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Confidential / © Siemens AG 2011. All rights reserved
Bringing Transparency in API operations
Indian Pharmaceutical Plants
Page 2
API Production present scenario
Key Drivers for transparency
Case study of Solvent
Journey of Solvent – Discussion on various stake
holders in Flow of solvent in a Manufacturing Plant
Problem or perception of Problem – Dissecting into the
real problems.
The Solution
Agenda
Confidential / © Siemens AG 2011. All rights reserved
An Entrepreneurs’ View
Plant Land
Infrastructure
Regulatory
Staffing
Raw Material ...
Solvents ... API
Systems
Equipment Black Box
Confidential / © Siemens AG 2011. All rights reserved
Start Bench Mark Improve
Detection of main
energy consumption
Support
Decide
Direction
Bring
Transparency Bau &
Montage
Optimize
Measure all inputs Bench Marking
Define Goals
Support
You can’t reach your destination unless you know where you
stand
Confidential / © Siemens AG 2011. All rights reserved
Case Study : Solvent Management
Why Solvent:-
o Constitutes upto 30 % of the cost
o Inflammable : Safety Hazard
o Upto 23% solvent remains ambiguous in the system
o No high level system , in which consolidated information is present
o Reporting is manual .
Page 6
Journey of Solvent in a Manufacturing Plant
• Recovery of solvent from
ML
• Ensuring right quality of
recovered solvent
• Co ordinate and transfer the
solvent back to Production
Blocks
Journey of Solvent • Management of Solvent
Procurement
• Ensuring that Right quantity
is available at Right Time
• Receipt of Solvent
• Updation in ERP
• Dispensing / Transfer of
solvents to Production
Blocks
• Manage Tank Farm
• Order Solvents to Stores
depending on requirement
and Batch planning
• Co ordinate with stores for
Cleaning requirements
• Co ordinate with Stores for
excess Solvent requirement
• Disposal of waste from SRS
Receipt of Material at Bulk
Storage / Raw Material
Warehouse.
• No real time measurement of
Quality and Quantity at time of
receipt {Beginning of loss }
• Manual receipt generation ,
possibility of wrong data
generation
• No real time measurement of
the solvents in the tanks
• Mixing of Batches ( GMP
Requirement is not
guaranteed)
Transfer of Liquid RM to
Production Blocks / Day
Tanks
• No real time measurement
and record of transferred
volume
• Absence of online and
traceable communication
system between the
production Blocks and
Warehouse.
• Losses of transfer is not
accounted for.
• Safety point , as everything is
manual with no online safety
interlock
Consumption of Liquid RM in
Production Blocks
• No real time measurement
and traceability of solvent.
• No accountability or
traceability of the Batch Wise
Solvent consumption.
• Ambiguity in purpose of
consumption .{For Production
or for Cleaning }
• Absence of on line data
validation .
• Possibility of data
manipulation
Transfer of MLs / Used RM to
SRS ( Solvent Recovery
system)
• No real time measurement
and record of transferred
volume
• Absence of online and
traceable communication
system between the
production Blocks and SRS.
• Losses of transfer is not
accounted for.
• Safety point , as everything is
manual with no online safety
interlock
Operation at SRS
• No control of critical process
parameters
• Lack of consistency in
recovery – no system by
which one can trace reason
for reduction in recovery
percentage
• No system by which Golden
Recovery Cycle can be
standardized.
• Empirical Operation , no
online measurement of quality
Page 7
Dedicated production Suite
Product dissolvable in water
Sample Data Analysis
Actual Total
Mar Feb Jan Dec
Solvent 1 (Fresh) 3203 19219 6406 35235 64064
Solvent 1 (Rec) 325368 276971 225403 227622 1055365
Solvent 1(Total) 328571.4 296190.5 231809.5 262857.1 1119429
Solvent 2 (Fresh) 40083.55 34461.44 36439.59 46156.81 157141
Solvent 2 (Rec) 83130.74 76609.99 50488.98 52414.62 262644
Solvent 2(Total) 123214.3 111071.4 86928.57 98571.43 419786
There is no reliable real time measurement and recording , this
data is derived from the BPR formula.
The recorded data is not correct due to reporting constraints
Page 8
Above data has been collated from the shift sheets of the
respective places.
None of the data matches with each other .
In order to take care of the additional storage capacity data of
four months was collated but still data do not match
Sample Data Analysis
.
MAR Mar Feb Feb Jan Jan Dec Dec
PB - SRS (PB) 203813 70892 179109 62298 228518 79485 253222 112833
PB-SRS (SRS) 238800 91950 217100 64400 325100 105550 311000 98350
SRS-PB (SRS) 243900 44360 208300 33800 329200 60400 294600 55900
SRS-PB (PB) 325368 83131 276971 76610 225403 50489 227622 52415
Solvent -1 Solvent -2 Solvent-1 Solvent-2 Solvent-1 Solvent-2 Solvent-1 Solvent-2
Page 9
Rs 1,75,44,264 worth of solvent are ambiguous.
One document showing batch wise consumption of solvent and
total Solvent reconciliation is not possible.
An consolidated system providing real time data at all three
locations will help immensely in bringing transparency in
solvent consumption
Sample Data Analysis
.
Solvent-1 Solvent-2 Diff Percentage Value Total Value
PB--- > SRS (PB) 864662 325508
-227338 -34742 -26.29217 -10.6733 -12503606 -2084537 Rs. -1,45,88,143.66 PB----> SRS (SRS) 1092000 360250
SRS----> PB (SRS) 1076000 194460
20635 -68184 1.917775 -35.0634 1134939.2 -4091060 Rs. -29,56,120.36 SRS-----> PB (PB) 1055365 262644
Page 10
Perception of Problem
The Solution
Problem
Lack of On- Line measurement systems across the
flow of Solvents in plants
Absence of Rule Based system
Focus on Administrative control rather than System
based control
Absence of Process Control Systems
Evaluate the requirements and come out with
implementation plan
Distinguish between business and process/ production
transactions.
Install on line Flow Meters at all critical points
Implement Best Practices in SRS
Problem or Perception of Problem
We did not received correct quantity of Solvent
Production consumed more quantity or
inconsistency in solvent consumption for same
product
There is lot of pilferage
SRS is not working efficiently
Precise and Accurate on-line measurement
Tracking of all transactions
Consistency in SRS operations
Comprehensive reporting package , which will enable
objective analysis
Page 11
The Solution : Solvent Management System
Journey of Solvent • On-Line Measurement at
receipt section
• Automatic up-dation in SAP
• Elimination of data entry
operations
• Elimination of data entry
• Clear demarcation of usage
of solvent
• On line measurement will
reduce Batch to Batch
inconsistency
• On line quality
measurement
• Implementation of Best
Practices
• Reduction in Manual
intervention
Stores:-
• Measurement of Solvents at
receipt and on line data
updation
• Elimination of inconsistent
data
• On line measurement of Tank
Levels – Quantification of
evaporation loss.
• Reduction in Paper work
Production Blocks:-
• Reduction in Manual Co
ordination
• On Line Measurement and
Batch wise data allocation
• Distinction between cleaning
and production usage.
• Transfer Loss will be visible
• Reduction in possibility of data
manipulation as data and
traceability of actions will be
available on line
Management:-
• On line availability of data
• Ability to compare inter plant
data
• There will be no transaction in
without on line measurement.
• On line indication of SRS
efficiency and recycled solvent
quality
• Reduction in parallel data
recording
SRS:-
• Consistency in operation by
implementation of process
control system
• Implementation of Best
Practices of EC-F is involved
• Reduction in Batch cycle as all
parameters will be controlled.
• Reasons for deviation can be
objectively indentified
• Reduction in Manual efforts
Page 12
The Solution : Solvent Management System
Receipt Subsystem
1. Receipt of solvent in Store
2. Storage of solvent in Tank Farm
3. Communication for transfer of solvent
4. Transfer of solvent from Tank Farm to Production Blocks
Production Block
1. Storage in Day
Tank
2. Usage in
Process
3. Txd to SRP
Production Block
1. Storage in Day
Tank
2. Usage in
Process
3. Txd to SRP
Production Block
1. Storage in Day
Tank
2. Usage in
Process
3. Txd to SRP
Solvent Recovery Subsystem
1. Receipt of solvent from Production Block
2. Solvent Recovery in Batch Mode
3. Storage of Recovered solvent according to QC / QA approval
4. Transfer of solvent from SRP to Proudction Block
1. CPU
2. HMIs
3. IOs
4. SyTech
5. Field Insts
1. CPU
2. HMIs
3. IOs
4. B Data with
Portal
5. Field Insts
Process System
Page 13
The Solution : Solvent Management System : Benefits
Creates transparency across the entire company through seamless Solvent balancing of the receipt ,
recovery and consumer facilities
Allows for a source and consumer related cost allocation and creates a connection to the accounting
system (e.g. ERP system)
Forms key values for substantiated information on increasing efficiency of solvent usage and recovery
Provides planning safety through production-related load and demand forecasts
Recreation of plant structure in accordance with the ERP system
Batch wise ( solvent) tracking & analysis of usage , for Fresh and Recovered solvents
Facility of assigning batch wise costing
Product Batch wise cost assignment
Page 14
Solvent Management – TTD
sustainable Solvent Tracking & Reconciliation
Phases of implementation – Know your location before starting the journey
Creation of
transparency & Costs-by -
cause-based
accounting
SRS Automation &
Cause & effect
documentation of
losses
Process
optimization
Operation
optimization
Installing measuring
points representing the
Solvent flow
Allocating
Solvent costs
to cost centers
Solvent cost per
production unit
Documenting
+
Continuous improvement process
+ =
Implement SRS
Automation
Achieve consistent
SRS operations
Link Batch wise
control
Document the losses
at each stage
Implement
measures to
reduces losses
Optimize SRS
(EC-F)
Minimum
Solvent Loss
Online
visualization of
solvent
consumption
Transparent
cost allocation
to production
Block
Phase 1a Phase 1 b Phase 2 Phase 3