siemens - competence in pharma

Siemens -Competence in Pharma

SPAES EVENT GOA - 2011

11.08.2011

SPAES EVENT GOA 2011 - PHARMA

Agenda – Breakout Session – Pharma – 15.30 till 17.00

SIEMENS IN PHARMA - 15.30 till 16.15Overview of World Pharmaceutical Markets – Siemens Perspective

Global Pharma market overviewUpcoming trends in Global Pharma Market

.Key Challanges for Pharma manufacturing

Most critical aspects in Manufacturing

Global Technology Trends to handle Pharma Challanges

Siemens - Your perfect Technology partner (Siemens solutions, Siemens Setup)

Detals of Siemens Portfolio including latest technology initiatives such as PAT, TRACK & TRACE, Micro Labs, LIMS etcDetails of Siemens Setup

Overview of Global Pharma References.Global Reference

SPAES EVENT GOA 2011 - PHARMA

Agenda

Emerging Technologies – 16.15 till 16.40PATePedigri

Line Intigration

SIEMENS PHARMA – INDIA – 16.40 till 16.50Siemens in Pharma – India ( Setup, competancy)Solutions capability in India, various types of solutions provided including key value add from Siemens side for solution & key references

Q&A Session – 16.50 till 17.00

Pharmaceutical Solutions - Siemens India setup & Competancy

Siemens - Competence in Pharma

Siemens basics pillars for the Pharma approach

Pharmaceutical industry

portfolioportfolioportfolio

sectorknow-how

sectorknow-how

organization


Pharmaceutical industry

SectorKnow-how

Organization Portfolio

STRONG & COMMITTED PHARMA TEAM

Partner to the Pharma industry

Process know-how

Strong “Project Management”capabilities

Experience in Automation of Unit Operations to Full Plant Automation

True Horizontal & Vertical Integration capability

The Team with a strong belief in creating a “Value Add” for customers.

Concept selling with “Manufacturing Challenges” as focal point

Strong “Validation” know-how


The Solutions Group

Business Development

Industry

SOLUTIONS FOR PROCESS AUTOMATION

Project Management

Engineering /

SW Development /

Validation /

Commissioning

Manufacturing

Competence Centre

Germany

Regional

Competence Centre

India

Pharmaceuticals

International Engineering Team


Partner to the Pharma industry - Horizontal integration

SOLUTIONS FOR PHARMA PRIMARY PROCESS AUTOMATION

Automation of Individual Unit Operations

Full Plant Automation

Turnkey Contract – Automation with Field Instrumentation & site erection

Conceptualization of Automation

Sharing of Best Automation Engineering Practices

Building Automation

Clean Room Automation

Security Systems

Fire Safety

Tank Farm Automation

Solvent Transfer system

Solvent Recovery system

Utility Automation

SIP Automation

Centrifuges (CG) & filtering

Layer Separation

Reactor Automation

Single FluidMultiple Fluid

And More….

Primary (Chemical/Biological)

Reaction/Fermentation

Separation Drying/conditioning

Secondary (Formulation)

Formulation Filling PackagingWeighing/Dispensing


Partner to the Pharma industry

Primary (Chemical/Biological)

Reaction/Fermentation

Separation Drying/conditioning

Secondary (Formulation)

Formulation Filling PackagingWeighing/Dispensing

- Horizontal integration

SOLUTIONS FOR PHARMA SECONDARY AUTOMATION

INDIVIDUAL MACHINE AUTOMATION

LINE INTEGRATION

UNIFORM PLATFORM FOR CONTROL


Partner to the Pharma industry - Vertical Integration

AnalyzersValves &Controls

Sensors &Instruments

Safety System

Lowvoltage

Drives &MotorsField devices

Advanced ProcessControl

ControlAccess/BuildingControl

Clean Room

monitoringHVACSCADA

HMIControl Batch

Execution Material Management SchedulingTrackingReporting Asset

managerLIMS(QA)

ProductAnalysis

Historian

Planning Raw Material Management

Long termPlanning &Scheduling

LossPrevention Financials Sales &

DistributionExploration & Appraisal

ProductSpecif.


Pharma Solution capabilities

SIP - “Steam In Place” or “Sterilization In Place”

Steam sterilization-in-place (more commonly known by its acronym as SIP) is coming into wider usage within the pharmaceutical and biotechnology industries as firms endeavor to increase the level of sterility assurance associated with those products made by aseptic processing. Despite this increase in interest, sterilization-in-place has not been given the attention its growing importance appears to warrant.

Four STEPS for SIP:

Vacuum Pulsation

Heating up

Sterilization hold period

Cooling with nitrogen system

Brief


What Do we Do?



Developed a standard Automation Solution for SIPThe Standard software blocks with required Sequences developed.Standard PLC / DCS hardware developedThe Standard field Instrumentation package developed.The standard blocks for simultaneous SIP operations of vessels developed.

Study the requirement of customer ( Number of equipments to be covered etc)Help customer defining the URSCustomize the “ Siemens Standard SIP package” to meet customer’s requirement

(Typically 10-15% customization is required)

Standard “Reporting” package developed.Standardized Validation protocol developed.


Achievements



Ready to implement solution for SIP Automation.

Optimization of time for Conceptualization of SIP Automation.

Flexibility of simultaneous SIP cycles for Vessels.

Sizable reduction in engineering & software development of solution.

Reduced time for “Going Live”

Overall reduced time scale for “Concept to Commissioning”

Completely Automated operations with required Human Machine interface.Flexibility of Phase wise addition of equipment in the system.Reduced Validation efforts.


Details of Solution





Solvent recovery System AutomationBrief

Need of SRP:

Reutilization of used solvent by means of Distillation.

Less wastage of used solvents. Environment Care.

Purification of Solvent.

Major Vessels involved in SRP:

ML (Mother Liquor Tank)

Still Vessel (Jacketed Vessel)

Distillation Column

Reflux Drum

Holdup / Product Vessel

Approved Vessel

Offspec Vessel – Off Specification Vessel

Condensers and Reboilers

Major Processes involved in SRP:

Layer Separation

pH Maintaining for Water insoluble(e.g.Toluene) only

Feed Charging

Total Reflux

Partial Reflux / Product Removal

Offspec Removal

Product Removal

Product Pumping

Offspec Pumping

Residue Draining

CIP (Clean In Process)


What Do we Do?


Developed a standard Automation Solution for SRPAutomation of Complete SRP Lineup.SRP operations for Single product or Multiple products developed.Routing of material through the easy selection process with high level of interlocks.Standardization of Temperature, Flow & Level control block for Columns.Standardization of SRP for recovery of MIXED solvents.Flexibility of Modifications in operation incorporated.Effective MIS reporting developed.

Study the requirement of customer ( Number of equipments to be covered etc)Help customer defining the URSCustomize the “ Siemens Standard SRP package” to meet customer’s requirement (Typically 10-

15% customization is required)

Solvent recovery System Automation


Achievements


Ready to implement solution for SRP Automation.

Faster & effective controls of Level, Flow & Temperature of columns.

Effective control of Level of Reflux Drum, maintaining the flow towards the column.

Faster SRP process due to technical know-how of SRP & standardized solution.

Ease of operations with reduced manual errors.

Improved flexibility of operations with possibility of equipment selection.

Completely Automated operations with required Human Machine interface.




Case Study – “Layer Separation”

Layer Separation:

Layer Separation is basically carried out for the solvents, which are water immiscible. e.g. Solvent “Toluene”.

In case of Production, Toluene gets mixed/reacted with HCL and NaOH as,

Toluene + HCl + NaOH Toluene + H2O + NaCl

(Pure) (Impure)

Toluene Distillation Toluene + Residue

(Impure) (Pure)

As the density of Toluene is less than water so, in ML tank upper layer is the Toluene and bottom layer of water can be easily removed under gravity




Application: Interface level detection and measurement

Lower Layer : Methylene Chloride

Dielectric Constant : 9.82 at 20 Deg.C

Upper Layer : Water

Dielectric Constant : 80.3 at 20 Deg.C

Tank Height : 1770mm

Tank Diameter : 1050mm




Customer had procured an XXXX Guided wave Radar but could not commission it!!

Guided wave Radar can only measure interface if the dielectric constant of upper layer is Less than the dielectric constant of lower layer

Application had higher dielectric constant of upper layer and low dielectric constant of lower layer

This meant that technology selection was not done correctly

XXXX advised the customer to mount the TDR downside up which was impractical.

Customer expected an immediate solution without delaying project schedule




Considering the urgency, Siemens offered an ‘Off the shelf” solution Capacitance level switch model CLS300 from stock

CLS300 was tuned to detect this interface layer. CLS300 is suitable for interface with upper layer of higher dielectric constant

We deputed our expert commissioning Engineer at site for tuning of CLS300

We modified the probe length at site locally to suit tank dimensions

We got the system up and running within 2 days!!

The cost of Siemens solution was 1/3 of the cost of XXX device.



Manufacturing facility

Adobe Acrobat Document


Process Automation Solutions Implemented at



Building Automation Solutions Implemented at


Ranbaxy – Dewas, Mohali, Gurgaon, P’Sahib. Aventis Pharma – Goa, Ankleshwar.

Astra Zeneca – Bangalore. Aurobindo Pharma – Hyderabad.

Emcure Pharma – Pune. Unichem – Pithambpur, Goa.

Dr. Reddy’s Labs – Hyderabad, Baddi Glaxo SmithKline – Mumbai, Nashik.

Plethico Pharma – Indore. Matrix Labs – Nashik, Hyderabad.

Watson – Goa, Ambarnath Eisai Pharma – Vaizag

Ratiopharm – Goa USV Ltd – Chiplun, Mumbai

Helvoet Pharma - Pune


Know-how

Resources

SolutionPlatforms

Integration

Industry specific: regulations (validation, GMP, ...)Process specific (from molecule to production)Engineering specificSystem specific - Batch / DCS / PLC / IT

Products / SystemsSystem Add-On’s

Local & regional resourcesProject ManagementEngineering Validation / QA

Experience in integration technologiesOne-stop shopping


SIEMENS added valueSIEMENS added value

Thank you very much for attention !

Mahesh K. ParkhiSiemens Ltd.I IA SP

Kalwa Works, Thane-Belapur RoadAiroli Node, Navi Mumbai – 400 601

Phone: +91 (22) 3326 5845Cellular: +91 (0) 9820313286

E-Mail: [email protected]

siemens - competence in pharma

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