electronic batch process recording system

15
POLMON 1 POLMON INSTRUMENTS PVT LTD An ISO 9001-2000 Company HYDERABAD,INDIA Since 1992

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Page 1: Electronic Batch Process recording system

POLMON 1

POLMON INSTRUMENTS PVT LTD

An ISO 9001-2000 Company

HYDERABAD,INDIA

Since 1992

Page 2: Electronic Batch Process recording system

POLMON 2

POLMON

About Polmon Since 1987, Polmon has grown into an accepted and acknowledged provider of Instrumentation and Process Automation Solutions for over 400 companies from the pharmaceutical, food and other industries.

We beliveAt Polmon we believe that ‘Customer is our Product Designer’. We actively LISTEN to our customers and work to appropriately address challenges, issues, problems they face. To enable us to deliver, we are quick to under stand, adopt to new technologies and standards such as GAMP, CFR 21, S 88, S 95 and other regulatory standards, with emphasis on the FDA requirements

Page 3: Electronic Batch Process recording system

POLMON 3

DIVISION 2DIVISION 1

POLMON VERTICALS

POLMON

AUTOMATION IT SOLUTIONS INSTRUEMNTS SERVICSES FERMENTORHEAT

TRANSFERING SYSTEM

Page 4: Electronic Batch Process recording system

POLMON 4

POLMON IN TO AUTOMATION

Reactor control Centralized synchronized clock system. Liquid dispensing system Hydrogenation automation Solvent recovery system Crystallization process Clean room parameters monitoring and recording Building management system Low pressure utility alarm system. Safety-exothermic reactions, toxic & hazardous gas monitoring. Dryer automation. Distillation column automation

Page 5: Electronic Batch Process recording system

POLMON 5

POLMON IN TO IT SOLUTIONS

Data Acquisition system Laboratory management System Electronic Batch recording system Computer System validation ERP interface

Operating with rich Pharmaceutical Domain Experts Functional Experts Technical Experts

Page 6: Electronic Batch Process recording system

POLMON 6

POLMON CLIENTELE

Page 7: Electronic Batch Process recording system

POLMON 7

ELECTRONIC BATCH RECORDING SYSTEM

Electronic Batch Record(EBR) is designed for comprehensive data collection, operator work instruction

execution, and electronic batch record reporting.

EBR displays batch records and manufacturing work instructions

online, providing the advantage of paperless data recording.

Page 8: Electronic Batch Process recording system

POLMON 8

KEY DELIVERABLES

Electronic BPR to improve productivity Shop floor on line Data entry. Reactor dedicated annunciations (Visual) Wrong Material, Expiry Material

identification Process Parameter control as per Recipe. Online documentation of process steps. Reduction of administrative work for maintaining manufacturing documents. Reducing the number of lost batches. Recognition of deviations at early stage Meeting compliance requirement

Page 9: Electronic Batch Process recording system

POLMON 9

SOFTWARE AND HARDWARE

HARDWARE

Intelligence electronic status boardPLCControl valveVacuum TransmitterSensorServer PCClient PCBarcode PrinterBarcode Scanner

SOFTWARE

Batch-I Batch (Server)SCADA-I Fix (Server)Batch-I Batch (Client)SCADA-I Fix (Client) Historian-I HistorianSQLBarcode SoftwareScanner SoftwareUnity Pro

Page 10: Electronic Batch Process recording system

POLMON 10

BPR Creation

Recipe creation and load in the Server and release for production.

Check the BPR and send to Q.A for approval.

Audit trial will be capture and Compiled

by Checked by and Approved by signature

will be capture,

Q.A approves the BPRs.Audit trial will

be capture

QA Assign Batch No and issue to Production for the Control Batch

Issued by signature and date and time will capture in

BPR.

Popup will come to the ware house “New Batch

has been released”.

Popup will come to the production “New Batch has

been released”.

Ware house will issue the material

to production

With Barcode label

If required production also will issue the raw material

With Barcode label & Manual (ex: Solvents)

Production Will Start the Batch (from Production

Client)

signature and date and time

will be captured for Batch Start

Bind the Units Required Unit Procedure wise

Start the Operation From

ESB

ESB Displays Batch No, Stage,

Status,Description

PROCESS FLOW

Page 11: Electronic Batch Process recording system

POLMON 11

SOFTWARE SYSTEMARCHITECTURE

Proficy Historian iFix, Batch Server Pack & iWorkinstruction

Batch Development Pack

Batch Integration Server

ERPSQL

iFix and Batch Client

iFix and Batch Client

iFix and Batch Client

iFix and Batch Client

iFix and Batch Client

iFix and Batch Client

Network Switch

Page 12: Electronic Batch Process recording system

POLMON 12

PROJECT SCHEME

Ethernet

PLC

SERVER

PRODUCTION

WARE HOUSEQCQA

HISTORIAN

Weighing Balance Barcode

Printer

Date timeB.NOP/S/OPStatus

Date timeB.NOP/S/OPStatus

IESB3Date timeB.NOP/S/OPStatus

IESB4Date timeB.NOP/S/OPStatus

IESB5Date timeB.NOP/S/OPStatus

IESB6Date timeB.NOP/S/OPStatus

IESB7Date timeB.NOP/S/OPStatus

IESB8Date timeB.NOP/S/OPStatus

IESB9Date timeB.NOP/S/OPStatus

IESB10Date t imeB.NOP/S/OPStatus

Ethernet

Modbus RS-485

IESB2Date time B.NOP/S/OPStatus

IESB1

Modbus RS-485

Weighing Balance Barcode

Printer

IESB1 IESB2

Date time B.NOP/S/OPStatus

Date time B.NOP/S/OPStatus

IESB3Date time B.NOP/S/OPStatus

IESB4Date time B.NOP/S/OPStatus

Date time B.NOP/S/OPStatus

Date t ime B.NOP/S/OPStatus

IESB5 IESB6 IESB7Date time B.NOP/S/OPStatus

Date time B.NOP/S/OPStatus

Date time B.NOP/S/OPStatus

IESB8 IESB9 IESB10

DEVELOPMENTLevel 1

Level 2

Page 13: Electronic Batch Process recording system

POLMON 13

INTEGRATED MANUFACTURING PROCESS

TE 1

R

CV

M

Steam Brine

RT

V2

V3 V4 V5

TI

TO IESB

From PLC

TE2

Condensate

V1

TO IESB

Control Layer

Operation Layer

Business Layer

IESBKey Pad

TE1 TE2

Page 14: Electronic Batch Process recording system

POLMON 14

SAP Interface

ProcessOrder

ProcessOrder

ReleaseGenerate Batch. No

Confirm Order

Update batch data

Master Recipe

CreateApproveUseChange

Control Recipe

Assign Batch No.Batch Execution.Bind Equipment.Audit Trailing.Electronic Signature

Operations

Perform OperationIntegrate QC Data Integrate material DataElectronic SignatureTimeEvents

Reports

Generate Electronic RecordApprove RecordsArchive records

BATCHSAP SAP

Page 15: Electronic Batch Process recording system

POLMON 15

SAMPLE ELECTRONIC REPORT