In OSd we check our area qualification after 3 mnths.
In sterile area particle count is the part of routine work before start up.
In MNC company online particle counter on filling line is mandatory.
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Frequency of offline particle counting
Grade A: before and after activity.
Grade B: daily
GradeC:weekly
Grade D: monthly
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Can we manufacture tablet in unclassified area?
For GMP compliance Tab mfg must take place in class D
Is it mentioned in any guideline?
D at rest.During mfg due to dust generation particle count increases
Have u return riser in grade D area?
yes we have
What is cleaning frequency of return riser?
Have u read in any guideline for D area requirement for OSD?
on return grils we have aluminium washable filters and washed aftrr every product chang over
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Our SOP require Class D at rest for OSD.for this we have HEPA filters in All areas.
il try to provide guidline ref as soon
How many air changes per hour required for class D area?
Room pressure of granulation and compression will be positive or negative?
5-48 ACPH
in granulation and comp room pressure negative
In which working area more acph required?
in OSD primry mg areas hve dusty enverionment so purpose of diff prezzure is to prevent cross contamination.mean powder from one area should no come out to buffer area or coridors
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In OSD?or over all.?
over all in sterile area.
in OSD
more in granulaton bcz hve more dusty env.
then Comp
then coating.