Please tell me the sampling and analysis frequency of pure steam and the reference guidline for the same ???
The specification apply to pure steam is same to WFI.
Some adiitional test required in pure steam are as follows & guideline apply to that is EN285
Non condensable gases
NMT 3.5 % expressed in term of ml of gas per 100 ml of condensate EN285
Dryness fraction
NLT 0.90 EN285
Superheat
NMT 25 C EN285
Regards
Anup Sharma
The high purity water systems and pure steam systems will require testing at the sampling ports for one full year to indicate the ability of systems to maintain proper quality throughout one complete cycle of the seasons.
[b][COLOR=“blue”]Noncondensable gasses : NMT 3.5% expressed in terms of mL of gas per 100 mLof condensate, EN 285
Microbiology for total count less than or equall to 10 CFU/mL
Microbiology Absence of gram-negative rods
Endotoxin less tha or equall to 0.25 EU/mL
Conductivity 1.3 mS/cm @ 258C, USP !645O
Total organic carbon 0.5 ppm (500 ppb) maximum, USP <643>
Dryness fraction NLT 0.90, EN 285
Superheat NMT 258C, EN 285[/color][/b]
All use points will be sampled for a minimum of seven consecutive days including the water exit point from the generation plant to release the system for use.