Sterile area change rooms

Is it ok, to have common changing rooms (Primary/ surgical garment) for entering and leaving clean area? or separate change room is must!!


Dear All,
Any response!!


Sir, some companies are already in practice to have separate Entrance and exit . This will reduce or minimize the risk of bioburden to clean rooms.
Some cGMP regulatory expectations to have separate Entrance and exit .
This will allow to manage your clean room at atmost clean .
Even we have followed by 2010 to set up cepha facility at that time.

Common air lock ( remove street garments, slippers)

Change room 1st (entrance)
( hand sanitizer with primary Gowns)

Change room 2nd (entrance)
(hand sanitizer with secondary Gowns)
Room air lock- only stabilization no activity

Corridor /passage

Change room 1st (exist air lock)
No activity
Change room 2nd (exit to degown )

Finally common change Room to collect your street wears


This is correct way of entry and exit of aseptic area. it is acceptable by USFDA. exit change room 1 is used for gown swab procedure at time of exit.

Dear Mr. Rakesh,
can “Room air lock- only stabilization no activity”----Will be same for entry and exit?


Yeah sir,there is no activity.
Rakesh Kumar chowdhary

stabilization air lock is also known as buffer air lock, it should be separate room for entry and exit.

Thanks but, I mean to ask that is the "Airlock "
Can be common airlock for both entry and exit??

Yeah sir.