How Water For Injection is generated ?

We at Propack are prominent supplier of systems producing water for injection, which complies international standards, including USP, IP, BP and JP. The plants are manufactured as per FDA’s current Good Manufacturing Practices (cGMP) and ASME requirements and follows the basic principle of Distillation by Falling Film Evaporation.

This process involves a shell and tube heat exchangers (columns) where heat transfer is done by falling film evaporation. High temperatures are reached for every drop of water produced, thus ensuring sterility levels demanded for WFI.

Three stage separation of the Pyrogenic is achieved by:

1. Separation by gravity
2. Separation by path
3. Separation by centrifugal forces (Gmp)

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 a 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 worldwide pharmacopoeias.

SALIENT FEATURES

1. Material of construction SS 316L (DIN 1.4435) stainless steel with active surfaces being electro polished Non contact parts are made of ASAI 304.
2. Double tube sheet for first heat exchanger where boiler steam is used.
3. The insulation is made of glass wool covered by AISI 304 stainless steel sheet.
4. All pipes and tubes as per ASME BPE stamping with less than 0.5 Ra.
5. All contact parts to WFI are electro polished with state-of-the- art technology.
6. The piping system is manufactured with electro polished pipes being orbital welded with sanitary fittings and pharmaceutical-grade gaskets.
7. Expansion joint design for tube-to-tube sheet joints.
8. Exclusively designed top coolers 2 nos. as per cGMP.
9. PLC based operation with all required inter locks and validated logic with skid mounted AISI 304 stainless steel control panel.
10. Complete documentation to serve international audit requirements.

OPTIONAL FEATURES

1. Fully automatic plant with respect to boiler steam supply, cooling water flow rate and feed water flow rate.
2. All pipes and tubes as per ASME BPE stamping with less than 0.5 Ra
3. PLC system with SCADA duly validated as per 21 CFR part 1 1.
4. CE and UL certification is provided on request.
5. Double tube sheet for all pre-heaters and both top coolers.

PURE STEAM GENERATOR

As per EN 285 guidelines 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.

We manufacture Pure Steam Generators (PSG) 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 quality steam quality tests like non-condensable gases, degree of super heat and saturation test as per requirement. We have developed improvised equipment for removal of these gases before pure steam is produced.

The principle of operation is Distillation by Falling 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.

SALIENT FEATURES

1. Material of construction with SS 316L (DIN 1.4435) stainless steel with active surfaces electro polished Non contact parts are made of ASAI 304.
2. Double tube sheet for heat exchanger and all pre-heaters.
3. The insulation is made of glass wool covered by AISI 304 stainless steel sheet.
4. All pipes and tubes as per ASME BPE stamping with less than 0.5 Ra.
5. All contact parts to WFI are electro polished with state-of-the-art technology.
6. The piping system is manufactured with electro polished pipes with orbital welding, sanitary fittings and pharma grade gaskets.
7. Expansion joint design for tube-to-tube sheet joints.
8. PLC based operation with all required inter locks and validated logic with skid mounted AISI 304 stainless steel control panel.
9. Complete documentation to serve international audit requirements.

OPTIONAL FEATURES

1. Fully automatic plant with respect to boiler steam supply, cooling water flow rate and feed water flow rate.
2. PLC system with SCADA duly validated as per 21 CFR part 1 1.
3. CE and UL certification is provided on request.
4. Double tube sheet for all pre-heaters and both top coolers