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, steam sterilizers (autoclave), 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.
Pharmalab manufactures Pure Steam Generators to meet cGMP requirements. Condensate of this pure steam produced does meet 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. Pharmalab has developed improvised equipment for removal of these gases before pure steam is produced.
The basic principle of operation is Distillation by Thin Film Evaporation. 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.
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 equipment is as per ASME design, and is approved by CE for PED regulations as per European Union requirements.
- 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.
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