pa masterplan 2015 - old.aia-india.org

Confidential / © Siemens AG 2011. All rights reserved

Bringing Transparency in API operations

Indian Pharmaceutical Plants

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


An Entrepreneurs’ View

Plant Land

Infrastructure

Regulatory

Staffing

Raw Material ...

Solvents ... API

Systems

Equipment Black Box


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


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 .

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


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)


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

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

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


.

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

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


.

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

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

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

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

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

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

pa masterplan 2015 - old.aia-india.org

Documents