MCDP & PSG

Multicolumn Distillation Plant

distillation-plant
Gem pharma’s Multicolumn Distillation plant (MCDP) is designed to free water of germs and other impurities, making it sterile. The plant works on the principle of heat exchanger, which in turn helps to reduce the energy required in the water system. It produces pyrogen-free water at a much lower setup and cost as compared to the conventional methods.
-Multistage Centrifugal Feed Pump fabricated with SS 316. Maximum pressure 8-10 Kg/cm².
-SS Centrifugal Pump for cooling water transfer.
-Conductivity meter for feed water and final distillate.
-A suitable filter (PAL make) with S.S. housing for filtration of feed water.
• Pure sterile, pyrogen-free sterile distilled water conforming to I.P./B.P. Standards
• Positive air/gas venting to ensure pure distillate.
• Improvised cooler design for optimum efficiency.
• Electropolished crevice-less, inner contact surfaces.
• Sanitary Triclover fittings make quick and easy preventive maintenance possible.
• Panel board with PLC, microprocessor based controls to facilitate self-regulation and self-monitoring.
• Energy saving-low operating costs.
•  Heat exchanger in the first column with Double Tube Sheet Design as per USP requirement.
• Fully automatic operation-no attendant required
• All contact parts are fabricated with type 316 acid-resisting stainless steel and all joints and connections are sealed with Teflon gaskets.
• High distillate temperature-no extra heating necessary for storing pyrogen-free distilled water.
• Plants are available from 50 Litres/hour to 10000 Litres/hour.
• Complete documentation to meet and exceed international audit requirements.
• D.M. water storage tank with Float Control to maintain level of feed water.
• Steam Pressure reducing station with diaphragm type valve to adjust the steam pressure from 2 Kg/cm² to 7 Kg/cm² with an indicating pressure gauge.
• A part of feed water (approx. 30-33%) on the inside of the heat exchanger tubes is converted to steam because of surface film evaporation.
• A predetermined minimum amount passes through the column which causes both rapid heating of feed water and rapid cooling of boiler steam, therefore creating vapours at high velocity under pressure.
• This vapour rising through the entertained section is subjected to a 180 turn caused by centrifugal force.
• Due to spiralling motion, pure vapour rises upward through a vertical section outside the heat exchanger. Due to this unique centrifugal separation technique, the impurities such as endotoxins and pyrogen are removed.
• The purified vapour (steam) then moves towards the upper portion of the column.
• The pure steam in the first column serves as the source of heat for the second column. This process is repeated in all the 4 to 5 columns or more. Each column is working at a slightly lower temperature and pressure than the proceeding one.
• The heating energy requirements are reduced by 70% as external heat is required to vaporise only 30% of the feed water.

Pure Steam Generator

As per cGMP requirements it is recommended to use Pure Steam in place of filtered plant steam. This steam is used for all in-situ sterilization of vessels, Piping Distribution systems, autoclaves, and for humidification of sterile rooms. This will prevent contamination by particulate matter, organics and biological loads like Pyrogen, which is unavoidable in the case of plant (black) steam.

Gem Pharma manufactures Pure Steam Generators to meet cGMP requirements. Condensate of this pure steam produced meets all pharmacopoeia requirements of WFI like USP, IP, BP and JP. The plant is manufactured as per FDA current Good Manufacturing Practices (cGMP) and ASME requirements.

Pure Steam generated from this equipment also surpasses steam quality tests like non-condensable gases, degree of super heat and saturation test as per requirement. Gem Pharma has developed improvised equipment for removal of these gases before pure steam is produced.

Care is taken while designing to avoid crevices, which promote stagnation and stimulate bacterial growth. All contact parts where the Pure Steam is generated in this plant are electro polished. All pipe joints are orbitally welded. The column with which plant steam comes in contact has a double tube sheet construction to avoid the mixing of pure steam with plant steam in case there is a weld joint failure in the tube sheet. All gaskets are made from pure Teflon or Pharmaceutical grade Silicon.
• The plant is completely made with SS 316L (DIN 1.4435) stainless steel with active surfaces electro polished.
• Double tube sheet for heat exchanger and all pre-heaters.
• The insulation is made of glass wool covered by AISI 304 stainless steel sheet.
• All contact parts to WFI are electro polished with state-of-the-art technology.
• All pipes and tubes as per ASME BPE stamping with less than 0.5 Ra.
• The frame is made of AISI 304 stainless steel.
• The piping system is manufactured with electro polished pipes with orbital welding, sanitary fittings and pharma grade gaskets.
• Expansion joint design for tube-to-tube sheet joints.
• 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.
• Fully automatic plant with respect to boiler steam supply, cooling water flow rate and feed water flow rate.
• PLC system with SCADA duly validated as per 21 CFR part 1 1.
• CE and UL certification is provided on request.
• Double tube sheet for all pre-heaters and both top coolers.

• The basic principle of operation is Distillation by Thin Film Evaporation.
• A Double Tube Sheet Heat Exchanger provides heating of pre-treated feed water to saturation conditions, generating pure steam which expands into the evaporation column.
• This consists of shell and tube heat exchangers where heat transfer is done by falling film evaporation which gives assurance for achieving high temperature for every drop of water, assures the sterility aspect and separation of pyrogenic load done by centrifugal action generated during the up-ward movement of steam.
• Pure steam pressure is maintained by an electronic control system, modulating the supply steam control valve and monitoring the evaporator feed water.

Screen Shot 2022-07-11 at 6.44.37 PM
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    2024
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