We have a filling room class B, where filling of sterile injectable solution in glass vials is taking place. Outside the filling room we have 3 air-locks class B,C,D in row. In the filling room we have 15 filters.
We want to know the procedure to do smoke test in that room…We also have a FOG generator machine.
thank a lot
Smoke test should be performed with Titanium Tetra chloride and the same should be Video recorded.
There is a requirement of metal rod (any) & cotton / cotton cloth
Put the TiCl4 on cotton, which generates a smoke and this will be keep at air flow supply into the area (normally AHU supply grills) and check for the smoke should go into a sequential motion (no dead pockets) to the return grill.
All the process will be video recorded.
TiCl4 should be handled carefully with Acid Resistant gloves.
Why wouldn’t you just use dry ice? there are no residuals with that. that stuff seems scary to me.
We’ve been using, for several years now, fog machines. Safe, cheap, and effective. And we’ve only been taking pictures, not videos. Videos are cool and all, but you can’t attach it to a protocol…
Are there any detailed procedures available on what to look for when executing a smoke test - I have seen general guidelines to look for stagnation and excessive turbalence, but my experience of smoke tests so far is that they are very subjective. I’d be interested in getting some more objective tests.