Fungus limit for Aseptic area

Dear All,

Our manufacturing facility is manufacturing Aseptically filled sterile inject able. Is there any guideline have separate limit of fungus? Please guide.

Dear All,

Still I am waiting for the answer.

Sanjay

Please visit
https://www.pharmaguideline.com/2014/01/fungal-count-in-air-of-sterile-area.html

2 Likes

Hi There is no fungal limit separately, but if u give fungal count u should answer what is source of fungus in clean area, u are having 0.45 HEPA, fungal size is much bigger than that, then where it comes from??man movement leads to bacteria like staph and some other bacteria can be accepted but source of fungal is unanswerable…

hi
i have a question
i read the content for fungal specification but as the same of all contents in microbiological subjects i cant find the source of the subject.
please lead me.
thank you

Why we are doing postwetting and prewetting with Peptone Water in membrane filtration method? I want detailed answer

Fugal growth in the manufacturing facilities are not acceptable, that’s why there are no limits to it. If you get the fungal counts, find, kill and remove it.

1 Like

ECA recommends to specify a limit for fungi alone (e.g. 50% of total microbial count limit of room grade)