Hi Zahiruddeen. That immediate space surrounding your Grade A LFH must be Grade B per EU GMP Annex 1:
Grade B: For aseptic preparation and filling, this is the background cleanroom for grade A (where it is not an isolator).
Sincerely,
Tim Cser
Senior Technology Specialist
MilliporeSigma
916-759-1401
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Sent: Tuesday, February 28, 2023 6:24 AM
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Subject: [PMFLIST] MLT Testing area
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Dear all,
is it mandatory to LAF(Class-A) background area should be class -C(OSD)testing facilities.
Regards,
Zahiruddeen
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