MULTIPLE EFFEC T DISTILLED WATER STILLS ENGINEERING SUCCESS THROUGH FIVE DECADES Pharmalab India Pvt. Ltd. is a leading Engineering Company, with a reputation for designing, manufacturing, erecting and commissioning a variety of fabricated stainless steel process and packaging equipments. We have earned the trust of many major pharmaceutical, biotech, food & beverage, cosmetics and agro-chemical companies over the past 5 decades and currently serve their requirements through three manufacturing facilities. MULTIPLE EFFECT DISTILLED WATER STILL Over the last 25 years Pharmalab has been a leading supplier of plants producing water for injection, which meets international standards, including USP, IP, BP and JP. The plants are manufactured as per FDA- current Good Manufacturing Practices (cGMP) and ASME requirements and follow the basic principle of Distillation by Thin Film Evaporation. This process involves a shell and tube heat exchangers (columns) where heat transfer is done by falling film evaporation. Very high temperatures are reached for every drop of water produced, thus ensuring sterility levels demanded for WFI. Separation of the Pyrogenic load is achieved through centrifugal forces generated during the upward movement of the steam. During the process the feed and distilled water within the plant is in constant motion and hence there is no stagnancy. Impurities, along with the Pyrogenic load, are continuously purged from the last column. At start-up during pre-heating and self sanitizing the residual accumulated water will also drain off before WFI is produced. Our plant is designed to be crevice-free as crevices promote stagnation and stimulate bacterial growth. All columns are designed to ASME specifications and are approved by CE for PED regulations as per European Union requirements. All parts in the plant coming into contact with WFI and Pure Steam are electro polished, pipe joints are orbitally welded, gaskets are made from pure Teflon or pharmaceutical-grade silicon and the first column is double tube sheet designed to prevent pure steam mixing with plant steam, should there be a weld joint failure in the tube sheet. This state-of-the-art system delivers WFI of a quality standard for storage and distribution that is much higher than what is desired by pharmacopoeias throughout the world. UNIQUE PYROGEN SEPARATION AND REMOVAL SYSTEM Pharmalab’s Multiple Effect Distilled Water Still has a unique three-stage pyrogen removal system, which includes a specially designed centrifugal separation followed by separators. We have evolved a rationale for the removal of impure water by the means of a unique purging system. This ensures endotoxin removal exceeding Log 3 reduction. MULTIPLE EFFECT DISTILLED WATER STILL DIAGRAM SPECIFICATIONS Industrial Steam at 3 bar pressure Model Industrial Steam at 6 bar pressure Cooling water Capacity Approximate Dimensions WFI Outlet Ht Est. Wt Capacity Supply steam Supply steam Cooling Water Lph Kg/hr Lph Lph Kg/hr Lph LxDxH (mm) mm kg PWS 880-4 80 37 140 120 55 210 1400X900X2050 1325 350 PWS 881-4 150 69 225 230 106 345 2100X1300X2600 1670 800 PWS 882-4 300 138 420 460 212 644 2100X1300X2600 1670 900 PWS 883-5 500 135 650 750 203 975 2800X1300X3200 2225 1250 PWS 884-5 700 189 910 1000 270 1300 3000X1450X3150 2225 1500 PWS 890-5 1000 270 1300 1550 419 2015 3300X1600X3250 2300 2000 PWS 891-5 1500 405 1950 2250 608 2925 3900X1650X3600 2500 2500 PWS 892-6 2000 460 1500 3100 713 2325 4400X1650X3800 2650 3400 PWS 894-6 3000 690 2160 4500 1035 3240 4900X1800X4300 3200 6800 PWS 897-6 5000 1150 3000 7750 1783 4650 5200X2200X5100 3700 11000 * WFI TEMP. 90 deg. C to 95 deg. C (Gravity Flow) * Plant steam 3 to 6 bar- dry & saturated. * Cooling water at 25 deg C. * Feed water (purified water) at 25 deg C: supply 15 percent above WFI capacity. * MEDS can be made to operate 8 bar pressure on special request OUTSTANDING FEATURES • The plant is completely made with AISI 316 L stainless steel with active surfaces being electro polished. High current density Low current density area area Anodic film • Double tube sheet for first heat exchanger where boiler steam is used. • The insulation is made of glass wool covered by AISI 304 stainless steel sheet. • The frame is made of AISI 304 stainless steel. Before Electropolishing Surface profile reduced and smoothend Anodic film Chrome-rich bright surface • Orbital welding, sanitary fittings and pharmaceutical-grade gaskets are features of the piping system. After Electropolishing • Orbital welding for tube-to-tube sheet joints. • Two Specially designed top coolers as per cGMP. • PLC based operation with all required inter locks and validated logic with skid mounted AISI 304 stainless steel control panel. • Complete documentation to serve international audit requirements. Double Tube Sheet • Fully automatic plant with proportionate control for boiler steam, cooling water and feed water flow rate. • All pipes and tubes as per ASME BPE stamping. • PLC system with SCADA duly validated as per 21 CFR part 11. • CE and UL certification is provided on request. • Double tube sheet for all pre-heaters and both top coolers. • Sterilisation cycle of the equipment (self-sterilisation) • Sanitization cycle to include automatic sanitizing of columns and inter connecting pipes. • Additional columns to optimize the cooling water consumption. • Anti Rouging arrangement. DESIGNED FOR THE TIMES • New FAT area specially designed and built for Pharma grade equipments. • Full capacity trials during FAT simulating Pharmaceutical Facility conditions like dry steam and purified water ensures peace of mind. • In house facility to check endotoxin levels during FAT. Factory Acceptance Test (FAT Area) Pyrogen Testing Kit COMBO UNITS ( COMBINED PSG & WFI DISTILLATION UNIT ) A combined pure steam and distillation unit simplifies the production of ultra-pure media WFI and Pure steam. Instead of using two units, Pure steam and Water for Injection (WFI) can be generated with COMBO units in a single unit. This is made possible by the use of a specially designed first column with a larger surface area with the Falling film technique. The Combo units can produce the rated capacity of WFI or Pure steam, one at a time. The capacity of pure steam to WFI can be adjusted to match individual project requirements. Customer-specific versions with higher outputs and with individual configurations are available. Reduced investment cost & Less footprint: Since the COMBO units produce two ultra-pure media, both WFI and Pure steam from a single unit, the investment costs for the system and its periphery are reduced by up to 30 per cent, and the combined unit requires considerably less space than two separate units. Combo distillation unit skids are equipped with NCGR along with fully automatic control panel. The operating mode can be selected either to Pure steam or WFI . The NCGR will assure the non-condensable gas removal during the PSG mode, to meet the EN 285 / HTM2010 quality steam. Fully automatic production of the distillate guarantees USP grade WFI. Online printer can document production and process data in both operating mode. COMBO UNITS – THE PREFERRED COMBINATION Combo model 150/100 300/200 500/300 700/500 1000/700 1500/1000 2000/1500 3000/2000 5000/3000 Capacity: WFI 150 300 500 700 1000 1500 2000 3000 5000 Capacity: PSG 100 200 300 500 700 1000 1500 2000 3000 1. The above WFI output is obtained when input steam pressure is 3 bar. 2. The given pure steam output is obtained when input steam pressure is 6 bar. “ALL AND ANY INFORMATION IN THIS CATALOGUE IS SUBJECT TO CHANGE WITHOUT ANY NOTICE” Pharmalab India Private Ltd., Kasturi, Sanghvi Estate, 3rd floor, Govandi Station Rd, Govandi (E), Mumbai 400 088, INDIA. Tel.: +91-22-66 22 9900 • Fax: +91-22-66 22 9800 • E-mail: [email protected] • Website: www.pharmalab.com RNC/06/2013/100 3. Pressure of the output steam will be 3 bar.