Water management for the Pharmaceutical Industry2E200- 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 µS/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 µS/cm (20° C) ≤ 500 ppb ≤ 0.2 ppm ≤ 0.1 ppm ≤ 100 CFU/ml US Pharmacopeia Ion exchange, membrane process ≤ 1.1 µS/cm (20° C) downstream of Stage 1 ≤ 500 ppb ≤ 100 CFU/ml Distillation ≤ 1.1 µS/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 µS/cm (20° C) < 500 ppb ≤ 0.25 EU/ml membrane process same as WFI - 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. 21 CFR Part 11. 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 .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. These include iron. 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. Different processes are used. free chlorine.Raw water pretreatment Water treatment plants have to be protected against problematic components in the raw water to ensure dependable operation. . Experienced staff determine the optimum process steps on the basis of the available data. Dependability. manganese. cost effectiveness and operator convenience are the focus of our designs. These substances can cause malfunctions and have therefore to be eliminated from the raw water. organic material or colloidal suspended solids. The UF membrane is backwashed and sterilised automatically. and the bacterial count in the treated raw water is reduced by a factor of 1000. Drinking water Redox QISA PI PI Waste P Backwash filter Pipe separator To PW generation PISA FISA PI PI P 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 .e. the ultrafiltration plant also retains bacteria. endotoxins and colloidal silica.Raw water pretreatment The ULTRALIS ultrafiltration plant effectively eliminates colloidal matters (e. corrosion products). Unlike conventional multimedia filters. adapted to the respective raw water conditions. the entire raw water fed in is filtered through the membrane. Our ULTRALIS is operated by the deadend process. The silt density index SDI15 of the raw water is reduced to less than 3.g. i. 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 100.2 1.100 2.500 .400 1. preassembled on a rack.8 2.900 2.800 2.400 2. designed with a sloping bottom.200 2. Weight without tank Net weight approx.800 800 4000 4.000 1.100 1. spray ball and inspection opening Dosing station for NaOCl Flow meters for filtrate.0 150 45 15 9 50 40 100 5.800 1.0 4 2.1 0.0 50 15 5 3 32 25 50 2.1 25 20 40 1.0 100 30 10 6 40 32 80 4.200 12000 12.500 1.000 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.400 1.400 1. 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 2.0 30 10 3 1.500 1.100 2.000 8000 8.000 3.Raw water pretreatment ULTRALIS is delivered as a compact plant.2 2.500 2.0 2.500 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.100 1. kg mm mm mm mm mm kW kW DN DN DN m³/h m² m³/h m³/h m³ 2000 2.900 2.5 2. ° NaCl . The exchange resin tanks and the piping of the PHARMASOFT TS are made of 316L stainless steel. high flow rates and continuous flow through the resin beds result in a reduction of the microbial growth potential in standard operation.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 connection in series provides a reliable protection against hardness breakthroughs. Our PHARMASOFT has been designed as an automatic duplex softener with concurrent regeneration. Short regeneration cycles. Additionally. 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. The start of the automatic regeneration cycle is volume-controlled by a water meter. Sanitisation with hot water is carried out via the electric heater or steam-heated heat exchanger of the downstream ROCEDIS. The microbiology in the resin bed is controlled by regular automatic sanitisations with chemicals. The sanitisation interval can be shortened or extended as required. Drinking water PI PI dH QISA To ROCEDIS FQS Protection filter Pipe separator P NaCl Softener 1 Softener 2 Skid Brine tank 1 Brine tank 2 With the PHARMASOFT TS. 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. The unit is chemically sanitised. the microbiology in the resin beds is effectively destroyed periodically by sanitisation with hot water. hot water (80° or hot brine (60° C) C).and water-conserving countercurrent regeneration The advantages our softeners offer are the fail-safe and cost-effective operation. hardness breakthroughs are detected by a residual hardness meter (optional). 400 750 400 550 600 8.250 3.200 1.500 1.500 800 2.000 2.300 400 350 500 500 7.000 1.400 11.800 50 50 2. 200 750 1.300 200 350 500 400 4.100 105 7 190 25 25 1.Softening Like all our softeners the PHARMASOFT is also delivered as a compact plant on a stainless steel rack.600 50 50 2.300 850 56 1. 100 µm 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.180 77 2.800 15.600 1. kg kg mm mm mm Liter DN DN l/h l/h ° dH kg/ Reg.800 24.100 560 36 900 40 40 1.000 200 300 450 300 2.500 1.700 2. preassembled and wired: ● ● ● ● ● ● ● ● ● ● ● ● ● ● Raw water protective filter.500 2.500 1.550 101 3.000 50 50 2.500 800 2.500 6. Brine tank Width Depth Height Volume of each brine tank Weight Net weight PHARMASOFT approx.200 260 17 500 25 25 1. l/ Reg.400 1.) Capacity Salt demand Waste Mechanical connections Feed Soft water Dimensions incl. Net weight PHARMASOFT TS approx.200 2.000 450 650 .400 750 400 550 700 11. Softening ECOSOFT is a volume. SH + E Group. The sanitisation process is carried out automatically at short intervals without having to interrupt pharma water production. Compared to the conventional concurrent technology.and water consumption-controlled softener which features a very low specific salt consumption that is achieved by state-of-the-art countercurrent regeneration. 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 P ° . 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). The sanitisation interval can be shortened or extended as required. 600 2.600 93 4.200 2.400 6.000 11.750 500 500 200 310 3.250 2. Brine tank Width Depth Height Volume of brine tank Weight Net weight approx.500 2.400 50 40 600 10. kg mm mm mm l kW kW kg/h DN DN l/h l/h ° dH*m² kg/ Reg. l 300 2.300 200 350 2.000 1. preassembled and wired: ● ● ● ● ● ● ● ● ● ● ● ● ● Raw water protective filter.050 1.400 35.300 200 8 400 25 25 25 400 4.750 400 450 130 225 3.170 42 2. Heater Steam-heated heat exchanger Steam demand (120° @ 2 bar) C Dimensions incl.100 65 50 900 25.500 80 65 30 55 2. 100 µm 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.400 2.100 450 16 800 32 32 500 8.500 300 400 80 140 3.900 1.900 15.500 200 400 60 100 2.250 3.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.550 1.050 1.300 820 29 1.900 3.200 1.000 600 .840 66 3.900 1.000 22.900 1.000 1.000 65 50 700 15.) Capacity Salt demand Waste Mechanical connections Feed Soft water Thermal Sanitisation for ECOSOFT TS Electr.200 2. particles. TOC. An excellent microbiological water quality is achieved as a result of the integral structural design and the separation efficiency of 6000 MW. The major part of demineralisation is provided by reverse osmosis (RO). a chemicals-free membrane degasifier is added to the ROCEDIS to remove the free carbon dioxide. For the production of Highly Purified Water (HPW). 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. ● ● ● ● ● ● ● 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. where water components such as salts. little space required Easy to add on thanks to the modular design .PW and HPW generation Purified Water (PW) is produced from softened water by a combination of a reverse osmosis and electro-deionisation (ROCEDIS) process. Depending on the composition of the raw water. bacteria and pyrogens are retained on the surface of a semi-permeable membrane. Ultrafiltration serves as the last process step for the safe removal of bacteria and pyrogens. an ultrafiltration unit is connected downstream of the ROCEDIS. 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. chemically sanitisable ROCEDIS PW-TS – Generation of PW.eco concept enables a maximum water yield (WCF) through the entire process chain with unlimited availability. fully made of 316L stainless steel.8 µm Option: Pipes coming into contact with the product after the last process step of 316L.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. 5 µm 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. . The patented SB Plus and recycling concept not only saves drinking water. thermally sanitisable ROCEDIS HPW-TS – Generation of HPW.PW and HPW generation You can choose between different cGMP-compliant alternatives: ● ● ● ● ROCEDIS PW-PP – Generation of PW. basic material PP plastic. ready for connection. preassembled and wired: ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● Protective filter. thermally sanitisable The ROCEDIS is delivered as a compact unit in FDA/GMP-compliant pharma design. with UF connected downstream. piping coming into contact with the product of 316L stainless steel. 15“ The ROCEDIS. Ra ≤ 0. 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. e-polished (Ra ≤ 0. fully made of 316L stainless steel. chemically sanitisable ROCEDIS PW-SS – Generation of PW. fully made of 316L stainless steel. but also reduces the salt requirement of the upstream softener. 300 2.0 10.8 8000 8.000 2.9 12000 12.500 separate rack 50 40 100 24 3.0 12. 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. connection of system Dimensions of Skid Width Depth Height Weight Net weight approx.0 15.300 1.600 2. HT-PP) Electrical connection Electr.300 1.0 7.900 .800 2.000 1.000 5.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 µS/cm TI µS/cm FU PS+ FICSA QISA PISA PI PISA QISA To Storage tank Prefilter 5 µm P RO High pressure pump P Reverse Osmosis FI PI FI P 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. 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.300 2. connection of system Dimensions of Skid Width Depth Height Weight Net weight approx.300 900 1500 1.400 integrated 25 15 100 6 2.800 1.000 2.5 separate rack 50 40 100 18 2.500 6000 6.000 4.800 3000 3.200 separate rack 40 25 100 12 2.200 4000 4.300 1. HT-PP) Electrical connection Electr.100 2000 2.800 1.800 1.3 10000 10.500 2.800 1. connection of system Thermal Sanitisation Electrical heater Dimensions Width Depth Height Weight Net weight approx.300 2.000 20 20 30 2.500 separate rack 50 40 100 18 70 130 2.700 100 180 separate rack 50 40 100 24 120 220 3.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 µS/cm TI µS/cm FU PS+ FICSA QISA PISA PI PISA QISA To Storage tank Prefilter 5 µm P RO High pressure pump P Reverse Osmosis FI PI FI P 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.100 2.800 3000 3.300 10000 10.800 2. connection of system Thermal Sanitisation Steam-heated heat exchanger Steam demand (2 bar.200 separate rack 40 25 100 12 4000 4.000 15.000 10.000 4.800 1.800 1.000 12.800 1.000 2.500 2.000 5.500 10 15 2.000 7. 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.800 8000 8.400 40 6000 6.600 2.300 1. 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 1.300 1.000 1.000 2.900 12000 12.200 140 250 .300 2.100 2000 2.400 integrated 25 15 100 6 1500 1.300 2. 120°C) Dimensions Width Depth Height Weight Net weight approx.300 1. 900 2. 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 1.500 12.500 separate rack 50 40 100 18 70 130 4.300 2.800 8000 7.500 40 6000 5.600 2.400 integrated 25 15 100 6 1500 1. 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.300 2.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 µS/cm TI µS/cm FU PS+ TIC FICSA QISA PISA PI PISA QISA To Storage tank Prefilter 5 µm P Pump Heater P Reverse Osmosis FI PI FI P 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.800 5.500 2. connection of system Thermal Sanitisation Electrical heater Dimensions Width Depth Height Weight Net weight approx.500 10 15 3.400 15.300 2.600 1.100 20 20 30 3.100 2000 1.300 1.100 1.300 10000 9.300 1.300 2.850 4.200 separate rack 40 25 100 12 4000 3.900 12000 11.000 2.600 10.300 1. 120°C) Dimensions Width Depth Height Weight Net weight approx. connection of system Thermal Sanitisation Steam-heated heat exchanger Steam demand (2 bar.500 140 250 .800 3000 2.800 100 180 separate rack 50 40 100 24 120 220 4.700 7.420 2.000 1. optionally the first column is fitted with an integrated gas separator. amines. 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. silicates. thus ensuring their suitability for different customer requirements and operating environments. 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. TOC and conductivity from being fed in. ensuring stable operation under safe compliance with USP. while the subsequent columns have a gas outlet. The DESTOMAT WFI generation unit is supplied with purified water from our ROCEDIS units. EP and JP for many years. For an effective gas elimination. This prevents hazardous water components such as hardness. chlorides. ● ● ● ● ● ● ● ● ● 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 . recirculation of non-evaporated feedwater. continuous blowdown measurement. energy efficiency and dependability. The distillation columns are equipped with important new functions. Distillation against backpressure.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. the possibility of self-sanitisation and proportional control are just some of the unique process features which are available optionally. free carbon dioxide. The units are equipped with a commercially available programmable logic controller (PLC) from Siemens. an immediate phase transition from liquid to vapour state (flash evaporation) and a reversal of the direction of flow. 270 1. mechanically polished.000 4700 6 to 8 6. 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 MP277.880 6.450 3.850 2.630 1.900 3.780 700 250 4 or 5 210 295 380 1.800 3.100 1.175 2.890 860 2.300 3.890 860 2.010 1.750 5.100 3.636 10.500 3.670 6.000 5.0 4.400 980 2.450 1.670 1.743 4. condenser and cooler of DTS design Insulation of the evaporator section of the columns. evaporator.780 900 450 4 to 6 535 725 890 1.0 5.385 1.100 3. sightglass and level switch Preheater.5 2. of columns WFI capacity at 4 bar WFI capacity at 6 bar WFI capacity at 8 bar Electrical connection Electr.WFI generation TI PI TI PI TI TI PI LISA LISA LISA Heater TI Condenser QISA µS/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. * Depth Height Distillate outlet Weight Net weight approx.500 850 4 to 6 1.0 2. 8“ Option: Paper recorder or electronic recorder 21CFR Part 11-compliant DESTOMAT Qty.400 980 2.100 1.100 1. 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. drain.2 µm sterile filter in condenser vent pipe WFI conductivity meter (Mettler Toledo) Surfaces coming into contact with the product of 316L.250 * Width/ Weight at max.0 1. quantity of columns .000 4.750 4.0 5.150 2900 5 to 8 3.520 8.0 1.470 1. connection Dimensions Width max.900 1600 5 to 7 2.850 2.500 2. * kg mm mm mm mm kW l/h l/h l/h 150 4 or 5 160 195 225 1. The collection and continuous separation of the non-evaporated water droplets at the column bottom ensures a constant quality. ● ● ● ● ● ● ● ● ● 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 customer‘s operating media possible . Together with the standard proportional output control. immediate phase transition from liquid to vapour state (flash evaporation). this results in very fast reaction times and a Pure Steam of the highest quality. This results in an efficient sanitisation of the piping and a reduced feed water and heating steam consumption.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 core of the VAPOMAT is a separator column which safely removes pyrogens and other impurities through high velocities. the removal of non-condensable gases has become a major challenge for HP steam generators. Demisters are not required. A unique feature is the continuous recycling of nonevaporated feed water into the process (circulation). The VAPOMAT is supplied with purified water from our ROCEDIS units. the column is equipped with an integrated gas separator. The VAPOMAT HP steam generator meets these requirements. reversal of the direction of flow and centrifugal separation via spiral-shaped baffle plates. even if different volumes are drawn off. 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. For an effective gas elimination. 6 µm Seals FDA-compliant Vertically adjustable rack of steel.500 1.300 1.300 2.100 1. mm mm mm kg kW kg/h kg/h 150 95 130 0.000 4.000 265 450 325 490 1. preassembled and wired: ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● Column as a pressure vessel with vent.55 700 1. drain.050 1.700 560 1600 1.0 1.650 1.55 700 1.300 2.000 235 250 145 210 0.650 1.500 3.5 1.Pure Steam generation Gas outlet PI PISA Heating steam Circulation pump PI PS LISA Circulation tank FI TI µS/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.300 1.200 2.200 2.0 1.0 2.0 1. sightglass and level switch Column heat exchanger of DTS design Insulation of evaporator section of the column.950 2.655 .300 420 850 560 830 1. mechanically polished.160 4700 3.100 835 2900 1.650 1.550 4.500 3.950 3. ready for connection. Ra < 0. 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. epoxy resin coated Option: Rack of stainless steel Swicth cabinet with Siemens SPS S7-300 Touch panel Siemens TP177B.850 4.100 1. 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. It is fed to the consumers by one or several feed pumps via a loop system. HPW or WFI is delivered sanitised with ozone/ UV or hot water. Our compact SANICIRCLE unit for distribution of PW. To prevent microbial growth in the loop system. This is controlled by a pressure sensor 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. HPW.Storage and distribution system The high-purity water produced (PW. Unused water circulates in the loop back to the storage tank.Hot operation with continuous hot water sanitisation . You can choose between two sanitisation methods for storage and distribution: SANICIRCLE . preassembled ready for connection and wired.Cold operation with periodic hot water sanitisation .000) is maintained in the loop return pipe.Cold operation with ozone / UV sanitisation SANICIRCLE TS . the piping and pump are sized so that always a minimum velocity (Re > 10. WFI) is stored in a storage tank to cover the usual consumption peaks. As usually the purified water must be free of Ozone at the consumers. 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. the UV radiation of 200 to 300 nm has a germicidal effect by rendering the bacteria DNA inactive. Ra ≤ 0. In addition.Storage and distribution system The high-quality pharma-compliant „sanitary design“. The entire loop system is sanitised periodically by switching off the UV unit. 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.and underpressure Frequency-controlled centrifugal pump(s) of sanitary design Conductivity meter. . The generator continuously produces Ozone from a partial stream of the purified water with a specially developed electrolytic cell.8 µm 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 µS/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 P Skid The ozonized SANICIRCLE contains an electrolytic Ozone generator in the supply pipe of the loop. 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. 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: . 800 1.2 1.100 1.Storage and distribution system The SANICIRCLE TS storage and distribution system is operated cold or hot and sanitised periodically with hot water (> 80°C).000 1. connection Dimensions Width Depth Height Weight Net weight approx.100 700 20000 20 3 900 15 50 40 5.600 2.5 2.000 2.100 900 50000 50 6 900 51 100 65 15 2.5 2. kg mm mm mm kW DN DN m³/h g/h J/m² kW 5000 5 3 900 4 25 15 2. C) PW / HPW/ WFI TIA TIC FICA µS/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. pressurised hot water (121° or pure steam.100 .800 1.100 800 30000 30 3 900 36 80 50 7.100 600 15000 15 3 900 15 50 32 4.500 1.200 1. to ISO 1127) Return pipe (acc.0 1.000 2.500 1.0 2.600 2.300 2. to ISO 1127) Electrical connection Electr.300 2.100 600 10000 10 3 900 10 40 25 3. HPW and WFI or of the piping systems for Pure Steam. . Pressure drop calculations. optimum surface qualities. the maximum daily requirement. Experienced engineers support our customers in the planning and execution of tap management systems. CAD technology according to the latest state of the art is used for planning and project design. we assume the overall responsibility – from generation to the user. Taking into consideration the peak loads.Piping systems As a vendor of turn-key systems for purified utilities. as well as the use of orbital welding technology result in a reliable quality of the loop systems for PW. the flow velocity. Structures with little dead space. the pressure and temperature. we plan the pipe routing inside the building together with our customers. as well as a comprehensive documentation are part of our scope of services. the use of suitable materials (316L or PVDF) for the pharmaceutical industry. Process systems We are a competent partner of the pharmaceutical industry for all processes in connection with the production of sterile liquids. Our range of services comprises: ● ● Preparation and storage systems for parenterals. 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. suspensions and other solutions CIP/SIP systems tailored to each individual process We always place special emphasis on quality assurance and ease of operation. Pure steam Product WFI Nitrogen Caustic PIC Product Cooling water return Cooling water supply TI M Process tank LI PI . We develop an optimum and efficient solution on the basis of the specific requirements for the product and the customer‘s concepts. We effectively implement the customer-specific process and purification requirements on the basis of international norms and standards. The batching of the cleaning agents is reproducible. the functional specifications (flow diagram and functional description) are developed. raw materials or products must be prevented. the project starts with the user requirement specification (URS). Only a system that is free from residues and bioactive materials will allow safe and perfect production. From this. . sterilisation or sanitisation. thermally. Cleaning is carried out in three subsequent steps: ● ● ● Transport of the destabilising energy carrier to the contamination (mechanically. Any mixing of the cleaning media with the operating media. We firmly believe that each production process should commence with cleaning. The CIP / SIP station must be designed accordingly.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 system is finally defined by means of the subsequent design specification (DS). 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 chemical-physical and biological processes employed are adapted specifically to the individual circumstances and needs of our customers. Results from analyses and pilot projects are evaluated directly and translated into enhanced products. An anaerobic stage provides the possibility to generate energy by utilising the biogas produced. the purity achieved allows the waste water to be reused for secondary purposes.Waste water treatment Our specialists develop solutions for the different waste waters that are produced during drug production. They are supported by our corporate laboratory and pilot plant. . 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. In many cases. A biological stage with downstream MBR membrane unit treats the waste water in accordance with discharge requirements. Each modular unit has its own switch cabinet with control system and software. The power and control section voltage levels are set up and cabled separately as far as possible. ensure dependable operation and provide the data for quality and process control. According to our standard.Automation Our systems. 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. operator control and visualisation of the overall plant is implemented by a Siemens Touch Panel. equipped with state-of-the-art control systems. Data exchange between the units is effected by an in-plant Ethernet. . This considerably simplifies cabling and servicing. This concept results in a higher fail-safety because the individual units operate autonomously. The automation concept by SH + E Group is based on a modular design. 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. each switch cabinet is equipped with its own control system: Power supply 400VAC/50Hz 4 Potential free contacts: 1x Common fault. 15“ Access authorisation concept through passwords with different intervention depths . 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.Automation To assure independent operation of the production and/or distribution system during maintenance or repair. Automation We know we can rely on the modular units of Series S7/ ET200S. This provides flexibility for upgrading and considerably simplifies troubleshooting for servicing. Sensor and actuator cables can be connected directly to the units without intermediate terminal. . 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. These blocks were tested and qualified together with the display driver blocks for the visualisation systems. The automation concept is based on the standard software and standard blocks of Siemens. an individual Step 7 program is developed and transmitted to the PLC. Standardised software modules from SH + E Group are used for the system-specific application software. 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. The Siemens standard software WinCC flexible forms the basis for operator control and visualisation. .Automation To safeguard the automatic program runs of the system. This program coordinates the switching of all actuators and responds to the sensor signals and information read in. SH + E Group created a comprehensive pool of standard blocks. For the development of systems and unit software. 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. A specification document explaining and documenting the functioning. For planning of circuit diagrams and switch cabinets. parameters and tests was prepared for each block. Recorded and archived data is cyclically swapped out to an external memory or monitoring system.Automation Access to the operator panel is protected by passwords of different levels. 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. This allows long-term documentation and evaluation of the process course. the stored process data is given a checksum. After the parameters have been altered. Process values and messages are stored in internal data archives by WinCC flexible/ Archives. . entering the ID and the password is required. To determine whether the data has been altered subsequently. The process values are displayed as trend curves. Four operator levels are provided for access protection: Level 0: No password protection. they can be stored by pressing a key and are available for a recovery procedure if necessary. For user identification. Code word ageing can also be activated. Reading of the values is supported by a reading line. On request. an alarm window with details of the alarm is displayed. We offer our customers easy operation and observation through our remote service. e. we can offer you a design in accordance with 21CFR Part 11. Fault alarms are collected and applied to a floating contact. the software generates an alarm signal. Our systems are equipped with a modem for remote maintenance as standard. All alarms are stored in a fault alarm buffer and archived. Via the Internet and a server specially equipped for this application we can assure maximum support and a fast system analysis for our customers. An analog telephone line is provided by the customer. At the same time. with electronic recorder or software to guarantee conformity with 21CRF Part 11. the system can be operated and observed via a Client to be provided by the customer.g. allowing fast diagnosis. . it goes to a fail-safe state. If the system has to be shut down. selective operator interventions can be recorded and archived by means of an AuditTrail package.g. Optionally. thus creating a full operator terminal. Optionally. This documents the change history of the process. The faulty component (meter. e. Ethernet. A Sm@rtServer is installed on the operator panel. the alarms can also be made available at an interface.Automation If faults occur during system operation. Under the Sm@rtClient concept. for relaying to a control centre. Alarms are signaled by an indicator. motor) is displayed in red on the process display. increase in conductivity. IQ. The scope of testing is based on our hazard analysis. to GAMP Hazard Analysis DQ / Enhanced Design Review Operation Qualification (OQ) Detailed Planning Documents: PID. IQ. reports and SOPs are available for this purpose. Installation Qualification (IQ) Implementation . Standardised and tried-and-tested qualification documents such as protocols. The documents prepared by us comply with the specifications of FDA and the European Commissions. OQ are based on one another. ● ● ● ● ● ● ● Prepared protocols. List of Components. etc. 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. Circuit Diagram. reports and SOPs for DQ.Qualification and documentation SH + E Group has extensive experience with the qualification and documentation of systems in the pharmaceutical industry. The individual tests for the various qualification steps DQ (on request). gradient as far as applicable) against P&I diagrams and layout drawing Drainability Inspection of welds Optionally: Leakage test / hydraulic test (acc.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. to SOP Electrical line test acc. to cleaning record Identification / labelling ● ● ● ● Checking the switch cabinet against the electrical documentation acc. to SOP Software registration Inspection of the visualisation . At SH + E Group. accessibility. 3D rule.Qualification and documentation The Installation Qualification (IQ) provides documented evidence that the system has been installed in accordance with the planned requirements. the IQ is made up of three major steps: ● ● ● ● ● ● ● Material certificates to EN 10204 3. to SOP) Flushing of the system acc. All functions and installations are tested in accordance with an FAT test plan. steam. all process parameters and sequences. the OQ comprises the following tests: ● ● ● ● ● ● ● ● ● ● ● Checking the utilities (raw water. They are made up of the relevant shop drawings (P&I diagrams. as well as the process safety. compressed air failure. spare parts list and test certificates.. The OQ covers the inspection of all operating conditions (including Min..) 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. maintenance manual. restart behaviour) Performance test (water volume.. list of components. compressed air.Qualification and documentation The Operation Qualification (OQ) assures that all system components and systems are functioning in conformity with the specification and reproducibly. Max.. At SH + E Group. . conductivity. the system is subjected to a wet test on our test stand before it leaves the factory. Where possible. layout drawings). instrumentation & control) documentation. The documentation comprises the required documents according to our standard in German and in the metric system. if necessary TOC and Ozone) Documentation of the operator training Optionally: Field calibration of critical instruments acc. The Factory Acceptance Test (FAT) can be attended by the customer. regenerating salt. EMSR (electrical. conditions). to SOPs The system is tested in the factory. 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. A dense support network with competent logistics support assures rapid assistance. In addition. wishes and your time schedule – at a fixed price. implementation and service are an indispensable prerequisite for long-term customer loyalty. Our individual service packages are fully tailored to your needs. Rechner Kunde: Software für S7 Manager (Siemens) PCAnywere Rechner Hardware: Modem Teleservice Rechner (Server): Server für Version Works Software für Teleservice (Siemens) Software für S7 Manager (Siemens) PCAnywere Rechner Hardware: Analogmodem Herr Oskedra Internet SPS Kunde: S7 300/400 Herr Rall Modem Modem Herr Wöllner Netzwerk H+E Verbindungen zum Rechner über: Analogmodem ISDN Modem GSM Modem DSL UMTS Internet Netzwerk H+E Herr ??????? Verbindungen zum H+E Rechner über: Internet mit Modem . Our service team is available to you at any time for all inspection.Customer service tailored to your needs For trouble-free. safe and cost-effective operation of your system. Our convincing quality in terms of advice. professional support by our trained staff is an absolute necessity. servicing and maintenance tasks. 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. ________________________________________ Raw water analysis О Raw water analysis attached О Raw water data as follows Electr. ppm Chlorine. ° C TOC ………. river or lake) Other .... ………... cistern..... ppm CaCO3 Iron ………......... ozone. ppm Manganese ………. CFU/ml Total hardness ……….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. conductivity ………. µS/cm pH ………... ppm Bacteria count ……….. ° / ppm CaCO3 dH Alkalinity ………..g....... ________________________________________ Seasonal fluctuations О О Yes No ________________________________________ Scope of delivery Which plant systems are to be installed? PW / HPW system О О О О О Production Storage Distribution Loop Other…………… WFI system О О О О О Production Storage Distribution Loop Other…………… HP steam system О Production О HP steam piping О Other…………… . ppm SDI (15 min) ……….... Temperature ………... This questionnaire is intended to assist you in describing your requirements (please tick off or enter as appropriate): Raw water source О О О О Town water Well water Surface water (e.... ppm Silica (SiO2) ………. etc.... .. shifts a day The PW consumption at the point of use is: О acc.... µS/cm TOC ………....... EU/ml Other ……………………… ……………………… ________________________________________ Other spec.......... ppm Bacterial count ……….. to attached list of consumers Total consumption Short-term peak load …… m³/day …… m³/h …… hours per shift .... conductivity ………... KBE/ml Endotoxins ………... Electr.. requirements Sanitisation Which sanitisation method is to be used for the PW system? PW / HPW production О Thermal.... to EP Other ....Technical questionnaire – Purified utility systems – Page 2/4 Requirements for pharma water Which pharmacopoeias are to be complied with? О О О О EP (currently valid version) USP (currently valid version) Highly Purified Water acc.... 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) ________________________________________ Capacities of PW system Production runs not more than ……........ with hot water (> 80° C) О Thermal... 15“ Switch cabinet Rittal RAL 7035 Customer-spec. m³/h …….. to attached list of consumers …… kg/h ________________________________________ Peak load Control system Standard configuration (modular) PLC Siemens S7-300..... ……. m³/h m³ m³/h WFI system The WFI consumption at the point of use is: О acc............................. ________________________________________ . ……............... ................ storage and distribution Production Storage Distribution ……..... CPU IM 151-8 DP/PN Operator panel Siemens Multipanel MP377........ storage and distribution Production Storage Distribution …….. m³/h HD steam system The high-purity steam consumption at the point of use is: О acc.. m³ ……........Technical questionnaire – Purified utility systems – Page 3/4 PW system Desired capacities for PW production........ requirements .. to attached list of consumers Total consumption Short-term peak load …… m³/day …… m³/h Desired capacities for WFI production........... ................................................................................. ________________________________________ Further information Answer by FAX Please return to FAX +49 711 78 66 .... 60% min...................... ________________________________________ General requirements Our requirements for utilities and ambient conditions Ambient conditions Room temperature Humidity max........................................................ 6 bar Cooling water max................................................................ ........ ……………………………....... No..... ............................................................. ............................................................................................................................................................................................................... +/................................ 5 ° / max................ ...................... ....................................... ........... ............. . 12 ° (4 bar) C ________________________________________ .................................................................................... ________________________________________ Address Company address Contact Tel............. Fax No......Technical questionnaire – Purified utility systems – Page 4/4 Terms of delivery In accordance with INCOTERMS 2010 О О О О О EXW FOB CIP DAP Other ……………………………......................................... …………………………….......................................................................................316 .......................... ……………………………............................................................................................. ....... ........................... 35 ° C C Utilities Power 3 x 400V / 50 Hz............................. E-mail .................. . min..10% Compressed air oil-free.......................................................................................................................... .................................... 6 bar Saturated steam min....................... energy and process engineering.com www.com .SH+E Group ranks among the world's leading suppliers in the fields of water. Tel. +49 7748 9200-777 info@she-group. Based on its global presence.she-group. the SH+E GROUP has executed projects in more than 160 countries.