electronic batch process recording system
DESCRIPTION
TRANSCRIPT
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POLMON INSTRUMENTS PVT LTD
An ISO 9001-2000 Company
HYDERABAD,INDIA
Since 1992
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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
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DIVISION 2DIVISION 1
POLMON VERTICALS
POLMON
AUTOMATION IT SOLUTIONS INSTRUEMNTS SERVICSES FERMENTORHEAT
TRANSFERING SYSTEM
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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
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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
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POLMON CLIENTELE
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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.
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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
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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
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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
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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
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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
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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
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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
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SAMPLE ELECTRONIC REPORT