Local regulations may restrict the use of this product to below the conditions quoted.In the interests of development and improvement of the product, we reserve the right to change the specification without notice. © Copyright 2010

ISO 9001

Cert. No. LRQ 0963008

TI-P479-04CH Issue 1

MESMulti-Effect Still

DescriptionThe Spirax Sarco MES Multi-Effect Still distillation unit offers state of the ar t features designed to produce WFI(water for injection) for all pharmaceutical applications.The MES 1st effect incorporates a double tube sheet AISI 316L sanitary heat exchanger design to eliminate the risk of pure s team product ion contaminat ion f rom the p r imaryheating medium.Final distillation of WFI is condensed via a series of double tube sheet sanitary heat exchangers incorporating feedwater preheating and final distillate cooling mounted within theskid frame.The MES comes with a number of options to meet customer site specifications and requirements.The MES control system is provided with a PLC (programmable logic controller) which shall manage the operation of the MES, and a HMI (human machine interface), which allows you to manage the operations start-up and to control the MES operation sequences with the minimal interaction between the operator and the machine.

Key features:- Capacity range from 100 kg / h.

- Optimised column selection for maximum energy efficiency.

- Unique optimised downcomer system.

- Full PID level control for safe consistent performance.

- In-house design and manufacture, cGMP double tube sheet heat exchanger, ensuring high quality control and consistency.

- cGMP design and regulatory compliance.

Limiting conditionsPMO Maximum operating pressure 8 bar g

TMO Maximum operating temperature 175°C

PMA Maximum allowable pressure 12 bar g

TMA Maximum allowable temperature 191.7°C

Hydrostatic test pressure 12 bar g

Manufacturing and design standards:- FDA - Guide to Inspection of high purity water systems.

- Guide for Validation of Automated Systems in PharmaceuticalManufacture.

- European Commission - Good Manufacturing Practices.

- ASME BPE.

- European Pressure Equipment Directive 97 / 23 / EC.

- Option for compliance with CFR 21, Part 11.

Feedwater requirementsThe Spirax Sarco multi-effect stills are capable of producing WFI meeting USP criteria for water for injection when the feedwater is demineralised water free of silica, chlorine, amine and volatile substances.

Distillate qualitypH 5.0 – 7.0

Conductivity ≤ 1.3 μSiemens /cm @ 25°C

Chlorides Absent

Sulphates Absent

Calcium Absent

Metals Absent

Nitrates Absent

Micro-organisms Absent

Total bacteria count ≤ 10 cfu / 100 ml, pathogen free

Total organic carbon < 0.5 ppm

Endotoxin < 0.25 EU / ml

Utility requirementsElectrical feed 400 V / 3 ph / 50 Hz

Pneumatic feed 7 - 15 bar g

Note: Other voltages available on request.

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MES Multi-Effect Still TI-P479-04 CH Issue 1

Standard offering:- 316L stainless steel evaporator / separator heat exchanger units.

- Feedwater level control.

- Pure steam pressure transmitter.

- Plant steam pressure regulation.

- Stainless steel control panel and frame.

- 316L stainless steel sanitary relief valve.

- 316L stainless steel sanitary WFI condensers.

- 316L stainless steel sanitary WFI sample and divert valves.

- 316L stainless steel mult-stage centrifugal pump.

- Siemens automation (non-CRF 21, Part 11 compliant).

- 316L stainless steel sanitary tubing and valves.

- < 0.6 μm product contact finish.

- Automatic blowdown.

- Ceramic fibre insulation.

Materials of constructionProduct contact components Stainless steel 316L

Frame Stainless steel 304

Control panel Stainless steel 304

Insulation Ceramic fibre

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Flowrate and consumption when the plant steam pressure = 7 bar g

Model Number of effects WFI Plant steam actual flowrate (kg / h) consumption (kg / h)

MES100/3 3 126 52

MES200/3 3 230 95

MES400/3 3 390 161

MES750/4 4 593 195

MES1000/4 4 1 022 336

MES1500/4 4 1 525 505

MES2000/4 4 2 015 673

MES3000/4 4 3 094 1 009

MES5000/4 4 5 300 1 680

Note: In addition to our standard offering, for each model we can provide on request different variants with more effects to increaseenergy efficiency by decreasing the plant steam consumption of the selected system. For any relevant request please contact your nearest Spirax Sarco agency.

MES Multi-Effect Still TI-P479-04 CH Issue 1

Sizes and dimensions (approximate) in mmConnection sizes refer to the standard operating conditions (Plant steam: 7 bar g). Any different operating condition could cause variations to the connection sizes.

Sanitary clamp connections

Model Plant steam Condensate Feedwater WFI outlet Blowdown X Y Z inlet outlet inlet Height Width Depth

MES100/3 DN25 PN16 DN20 PN16 1" 1" 1" 2 600 2 100 1 200

MES200/3 DN25 PN16 DN15 PN16 1" 1" 1" 2 700 2 200 1 200

MES400/3 DN25 PN16 DN20 PN16 1" 1" 1" 2 950 2 300 1 200

MES600/4 DN40 PN16 DN20 PN16 1" 1" 1" 3 200 2 600 1 350

MES1000/4 DN40 PN16 DN25 PN16 1" 1½" 1" 3 300 2 950 1 350

MES1500/4 DN40 PN16 DN25 PN16 1½" 1½" 1" 3 350 3 050 1 600

MES2000/4 DN50 PN16 DN25 PN16 1½" 1½" 1" 3 350 3 300 1 700

MES3000/4 DN50 PN16 DN40 PN16 1½" 1½" 1" 3 350 3 500 1 800

MES5000/4 DN50 PN16 DN40 PN16 1½" 1½" 1" 3 650 3 750 2 000

C

A

F

D

E

H

E

D

A B

C FConnection Description A Plant steam B Condensate drainage C Water for injection D Feedwater E Blowdown MES F WFI drain G Cooling water supply H Cooling water return

X

Y

Z

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G

B

G H

MES Multi-Effect Still TI-P479-04 CH Issue 1

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Product nomenclature / selection

Pure steam generator MES MES

100 200 400 600Model number 1000 1000 1500 2000 3000 5000

Number of effects /N = Number of effects /4

Pressure vessel code A = ASME

C C = CE - PED

Control system S1 = Siemens S7-300 c / w touch screen panel

S1 S2 = Siemens S7-300 c / w touch screen panel CFR 21 Part II compliant 0I = No recorder

Recorder IP = 1 channel paper recorder

6PL 6P = 6 channel paper recorder 6PL = 6 channel paperless COMD = No communications Communications COM1 = Ethernet COM 1 COM2 = Profibus

Documentation (1 off hard copy)

- Quality plan.

- Design specifications.

- Functional specifications.

- Operation and maintenance instructions.

- Control panel instructions.

- General arrangement drawing.

- Pipe and instrumentation diagrams.

- Control schematic and panel layouts.

- List of components.

- Component manuals.

- Certificate of conformance for applicable product contact components.

- Mill certificates for all welded components.

- Welder and weld inspector certificates.

- Calibration certificates.

- Standard orbital weld logs and inspection reports.

- Passivation reports.

- Recommended spares parts list.

- Factory Acceptance Test (FAT) protocol.

Selection example: MES 1000 /4 - C - SS - S1 - 6PL - COM 1

How to order example: 1 off Spirax Sarco MES1000/4-C-SS-S1-6PL -COM1 being CE-PED compliant. The frame and control panel is to be stainless steel 304. The control system is to be Siemens S7-300 c / w touch screen panel and the recorder is to be 6 channel paperless. Ethernet communications.

Please note: Any further options (see page 5) must be stated on your order request.

MES Multi-Effect Still TI-P479-04 CH Issue 1

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Optional extras Item Code Description

Surface finish

Electropolish to 0.4 μm Ra 0201 Internal surfaces electropolished to 0.4 μm Ra.

Energy efficency

Additional effects Additional effects selected to decrease plant steam consumption.

Pure steam outlet from 1st effect

Manual diaphragm valve 0101 Manually operated sanitary diaphragm valve for isolation of pure steam outlet.

Actuated diaphragm valve 0102

Pneumatically actuated sanitary diaphragm valve for automatic open and closure of pure steam outlet valve. Manual ball valve 0103 Manually operated sanitary ball valve for isolation of pure steam outlet.

Actuated ball valve 0104 Pneumatically actuated sanitary ball valve for automatic open and closure of pure steam outlet valve. STERI-TROL (PID control valve) 0105 Pneumatically actuated sanitary PID control valve for modulated control of pure steam outlet valve.

Feedwater

Feedwater conductivity measurement 0401 Sanitary cell and transmitter for feedwater conductivity monitoring.

Blowdown Blowdown cooler 0701 Blowdown cooler option allows the reduction of blowdown temperature to a defined value. All the water contact parts are in 316L stainless steel.

Documentation options

Boroscope inspection of welds 0801 Boroscope 100% visual inspection of welds, digital format.

IQ, OQ, and DQ protocols 0802 IQ, OQ and DQ protocols provided on Spirax Sarco standard templates.

Additional hard copies (1 supplied as standard) 0803 Additional hard copies available on request.

Electronic copy (not supplied as standard) 0804 Electronic copies supplied on compact disc available on request.

Test options

Client witnessed FAT 0901

SAT 0902 Site Acceptance Test, documentation and execution.

LAL test 0903 Limulus amebocyte lysate (LAL) test for detection and quantification of bacterial endotoxin.

EU / USP WFI test 0904 EU / USP compliance laboratory WFI testing.

Service and Maintenance

Additional days for FAT 1001 Additional days for FAT execution.

Supervision of installation 1002

Commissioning 1003

Operator / maintenance staff training 1004

One year operation spare parts 1005

One year maintenance contract 1006

Critical spare parts including plant steam and feedwater control valves, Critical spare parts 1007 feedwater level control system and PLC with relevant configuration software.

IQ, OQ, DQ execution 1008