Quality Specifications:

USP, IP, BP and

JP.

Standards:

The plant shall be manufactures as per FDA- current Good

Manufacturing Practices (cGMP) and ASME Requirements

Type of System:

The plant shall be essentially a Three Effects Evaporator

with Falling Film heat exchangers

Specific Needs:

The plant should be crevice-free from crevices to avoid

bacterial growth. All wetted parts shall be electro
polished.

Welding:

All welding joints shall be orbital welded

Gaskets and O-Rings:

Pure Food Grade virgin Teflon or Pharmaceutical grade

silicon.

Specific Features:

UNIQUE PYROGEN SEPARATION AND REMOVAL SYSTEM

MULTIPLE EFFECT DISTILLED
WATER STILL
ENGINEERING SUCCESS THROUGH
FIVE DECADES
MULTIPLE EFFECT DISTILLED WATER STILL
* 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 (puried water) at 25 deg C: supply 15 percent above WFI capacity.
* MEDS can be made to operate 8 bar pressure on special request
Industrial Steam at 3 bar pressure Industrial Steam at 6 bar pressure Approximate
Dimensions WFI Outlet Ht Est. Wt
Model Capacity Supply steam Cooling water Capacity 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
DIAGRAM
SPECIFICATIONS
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.
The plant is completely made with AISI 316 L stainless steel with active
surfaces being electro polished.
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.
Orbital welding, sanitary fittings and pharmaceutical-grade gaskets are
features of the piping system.
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.
Surface prole reduced
and smoothend Anodic lm Chrome-rich bright surface
High current density
area Low current density
area
Anodic lm
Before Electropolishing
After Electropolishing
Double Tube Sheet
DESIGNED FOR THE TIMES
OUTSTANDING FEATURES
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
A combined pure steam and distillation unit simplies 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 rst column with a larger surface
area with the Falling lm
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-specic
versions with higher outputs and with individual congurations 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.
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.
3. Pressure of the output steam will be 3 bar.