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Highest product quality thanks to perfect integration of all components
Pharmaceutical Industry
Infrastructure 14
Selected technologies 16
Industrial Identification 26
2
Your challenge is our passion
Pharmaceutical manufacturers are seeking to press ahead quickly in response to competitive and pricing pres-
sures in the pharmaceutical market. Improvements in performance and capability are high on the agenda with
the goals of reducing time-to-market, lowering the cost-base, increasing quality and efficiency and matching
market requirements with a demand-driven supply chain. At the same time, regulatory changes provide signifi-
cant opportunities for improvement and innovation in the production and manufacture of pharmaceuticals.
The competitive environment for pharmaceutical manu- When you partner with Siemens, you get:
facturing is more intensive than ever. Wider scientific and • A product portfolio for key process steps in the
demographic trends are also shaping the future direction value chain
of production. We are not far from a time when pharma- • Solutions to improve productivity, quality and
ceutical manufacturing will need to prepare for an era of supply challenges
personalized medicines. At the same time, the patient • Fewer different components – simplifying spare parts
population is living longer with a consequent impact on inventory and ensuring highly efficient maintenance
demand and the creation of additional pricing pressures. • The assurance of a leading global brand delivering
Pharmaceutical production is preparing for a future that leading-edge automation technology
will see new flexible manufacturing strategies being de- • People who understand your industry needs and can
ployed alongside high-volume output. configure solutions to match your operating conditions
3
Your partner for precision
Precision and accuracy are vital in pharmaceutical manufacturing. Patient safety and regulatory compliance
are critical. Companies need to enjoy complete trust and confidence, knowing that their process instrumentation
Whatever part of the industry you focus on, whether you The Siemens approach:
are a manufacturer of biological or chemical active phar- • Emphasis on user-friendly products – for safer
maceutical ingredients (APIs) or are engaged in dosage operation
vector manufacturing, you can be assured that Siemens • High degree of product safety – through maximum
quality and product know-how will help you meet your process transparency
business and customer goals: • Optimal resource efficiency – through innovative
platform concepts
Product life cycle planning
• Flexibility – for faster and safer manufacturing
You need a partner who can meet your needs throughout
changeover
the entire life cycle of your product, whether by hastening
• Increased productivity – with optimal solutions
the drug from trials into full-scale market production or by
for the operating phase
helping you to achieve manufacturing excellence and
while maintaining a competitive cost-base. Customer benefits:
• Fast commissioning, short ramp-up times
Optimal asset valuation
• Low total cost of ownership (TCO)
The diagnostic capabilities of our instrumentation solu-
• Quick return on investment
tions, in combination with evaluation and MES systems,
• Continual improvement through innovative service
provide you with the information you need to leverage
and support concepts
maximum productivity from your manufacturing assets.
• Traceability to ensure manufacturing quality through
You are able to plan effectively for any production
completely integrated production
changes and maintenance.
• Maximum compatibility and innovation assuring your
Pharma knowledge confidence in the future
Our products and knowledge of the industry can help you
stay at the forefront of the pharmaceutical industry with
respect to regulatory compliance and your competitive
edge. We appreciate, for example, that process analytical
technology (PAT) is much more than just sensing and
includes both design and production. Similarly, we offer
extensive experience of compliance with the require-
ments of 21 CFR Part 11.
4
Level
Flow
Pressure
Temperature
Positioning
Weighing
Process protection
Gas analytics
Gas chromatography
CGA
In-situ
Liquid analytics
Identification
Software
5
Chemical Active
Pharmaceutical PREPARATION
safety.
TANK FARM
6
Chemical APIs Biological APIs Pharmaceutical manufacturing (solids) Pharmaceutical manufacturing (liquids) Infrastructure
Heating / Heating /
Cooling Cooling
SYNTHESIS REACTION
Condenser
Feeder
Feeder vessel vessel
Granulator
Reaction
Cooler
vessel
Wet
sieve
Heating / Heating / Heating / Vacuum
Cooling Cooling Cooling Dryer
Centrifuge
Heating / Cooling
Dry
sieve
Vacuum
Bunker
Heating /
Dryer
Cooling
7
Biological Active Pharmaceutical
Ingredients (Bio APIs)
Much of the future of the pharmaceutical industry belongs to biotechnologically manufactured active ingredi-
ents. As a rule, Bio APIs are very expensive products with high temperature and shearing sensitivity. They are
also sensitive to pH, pressure, contaminants and the accumulation of waster material, all of which requires a
complex concentration and separation process. Fermentation lies at the heart of the production process for
these substances. The challenge is to create the right grouping of conducive materials, buffers and air / gases
that facilitate the optimum environment for the growth and production of cultures.
The product is harvested and cleaned after fermentation, poses considerable challenges. The requisite investment
rendering it usable as a Bio API at a later stage. The proce- in plants and equipment is considerable. Precise control
dure demands high requirements on hygiene and repro- and measurement of the fermentation and downstream
ducibility. The subsequent downstream process, wherein processes is essential in securing increased reproducibility
the desired molecules are separated and purified, also and uniform consistency.
8
Chemical APIs Biological APIs Pharmaceutical manufacturing (solids) Pharmaceutical manufacturing (liquids) Infrastructure
Inoculate cabin
Clean room
Filter
Separator
SEPARATION / HARVEST
Mixing /
Harvesting Collecting vessel
vessel
Heating /
Cooling
Additives
Cell disruption
Heating / Extracellular
Cooling
Intracellular
Heating /
Cooling
PURIFICATION
Feeder vessels Feeder vessels Freeze dryer
Capture Purification
chromatography chromatography
Pulsation Pulsation Micro-
damper damper filtration
Filter Filter
Heat exchanger
Heat exchanger
Liquid Dried
product product
Secondary manufacturing
Heating / Heating /
Cooling Cooling
9
Pharmaceutical
manufacturing (solids)
Active Pharmaceutical Ingredients (APIs) must be formulated in such a way that the patient receives the
prescribed dosage. Products are manufactured in a variety of different vectors: tablets, capsules, solutions,
suspensions, emulsions, gels, creams (oil-in-water emulsions), ointments (water-in-oil emulsions) and aerosols
10
Chemical APIs Biological APIs Pharmaceutical manufacturing (solids) Pharmaceutical manufacturing (liquids) Infrastructure
Wet
FINISHING sieve PREPARATION &
Granulator FORMULATION
Dryer Dryer
Pelletizing
Air
Air
DISPENSING
Dry
Blending sieve
Tablet
pressing Preliminary products
and binder
Coater
Capsule
filling
Washing machine
PACKAGING Blister
machine
Dosing
Counter
machine
Stretch-banding machine
Loading / Transportation
11
Pharmaceutical
manufacturing (liquids) PREPARATION & FORMULATION
DISPENSING
Liquids
Liquid mixing and liquid blending are two of the most
complicated pharmaceutical manufacturing unit opera-
tions. The blending of dissimilar fluids, such as oil and SYRINGE &
water, or the incorporation of solids into the liquid manu- DELIVERY DEVICE:
Preparation vessel
facturing process makes liquid mixing and liquid blending
VIAL & AMPOULE:
a processing challenge. Siemens equipment, underpinned Formulation vessel
by technical knowledge, provides exact monitoring of CREAM & OINTMENT:
your process, thus ensuring consistent product quality. Water phase vessel
SYRUPE:
Sugar melting vessel
Heating / Cooling
Transfer
pump
Filter
Final
sterile
filter
SYRINGE &
DELIVERY DEVICE:
Holding vessel
VIAL & AMPOULE:
Collecting vessel
CREAM & OINTMENT:
Wax phase vessel
SYRUPE:
Manufacturing vessel
Heating / Cooling
Transfer
pump
Chemical APIs Biological APIs Pharmaceutical manufacturing (solids) Pharmaceutical manufacturing (liquids) Infrastructure
Washing Sterilization
machine tunnel Inspection Ampoule closing
VIAL AMPOULE
Leak
Freeze drying Sealing testing
Stretch-banding
machine
Port washing Labeler
SYRINGE FINISHING
Assembly Filling Blister machine
Terminal Anti-counter-
sterilization Plunger rod feiting system
Stoppering (optional) Inspection Labeling assembly assembly
Loading / Transportation
13
Infrastructure
STORAGE
Utilities are indispensable to efficient pharmaceutical POWDERY INGREDIENTS
important resource.
PACKAGE UNITS
HEATING / COOLING UNIT
At the end of the production process, wastewater and flue
gases are generated, especially in the manufacture of
APIs. Emissions can be minimized in production but may
not be entirely avoidable. Therefore, the remaining off- Heating
Cooling
CIP / SIP
Hea-
ting / Cooling
Level Flow
14
Chemical APIs Biological APIs Pharmaceutical manufacturing (solids) Pharmaceutical manufacturing (liquids) Infrastructure
UTILITIES
SOLVENT RECOVERY EXHAUST AIR PROCESSING Quencher H2O scrubber NaOH scrubber
Condensate
tank Waste water
Supply Exhaust gas
treatment
Slag
removal
Heat
product
PURE STEAM WASTE WATER TREATMENT
Heating Pre-
steam clarification
Condensate Waste
Pure water
steam
Slurry
Heating
Module II
COMPENDIAL
WATER Disinfection / de-
ION contamination
EXCHANGER
Filter Residual
Post-clarification
Carbonate ion
removal exchanger
Ash removal
Heating WFI
Kiln
Slag removal
Bunker
15
Pressure
Precise measurement combined with hygienic design
16
Pressure Temperature Valve positioning Weighing Software
Temperature
Siemens offers many differently designed resistance
17
Valve positioning
Nearly all pharmaceutical processes in primary produc-
18
Pressure Temperature Valve positioning Weighing Software
Weighing
Weighing and proportioning is a central aspect of suc-
years – worldwide.
19
Pressure Temperature Valve positioning Weighing Software
Software
With different communication protocols and the
20
Process Instrumentation
and Analytics product range
Siemens offers the most comprehensive product range for the pharmaceutical industry and has a solution
Flow
measurement
Pressure Temperature
Weighing
measurement measurement
21
Level
measurement
Radar
SITRANS LR200 and SITRANS LR250 offer continuous SITRANS LR260 and SITRANS LR560 offer 2-wire, guided wave radar transmitter for
monitoring of liquids and slurries in storage / process continuous monitoring of solids for a variety short- to medium-range level, level / interface,
vessels. SITRANS LR250 is available with fully resistive of silos or storage bins. and volume measurement of liquids and
PVDF antenna design for use in sanitary environments. solids.
Remote monitoring
Positioning Process Protection
and displays
Positioner for linear and rotary actu- Most MFA 4p motion sensing probes SITRANS AS100 detects changes in SITRANS RD100 / 200 are remote
ators. Particularly flexible stroke as well as the Millpulse 600 can be high-frequency sound waves result- displays for process instrumentation.
range, intelligent diagnostics and mounted up to 100 mm (4”) from the ing from particle impacts on equip- SITRANS RD500 provides integrated
communicates either via HART, ferrous target, reducing the chance ment. In combination with SITRANS web access, alarm event handling,
PROFIBUS PA or Foundation Fieldbus. of damage to the probe and the CU02 alarm control unit, it detects and data capture.
equipment. SITRANS WM100 zero- and reacts instantly to changes in
speed alarm switch provides equip- solids flow.
ment protection even in harsh
conditions.
22
Process Instrumentation and Analytics product range
Process Analytics
23
Totally Integrated Automation
ERP – Enterprise Resource Planning
TIA Portal
Control Level
Field Level
PROFIBUS PA
Totally HART
Integrated
Automation
IO-Link
Products from the controller level to the field level Totally Integrated Automation integrates not only the pro-
With Totally Integrated Automation (TIA), Siemens is the duction process but all parts of the company – from the
only provider of an end-to-end integrated portfolio of field level to the management level. The result: a perfectly
products and systems for the automation of the entire coordinated overall concept that enables higher
production workflow. From the goods receiving area to productivity.
the finished goods warehouse.
Totally Integrated Automation reduces the complexity of
the automation solution and enables what really counts:
the practical combination of optimally coordinated indi-
vidual components – without interface problems.
24
Totally Integrated Automation Industrial Identification Services and support
Plant Engineering
COMOS
Ethernet
Industrial Ethernet
PROFINET
Industrial Ethernet
PROFIBUS
SIMATIC Distributed I / O SINAMICS Drive Systems Low-Voltage Distribution AS-Interface
Totally
Integrated
Power
SIMOTICS Motors
25
Industrial Identification
Today, efficient tracking and tracing plays an increasingly important role in all industries. Legal requirements
and rising demands for process quality have made full traceability with the perfect identification system virtual-
ly indispensable. The best answer for addressing this challenge: SIMATIC Ident, our comprehensive industrial
identification portfolio, which offers complete documented histories of products, components and systems. With
industrial identification, each product leaves a digital trace that can be traced and documented all the way back
Industrial Ethernet
PROFINET/
Industrial Ethernet Industrial Ethernet
PROFIBUS RS232/RS422
Acquisition level
RF620A ANT 18
SCALANCE
X108PoE
IO-Link
ASM MV420 RF180C/
Reader 456/ RF182C
RF160C (TCP/IP)
RF220R RF340R RF350R RF210R MV440 RF240R
RF630R RF640R
26
Totally Integrated Automation Industrial Identification Services and support
Our services range from consulting and engineering, Service around the clock
connection to the control system and comprehensive Our online support system offers rapid, comprehensive
after-sales services: assistance regardless of time or location. From product
support to service information, the online support of
• System and schedule planning
Siemens Industry Automation and Drive Technologies is
• Complete design planning and engineering of
your first choice – around the clock, 365 days a year.
the field devices
• Consultation on the selection of process instruments
www.siemens.com / automation / service&support
and analytics
• System documentation
• Installation, testing and commissioning
• Comprehensive after-sales service
Service around the world
Plants must function reliably around the clock. Efficient
and effective process instrumentation and analytics are an
indispensable prerequisite to this end. You also need to be
certain of fast and competent service from your supplier.
Siemens is a global company that reacts locally. Whether
you require consulting, quick delivery or installation of
new devices, the Siemens network of specialists is avail-
able to you around the world, whatever your location.
27
More information:
www.siemens.com / sensors / pharma
Siemens AG Subject to change without prior notice 06 / 12 The information provided in this brochure contains merely
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in case of actual use do not always apply as described or which
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