Startup and close down procedure of manufacturing area

1.0 Objective
To lay down a procedure for startup & close down of manufacturing area.
2.0 Scope
This Standard Operating Procedure is applicable for start up and close down procedure of manufacturing area at ABC company.
3.0 Responsibility
3.1 Officer Production
3.2 Head Production
4.0 Abbreviations and Definitions
SOP : Standard Operating Procedure
PC : Production Capsule
F : Format
No. : Number
5.0 Procedure
5.1 Before start up & after shutdown
5.1.1 Washing area
5.1.1.1 Check the cleanliness of purified water valves.
5.1.1.2 Check cleanliness of SS pots & lids.
5.1.2 Granulation area
5.1.2.1 Check relative humidity & temperature of the area.
5.1.2.2 Check proper cleaning the machine and its accessories.
5.1.2.3 Check proper power, compressed air & water supply.
5.1.2.4 Check proper fitting of machine change parts.
5.1.2.5 Check all equipment required to start compounding & get them thoroughly washed and

rinsed with purified water.
5.1.3 Capsule filling machine.
5.1.3.1 Cleaning of area with disinfectant solution at least twice.
5.1.3.2 Check working of filling machine.
5.1.3.3 Check grease in filling machine.
5.1.3.4 Check the pressure of room & change rooms.
5.1.3.5 Check temperature of the filling room.
5.1.3.6 Get area cleaned before starting fumigation.
5.1.4 Blister / strip machine:
5.1.4.1 Cleaning of area with disinfectant solution at every day.
5.1.4.2 Check the temperature & relative humidity of the room.
5.1.4.3 Keep separate the blister / strip under sealing roller.
5.1.4.4 Recheck all the process parameter after restarting the machine.
5.1.4.5 Get area cleaned before starting fumigation.
5.1.4.6 Check proper fitting of machine change parts.
5.1.5 Packing line
5.1.5.1 Keep packing materials, batch ready for packing.
5.1.5.2 Check all accessories required for packing.
5.1.5.3 Confirm line clearance before packing start up.
5.2 Close down procedure
5.2.1 Intimate to maintenance department for switch OFF the dehumidifier & air conditioners.
5.2.2 Intimate to maintenance office for switch OFF the exhaust system of the any department.
5.2.3 Switch OFF the switches of all the equipment.
5.2.4 Check that the water taps are closed properly.
5.2.5 Check that the vacuum valves are closed properly.
5.2.6 Check that the compressed air valves are closed properly.
5.2.7 Check that all balances are switched OFF.
5.2.8 Switch OFF all the lights of cubicles.
5.2.9 Switch OFF the computers.
5.2.10 Check the following points for cleanliness
5.2.11 All in process containers are closed & cleaned from outside.
5.2.12 All the machines in the department are cleaned & mains of machine are switched OFF.
5.2.13 Floor of all the area is cleaned.
5.2.14 Walls of the manufacturing / filling cubicles.
5.2.15 Switch OFF all the main switches except production office cabins & the main corridor.

Section to be locked if instructed by the department In charge
5.2.16 if any section to be locked collect the keys from the department keyboard, lock it and put it

back on its appropriate no. on the keyboard.
5.2.17 Take a sticker & collect the main key of the department.
5.2.18 Mark the safety points observation on the safety checklist.
5.2.19 Switch OFF all the lights of the main corridor, production office & finally the main switch.
5.2.20 Lock the department & seal the lock by a signed sticker.
5.2.21 Hand over the keys & safety checklist at the security gate.
5.2.22 At the end of the day’s work, the officer has to write a daily check cleanliness & safety check report.

Any abnormal observation or deviation should be given in writing of the department head / security.
6.0 Forms and Records
6.1 None
7.0 Distribution
7.1 Master Copy – Documentation Cell (Quality Assurance)
7.2 Controlled Copy – Production Department
8.0 History