Pure Steam Quality Test Kit

In the mid 1970s the British National Health Service was incurring significant costs as the results of failed porous load/equipment sterilization cycles. Failures were principally due to wet loads, the failure of chemical indicators on packaging and in the Bowie-Dick test to properly change colour and air detectors causing cycles to automatically fail. In addition to the evident quality issues, this resulted in loads having to be re-packed and re-sterilized at considerable expense.

Now as a cGMP, HTM 2020 and EN 285 has defined the quality of steam used for sterilization purpose. It is necessary to ensure and validate the quality of steam on regular basis. Pharmalab uses a Steam Quality Test Kit to facilitate this process smoothly. This kit is available as a product for all our clients need.

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 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 pharmacopoeias throughout the world.

 

Outstanding Features

• 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.
• All contact parts to WFI are electro polished with state-of-the- art technology.
• The frame is made of AISI 304 stainless steel.
• The piping system is manufactured with electro polished pipes being orbital welded with sanitary fittings and pharmaceutical-grade gaskets
• 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.

 

Optional Features

• Fully automatic plant with respect to boiler steam supply, cooling water flow rate and feed water flow rate.
• All pipes and tubes as per ASME BPE stamping with less than 0.5 Ra.
• 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.

 

Features:

• The plant is completely made of AISI 316 L stainless steel with active surfaces being electropolished.
• 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.
• All contact parts to WFI are electro polished with state-of-the- art technology.
• The frame is made of AISI 304 stainless steel.
• The piping system is manufactured with electro polished pipes being orbital welded with sanitary fittings and pharmaceutical-grade gaskets
• Orbital welding for tube-to-tube sheet joints.
• Two Specially designed top coolers as per cGMP
• PLC based operation with all required interlocks and validated logic with skid mounted AISI 304 stainless steel control panel.
• Complete documentation to serve international audit requirements.

• Pay Mode Terms: T/T (Bank Transfer),Other