1.0 OBJECTIVE:
To
lay down the procedure of fumigation in production area by using 5 %
Gramicid and Fogger.
2.0 SCOPE:
This
SOP shall be applicable for all the area of Production.
3.0 RESPONSIBILITY:
3.1 Execution
: Operator
3.2 Checking :
Production Pharmacist & Above
4.0 ACCOUNTABILITY:
HOD-Production / Assigned Designee
5.0 PROCEDURE:
5.1 Fumigation
should be carried out at the end of the production operation twice in a
month and whenever required.
5.2 Production
person shall ensure that raw Material, finished goods, intermediates or in
process goods should not be present in area of Fumigation. If present cover all
the materials with polythene bags.
5.3 Always use
nose-mask and Goggles while doing fumigation as Gramicid is irritating to
human eye.
5.4 Windows,
doors should be closed; AHU’s should be switched off before starting fumigation.
5.5 Place 5%
Gramicid in the fogger and switch “ON” the fogger.
5.6 After
fumigation of area is complete, Switch “OFF” the fogger and affixed the label
as “Area under fumigation, do not enter” on every side of the
entrance. Allow the fumigation fumes to stay for about 6-7 hrs.
5.7 After the
specified time of fumigation is over, enter the area only by starting exhaust
for about 30 minutes.
5.8 Conduct
cleaning before processing any product in the concerned area.
5.9 After 30
minutes, start the AHU’s allow to stabilize to attend required temperature and
humidity then start the routine production operation.
5.10 Fill the
“Fumigation Record”.
6.0 ABBREVIATIONS:
6.1 SOP:
Standard Operating Procedure
6.2 Q.A.:
Quality Assurance
6.3 HOD: Head
of The Department