Water management for the Pharmaceutical Industry

2E200- Version 001 Date 22.03.2012

Water in its purest form

Water is the most important natural resource worldwide. Water, treated to drinking water quality, is the number one foodstuff. Water is also the basic carrier for pharmaceutical processes and products.

Water is our core competence

Being a leading manufacturer, we develop and produce systems for process and ultrapure water treatment, waste water treatment, and water and resource recovery. We implement for you:

Raw water pretreatment Production, storage and distribution of PW, HPW, WFI and pure steam Loop systems Process plants Waste water treatment Automation systems Qualification and documentation in accordance with cGMP

We provide pragmatic solutions for pharmaceutical applications, both as standard compact systems which operate reliably thanks to their perfected and innovative technology, and as individual systems offering standardised processes of the highest quality combined flexibly according to market- and customer-specific requirements.

Satisfying customer requests

As a dependable partner, we support our customers throughout the lifecycle of their plants, from consulting and basic engineering, construction of the system, delivery and installation on the site, commissioning, qualification, through to after-sales service. SH + E Group services create trust and give safety assurances. You can choose from demand-oriented after-sales service through to full service offerings, including spare parts and chemicals management. Analyses carried out in our in-house laboratory are also part of our range of services, in addition to servicing, maintenance and calibration. We develop forward-looking concepts according to the latest state of the art for you which:

Minimise the water requirement Increase the availability Improve the water quality Conserve energy Cut costs

Take us by our word

Requirements / Guidelines
For the production of water for pharmaceutical applications, the pharmacopoeias require water of drinking water quality as the basic material. In addition, our plant design is based on the following standard conditions:

Drinking Water Conductivity Total Hardness Iron Manganese Silica SiO2 Total Organic Carbon TOC Silt Density Index SDI 15 Others

acc. to TrinkwV 2001 < 1,000 S/cm < 20 dH < 0.05 ppm < 0.05 ppm < 20 ppm < 2 ppm < 3 free of oxidantes

Should the raw water not meet these conditions, additional raw water treatment stages may be necessary.

Pharma water qualities

The different pharma water qualities are defined in the pharmacopoeias: European Pharmacopoeia (EP) Purified Water ( Aqua purificata) Highly Purified Water (Aqua valde purificata) Water for Injection ( Aqua ad iniectabile) United States Pharmacopeia (USP) Purified Water (PW) Water for Injection (WFI)

Purified Water (PW, Aqua Purificata - AP) is water for the preparation of medicines other than those
that are required to be both sterile and apyrogenic, unless otherwise justified and authorised.

Water for Injection (WFI) is water for the preparation of medicines for parenteral administration
when water is used as vehicle (water for injection in bulk) and for dissolving or diluting of substances or preparations for parenteral administration (sterilised water for injection).

Highly Purified Water (HPW) is intended for the use in the preparation of the medicinal products
where water of high biological quality is needed, except where Water for Injection is required.

Requirements / Guidelines

The quality of pharma water for the production of drugs and active agents is defined in the United States, European and other country-specific pharmacopoeias:

Purified Water (PW) Production process Electr. conductivity TOC Nitrate Heavy metals Colony-forming units Water for Injection (WFI) Production process Electr. conductivity TOC Nitrate Heavy metals Colony-forming units Bacterial endotoxins Highly Purified Water (HPW) Production process Quality

European Pharmacopeia Ion exchange, membrane process 4.3 S/cm (20 C) 500 ppb 0.2 ppm 0.1 ppm 100 CFU/ml

US Pharmacopeia Ion exchange, membrane process 1.1 S/cm (20 C) downstream of Stage 1 500 ppb 100 CFU/ml

Distillation 1.1 S/cm (20 C) 500 ppb 0.2 ppm 0.1 ppm 10 CFU/ 100 ml 0.25 EU/ml

Distillation or membrane process 1.1 S/cm (20 C) < 500 ppb 0.25 EU/ml

membrane process same as WFI

Requirements / Guidelines
Guidelines for the design and implementation of a pharma water treatment plant:

Water qualities /
analysis methods

USP (current version) European Pharmacopoeia (EP current version) Guide to Inspection of High-Purity Water Systems 21 CFR 210/211, 21 CFR Part 11, 21 CFR 177 Annex 15 to the EU Guide to
Good Manufacturing Practice

FDA regulations

European Commission (EG)

PIC/S

Guide to Good Manufacturing Practice for

Medicinal Products

GAMP ISPE Baselines

Guide for Validation of Automated Systems

Pharmaceutical Engineering Guides.

Volume 4 Water and Steam Systems

Company-specific instructions

Pharma water is produced by the following steps:

Highly Purified Water

Removal of Pyrogens Distillation Ultrafiltration

Water for Injection

Only USP and JP

Purified Water (Aqua Purificata)

Demineralisation / Reduction of TOC Electro-deionisation Reverse Osmosis Ion-exchange

Pure Steam

Drinking water

Raw water pretreatment

Water treatment plants have to be protected against problematic components in the raw water to ensure dependable operation. These include iron, manganese, free chlorine, organic material or colloidal suspended solids. These substances can cause malfunctions and have therefore to be eliminated from the raw water. Different processes are used, depending on the raw water quality:

Raw water ultrafiltration Sand or gravel filters Multimedia filters Activated carbon filters UV oxidation / UV sterilisation Chemicals dosing stations

A careful analysis of the existing raw water quality is crucial. Experienced staff determine the optimum process steps on the basis of the available data. Dependability, cost effectiveness and operator convenience are the focus of our designs.

Raw water pretreatment

The ULTRALIS ultrafiltration plant effectively eliminates colloidal matters (e.g. corrosion products). Unlike conventional multimedia filters, the ultrafiltration plant also retains bacteria, endotoxins and colloidal silica. The silt density index SDI15 of the raw water is reduced to less than 3, and the bacterial count in the treated raw water is reduced by a factor of 1000. Our ULTRALIS is operated by the deadend process, i.e. the entire raw water fed in is filtered through the membrane. The UF membrane is backwashed and sterilised automatically, adapted to the respective raw water conditions.

Drinking water

Redox

QISA

PI

PI

Waste
P

Backwash filter

Pipe separator

To PW generation

PISA

FISA PI PI

FSA LIS PISA LISA

NaOCl Dosing station UF Moduls

Backwash pump

Filtrate pump

Filtrate tank

Skid

Advantages

Optimum pretreatment for the downstream ROCEDIS Reduction of the silt density index SDI Reduction of bacteria Reduction of nutrients (TOC) Modular design, easy to upgrade

Raw water pretreatment

ULTRALIS is delivered as a compact plant, preassembled on a rack, comprising:

Input control valve to set a constant filtrate flow Connection for an SDI meter Backwash-type 100 m protective filter Ultrafiltration modules as hollow-fibre modules with a separation limit of 100,000 MW (molecular weight) Low-noise centrifugal pumps of stainless steel/grey cast iron for operation and backwashing Filtrate tank as a PE circular tank to hold the backwashing water, designed with a sloping bottom, spray ball and inspection opening Dosing station for NaOCl Flow meters for filtrate, backwashing water and chemical Pressure gauges for filtrate and concentrate Piping of PVC Rack of stainless steel with level elements Autonomous switch cabinet with own control system via Siemens SPS S7-ET200S

Series

ULTRALIS Capacity (filtrate) Filter area Capacity of backwash pump at 2.5 bar Capacity of filtrate pump at 5 bar Volume of filtrate tank Mechanical connections Raw water Filtrate Back-flushing / waste water Electrical connections Backwsh pump Filtrate pump Dimensions of UF Skid Width Depth Height Dimensions of filtrate tank Diameter Total height approx. Weight without tank Net weight approx. kg mm mm mm mm mm kW kW DN DN DN m/h m m/h m/h m

2000 2.0 30 10 3 1.1 25 20 40 1.1 0.8 2,500 1,500 2,100 1,400 1,800 800

4000 4.0 50 15 5 3 32 25 50 2.2 1.5 2,500 1,500 2,100 1,400 2,400 1,000

8000 8.0 100 30 10 6 40 32 80 4.0 2.2 2,900 2,100 2,000 1,800 2,800 1,200

12000 12.0 150 45 15 9 50 40 100 5.0 4 2,900 2,100 2,200 2,000 3,400 1,500

Softening
Softeners are an elementary process component of a water treatment plant for the production of highly purified water in accordance with USP/EP. The perfect and reliable functioning of the downstream membrane processes such as reverse osmosis and electrodeionisation can only be ensured by the complete elimination of the hardness components Calcium and Magnesium contained in the raw water. We offer two alternative designs:

PHARMASOFT
a volume-controlled softener with central control valve and concurrent regeneration

ECOSOFT
a volume-controlled softener with single valve control and salt- and water-conserving countercurrent regeneration The advantages our softeners offer are the fail-safe and cost-effective operation. The connection in series provides a reliable protection against hardness breakthroughs. Additionally, hardness breakthroughs are detected by a residual hardness meter (optional). Short regeneration cycles, high flow rates and continuous flow through the resin beds result in a reduction of the microbial growth potential in standard operation. The microbiology in the resin bed is controlled by regular automatic sanitisations with chemicals, hot water (80 or hot brine (60 C) C). Our PHARMASOFT has been designed as an automatic duplex softener with concurrent regeneration. The start of the automatic regeneration cycle is volume-controlled by a water meter. The unit is chemically sanitised.

Drinking water

PI

PI
dH

QISA

To ROCEDIS

FQS

Protection filter

Pipe separator

NaCl

Softener 1

Softener 2

Skid

Brine tank 1

Brine tank 2

With the PHARMASOFT TS, the microbiology in the resin beds is effectively destroyed periodically by sanitisation with hot water. The sanitisation interval can be shortened or extended as required. Sanitisation with hot water is carried out via the electric heater or steam-heated heat exchanger of the downstream ROCEDIS. The exchange resin tanks and the piping of the PHARMASOFT TS are made of 316L stainless steel.

NaCl

Softening
Like all our softeners the PHARMASOFT is also delivered as a compact plant on a stainless steel rack, preassembled and wired:

Raw water protective filter, 100 m Pipe separator Two exchange vessels of FRP Option: Exchange vessels of 316L stainless steel for thermal sanitisation Two central control valves for the 5-stage regeneration process Two fillings of high-performance ion exchange resin Two brine preparation tanks of PE with the necessary internals Equipment for chemical sanitisation Option: Equipment for thermal sanitisation with hot water (> 80 C) Water flow meter with contact Option: Residual hardness measurement TESTOMAT 2000 Piping of PP or 316L stainless steel Rack of stainless steel with level elements Control via common switch cabinet of ROCEDIS

PHARMASOFT (TS) Softwater Feed (max.) Capacity Salt demand Waste Mechanical connections Feed Soft water Dimensions incl. Brine tank Width Depth Height Volume of each brine tank Weight Net weight PHARMASOFT approx. Net weight PHARMASOFT TS approx. kg kg mm mm mm Liter DN DN l/h l/h dH kg/ Reg. l/ Reg.

200 750 1,100 105 7 190 25 25 1,500 800 2,000 200 300 450

300 2,250 3,200 260 17 500 25 25 1,500 800 2,300 200 350 500

400 4,500 6,100 560 36 900 40 40 1,500 1,000 2,300 400 350 500

500 7,400 11,300 850 56 1,600 50 50 2,000 1,200 2,400 750 400 550

600 8,800 15,200 1,180 77 2,000 50 50 2,500 1,500 2,400 750 400 550

700 11,800 24,600 1,550 101 3,800 50 50 2,500 1,700 2,400 1,000 450 650

Softening
ECOSOFT is a volume- and water consumption-controlled softener which features a very low specific salt consumption that is achieved by state-of-the-art countercurrent regeneration. Compared to the conventional concurrent technology, the salt and water consumption is about 30% lower.

With the ECOSOFT TS, the microbiology in the resin beds is effectively destroyed and removed periodically through sanitisation with hot brine (>60 developed by C), SH + E Group. The sanitisation process is carried out automatically at short intervals without having to interrupt pharma water production. The sanitisation interval can be shortened or extended as required.

FI

PI

Drinking water

PI

PI FQS
TICSA

P
FI FI

Protection Pipe filter separator

FI PI

LS

Heater NaCl Brine tank

dH

PI

QISA

To ROCEDIS

Softener 1

Softener 2

TISA

Skid

Softening

Low salt and water consumption thanks to state-of-the-art countercurrent technology Automatic start of the sanitisation cycle after every xth regeneration High sanitisation effect as a result of the combination of high temperature (> 60 and brine C) treatment PW production not interrupted during sanitisation of a softener column No corrosion problem thanks to the design of plastic material (maximum temperature 65 C)

The ECOSOFT TS softener is delivered as a compact unit, preassembled and wired:

Raw water protective filter, 100 m Pipe separator Two exchange vessels of FRP Pneumatic diaphragm valves of PP Two fillings of high-performance ion exchange resin One brine preparation tank of PE with the required internals Equipment for chemical sanitisation Electric heater or steam-heated plate heat exchanger for thermal sanitisation with hot brine (> 60 C) Contact-type water meter Option: Residual hardness measurement TESTOMAT 2000 Piping of PP Rack of stainless steel with level elements Autonomous switch cabinet with own control system via SPS Siemens S7-ET200S

ECOSOFT (TS) Softwater Feed (max.) Capacity Salt demand Waste Mechanical connections Feed Soft water Thermal Sanitisation for ECOSOFT TS Electr. Heater Steam-heated heat exchanger Steam demand (120 @ 2 bar) C Dimensions incl. Brine tank Width Depth Height Volume of brine tank Weight Net weight approx. kg mm mm mm l kW kW kg/h DN DN l/h l/h dH*m kg/ Reg. l

300 2,250 3,300 200 8 400 25 25 25

400 4,400 6,100 450 16 800 32 32

500 8,000 11,300 820 29 1,400 50 40

600 10,900 15,200 1,170 42 2,000 65 50

700 15,000 22,000 1,840 66 3,100 65 50

900 25,400 35,600 2,600 93 4,500 80 65

30 55 2,900 1,200 2,300 200 350 2,900 1,200 2,500 200 400

60 100 2,900 1,250 2,500 300 400

80 140 3,050 1,400 2,750 400 450

130 225 3,050 1,500 2,750 500 500

200 310 3,550 1,900 3,000 1,000 600

PW and HPW generation

Purified Water (PW) is produced from softened water by a combination of a reverse osmosis and electro-deionisation (ROCEDIS) process. The major part of demineralisation is provided by reverse osmosis (RO), where water components such as salts, TOC, particles, bacteria and pyrogens are retained on the surface of a semi-permeable membrane. Electro-deionisation (CEDI) is an electrochemical membrane process which demineralises the reverse osmosis permeate continuously to a very low conductivity of the highly purified water. The values remain significantly below those required by the pharmacopoeias. Depending on the composition of the raw water, a chemicals-free membrane degasifier is added to the ROCEDIS to remove the free carbon dioxide. For the production of Highly Purified Water (HPW), an ultrafiltration unit is connected downstream of the ROCEDIS. Ultrafiltration serves as the last process step for the safe removal of bacteria and pyrogens. An excellent microbiological water quality is achieved as a result of the integral structural design and the separation efficiency of 6000 MW.

Constantly high HPW quality according to USP / EP Reduction of bacteria and pyrogens Chemicals-free operation High water yield Comfortable sampling by means of a sampling panel Compact, little space required Easy to add on thanks to the modular design

PW and HPW generation

You can choose between different cGMP-compliant alternatives:

ROCEDIS PW-PP Generation of PW, basic material PP plastic, piping coming into contact with the product of 316L stainless steel, chemically sanitisable ROCEDIS PW-SS Generation of PW, fully made of 316L stainless steel, chemically sanitisable ROCEDIS PW-TS Generation of PW, fully made of 316L stainless steel, thermally sanitisable ROCEDIS HPW-TS Generation of HPW, fully made of 316L stainless steel, with UF connected downstream, thermally sanitisable

The ROCEDIS is delivered as a compact unit in FDA/GMP-compliant pharma design, ready for connection, preassembled and wired:

Protective filter, 5 m Automatic valve in the inlet for safety shutdown Control valve or pressure reducer for maintaining a constant feed pressure Low-noise high-pressure pump of 316 stainless steel, with attached frequency converter RO pressure pipes of FRP or 316L Membrane elements of energy-conserving ultralow pressure design Option: Membrane degasifier for CO2 removal EDI stacks of pressure-resistant, leak-free pharma design Option: EDI stack of hot-water resistant design Option: Downstream ultrafiltration unit for HPW production Pharma safety valve to protect the EDI from pressure surges Sterile sampling after each process step High-quality conductivity meters downstream of RO and EDI (Mettler) Pressure and temperature transmitters for determination of the pressure and temperature conditions System piping of PP plastic or stainless steel Pipes coming into contact with the product from the outlet of the RO or EDI of 316L, Ra 0.8 m Option: Pipes coming into contact with the product after the last process step of 316L, e-polished (Ra 0.6 m) and ferrite content <1% / <3% Discard circuit quality-controlled for secure HPW output Autonomous switch cabinet with own control system via Siemens SPS S7-ET200S Touch panel Siemens MP377, 15

The ROCEDIS.eco concept enables a maximum water yield (WCF) through the entire process chain with unlimited availability. The patented SB Plus and recycling concept not only saves drinking water, but also reduces the salt requirement of the upstream softener.

PW generation
Our cost-effective basic model ROCEDIS PW-PP for PW generation:

Piping of PP Pipes coming into contact with the product from the EDI outlet of 316L Chemical sanitisation via a dosing pump Low capital costs

PP
Air

316L

From Softener
PI

PI PS-

PI

TI
S/cm

TI
S/cm

FU

PS+

FICSA

QISA

PISA

PI

PISA

QISA

To Storage tank

Prefilter 5 m

RO High pressure pump

Reverse Osmosis
FI

PI FI

Membrane degasifier (Option)

PI P P

EDI

FISA FISA

LIS

Dosing pump for chemical sanitisation

PI

Skid

ROCEDIS PW-PP Product capacity (PW) Soft water feed Softening Mechanical connections Soft water (flange DIN EN 1092-1) Product (clamp nozzle DIN 32676) Waste water (pipe end, HT-PP) Electrical connection Electr. connection of system Dimensions of Skid Width Depth Height Weight Net weight approx. ROCEDIS PW-PP Product capacity (PW) Soft water feed Softening Mechanical connections Soft water (flange DIN EN 1092-1) Product (clamp nozzle DIN 32676) Waste water (pipe end, HT-PP) Electrical connection Electr. connection of system Dimensions of Skid Width Depth Height Weight Net weight approx. kg mm mm mm kW DN DN DN l/h l/h l/h kg mm mm mm kW DN DN DN l/h l/h

500 500 700

1000 1,000 1,400 integrated 25 15 100 6 2,800 1,300 2,300 900

1500 1,500 2,100

2000 2,000 2,800

3000 3,000 4,200 separate rack 40 25 100 12 2,800 1,300 2,300 1,200

4000 4,000 5,500

6000 6,0 7,8

8000 8,0 10,3

10000 10,0 12,9

12000 12,0 15,5

separate rack 50 40 100 18 2.800 1.600 2.300 1.500

separate rack 50 40 100 24 3.800 2.000 2.300 1.800 1.900

PW Generation
Our ROCEDIS PW-SS/TS for demanding applications:

Piping completely of 316L stainless steel Chemical sanitisation Option: Thermal sanitisation by means of an electric continuous-flow heater or steam-heated heat exchanger

Air

From Softener
PI

PI PS-

PI

TI
S/cm

TI
S/cm

FU

PS+

FICSA

QISA

PISA

PI

PISA

QISA

To Storage tank

Prefilter 5 m

RO High pressure pump

Reverse Osmosis
FI

PI FI

Membrane degasser (Option)

PI P P

EDI

FISA FISA PI

LIS

Chemical Sanitisation

Skid

ROCEDIS PW-SS/TS Product capacity (PW) Soft water feed Softening Mechanical connections Soft water (flange DIN EN 1092-1) Product (clamp nozzle DIN 32676) Waste water Electrical connection Electr. connection of system Thermal Sanitisation Electrical heater Dimensions Width Depth Height Weight Net weight approx. ROCEDIS PW-SS/TS Product capacity (PW) Soft water feed Softening Mechanical connections Soft water (flange DIN EN 1092-1) Product (clamp nozzle DIN 32676) Waste water Electrical connection Electr. connection of system Thermal Sanitisation Steam-heated heat exchanger Steam demand (2 bar, 120C) Dimensions Width Depth Height Weight Net weight approx. kg mm mm mm kW kW kW DN DN DN l/h l/h l/h kg mm mm mm kW kW DN DN DN l/h l/h

500 500 700

1000 1,000 1,400 integrated 25 15 100 6

1500 1,500 2,100

2000 2,000 2,800

3000 3,000 4,200 separate rack 40 25 100 12

4000 4,000 5,500

10

15 2,800 1,300 2,300 1,000

20

20

30 2,800 1,300 2,300 1,400

40

6000 6,000 7,800

8000 8,000 10,300

10000 10,000 12,900

12000 12,000 15,500

separate rack 50 40 100 18 70 130 2,800 1,600 2,300 1,700 100 180

separate rack 50 40 100 24 120 220 3,800 2,000 2,300 2,100 2,200 140 250

HPW generation
Our ROCEDIS HPW-TS meets the highest requirements for the production of HPW according to EP or of WFI according to USP:

Piping completely of 316L stainless steel Thermal sanitisation by means of an electric continuous-flow heater or steam-heated heat exchanger Final ultrafiltration to reduce bacteria and pyrogens

Air

From Softener
PI

PI PS-

PI

TI
S/cm

TI
S/cm

FU

PS+

TIC

FICSA

QISA

PISA

PI

PISA

QISA

To Storage tank

Prefilter 5 m

Pump

Heater

Reverse Osmosis
FI

PI FI

Membrane degasser (Option)

PI P P

EDI

FISA FISA PI

Skid

ROCEDIS HPW-TS Product capacity (PW) Soft water feed Softening Mechanical connections Soft water (flange DIN EN 1092-1) Product (clamp nozzle DIN 32676) Waste water Electrical connection Electr. connection of system Thermal Sanitisation Electrical heater Dimensions Width Depth Height Weight Net weight approx. ROCEDIS HPW-TS Product capacity (PW) Soft water feed Softening Mechanical connections Soft water (flange DIN EN 1092-1) Product (clamp nozzle DIN 32676) Waste water Electrical connection Electr. connection of system Thermal Sanitisation Steam-heated heat exchanger Steam demand (2 bar, 120C) Dimensions Width Depth Height Weight Net weight approx. kg mm mm mm kW kW kW DN DN DN l/h l/h l/h kg mm mm mm kW kW DN DN DN l/h l/h

500 470 700

1000 950 1,400 integrated 25 15 100 6

1500 1,420 2,100

2000 1,900 2,800

3000 2,850 4,200 separate rack 40 25 100 12

4000 3,800 5,500

10

15 3,100 1,300 2,300 1,100

20

20

30 3,600 1,300 2,300 1,500

40

6000 5,700 7,800

8000 7,600 10,300

10000 9,500 12,900

12000 11,400 15,500

separate rack 50 40 100 18 70 130 4,000 1,600 2,300 1,800 100 180

separate rack 50 40 100 24 120 220 4,500 2,000 2,300 2,300 2,500 140 250

WFI generation
The DESTOMAT multiple effect water still with its unique falling-film evaporation technology features an innovative patented column design and enhanced process technology and offers an even higher output, energy efficiency and dependability. The DESTOMAT WFI generation unit is supplied with purified water from our ROCEDIS units. This prevents hazardous water components such as hardness, silicates, amines, chlorides, free carbon dioxide, TOC and conductivity from being fed in, ensuring stable operation under safe compliance with USP, EP and JP for many years.

The distillation columns are equipped with important new functions, thus ensuring their suitability for different customer requirements and operating environments. Distillation against backpressure, recirculation of non-evaporated feedwater, continuous blowdown measurement, the possibility of self-sanitisation and proportional control are just some of the unique process features which are available optionally.

The core of the DESTOMAT distillation unit is the separation column a falling-film evaporator of new compact design (patent applied for) which safely eliminates impurities through high velocities in spiralshaped baffle plates, an immediate phase transition from liquid to vapour state (flash evaporation) and a reversal of the direction of flow. For an effective gas elimination, optionally the first column is fitted with an integrated gas separator, while the subsequent columns have a gas outlet. The units are equipped with a commercially available programmable logic controller (PLC) from Siemens. An operator panel from Siemens is installed to enable detection of the units current operating state or intervention in the automatic operation of the unit.

WFI production at a high temperature High energy utilisation Multi-stage separation Option: Simultaneous distillation and high-purity steam generation Option: Separation of non-condensable gases Option: Distillation against backpressure Option: Output control Easy to maintain FAT with simulation of the customers operating media possible

WFI generation

TI PI

TI PI

TI

TI PI

LISA

LISA

LISA

Heater
TI

Condenser QISA

S/cm

WFI Heating steam Condensate Blow Down Blow Down Reject

FI

PW
Feed pump Feed tank

The DESTOMAT by SH + E Group is made up of the following components:

Columns as pressure vessels with vent, drain, sightglass and level switch Preheater, evaporator, condenser and cooler of DTS design Insulation of the evaporator section of the columns, preheater Option: Gas separator with spray nozzle in the first column Feed water pump as a multi-stage centrifugal pump of SS 316 and buffer tank Safety pressure relief valve for heating steam pipe Pressure transducer for high-purity steam pressure control Flow meter for feed water 0.2 m sterile filter in condenser vent pipe WFI conductivity meter (Mettler Toledo) Surfaces coming into contact with the product of 316L, mechanically polished, Ra < 0.6 m Seals FDA-compliant Vertically adjustable rack of coated steel Option: Rack of stainless steel Switch cabinet with Siemens SPS S7-300 Touch panel Siemens SIMATIC TP177B Option: Colour touch panel Siemens SIMATIC MP277, 8 Option: Paper recorder or electronic recorder 21CFR Part 11-compliant

DESTOMAT Qty. of columns WFI capacity at 4 bar WFI capacity at 6 bar WFI capacity at 8 bar Electrical connection Electr. connection Dimensions Width max. * Depth Height Distillate outlet Weight Net weight approx. * kg mm mm mm mm kW l/h l/h l/h

150 4 or 5 160 195 225 1.0 1,400 980 2,100 1,780 700

250 4 or 5 210 295 380 1.0 1,400 980 2,100 1,780 900

450 4 to 6 535 725 890 1.0 2,890 860 2,850 2,270 1,500

850 4 to 6 1,010 1,385 1,670 1.5 2,890 860 2,850 2,470 1,900

1600 5 to 7 2,175 2,900 3,450 3.0 4,450 1,100 3,500 2,800 3,150

2900 5 to 8 3,743 4,880 6,000 4.0 5,100 1,100 3,500 3,000 5,000

4700 6 to 8 6,520 8,636 10,750 5.0 5,630 1,750 4,300 3,670 6,250

* Width/ Weight at max. quantity of columns

Pure Steam generation

Sterilisation processes in the pharmaceutical industry require high-quality Pure Steam (PS) with careful pressure control and short supply time. In recent years, the removal of non-condensable gases has become a major challenge for HP steam generators. The VAPOMAT HP steam generator meets these requirements. The VAPOMAT is supplied with purified water from our ROCEDIS units. The Pure Steam generator is based on an innovative patented process that combines the advantages of the thin falling film and thermosiphon operating principles for the first time. Together with the standard proportional output control, this results in very fast reaction times and a Pure Steam of the highest quality.

The core of the VAPOMAT is a separator column which safely removes pyrogens and other impurities through high velocities, immediate phase transition from liquid to vapour state (flash evaporation), reversal of the direction of flow and centrifugal separation via spiral-shaped baffle plates. Demisters are not required. For an effective gas elimination, the column is equipped with an integrated gas separator. A unique feature is the continuous recycling of nonevaporated feed water into the process (circulation). This results in an efficient sanitisation of the piping and a reduced feed water and heating steam consumption.

The collection and continuous separation of the non-evaporated water droplets at the column bottom ensures a constant quality, even if different volumes are drawn off.

Quick reaction to varying HP steam demands Proportional output control Continuously circulating hot feed water Multi-stage separation Continuous separation of non-condensable gases Option: Blow-down cooler No moving parts Little space requirement and low height FAT with simulation of the customers operating media possible

Pure Steam generation

Gas outlet
PI PISA

Heating steam

Circulation pump

PI

PS

LISA

Circulation tank

FI TI
S/cm

PIA

PW
Heater Feed pump

QISA

Sampling

Blow Down

Condenser

The VAPOMAT is delivered as a compact unit in FDA/GMP-compliant pharma design, ready for connection, preassembled and wired:

Column as a pressure vessel with vent, drain, sightglass and level switch Column heat exchanger of DTS design Insulation of evaporator section of the column, preheater and circulation tank Feed water circulation pump as a multi-stage centrifugal pump of SS 316 Circulation tank Safety pressure relief valve for heating steam pipe Pressure transducer for HP steam pressure control Option: Conductivity meter in the condensed HP steam and feed water Surfaces coming into contact with the product of 316L, mechanically polished, Ra < 0.6 m Seals FDA-compliant Vertically adjustable rack of steel, epoxy resin coated Option: Rack of stainless steel Swicth cabinet with Siemens SPS S7-300 Touch panel Siemens TP177B, 4 Option: Paper recorder or electronic recorder 21CFR Part 11-compliant

VAPOMAT Capacity at 6 bar heating steam Capacity at 8 bar heating steam Electrical connection Electr. connection Dimensions Width Depth Height Weight Net weight approx. mm mm mm kg kW kg/h kg/h

150 95 130 0.55 700 1,200 2,000 235

250 145 210 0.55 700 1,200 2,000 265

450 325 490 1.0 1,300 1,300 2,300 420

850 560 830 1.0 1,300 1,300 2,700 560

1600 1,100 1,650 1.5 1,650 1,500 3,100 835

2900 1,950 2,950 3.0 1,650 1,500 3,500 1,160

4700 3,000 4,550 4.0 2,050 1,850 4,100 1,655

Storage and distribution system

The high-purity water produced (PW, HPW, WFI) is stored in a storage tank to cover the usual consumption peaks. It is fed to the consumers by one or several feed pumps via a loop system. Unused water circulates in the loop back to the storage tank. To prevent microbial growth in the loop system, the piping and pump are sized so that always a minimum velocity (Re > 10,000) is maintained in the loop return pipe. The pump is equipped with a frequency converter to adjust the volume delivered to the volume actually drawn off from the loop and to keep the water pressure at the consumer constant. This is controlled by a pressure sensor in the loop return pipe. Our compact SANICIRCLE unit for distribution of PW, HPW or WFI is delivered sanitised with ozone/ UV or hot water, preassembled ready for connection and wired.

You can choose between two sanitisation methods for storage and distribution: SANICIRCLE - Cold operation with ozone / UV sanitisation SANICIRCLE TS - Cold operation with periodic hot water sanitisation - Hot operation with continuous hot water sanitisation

Storage and distribution system

The high-quality pharma-compliant sanitary design, combined with the continuous sanitisation with ozone or the periodic sanitisation with hot water guarantee that the very high quality of the water produced is maintained in the storage and distribution system:

Pharma-compliant storage tank of 316 L stainless steel of pressureless or pressure-resistant design Level control by capacitive level probe Sterile air filter 0.2 m for ventilation Conductivity increase prevented by a CO2 adsorber Bursting disc with integrated signal generator or safety valve for protection against over- and underpressure Frequency-controlled centrifugal pump(s) of sanitary design Conductivity meter, pressure gauge and flow meter in the return pipe Option: TOC meter in the return pipe Option: Cooler in the return pipe Materials coming into contact with the product of 316L, Ra 0.8 m Seals FDA-compliant All system components with little dead space (3D rule) and fully drainable Autonomous switch cabinet with own control via Siemens SPS S7-ET200S

TI
S/cm

PW / HPW

TI

TIC

PIS

QISA

FIA

Loop Return
P

TI LISA

TI

Cooler

O3

Ozone generator

QISA

Storage ttank

FU

QUV PI

Loop Supply
Distributionpump
P

UV Unit

Skid

The ozonized SANICIRCLE contains an electrolytic Ozone generator in the supply pipe of the loop. The generator continuously produces Ozone from a partial stream of the purified water with a specially developed electrolytic cell. As usually the purified water must be free of Ozone at the consumers, the Ozone is removed in the loop supply pipe to below detection limit by a pharma-compliant UV unit which requires a radiation dose of not less than 900 J/m at 254 nm. In addition, the UV radiation of 200 to 300 nm has a germicidal effect by rendering the bacteria DNA inactive. The entire loop system is sanitised periodically by switching off the UV unit.

Storage and distribution system

Our SANICIRCLE for sanitisation of the storage and distribution system with Ozone has the following features:

UV unit with stainless steel reactor housing, low-pressure radiator and individual monitoring of the UV radiators Ozone generator with stainless steel electrolytic cell Continuous monitoring of the Ozone concentration at three control points by a calibratable meter Option: DTS heat exchanger (cooler) to avoid an undesirable temperature rise

The advantages of our SANICIRCLE are convincing:

Effective continuous sanitisation at a low ozone concentration (20-50 ppb) Loop temperature up to 30 possible without risk C Reduction of nutrients (TOC) Degradation of endotoxins Effective bacteria reduction High system integrity (no contamination from outside possible) No labour- and cost-intensive insulation required Low operating expenses Easy installation Little maintenance required

The high quality of the purified water is maintained:

Storage and distribution system

The SANICIRCLE TS storage and distribution system is operated cold or hot and sanitised periodically with hot water (> 80C), pressurised hot water (121 or pure steam. C)

PW / HPW/ WFI

TIA TIC FICA

S/cm

QISA

PICSA

Loop Return
TI TI TI TI P

Heater
LISA

Cooler

TIRA

FU Storage tank Distribution pump

QUV PISA

Loop Supply
UV Unit
P

Skid

All SANICIRCLE TS are additionally equipped with:

Storage tank of pressure-resistant design Spray ball in the return pipe Safety valve at the storage tank Heating jacket for sterile air filter DTS heat exchanger (heater/cooler) Insulation of tank and piping UV unit (for cold operation only)

SANICIRCLE (TS) Capacity of distribution pump Ozone dosing rate UV radiation Capacity of cooler at T=2 (+10%) C Mechanical connections Supply pipe (acc. to ISO 1127) Return pipe (acc. to ISO 1127) Electrical connection Electr. connection Dimensions Width Depth Height Weight Net weight approx. kg mm mm mm kW DN DN m/h g/h J/m kW

5000 5 3 900 4 25 15 2.2 1,800 1,000 2,100 600

10000 10 3 900 10 40 25 3.0 1,800 1,000 2,100 600

15000 15 3 900 15 50 32 4.0 2,000 1,300 2,100 700

20000 20 3 900 15 50 40 5.5 2,200 1,300 2,100 800

30000 30 3 900 36 80 50 7.5 2,500 1,600 2,100 900

50000 50 6 900 51 100 65 15 2,500 1,600 2,100 1,100

Piping systems
As a vendor of turn-key systems for purified utilities, we assume the overall responsibility from generation to the user. Taking into consideration the peak loads, the maximum daily requirement, the flow velocity, the pressure and temperature, we plan the pipe routing inside the building together with our customers. Pressure drop calculations, as well as a comprehensive documentation are part of our scope of services. CAD technology according to the latest state of the art is used for planning and project design. Structures with little dead space, optimum surface qualities, the use of suitable materials (316L or PVDF) for the pharmaceutical industry, as well as the use of orbital welding technology result in a reliable quality of the loop systems for PW, HPW and WFI or of the piping systems for Pure Steam. Experienced engineers support our customers in the planning and execution of tap management systems.

Process systems
We are a competent partner of the pharmaceutical industry for all processes in connection with the production of sterile liquids. We effectively implement the customer-specific process and purification requirements on the basis of international norms and standards. Our range of services comprises:

Preparation and storage systems for parenterals, suspensions and other solutions CIP/SIP systems tailored to each individual process

We always place special emphasis on quality assurance and ease of operation. Mixing tanks can be designed for the most varying products. In many cases, these are used in solidliquid or liquid-dry form or as a combination of both. We develop an optimum and efficient solution on the basis of the specific requirements for the product and the customers concepts.

Pure steam Product WFI Nitrogen Caustic

PIC

Product

Cooling water return

Cooling water supply

TI

M Process tank
LI

PI

Process systems
The following essential points have to be considered in the design of mixing tanks:

Sanitary design Suitable mixing devices Cleaning or intermediate cleaning Product losses Dosing accuracy Traceability Batch separation Drainability Separation of different media (double block and bleed) Sanitisability / sterilisability

As a rule, the project starts with the user requirement specification (URS). From this, the functional specifications (flow diagram and functional description) are developed. The system is finally defined by means of the subsequent design specification (DS). We firmly believe that each production process should commence with cleaning, sterilisation or sanitisation. Only a system that is free from residues and bioactive materials will allow safe and perfect production. The CIP / SIP station must be designed accordingly. Cleaning is carried out in three subsequent steps:

Transport of the destabilising energy carrier to the contamination (mechanically, thermally, chemically) Destabilisation by converting the contamination into a transportable condition by the chemical and physical action of the cleaning agents Removal of the destabilised contamination from the surface

Reproducible system cleaning is deemed to be the central quality criterion:

The contact temperature and time of the cleaning media used are constant during the cleaning time. The batching of the cleaning agents is reproducible. Any mixing of the cleaning media with the operating media, raw materials or products must be prevented.

Waste water treatment

Our specialists develop solutions for the different waste waters that are produced during drug production. The chemical-physical and biological processes employed are adapted specifically to the individual circumstances and needs of our customers. They are supported by our corporate laboratory and pilot plant. Results from analyses and pilot projects are evaluated directly and translated into enhanced products. Our scope of delivery includes own processes (some patented) and standardised plant concepts for:

Physical-chemical treatment by sedimentation or flotation Aerobic/anaerobic biological treatment in membrane bioreactors or bio-aeration Inactivation of active substances by UV oxidation together with ozone or hydrogen peroxide Sterilisation and decontamination of infectious and bioactive substances from biotechnology

The waste waters from drug production are treated by means of neutralisation and sludge separation. A biological stage with downstream MBR membrane unit treats the waste water in accordance with discharge requirements. In many cases, the purity achieved allows the waste water to be reused for secondary purposes. An anaerobic stage provides the possibility to generate energy by utilising the biogas produced.

Automation
Our systems, equipped with state-of-the-art control systems, ensure dependable operation and provide the data for quality and process control. Our automation concept is developed and qualified according to GAMP guidelines and the EEC-GMP guide. Its core is a commercially available programmable logic control system (PLC/SPS) from Siemens. The automation concept by SH + E Group is based on a modular design. Each modular unit has its own switch cabinet with control system and software. This concept results in a higher fail-safety because the individual units operate autonomously. Data exchange between the units is effected by an in-plant Ethernet. According to our standard, operator control and visualisation of the overall plant is implemented by a Siemens Touch Panel.

400VAC power section

Control section

Internal processing modules

External processing modules

The configuration inside the switch cabinet follows a modular concept by separating the modules for internal and external signal processing. This considerably simplifies cabling and servicing. The power and control section voltage levels are set up and cabled separately as far as possible.

Automation
To assure independent operation of the production and/or distribution system during maintenance or repair, each switch cabinet is equipped with its own control system:

Power supply 400VAC/50Hz

4 Potential free contacts: 1x Common fault, 3 x Reserve Ethernet

Power supply 400VAC/ 50Hz

4 Potential free contacts: 1x Common fault, 3 x Reserve

Telephone line analogue

CPU IM151-8 PN/DP

CPU IM151-8 PN/DP Moros MP377 15

ET200S

ET200S

Switch cabinet Generation Field instruments

Emergency Stop installed on Rack

Switch cabinet Storage/ Distribution Field instruments

Instruments 4-20mA Sensors 24VDC

Drives

Instruments 4-20mA Sensors 24VDC

Drives

other stations

Automatic operation Commercially available PLC Independent operation of individual units thanks to the modular design Use of validated software modules Controlled behaviour during a failure of operating media or limit value exceed Easy and clear operator control through colour Touch Panel MP377, 15 Access authorisation concept through passwords with different intervention depths

Automation
We know we can rely on the modular units of Series S7/ ET200S. Sensor and actuator cables can be connected directly to the units without intermediate terminal. This provides flexibility for upgrading and considerably simplifies troubleshooting for servicing.

A colour operator control panel from Siemens is installed to allow detection of the current operating state of the system or intervention in the automatic sequence of the system.

Automation

To safeguard the automatic program runs of the system, an individual Step 7 program is developed and transmitted to the PLC. This program coordinates the switching of all actuators and responds to the sensor signals and information read in. The automation concept is based on the standard software and standard blocks of Siemens. For the development of systems and unit software, SH + E Group created a comprehensive pool of standard blocks. These blocks were tested and qualified together with the display driver blocks for the visualisation systems. A specification document explaining and documenting the functioning, parameters and tests was prepared for each block. The part to be qualified is reduced through the use of these software standards because only the new linkings between the standard blocks have to be qualified.

For planning of circuit diagrams and switch cabinets, SH + E Group relies on the EPLAN P8 planning tool. This tool allows a modular design and qualification of the planning course by means of standardised macro plans.

The Siemens standard software WinCC flexible forms the basis for operator control and visualisation. Standardised software modules from SH + E Group are used for the system-specific application software.

Automation
Access to the operator panel is protected by passwords of different levels. For user identification, entering the ID and the password is required. Code word ageing can also be activated. Four operator levels are provided for access protection: Level 0: No password protection. Only information can be read (display selection and fault indications) Level 1: Plus operation of the system Level 2: Plus parameter setting Level 3: Plus password administration

All setting parameters of the system are deposited in a formulation as a security backup. After the parameters have been altered, they can be stored by pressing a key and are available for a recovery procedure if necessary. The process values are displayed as trend curves. Reading of the values is supported by a reading line.

Process values and messages are stored in internal data archives by WinCC flexible/ Archives. This allows long-term documentation and evaluation of the process course. To determine whether the data has been altered subsequently, the stored process data is given a checksum. Recorded and archived data is cyclically swapped out to an external memory or monitoring system.

Automation
If faults occur during system operation, e.g. increase in conductivity, the software generates an alarm signal. If the system has to be shut down, it goes to a fail-safe state. Alarms are signaled by an indicator. The faulty component (meter, motor) is displayed in red on the process display. At the same time, an alarm window with details of the alarm is displayed, allowing fast diagnosis. All alarms are stored in a fault alarm buffer and archived.

Optionally, selective operator interventions can be recorded and archived by means of an AuditTrail package. This documents the change history of the process. Fault alarms are collected and applied to a floating contact. Optionally, the alarms can also be made available at an interface, e.g. Ethernet, for relaying to a control centre. A Sm@rtServer is installed on the operator panel. Under the Sm@rtClient concept, the system can be operated and observed via a Client to be provided by the customer, thus creating a full operator terminal. On request, we can offer you a design in accordance with 21CFR Part 11, with electronic recorder or software to guarantee conformity with 21CRF Part 11. We offer our customers easy operation and observation through our remote service. Our systems are equipped with a modem for remote maintenance as standard. An analog telephone line is provided by the customer. Via the Internet and a server specially equipped for this application we can assure maximum support and a fast system analysis for our customers.

Qualification and documentation

SH + E Group has extensive experience with the qualification and documentation of systems in the pharmaceutical industry. Standardised and tried-and-tested qualification documents such as protocols, reports and SOPs are available for this purpose. The individual tests for the various qualification steps DQ (on request), IQ, OQ are based on one another. The scope of testing is based on our hazard analysis. The documents prepared by us comply with the specifications of FDA and the European Commissions.

Prepared protocols, reports and SOPs for DQ, IQ, OQ Optimally adapted to our systems The scope of testing is based on the SH + E Group hazard analysis Specially trained experts Design according to GMP and GAMP Own test bench for wet tests Option: Drawing up of the specification and hazard analysis

Our qualification is based on the V-Model of the ISPE Guide or the definition in GAMP:

User Requirements Specification (URS)

Performance Qualification (PQ)

Functional Specification (FS) acc. to GAMP Hazard Analysis DQ / Enhanced Design Review

Operation Qualification (OQ)

Detailed Planning Documents: PID, List of Components, Circuit Diagram, etc.

Installation Qualification (IQ)

Implementation

Qualification and documentation

The Installation Qualification (IQ) provides documented evidence that the system has been installed in accordance with the planned requirements. At SH + E Group, the IQ is made up of three major steps:

Material certificates to EN 10204 3.1 FDA declaration of conformity for parts coming into contact with the product Factory calibration certificates for quality-relevant instruments Welding documentation Receiving inspection documents Operating and maintenance manual Technical documentation for individual components

Checking the completeness against P&I diagrams and list of components Inspection of filters and membrane elements Mechanical inspection (installation, accessibility, 3D rule,gradient as far as applicable) against P&I diagrams and layout drawing Drainability Inspection of welds Optionally: Leakage test / hydraulic test (acc. to SOP) Flushing of the system acc. to cleaning record Identification / labelling

Checking the switch cabinet against the electrical documentation acc. to SOP Electrical line test acc. to SOP Software registration Inspection of the visualisation

Qualification and documentation

The Operation Qualification (OQ) assures that all system components and systems are functioning in conformity with the specification and reproducibly. The OQ covers the inspection of all operating conditions (including Min., Max. conditions), all process parameters and sequences, as well as the process safety. At SH + E Group, the OQ comprises the following tests:

Checking the utilities (raw water, compressed air, regenerating salt, steam,...) Inspection of filters and membrane elements Setting of the process parameters Checking the sanitisation Checking the sense of rotation of the motors Software test Password test Stress test (power failure, compressed air failure, restart behaviour) Performance test (water volume, conductivity, if necessary TOC and Ozone) Documentation of the operator training Optionally: Field calibration of critical instruments acc. to SOPs

The system is tested in the factory. Where possible, the system is subjected to a wet test on our test stand before it leaves the factory. All functions and installations are tested in accordance with an FAT test plan. The Factory Acceptance Test (FAT) can be attended by the customer.

The documentation comprises the required documents according to our standard in German and in the metric system. They are made up of the relevant shop drawings (P&I diagrams, layout drawings), maintenance manual, EMSR (electrical, instrumentation & control) documentation, list of components, spare parts list and test certificates.

Customer service tailored to your needs

For trouble-free, safe and cost-effective operation of your system, professional support by our trained staff is an absolute necessity. Our convincing quality in terms of advice, implementation and service are an indispensable prerequisite for long-term customer loyalty. Our service team is available to you at any time for all inspection, servicing and maintenance tasks. Our individual service packages are fully tailored to your needs, wishes and your time schedule at a fixed price. The fixed-price agreement contributes to cost transparency for operation of your system. We are at your service whenever you need us +49 (0) 711 78 66-261

Our regional service engineers are on call 24 hours a day and can be contacted via our central Service Hotline. A dense support network with competent logistics support assures rapid assistance.

In addition, the following further services are available to you:

Recalibration service Teleservice via modem Spare parts and operating supplies Valve diaphragm replacement

Process consultation Operating data evaluation Training Analysis service

Our teleservice via a modem allows easy operation and observation of all systems connected.

Rechner Kunde: Software fr S7 Manager (Siemens) PCAnywere Rechner Hardware: Modem

Teleservice Rechner (Server): Server fr Version Works Software fr Teleservice (Siemens) Software fr S7 Manager (Siemens) PCAnywere Rechner Hardware: Analogmodem Herr Oskedra

Internet
SPS Kunde: S7 300/400 Herr Rall

Modem

Modem
Herr Wllner

Netzwerk H+E

Verbindungen zum Rechner ber: Analogmodem ISDN Modem GSM Modem DSL UMTS Internet Netzwerk H+E

Herr ???????

Verbindungen zum H+E Rechner ber: Internet mit Modem

Technical questionnaire Purified utility systems Page 1/4

Your requirements Your information is of great importance to us, because only detailed information will enable us to draw up a tailor-made offer for you. This questionnaire is intended to assist you in describing your requirements (please tick off or enter as appropriate):

Raw water source

Town water Well water Surface water (e.g. cistern, river or lake) Other ............................................

________________________________________ Raw water analysis Raw water analysis attached Raw water data as follows Electr. conductivity .. S/cm pH . Temperature . C TOC . ppm Bacteria count . CFU/ml Total hardness . / ppm CaCO3 dH Alkalinity . ppm CaCO3 Iron . ppm Manganese . ppm Silica (SiO2) . ppm Chlorine, ozone, etc. . ppm SDI (15 min) . ________________________________________ Seasonal fluctuations

Yes No

________________________________________ Scope of delivery Which plant systems are to be installed? PW / HPW system Production Storage Distribution Loop Other WFI system Production Storage Distribution Loop Other

HP steam system Production HP steam piping Other

Technical questionnaire Purified utility systems Page 2/4

Requirements for pharma water Which pharmacopoeias are to be complied with? EP (currently valid version) USP (currently valid version) Highly Purified Water acc. to EP Other ................................................ Electr. conductivity . S/cm TOC . ppm Bacterial count . KBE/ml Endotoxins . EU/ml Other ________________________________________

Other spec. requirements

Sanitisation

Which sanitisation method is to be used for the PW system? PW / HPW production Thermal, with hot water (> 80 C) Thermal, with hot water + hot brine Cold, with chemicals PW storage and distribution system Cold storage with ozone/UV sterilisation Cold storage with UV and periodic hot water sanitisation (80 C) Hot storage and distribution (80 C) HPW / WFI storage and distribution system Cold storage with ozone/UV sterilisation Hot storage and distribution (80 C) ________________________________________

Capacities of PW system

Production runs not more than . shifts a day The PW consumption at the point of use is: acc. to attached list of consumers Total consumption Short-term peak load m/day m/h hours per shift

Technical questionnaire Purified utility systems Page 3/4

PW system Desired capacities for PW production, storage and distribution Production Storage Distribution . . . m/h m m/h

WFI system

The WFI consumption at the point of use is: acc. to attached list of consumers Total consumption Short-term peak load m/day m/h

Desired capacities for WFI production, storage and distribution Production Storage Distribution . m/h . m . m/h

HD steam system

The high-purity steam consumption at the point of use is: acc. to attached list of consumers kg/h ________________________________________

Peak load

Control system

Standard configuration (modular) PLC Siemens S7-300, CPU IM 151-8 DP/PN Operator panel Siemens Multipanel MP377, 15 Switch cabinet Rittal RAL 7035 Customer-spec. requirements ................................................... ................................................... ________________________________________

Technical questionnaire Purified utility systems Page 4/4

Terms of delivery In accordance with INCOTERMS 2010 EXW FOB CIP DAP Other

. . . . ________________________________________

General requirements

Our requirements for utilities and ambient conditions Ambient conditions Room temperature Humidity max. 60%

min. 5 / max. 35 C C

Utilities Power 3 x 400V / 50 Hz, +/- 10% Compressed air oil-free, min. 6 bar Saturated steam min. 6 bar Cooling water max. 12 (4 bar) C ________________________________________ ............................................................................................................ ............................................................................................................ ............................................................................................................ ............................................................................................................ ............................................................................................................ ............................................................................................................ ............................................................................................................ ________________________________________ Address Company address Contact Tel. No. Fax No. E-mail ...................................................................... ...................................................................... ...................................................................... ...................................................................... ...................................................................... ...................................................................... ...................................................................... ________________________________________

Further information

Answer by FAX

Please return to

FAX +49 711 78 66 - 316

SH+E Group ranks among the world's leading suppliers in the fields of water, energy and process engineering. Based on its global presence, the SH+E GROUP has executed projects in more than 160 countries.

Tel. +49 7748 9200-777 info@she-group.com www.she-group.com