Sterile area change rooms

Quality Assurance
1

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

Thanks

2

Dear All,
Any response!!

Thanks

3

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

2 Likes
4

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.

5

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

Thanks

6

Yeah sir,there is no activity.
Regards
Rakesh Kumar chowdhary

7

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

8

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

9

Yeah sir.