Pharmalab manufactures Pure Steam Generators to match international GMP requirements. Condensate of this pure steam produced does meet all pharmacopoeial requirements of WFI like USP, IP, BP and JP. The plant is manufactured as per cGMP and under ISO 9000-2000 certified manufacturing facility. Pharmalab has supplied over 200 units, since more than 8 years, internationally.

New GMP requirements recommend to use Pure Steam in place of filtered plant steam. This steam is used for all in-situ sterilization of vessels and piping distribution system, for steam sterilizers (autoclave) and for humidification of sterile room. This will avoid the contaminations of particulate matter, organics and, biological load like pyrogens is eliminated which is unavoidable in case of plant (black) steam.

Pure Steam generated from the equipment also surpasses the steam quality tests like noncondensable gases, super heat and saturation test as per requirement. In case of cold, feed water supply to the generator removal of non-condensable gases becomes difficult. Pharmalab has developed improvised equipment for removal of these gases before Pure Steam is produced.

Basic principal of operation is Thin Film Evaporation Distillation. Consist of shell and tube heat exchangers (columns) where the heat transfer is done by falling film evaporation which gives assurance for achieving the high temperature for every drop of water, assures the sterility aspect of the WFI produced. And separation of pyrogenic load is done by centrifugal action generated during up-ward movement of the steam.

Care is taken while designing to avoid the crevices, which promotes stagnation and stimulates bacterial growth. All contact parts where the Pure Steam generated in this plant are electro polished. All pipe joints are orbit ally welded. The main column where plant steam is in contact is in double tube construction to avoid the mixing of pure steam with plant steam in case there is a weld joint failure in the tube sheet. Gaskets used are from pure teflon or pharmaceutical grade silicon. Columns are designed as per ASME design, and are approved by CE for PED regulations as per European Union requirement.

As a part of new cGMP compliance, real time printing facility is also available for the fault events and recording of important parameters.

Pharmalab can offer all documents like DQ, IQ, and OQ (FAT) and operation manual. And support customer for SAT.

Pharmalab is providing complete solution for CIP and SIP for all application with control system and along with a validation programme. Technical support is available for selection of the system and supported for after sales support.

Further details can be obtained from:
Star Metal Compound, L.B.S. Marg,
Vikhroli (W),
Mumbai - 400 083.
Tel : 91-22-25782559
Fax: 91-22-25792895
Email : mkt@pharmalab.com