly "or#bench is available for Dispensing perators to 0uery and view the list of materials weighed in Dispensing. During the Dispensing process- the system gives online access to Standard perating Procedures .S Ps/- detailed ac#nowledgeable wor# instructions and simplified E-signatures processes.

Salient Features The following modes of Dispensing are supported ! 4ull %ontainer- Source %ontainer and Target %ontainer ! however- customers can limit the modes that they want to be able to use. *n the 4ull %ontainer mode- the entire container of material is used in the Batch. This Dispensing process involves re-weighing the container to ma#e sure that the net weight is what is re0uired- the container is labelled and sent to the shopfloor. The Source %ontainer mode involves ta#ing some material out of the original container and then weighing and labelling the original container for usage in a Batch. *n the Target %ontainer mode- material is ta#en out from the original container and placed in a Target %ontainer which is then weighed- labelled and then consumed on the shopfloor. *n some industries- there maybe regulations against using material which is not in its original container- thus prohibiting this Dispensing mode which may then be disallowed in the Dispensing. Dispensing can be done not only for ingredients used in a Batch- but also for materials issued for a process- for e3ample- filters maybe dispensed for filtration process in a Biotech environment. nce Dispensing has been done- the dispensed material can)t be used in any other batchit has to be used in the particular Batch or peration it was dispensed for. Thus- chec#s are put in the system so that once an ingredient in a &ecipe is defined for Dispensingthere is a chec# to ensure that there is a Dispensing record associated with that ingredient before it allows it to be consumed in the Batch. "hen a Batch is cancelled- ingredients dispensed for it can be used in another batch provided regulation permit. To do this- the batch must be reversed dispensed and the ingredients re-dispensed for the other batch. Dispensing does not create an *nventory transaction and happens at the same subinventory that the ingredients are being consumed from in a Batch. The Dipensing operation does not decrement *nventory although a Dispense record is associated for that 0uantity. The inventory is decremented only when the material is consumed in the Batch. %urrently- the Dispensing functionality does not support Dispense 2reas comprising of Dispense booths having their own subinventory where ingredients would be moved from the Stores to the Dispense area$ booth for Dispensing and then to the shopfloor. This is earmar#ed for furure releases. 2lso- Dispensing currently supports only pre-weighing a single ingredient. 2lthough- mi3ing two or more ingredients and then dispensing them out in a formulation- maybe presently modelled as a Phantom in the main batch- this is a future enhancement #nown as 5Pre-Mi3 Dispensing). Some of the other future enhancements in the Dispensing area are ! Dispensing supervisor wor#bench &eusable container management

The Batch Process Flow The process flow for a Batch between the e3isting PM Process E3ecution functionality and the new Dispensing functionality can be depicted in the responsibilities of the different 6sers as follows Process Engineer/Formulator - %reates and maintain recipes and advanced process

instructions.
Production Supervisor - %reates batches- &eserves materials- &elease batches $ steps

Modifies batch ingredients- steps- resources- (ogs nonconformances- Prints product labels- %ompletes and %loses batches $ steps
Production Operator - Progresses batch steps- Performs process instructions- &ecords

actual material transactions- &ecords process parameter actual values- %reates 0uality samples
Dispensing Operator - Performs dispensing tas#s- Performs reverse dispensing

Dispense Example *n this 'ote- the setup and processing illustrating the Dispensing functionality is done for rgani1ation ! (2+ ! and thus all the setups are done in this organi1ation. The Dispense ingredient is *tem ! 7789 .Stearic 2cid/ ! for &ecipe 7:8+.

Setups Required for Dispensin .+/ Basic Setup of MES perations The concurrant program; <Enable MES for Process Manufacturing 4unctionality< needs to be run once on an instance when the MES Process perations product is first installed to enable the MES perations functionality integration with PM Process E3ecution in that instance. This is a generic step needed to enable the MES perations functionality and can be run from the =MES for Process Manufacturing 2dministrator= &esponsibility. Prior to running this concurrant prgram- the profile; >?M ; MES for Process Manufacturing is Enabled@ is set to 5'o)- this is changed to 5Aes) once the concurranrt program is successfully completed.

.,/ Dispensing Setup .i/ Document 'umbering &ules ! ne can Search for e3isting rules- or- create new ones. &esp; 'MES for Process Manufacturing Administrator> Setup> Document Numbering> Create:
There are two t pes of Dispense transactions that can be created ! "Dispense# and "Dispense $e%ersa&#' The format for the uni(ue numbers generated for each Dispense transaction can be setup here' The ")ormat E*amp&e# fie&d disp&a s the number format as each attribute is popu&ated in this setup screen+

.ii/ Dispensing Setup ! ne can Search for e3isting rules- or- create new ones. &esp; 'MES for Process Manufacturing
Administrator> Setup> Dispensing Setup

ne can Search for e3isting rulesThe Dispensing ru&es ha%e the fo&&owing statuses: Not ,n -se ! There are no Acti%e batches for these ru&es and the can be changed' Past Dues ! These are no &onger effecti%e and can be usefu& in an Audit' -sed ! ,ndicate the ru&es that are used in an Acti%e batch and cannot be changed'

.r create new ones >

The Dispensing rules can be setup specific to an *tem- *temrg or for *temrg-&ecipe combination. *n the rule hierarchy- a more specific rule ta#es precedance over higher level rules. The Dispense 6 M needs to be convertible to the formulation $ batch 6 M. The >Dispense &e0uired@ field would be !5Aes). Bowever- this can be 5'o) when doing a data load initially and be changed later on. "hen dispensing- the system allows multiple partial dispenses below the lower tolerancebut over-tolerance dispensing is not allowed. The start-date needs to be specified to indicate when the rule becomes effective. .iii/ Setting up a %ontainer *tem "hen performing Dispensing- a Source and Target %ontainer needs to be selected. Thusat least one %ontainer *tem type needs to be setup in order to define a tare weight for the container. %ontainer management .e.g- container status- whether clean or not- reusable etc./ is not available currently- but is earmar#ed for the future.

%ontainer - chec#ed. "eight 6 M C *gredient dispensable 6 M 6nit "eight C Tare "t.

*f there is a mismatch between the %ontainer *tem 6 M and the 6 M in which the ingredient is being Dispensed- then the %ontainer *tem will not be available for selection in the Dispensing screen. The %ontainer item needs to be assigned to the organi1ation where dispensing would happen n the Master *tems form; Tools D rgani1ation 2ssignment ;

%ontainer *tem DEP% 'T+ is assigned to rgn; (2+.

.iv/ Defining a Device ! *t is necessary to define at least one Device so that Dispensing transaction can be initiated. 2 Device should be created for every Scale e0uipment that is present. &esp; MES for Process Manufacturing 2dministrator; SetupD Defining Devices 4or DispensingDevice Type C Scale. The Subinventory defined here is where the ingredients will be consumed from. 2n > utput Method@ of 52P*) also needs to be specified for the Device for it to be used for Dispensing. 2lthough the Device definition is a part of the "arehouse Management System ."MS/a separate license is not needed to access this form. The "MS 6ser ?uide would have further details on the other fields on this form. .v/ 2ssigning Device to Business Events !

This Device needs to be associated with the following Business Event in the Dispensing organi1ation ! Process Dispensing Event. .The other Business Event used by the MES perations module is ! Process Parameter Event.This is used to capture process parameters e.g- temp.- pressure- r.p.m- etc./. These are the two events for which the device integration has been enabled to capture actual values. The Device has to be 5Enabled)52uto *nvo#ed) and have the 5Ferification (evel &e0uired) set to 5subinventory)

Production Supervisor Responsi!ilit"# $reate% Reserve and Release Batch .i/ %reate a Batch G988: with the Dispense material that has Dispensing rules setup using the Production Supervisor responsibility.

*n the current e3ample ! &ecipe 7:8+ ! has a dispensable ingredient 7789.

'ote the 5Dispensable) flag chec#ed for the ingredient 7789. This chec#bo3 is not updateable and is based on the Dispensing rules setup. .ii/ Dispensing currently re0uires that a detailed reservation e3ists prior to Dispensingi.e.- a (ot needs to be specified for the ingredient. nly the Production Supervisor currently does this- in future releases- a new responsibility ! Dispense Supervisor ! would be available for this. %reating a detailed reservation for the ingredient lines could be done either individually for each line via >&eservations@ or for the entire batch via >2uto Detail Batch@ which reserves all the ingredient lines on the batch by assigning their 0tys to lots. n the Tool bar; *nventory D 2uto Detail Batch

This &eserves all the ingredient lines on the Batch !

.iii/ 'e3t- &elease the Batch; 2ctions D &elease Since all the ingredient have 5%onsumption Type) as 52utomatic)- they are all consumed on the Batch e3cept for the dispense material 7789 which needs to be dispensed before it can be consumed. *f one clic#s on the 5Transact) chec# bo3 on the Material E3ceptions form to consume this Dispendable ingredient- the following error is got ! >Transactions cannot be created as material has to be dispensed before creating transactions@. Scrolling to the right on the Material E3ceptions form the *tem 7789 is indicated to be5Dispensable) and having 5Pending &eservations).

%ontinue by clic#ing >Proceed@.

2ll the items e3cept the *tem 7789 have been consumed on the Batch.

The >Fiew Material Transactions@ screen .Tool bar; *nventory D Fiew Material Transactions/ is as follows -

.iv/ 'e3t- &elease the first few Steps on this Batch so that the perators can wor# on them. n the Batch Detail form; Steps D 2ctions D &elease Steps;

Steps +8- ,8 and :8 have been released to the Shopfloor.

Dispensin Operator Responsi!ilit"# Dispense &aterial .i/ Dispensing Search D The Dispensing function can be carried out from within the 5Dispensing perator) or the 5MES for Process Manufacturing 2dministrator) &esponsibilities. &esp; Dispensing perator D Dispensing D Dispendable Material This screen brings up the material that has to be dispensed. Specify the rgani1ation that Dispensing has to be done in and clic# H?oI. nce the organi1ation conte3t has been enabled various critera can be used to Search for material to be be Dispensed- e.g.- by Batch- Product etc. The Status defaults to 5Detail (evel &eservations) as only these ingredients can be Dispensed. The 5Dispense 2rea) is the subinventory where the ingredients are being consumed. The chec#bo3 5Show Partially Dispensed within Tolerance) if unchec#ed .default setting/ would not list any Dispensable ingredients which has already been partially dispensed to above its (ower Tolerance level. *f chec#ed- it would list out Dispensable ingredients that are between the 6pper and the (ower Tolerance levels.

.ii/ Dispense D Searching by the Batch 'o.; G988:- brings up the material to be dispensed.

Select the Dispense *tem via the radio button and clic# on Dispense. This brings up the Dispensing screen.

The Dispense Mode can be ! 4ull %ontainerTarget %ontainer or Source %ontainer as described earlier. The Source Device field is needed for reading from a Device automatically and is not re0d. for manual data entry-

Entering in the Source %ontainer- populates the %ontainer Tare wt. and the ?ross wt. of dispense material. The full 0ty re0d. is dispensed in this e3ample for simplicity. *n case of ha1ardous goods- the %ontainer maybe sealed with a Band that has a uni0ue code on it. This maybe entered as the Security Tag and printed on the Dispense (abel. (abels maybeselected to be printed as re0d. 2 Pallet (abel will always default to be printed the first time any ingredient is Dispensed for a Batch and has the Batch 'o.on it. 2ll the subse0uent materials that need to be dispensed for that Batch would go on the Pallet The Dispense (abel goes on the Dispense material and has the Batch 'o.- peration 'o. The Material (abel is for the material that is not dispensed but is going bac# to the *nventory Stores. Thus- is for a mode other than a 54ull %ontainer) mode and has the >new@ 0ty or weight on it. H2pplyI to Dispense the material. .iii/ (abel Printing D The ne3t screen indicates the (abels that will be printed for the Dispense transaction .these are the ones that were selected in the Dispense transaction/. *n this e3ample- these are; Dispense Pallet and Process Dispense Material. The (abel Printing can be E&ES controlled to control their printing. H2pplyI to print the (abels.

.iv/ Dispensing %onfirmation D This screen provides a confirmation of the Dispensing as follows !
/' 9' ,tem 0012 3uantit : /24'50625 was dispensed' Dispense Number is D7P8111128TST' :abe& print re(uest ,Ds /16; and /162 were submitted successfu&& '

The (abel Print re0uest *ds are output files that are available for :rd party labelling software to print labels. This screen also shows that the 5Pending Dispense Juantity) for *tem 7789 is now 1ero.

Production Supervisor Responsi!ilit"# Transact Dispense &tl' ( $omplete Batch 'ow that the *tem 7789 has been dispensed on the Batch G988:- this material can now be transacted on this Batch and the Batch completed. .i/ Juery up the Batch using Production Supervisor &esponsibility D

This screen shows that *tem 7789 has a &eserved Jty of; ::8 (B. This 0ty has now been dispensed to this batch and can be consumed in it. .ii/ HTransact MaterialI brings up the Material Transaction form indicating that *tem 7789 still has 0ty ! ::8 (B ! yet to be transacted.

.iii/ %hec#ing the Transact chec# bo3 and Transacting the *tem 7789 ! consumes it in the Batch G988:.

This Batch can now be %ompleted using the e3isting standard Process E3ecution functionality.

REFERE)$ES

+. &+, 4ield &eadiness "or#shop ! racle MES perations ! Kohn Danese. ,. 4unctional T *s for MES perations.