water management for the pharmaceutical industry -...

Water management for the

Pharmaceutical Industry

2E200- Version 001 – Date 22.03.2012

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 supply:

● 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 life cycle 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

Water in its purest form

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:

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 Pharmacopoeia (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

Drinking Water acc. to TrinkwV 2001

Conductivity < 1,000 µS/cm

Total Hardness < 20 °dH

Iron < 0.05 ppm

Manganese < 0.05 ppm

Silica SiO2 < 20 ppm

Total Organic Carbon TOC < 2 ppm

Silt Density Index SDI 15 < 3

Others free of oxidantes

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) European Pharmacopeia US Pharmacopeia

Production processIon exchange,

membrane process

Ion exchange,

membrane process

Electr. conductivity ≤ 4.3 µS/cm (20°C)≤ 1.1 µS/cm (20°C)

downstream of Stage 1

TOC ≤ 500 ppb ≤ 500 ppb

Nitrate ≤ 0.2 ppm -

Heavy metals ≤ 0.1 ppm -

Colony-forming units ≤ 100 CFU/ml ≤ 100 CFU/ml

Water for Injection (WFI)

Production process DistillationDistillation or

membrane process

Electr. conductivity ≤ 1.1 µS/cm (20°C) ≤ 1.1 µS/cm (20°C)

TOC ≤ 500 ppb < 500 ppb

Nitrate ≤ 0.2 ppm -

Heavy metals ≤ 0.1 ppm -

Colony-forming units ≤ 10 CFU/ 100 ml -

Bacterial endotoxins ≤ 0.25 EU/ml ≤ 0.25 EU/ml

Highly Purified Water (HPW)

Production process membrane process -

Quality same as WFI -

Water for Injection

Purified Water

(Aqua Purificata) Pure Steam

Highly Purified

Water

Drinking water

Demineralisation /

Reduction of TOC

Electro-deionisation

Reverse Osmosis

Ion-exchange

Removal of Pyrogens

Distillation

Ultrafiltration

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

Pharma water is produced by the following steps:

● GAMP

● ISPE Baselines

● Water qualities /

analysis methods

● FDA regulations

● European Commission (EG)

● Company-specific instructions

● PIC/S

● 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

● Guide to Good Manufacturing Practice for

Medicinal Products

● Pharmaceutical Engineering Guides.

Volume 4 Water and Steam Systems

● Guide for Validation of Automated Systems

Only USP and JP


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.


● 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

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 dead-

end 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.

Advantages

Skid

To

PW generation

PI

PI

PISA

NaOCl

LIS

FISA

Waste

PI

LISA

PISA

FSA

PIQISA

Redox

Drinking

water

P

P

UF ModulsBackwash

pump

Filtrate

pump

Filtrate

tankDosing station

Backwash

filter

Pipe

separator

Skid

To

PW generation

PI

PI

PISA

NaOCl

LIS

FISA

Waste

PI

LISA

PISA

FSA

PIQISA

Redox

Drinking

water

P

P

UF ModulsBackwash

pump

Filtrate

pump

Filtrate

tankDosing station

Backwash

filter

Pipe

separator

Skid

To

PW generation

PIPI

PIPI

PISAPISA

NaOCl

LISLIS

FISAFISA

Waste

PIPI

LISALISA

PISAPISA

FSAFSA

PIPIQISAQISA

Redox

Drinking

water

PP

PP

UF ModulsBackwash

pump

Filtrate

pump

Filtrate

tankDosing station

Backwash

filter

Pipe

separator

Models

ULTRALIS is delivered as a compact plant, pre-assembled on a rack, comprising:

● Input control valve to set a constant filtrate flow

● Connection for an SDI meter

● Backwash-type 100 µm 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


ULTRALIS 2000 4000 8000 12000

Capacity (filtrate) m³/h 2.0 4.0 8.0 12.0

Filter area m² 30 50 100 150

Capacity of backwash pump at 2.5 bar m³/h 10 15 30 45

Capacity of filtrate pump at 5 bar m³/h 3 5 10 15

Volume of filtrate tank m³ 1.1 3 6 9

Mechanical connections

Raw water DN 25 32 40 50

Filtrate DN 20 25 32 40

Back-flushing / waste water DN 40 50 80 100

Electrical connections

Backwsh pump kW 1.1 2.2 4.0 5.0

Filtrate pump kW 0.8 1.5 2.2 4

Dimensions of UF Skid

Width mm 2,500 2,500 2,900 2,900

Depth mm 1,500 1,500 2,100 2,100

Height mm 2,100 2,100 2,000 2,200

Dimensions of filtrate tank

Diameter mm 1,400 1,400 1,800 2,000

Total height approx. mm 1,800 2,400 2,800 3,400

Weight without tank

Net weight approx. kg 800 1,000 1,200 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 a central control valve and concurrent regeneration

ECOSOFT

a volume-controlled softener with a single valve control and salt- and water-conserving counter-current

regeneration

The advantages our softeners offer are their fail-safe and cost-effective operation. Their connection in

series provides a highly reliable protection against hardness breakthroughs. Additionally, hardness

breakthroughs are detected by an optional residual hardness meter. Short regeneration cycles, high

flow rates and continuous flow through the resin beds result in a minimisation of the microbial growth

potential in normal operation. The microbiology in the resin bed is controlled by regular automatic

sanitisations with chemicals, hot water (80°C) or hot brine (60°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.

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.

PI

Drinking

water

NaCl

PI°dH

QISA

FQS

To

ROCEDIS

Skid

NaCl

P

Softener 1

Brine tank 1

Protection

filter

Pipe

separator

Brine tank 2

Softener 2

PIPI

Drinking

water

NaCl

PIPI°dH

QISA

FQS

To

ROCEDIS

Skid

NaCl

PP

Softener 1

Brine tank 1

Protection

filter

Pipe

separator

Brine tank 2

Softener 2

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 µm

● Pipe separator

● Two FRP exchange vessels

● Option: 316L stainless steel exchange vessels for thermal sanitisation

● Two central control valves for the 5-stage regeneration process

● Two fillings of high-performance ion exchange resin

● Two PE brine preparation tanks 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 in PP or 316L stainless steel

● Stainless steel rack and level elements

● Control via common switch cabinet of ROCEDIS

Softening

PHARMASOFT (TS) 200 300 400 500 600 700

Softwater l/h 750 2,250 4,500 7,400 8,800 11,800

Feed (max.) l/h 1,100 3,200 6,100 11,300 15,200 24,600

Capacity °dH 105 260 560 850 1,180 1,550

Salt demand kg/ Reg. 7 17 36 56 77 101

Waste l/ Reg. 190 500 900 1,600 2,000 3,800


Feed DN 25 25 40 50 50 50

Soft water DN 25 25 40 50 50 50

Dimensions incl. Brine tank

Width mm 1,500 1,500 1,500 2,000 2,500 2,500

Depth mm 800 800 1,000 1,200 1,500 1,700

Height mm 2,000 2,300 2,300 2,400 2,400 2,400

Volume of each brine tank Liter 200 200 400 750 750 1,000

Weight

Net weight PHARMASOFT approx. kg 300 350 350 400 400 450

Net weight PHARMASOFT TS approx. kg 450 500 500 550 550 650

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 counter-current 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°C), developed by

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.

Softening

°dH

QISA

FQS

To

ROCEDIS

Skid

NaCl

Brine tank

FI PI

PI PI

P

FI PI

P

FIFI

LS

PI

Protection

filter

Pipe

separatorHeater

TISA

TICSA

Drinking

water

Softener 2Softener 1

°dH

QISA

FQS

To

ROCEDIS

Skid

NaCl

Brine tank

FIFI PIPI

PIPI PIPI

PP

FIFI PIPI

PP

FIFIFIFI

LSLS

PIPI

Protection

filter

Pipe

separatorHeater

TISA

TICSATICSA

Drinking

water

Softener 2Softener 1

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°C) and brine

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 µm

● Pipe separator

● Two FRP exchange vessels

● PP pneumatic diaphragm valves

● Two fillings of high-performance ion exchange resin

● One PE brine preparation tank 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 in PP

● Stainless steel rack with level elements

● Autonomous switch cabinet with own control system via SPS Siemens S7-ET200S

ECOSOFT (TS) 300 400 500 600 700 900

Softwater l/h 2,250 4,400 8,000 10,900 15,000 25,400

Feed (max.) l/h 3,300 6,100 11,300 15,200 22,000 35,600

Capacity °dH*m² 200 450 820 1,170 1,840 2,600

Salt demand kg/ Reg. 8 16 29 42 66 93

Waste l 400 800 1,400 2,000 3,100 4,500


Feed DN 25 32 50 65 65 80

Soft water DN 25 32 40 50 50 65

Thermal Sanitisation for ECOSOFT TS

Electr. Heater kW 25

Steam-heated heat exchanger kW 30 60 80 130 200

Steam demand (120°C @ 2 bar) kg/h 55 100 140 225 310

Dimensions incl. Brine tank

Width mm 2,900 2,900 2,900 3,050 3,050 3,550

Depth mm 1,200 1,200 1,250 1,400 1,500 1,900

Height mm 2,300 2,500 2,500 2,750 2,750 3,000

Volume of brine tank l 200 200 300 400 500 1,000

Weight

Net weight approx. kg 350 400 400 450 500 600

PW and HPW generation

Purified Water (PW) is produced from softened water by a combination of a reverse osmosis and

electro-deionisation (ROCEDIS) process. Most of the demineralisation takes place in a reverse

osmosis (RO) system, 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 electro-

chemical membrane process which demineralises the reverse osmosis permeate continuously to the

very low conductivity required for highly purified water. The values remain significantly below those

required by the pharmacopoeias.

Depending on the composition of the raw water, a chemical-free membrane degasser 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

The ROCEDIS is delivered as a compact unit in FDA/GMP-compliant pharma design, ready for

connection, preassembled and wired:

● Protective filter, 5 µm

● Automatic inlet valve for safety shutdown

● Control valve or pressure reducer to maintain a constant feed pressure

● Low-noise high-pressure pump in 316 stainless steel, with frequency innverter

● RO pressure pipes in FRP or 316L

● Membrane elements of energy-conserving ultralow pressure design

● Option: Membrane degasser 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

● System piping in polypropylene or stainless steel

● Pipes in contact with the product from the outlet of the RO or EDI in 316L, Ra ≤ 0.8 µm

● Option: Pipes in contact with the product after the last process step in

316L, e-polished (Ra ≤ 0.6 µm) 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.

You can choose between different cGMP-compliant alternatives:

● ROCEDIS PW-PP – Generation of PW,

basic material polypropylene, except pipework in contact with the product in 316L stainless

steel, chemically sanitisable

● ROCEDIS PW-SS – Generation of PW,

totally 316L stainless steel, chemically sanitisable

● ROCEDIS PW-TS – Generation of PW,

totally 316L stainless steel, thermally sanitisable

● ROCEDIS HPW-TS – Generation of HPW,

totally 316L stainless steel, with UF connected downstream, thermally sanitisable

PW and HPW 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

PW generation

ROCEDIS PW-PP

Product capacity (PW) l/h

Soft water feed l/h

Softening


Soft water (flange DIN EN 1092-1) DN

Product (clamp nozzle DIN 32676) DN

Waste water (pipe end, HT-PP) DN

Electrical connection

Electr. connection of system kW

Dimensions of Skid

Width mm

Depth mm

Height mm

Weight

Net weight approx. kg

ROCEDIS PW-PP


Soft water feed l/h

Softening l/h




Waste water (pipe end, HT-PP) DN



Dimensions of Skid

Width mm

Depth mm

Height mm

Weight


10000 12000

6,0

7,8

8,0

10,3

10,0 12,0

12,9 15,5

3.800

2.000

2.300

50

40

100

50

40

100

1,300

2,300

900 1,200

1.500 1.800 1.900

separate rack separate rack

1.600

18 24

2.800

2.300

separate rack

25

15

100

40

25

100

3,000 4,000

700 1,400 2,100 2,800 4,200 5,500

1,500 2,000

6 12

2,800 2,800

500 1000 1500

500 1,000

2000 3000

integrated

6000

1,300

2,300

8000

4000

Air

Skid

To

Storage

tank

From

Softener PI

PS-

PI

PS+µS/cm

PI

FICSA

TI

QISA

FI FI

PISAPI

LIS

Membrane

degasifier

(Option)

Reverse

OsmosisRO High

pressure pumpPrefilter

5 µm

PPP

Dosing

pump for

chemical

sanitisation

FU

PP 316L

TI

QISA

PI

PI

FISA

P P

µS/cm

EDI

PI

FISA

PISA

Air

Skid

To

Storage

tank

From

Softener PIPI

PS-

PIPI

PS+µS/cm

PIPI

FICSAFICSA

TITI

QISA

FIFI FIFI

PISAPISAPIPI

LISLIS

Membrane

degasifier

(Option)

Reverse

OsmosisRO High


5 µm

PPPPPP

Dosing

pump for

chemical

sanitisation

FU

PP 316L

TITI

QISA

PIPI

PIPI

FISAFISA

PP PP

µS/cm

EDI

PIPI

FISAFISA

PISAPISA

Our ROCEDIS PW-SS/TS for demanding applications:

● Piping totally 316L stainless steel

● Chemical sanitisation

● Option: Thermal sanitisation by means of an electric continuous-flow heater or

steam-heated heat exchanger

PW Generation

ROCEDIS PW-SS/TS


Soft water feed l/h

Softening




Waste water DN



Thermal Sanitisation

Electrical heater kW

Dimensions

Width mm

Depth mm

Height mm

Weight


ROCEDIS PW-SS/TS


Soft water feed l/h

Softening l/h




Waste water DN




Steam-heated heat exchanger kW

Steam demand (2 bar, 120°C) kW

Dimensions

Width mm

Depth mm

Height mm

Weight


15,500

100

70

12000

6,000

7,800

8,000

10,300

10,000 12,000

12,900

1,000 1,400

140

10000

18 24

50

40

100

50


1,600

40

3,800

100 120

220 250130 180

25

15

100

2,800

6000

1,300

2,300

4000

6 12

700 1,400 2,100 2,800

40

25

100

2000 3000

integrated

10

1,500

4,200

500 1000 1500

500 1,000

1,300

2,300

15 20

2,800

2,000 3,000

separate rack

30 40

4,000

5,500

20

8000

2,000

2,300

1,700 2,100 2,200

2,300

2,800

From

Softener

Air

Skid

PI

PS-

PI

PS+µS/cm

PI

FICSA

TI

QISA

FI FI

PISAPI

LIS

PPP

Chemical

Sanitisation

FU

TI

QISA

PI

PI

FISA

P P

µS/cm

PI

FISA

PISA

Membrane

degasser

(Option)

Reverse

OsmosisRO High


5 µm EDI

To

Storage

tank

From

Softener

Air

Skid

PIPI

PS-

PIPI

PS+µS/cm

PIPI

FICSAFICSA

TITI

QISA

FIFI FIFI

PISAPISAPIPI

LISLIS

PPPPPP

Chemical

Sanitisation

FU

TITI

QISA

PIPI

PIPI

FISAFISA

PP PP

µS/cm

PIPI

FISAFISA

PISAPISA

Membrane

degasser

(Option)

Reverse

OsmosisRO High


5 µm EDI

To

Storage

tank

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

of WFI according to USP:

● Piping totally316L stainless steel

● Thermal sanitisation by means of an electric continuous-flow heater or steam-heated heat

exchanger

● Final ultrafiltration to reduce bacteria and pyrogens

HPW generation

ROCEDIS HPW-TS


Soft water feed l/h

Softening




Waste water DN




Electrical heater kW

Dimensions

Width mm

Depth mm

Height mm

Weight


ROCEDIS HPW-TS


Soft water feed l/h

Softening l/h




Waste water DN




Steam-heated heat exchanger kW

Steam demand (2 bar, 120°C) kW

Dimensions

Width mm

Depth mm

Height mm

Weight


4,000

2,000

2,300

1,800 2,300 2,500

2,300

40

3,800

5,500

20

950

1,300

2,300

15 20

3,600

1,900 2,850

separate rack

30

2000 3000

integrated

10

1,420

4,200

500 1000 1500

470

4000

6 12

700 1,400 2,100 2,800

40

25

100

130 180

25

15

100

3,100

6000

1,300

2,300

8000

50


1,600

40

4,500

100 120

220 250

12,900

1,100 1,500

140

10000

18 24

50

40

100

15,500

100

70

12000

5,700

7,800

7,600

10,300

9,500 11,400

Skid

PI

PS-

PI

PS+ TICµS/cm

PI

FICSA

TI

QISA

FI FI

PISA

TI

QISA

PI

PI

FISA

PI

PPPP P

µS/cmFU PI

FISA

PISA

From

Softener

Air

Membrane

degasser

(Option)

Reverse

OsmosisPumpPrefilter

5 µm EDI

To

Storage

tank

Heater

Skid

PIPI

PS-

PIPI

PS+ TICTICµS/cm

PIPI

FICSAFICSA

TITI

QISA

FIFI FIFI

PISAPISA

TITI

QISA

PIPI

PIPI

FISAFISA

PIPI

PPPPPPPP PP

µS/cmFU PIPI

FISAFISA

PISAPISA

From

Softener

Air

Membrane

degasser

(Option)

Reverse

OsmosisPumpPrefilter

5 µm EDI

To

Storage

tank

Heater

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.

WFI generation

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 feed water,

continuous blow-down measurement, the

possibility of self-sanitisation and

proportional control are just some of the

unique process features which are

available as options.

The core of the DESTOMAT distillation unit is the separation column – a falling-film evaporator of new

and compact design (patent applied for) which safely eliminates impurities through high velocities in

spiral-shaped baffle plates, an immediate phase transition from liquid to vapour state (flash evaporation)

and a reversal of the direction of flow. For effective gas elimination, the first column can be fitted with an

integrated gas separator as an option, while the subsequent columns have a gas outlet. The units are

equipped with a commercially available programmemable logic controller (PLC) from Siemens. An

operator panel from Siemens is installed to enable detection of the unit‘s 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 customer‘s operating media possible

The DESTOMAT by SH + E Group comprises the following components:

● Columns as pressure vessels with vent, drain, sight glass and level switch

● Pre-heater, 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 µm 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 µm

● 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

WFI generation

DESTOMAT 150 250 450 850 1600 2900 4700

Qty. of columns 4 or 5 4 or 5 4 to 6 4 to 6 5 to 7 5 to 8 6 to 8

WFI capacity at 4 bar l/h 160 210 535 1,010 2,175 3,743 6,520




Electr. connection kW 1.0 1.0 1.0 1.5 3.0 4.0 5.0

Dimensions

Width max. * mm 1,400 1,400 2,890 2,890 4,450 5,100 5,630

Depth mm 980 980 860 860 1,100 1,100 1,750

Height mm 2,100 2,100 2,850 2,850 3,500 3,500 4,300

Distillate outlet mm 1,780 1,780 2,270 2,470 2,800 3,000 3,670

Weight

Net weight approx. * kg 700 900 1,500 1,900 3,150 5,000 6,250

* Width/ Weight at max. quantity of columns

LISALISA

FI

PW

Heating steam Condensate

WFI

TI

QISAµS/cm

TI

TI

Feed pump

Heater

Condenser

Feed tank

LISA

PI

TI TI

TI

PI

Blow Down Blow Down

PI

Reject

LISALISALISALISA

FIFI

PW

Heating steam Condensate

WFI

TITI

QISAµS/cm

TITI

TI

Feed pump

Heater

Condenser

Feed tank

LISALISA

PIPI

TITI TITI

TI

PI

Blow Down Blow Down

PIPI

Reject

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

“thermo-siphon” 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.

Pure Steam generation

● Rapid 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

● Low space requirement and low height

● FAT with simulation of the customer‘s operating media possible

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 non-

evaporated 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.

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, sight glass 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 in 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 µm


● Vertically adjustable rack of steel, epoxy resin coated

● Option: Stainless steel rack

● Switch cabinet with Siemens SPS S7-300

● Touch panel Siemens TP177B, 4“

● Option: Paper recorder or electronic recorder 21CFR Part 11-compliant

Pure Steam generation

VAPOMAT 150 250 450 850 1600 2900 4700

Capacity at 6 bar heating steam kg/h 95 145 325 560 1,100 1,950 3,000

Capacity at 8 bar heating steam kg/h 130 210 490 830 1,650 2,950 4,550


Electr. connection kW 0.55 0.55 1.0 1.0 1.5 3.0 4.0

Dimensions

Width mm 700 700 1,300 1,300 1,650 1,650 2,050

Depth mm 1,200 1,200 1,300 1,300 1,500 1,500 1,850

Height mm 2,000 2,000 2,300 2,700 3,100 3,500 4,100

Weight

Net weight approx. kg 235 265 420 560 835 1,160 1,655

FI

PW

Heating steam

Condenser

TI

QISAµS/cm

Heater Feed pump

LISA

Circulation

pump

Circulation

tank

Blow Down

PISA

PS

Gas

outlet

PI

PI

PIA

Sampling

FIFI

PW

Heating steam

Condenser

TITI

QISAµS/cm

Heater Feed pump

LISALISA

Circulation

pump

Circulation

tank

Blow Down

PISA

PS

Gas

outlet

PIPI

PIPI

PIAPIA

Sampling

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-purity water produced (PW, HPW, WFI) is stored in a tank to cover the normal consumption

peaks. It is fed to the consumers by one or more 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 a minimum velocity (Re > 10,000) is always maintained in the loop

return pipe. The feed pump frequency inverter-controlled 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.

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 µm 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 µm


● All system components with little dead space (3D rule) and fully drainable

● Autonomous switch cabinet with own control via Siemens SPS S7-ET200S

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/m² 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.


QUV

TI

TITI

TIC

TI

QISAPIS FIAµS/cm

Loop

Return

Loop

Supply

PW /

HPW

Skid

LISA

PIFU

QISA

O3

P

P

Storage

ttank

Distribution-

pumpUV Unit

P

Ozone

generator

Cooler

QUVQUV

TITI

TITITITI

TICTIC

TITI

QISAPISPIS FIAFIAµS/cm

Loop

Return

Loop

Supply

PW /

HPW

Skid

LISALISA

PIPIFU

QISA

O3

PP

PP

Storage

ttank

Distribution-

pumpUV Unit

PP

Ozone

generator

Cooler

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°C possible without risk

● 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:

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)


The SANICIRCLE TS storage and distribution system is operated cold or hot and sanitised periodically

with hot water (> 80°C), pressurised hot water (121°C) or pure steam.

SANICIRCLE (TS) 5000 10000 15000 20000 30000 50000

Capacity of distribution pump m³/h 5 10 15 20 30 50

Ozone dosing rate g/h 3 3 3 3 3 6

UV radiation J/m² 900 900 900 900 900 900

Capacity of cooler at ΔT=2°C (+10%) kW 4 10 15 15 36 51


Supply pipe (acc. to ISO 1127) DN 25 40 50 50 80 100

Return pipe (acc. to ISO 1127) DN 15 25 32 40 50 65


Electr. connection kW 2.2 3.0 4.0 5.5 7.5 15

Dimensions

Width mm 1,800 1,800 2,000 2,200 2,500 2,500

Depth mm 1,000 1,000 1,300 1,300 1,600 1,600

Height mm 2,100 2,100 2,100 2,100 2,100 2,100

Weight

Net weight approx. kg 600 600 700 800 900 1,100

Loop

Return

TITI

PISA

TIA

QISA PICSAFICAµS/cm

Loop

Supply

PW /

HPW/

WFI

Skid

LISA

TIRA

P

P

Heater

TITI

Cooler

QUVFU

TIC

Storage

tank

Distribution

pumpUV Unit

Loop

Return

TITITITI

PISAPISA

TIATIA

QISA PICSAPICSAFICAFICAµS/cm

Loop

Supply

PW /

HPW/

WFI

Skid

LISALISA

TIRATIRA

PP

PP

Heater

TITITITI

Cooler

QUVQUVFU

TICTIC

Storage

tank

Distribution

pumpUV Unit

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.

Piping 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 solid-

liquid 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 customer‘s concepts.

Process systems

Product

PIC

TI

Process tank

Caustic

WFI

PI

Nitrogen

Cooling water

return

Cooling water

supply

M

LI

Pure steam

Product

Product

PICPIC

TI

Process tank

Caustic

WFI

PI

Nitrogen

Cooling water

return

Cooling water

supply

M

LI

Pure steam

Product

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

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.

Our specialists develop solutions for the different wastewaters 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 facilities. 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:

● Physico-chemical treatment by sedimentation or flotation

● Aerobic/anaerobic biological treatment in membrane bioreactors

or bio-aeration

● De-activation of active substances by UV oxidation together with ozone or hydrogen peroxide

● Sterilisation and decontamination of infectious and bioactive substances from biotechnology

Waste water treatment

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.

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 programmemable

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.

Automation

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.

Internal

processing

modules

External

processing

modules

400VAC power section Control section

To ensure independent operation of the production and/or distribution system during maintenance

or repair, each switch cabinet is equipped with its own control system:

● 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 levels

Automation

other stations

4 Potential free

contacts:

1x Common fault,

3 x Reserve

Switch cabinet

Generation

Power supply

400VAC/50Hz

Ethernet

4 Potential free

contacts:

1x Common fault,

3 x Reserve

Switch cabinet

Storage/

Distribution

Power supply

400VAC/ 50Hz

DrivesInstruments 4-20mA

Sensors 24VDC

Field instruments

Telephone line

analogue

ET200S

MP377 15”

CPU

IM151-8

PN/DP

Moros

Emergency Stop

installed on

Rack

ET200S

CPU

IM151-8

PN/DP


Sensors 24VDC

Field instruments

other stations

4 Potential free

contacts:

1x Common fault,

3 x Reserve

Switch cabinet

Generation

Power supply

400VAC/50Hz

Ethernet

4 Potential free

contacts:

1x Common fault,

3 x Reserve

Switch cabinet

Storage/

Distribution

Power supply

400VAC/ 50Hz


Sensors 24VDC

Field instruments

Telephone line

analogue

ET200S

MP377 15”

CPU

IM151-8

PN/DP

Moros

Emergency Stop

installed on

Rack

ET200S

CPU

IM151-8

PN/DP


Sensors 24VDC

Field instruments

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.

Automation

A colour operator control panel from Siemens is included to allow detection of the current operating

state of the system or intervention in the automatic sequence of the system.

To safeguard the automatic programme runs of the system, an individual Step 7 programme is

developed and transmitted to the PLC. This programme 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 from 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

links between the standard blocks have to be qualified.

Automation

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.

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.

Automation

Access to the operator panel is protected by passwords at 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

Should a fault 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 signalled 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.

mailto:Sm@rtClient

Qualification and documentation

Hazard Analysis

DQ / Enhanced

Design Review

User

Requirements

Specification

(URS)

Functional

Specification (FS)

acc. to GAMP

Performance

Qualification

(PQ)

Operation

Qualification

(OQ)

Installation

Qualification

(IQ)

Implementation

Detailed

Planning Documents:

PID, List of

Components,

Circuit Diagram, etc.

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:

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


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.


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:

Customer service tailored to your needs

Our tele-service via a modem allows easy operation and observation of all

systems connected.

Herr Oskedra

Herr Rall

Teleservice Rechner (Server):

Server für Version Works

Software für Teleservice (Siemens)

Software für S7 Manager (Siemens)

PCAnywere

Rechner Hardware:

Analogmodem

Verbindungen zum Rechner über:

Analogmodem

ISDN Modem

GSM Modem

DSL

UMTS

Internet

Verbindungen zum H+E Rechner über:

Internet mit Modem

Netzwerk H+E

Herr Wöllner

Herr ???????

Rechner Kunde:

Software für S7 Manager

(Siemens)

PCAnywere

Rechner Hardware:

Modem

Internet

ModemModem

SPS Kunde:

S7 300/400

Netzwerk H+E

● Recalibration service

● Tele-service via modem

● Spare parts and operating

supplies

● Valve diaphragm replacement

● Process consultation

● Operating data evaluation

● Training

● Analysis service

Your information is of great importance to us, since 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 or enter as appropriate):

О Town water

О Well water

О Surface water (e.g. cistern, river or lake)

О Other ............................................

________________________________________

О Raw water analysis attached

О Raw water data as follows

Electr. conductivity ………..µS/cm

pH ……….

Temperature ………. °C

TOC ………. ppm

Bacteria count ………. CFU/ml

Total hardness ………. °dH / ppm CaCO3

Alkalinity ………. ppm CaCO3

Iron ………. ppm

Manganese ………. ppm

Silica (SiO2) ………. ppm

Chlorine, ozone, etc. ………. ppm

SDI (15 min) ……….

________________________________________

О Yes

О No

________________________________________

Which plant systems are to be installed?

Your requirements

Raw water source

Raw water analysis

Seasonal

fluctuations

Scope of delivery

Technical questionnaire – Purified utility systems – Page 1/4

PW / HPW system

О Production

О Storage

О Distribution

О Loop

О Other……………

WFI system

О Production

О Storage

О Distribution

О Loop


HP steam system

О Production

О HP steam piping


Which pharmacopoeias are to be complied with?

О EP (currently valid version)

О USP (currently valid version)

О Highly Purified Water acc. to EP

О Other ................................................

Other spec. requirements Electr. conductivity ………. µS/cm

TOC ………. ppm

Bacterial count ………. KBE/ml

Endotoxins ………. EU/ml

Other ………………………

………………………

________________________________________

Which sanitisation method is to be used for the PW system?

PW / HPW production

О Thermal, with hot water (> 80°C)

О Thermal, with hot water + hot brine

О Cold, with chemicals

PW storage and distribution system

О Cold storage with ozone/UV sterilisation

О Cold storage with UV and periodic hot water sanitisation (80 °C)

О Hot storage and distribution (80 °C)

HPW / WFI storage and distribution system

О Cold storage with ozone/UV sterilisation

О Hot storage and distribution (80 °C)

________________________________________

Production runs not more than

……. shifts a day …… hours per shift

The PW consumption at the point of use is:

О acc. to attached list of consumers

Total consumption …… m³/day

Short-term peak load …… m³/h

Requirements for

pharma water

Sanitisation

Capacities of

PW system


Desired capacities for PW production, storage and distribution

Production ……. m³/h

Storage ……. m³

Distribution ……. m³/h

The WFI consumption at the point of use is:


Total consumption …… m³/day

Short-term peak load …… m³/h

Desired capacities for WFI production, storage and distribution

Production ……. m³/h

Storage ……. m³

Distribution ……. m³/h

The high-purity steam consumption at the point of use is:


Peak load …… kg/h

________________________________________

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 ...................................................

...................................................

________________________________________

PW system

WFI system

HD steam system

Control system


In accordance with INCOTERMS 2010

О EXW

О FOB …………………………….

О CIP …………………………….

О DAP …………………………….

О Other …………………………….

________________________________________

Our requirements for utilities and ambient conditions

Ambient conditions

Room temperature min. 5 °C / max. 35 °C

Humidity max. 60%

Utilities

Power 3 x 400V / 50 Hz, +/- 10%

Compressed air oil-free, min. 6 bar

Saturated steam min. 6 bar

Cooling water max. 12 °C (4 bar)

________________________________________

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________________________________________

Company ......................................................................

address ......................................................................

......................................................................

Contact ......................................................................

Tel. No. ......................................................................

Fax No. ......................................................................

E-mail ......................................................................

________________________________________

Please return to FAX +49 711 78 66 - 316

Terms of delivery

General

requirements

Further

information

Address

Answer by FAX


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

[email protected]

www.she-group.com

mailto:[email protected]

