SOP FOR MANUFACTURING OPERATION START UP AND SHUT DOWN IN THE AREA
OBJECTIVE: To lay down the procedure for Manufacturing Operation start up and close down the activity.
SCOPE: This procedure is applicable for activities to be carried out before start up and after close down the Activity..
RESPONSIBILITY: It is the responsibility of operator and production supervisors to follow the procedure as prescribed in this SOP.
Officer Production/Supervisor or designee is responsible for execution of SOP and maintaining the records.
Technician/Officer or designee of engineering department is responsible for the maintenance/repair work of the machine if any break down occurs during the operation.
Manager/Executive or designee of Production department is responsible for giving the training on regarding tasks and review the related records.
ACCOUNTABILITY: Head of the Production Department.
PROCEDURE:
Before start up and after shutdown:
Washing area:
Check the cleanliness of purified water valves.
Check cleanliness of SS pots and lids.
Granulation area:
Check relative humidity and temperature of the area.
Check proper cleaning of the machine and its accessories.
Check proper power, compressed air and water supply.
Check proper fitting of machine change parts.
Check all equipment required to start compounding and get them thoroughly washed and rinsed with purified water.
Dry syrup filling machine:
Cleaning of area with disinfectant solution at least twice.
Check working of conveyor and filling machine.
Check grease in filling machine.
Check the pressure of room corridor.
Check temperature of the filling room.
Get area cleaned before starting fumigation.
Induction sealing machine:
Cleaning of area with disinfectant solution
Run machine without bottles for few minutes. Observe any abnormal sound.
Take trail of sealing of bottles.
Lubricate the machine & keep ready for use.
Inspection table:
Cleaning of area with disinfectant solution
Keep batch ready in inspection table.
Remove labels of the product other than those that are under inspection.
Take run of machine.
Labeling machine:
Cleaning of area with disinfectant solution
Keep batch and labels ready for labeling on the first day of the startup.
Remove previously labeled products from area.
Check all accessories required for labeling.
Packing line:
Cleaning of area with disinfectant solution
Keep packing materials, batch ready for packing.
Check all accessories required for packing.
Confirm line clearance before packing start up.
Compression Machine:
Cleaning of area with disinfectant solution
Check the granules container for proper product batch details.
Keep the two plastic containers/SS containers with double polybags below the discharge chute of De-duster machine.
Charge the granules in both the hoppers; rotate the wheel by hands to fill the feed frame with Powder.
Rotate the machine and disposed of the tablets compressed of initial two to three rounds.
Set the parameters as per specification given below Start the compression machine as per their respective SOP and set the compressed tablet parameter as per specification. All parameters should meet the specification. Check each individual tablet from LHS & RHS for physical test parameters and record in the provided table. During tablet parameter setting all compressed tablets shall be collected in a poly bag and shall be discarded as non-recoverable rejects. Bring the all containers of lubricated granules in compression area.
Auto Coating Machine:
Cleaning of area and drain with disinfectant solution.
Ensure the cleanliness of the coating solution preparation area, equipments, scoop and other accessories and ensure that it is free from the remains of the previous Batch / Product.
Check and ensure that all persons shall follow the gowning procedure.
What work is happening in the area and for which product with another details like Batch No, Mfg. date, Expiry date, Batch Size etc. update this on area status board.
Check and ensure that all activity is done as per respective SOP.
Close down procedure:
Intimate to Engineering department for switch OFF the dehumidifier and air conditioners.
Intimate to Engineering department for switch OFF the exhaust system of the department.
Switch OFF the switches of all the equipment.
Check that the water taps are closed properly.
Check that the vacuum valves are closed properly.
Check that the compressed air valves are closed properly.
Check that all balances are switched OFF.
Switch OFF all the lights of cubicles.
Switch OFF the computers.
Check the following points for cleanliness
All in process containers are closed and cleaned from outside.
All the machines in the department are cleaned and mains of machine are switched OFF.
Floor of all the area is cleaned.
Walls of the manufacturing/filling cubicles.
Switch OFF all the main switches except production office cabins and the main corridor. (Section to be locked if instructed by the department head).
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.
Take a sticker and collect the main key of the department.
Mark the safety points observation on the safety checklist.
Switch OFF all the lights of the main corridor, production office and finally the main switch.
Lock the department.
Hand over the keys at the security gate.
At the end of the day’s work, the officer has to check cleanliness and safety check point. Any abnormal observation or deviation should be informed to the department head.