Standard operating procedure for changing clothes before entering in the pharmaceutical industry is describe in this post.
OBJECTIVE:
To define a procedure
for entry and changing of clothes in change room as a routine procedure in a
pharmaceutical industry.
SCOPE:
This is applicable to all
the personnel, employees and visitors of the pharmaceutical industry.
RESPONSIBILITY:
Executives, office
staff, engineers, workers, and visitors.
ACCOUNTABILITY:
Head of the Department.
PROCEDURE:
PRECAUTIONS:
PERSONAL HYGIENE:
Shower each day before
entry.
Control dermatitis and
dandruff.
Do not smoke before or
after entry.
No chewing gum or
tobacco.
No cosmetics, jewelry
or wrist watches should be worn.
Leave all personal
items in changing room (wallets, keys, comb, etc).
Avoid coughing and
sneezing if unavoidable leaves the clean room.
Do not move vigorously
because brisk movements shed large particles from body movement.
DRESS CODE AND HYGIENE:
Color coding of uniforms:
White:
Production/ Office staff.
Sky
blue: Quality control/ Quality assurance/ Office staff.
Off-white:
Microbiology/
Office staff.
Brown:
Engineering.
Steel
grey: Warehouse.
Moss
green/ disposable garments: Visitors.
Garments should be changed
and washed once in a week.
Dress should be worn
properly.
Visitors gown can be
dispose of after use.
In emergency situation
extra uniform or dress should be available for use.
GOWNING:
Gown should be lint
free and non-shedding.
Gown include jacket,
trouser, cap face mask, beard or moustache cover, gloves, dedicated shoe and
shoe covers, socks.
Gown should be worn
properly.
After use should be
placed in a proper bin.
METHOD:
Wash hands with liquid
soap and dry with hand dryer at the entrance of change room.
Disinfect hands with
2.5% Dettol and enter into the change room
Sitting on the step
over bench outside shoes shall be removed, and shoes dedicated for grey side of
step over bench shall be put on.
The outside shoe shall
be kept in the locker at the change area.
The outside clothes
shall be removed, kept in locker.
Half sleeves T-shirt
shall be put on.
The shoes dedicated for
grey side of step over bench shall be kept in the grey side box of the step
over bench before crossing it.
Sitting on the step
over bench it shall be crossed swinging the leg over the bench.
The shoes dedicated for
white side of step over bench shall be put on.
Then, attire shall be
put on in the following sequence:
Put
on the colored cap which is dedicated to each department accordingly, to
completely cover hair and ears.
Wear
colored jacket and then colored trouser, accordingly. Tuck the shirt in the
trouser.
Put
on socks and shoes dedicated for area.
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