PQ of pure steam

GOOD DOCUMENTATION PRACTICE (GDocP) DEVIATION AND DISCREPANCY HANDLING
1

Dear sir,
PQ of pure steam should be done in three phase like wateror not,if yes plz suggest me what will be frequency of testing.

Regards

Hameeda

2

Hameeda,
You will perform PQ of Pure Steam Generator(PSG) only once. You might as well do revalidation and requalification studies after some period of time or incase you have a problem depending up on Validation Schedules you ink in your Validation Master Plan (VMP).

You will always use purified water or even WFI in some casses. Before you start to validate your PSG your water Generation systems must pass atleast 2nd Phase of their validation duration. This would ensure what WATER you feed into your PSG is as per specified standards.
Initially during qualification procedures you will also mention the type of water you feed into PSG & also mention the quality attributes that particular feed must have.

Unless you are sure that Feed(Water) meets the standards you must not start PQ of PSG.

3

if you have done all utilities qualification except the PS. I suggest you to validate as water, so, with 3 stages and during one year. You can assess your critical seasons stages where you should carry out a tightened sampling and with the results establish a routinary sampling program.

4

It is mandatory (FDA and EC) that steam quality is validated at least annually.
It is essential to validate:-

Distribution is adequate/dryness/superheat/none condensable gases.
further details are available at
www.validation-online.net/steam-quality.html

Regards
Ale

5

I have a bit different opinion than Durga Prasad with regard to usage of water (PFW/WFI). Water can be used for the purpose other than commercial production after satisfactorily passing in phase one validation. Further it can be used for commercial production after sucessful run of phase two validation.
I agree with alex for requirement of steam quality revalidation annually but need not be at all user points. It can be selected /decided based on criticality of user point.

6

I have the same question with Hameeda,if we do the PQ on 3 phases like water(PW/WFI),if there are a lot of use points, the sampling will be very large and measuring will take up much time, even have no time to complete sampling in one day.

7

In addition
Three other quality test is required

  1. Non -Condensable gases (NMT 3%)
  2. Super heat (NMT 25ºC)
  3. Dryness fraction (>0.90 for liquid load and > 0.95 for metal load)

All the above parameters affact the sterilization process carried out by pure steam (moist heat steriization)