AMPOULE FILLING MACHINE

1.0 PURPOSE

It is established to provide a procedure for proper filling and sealing of ampoules.

2.0 SCOPE

This is applicable for proper filling and sealing of Ampoule in the liquid Injectables manufacturing section.

3.0 RESPONSIBILITY

Maintenance officer (Mechanical / Electrical)
Maintenance Supervisor (Mechanical / Electrical)

4.0 PROCEDURE

The Ampoule Filling Machine with instrument Code No. is handled in the following way.

5.0 MAINTENANCE

5.1 MONITORING OF MACHINE MAINTENANCE:

Time to time check each and every part of Ampoule Filling machine according to the maintenance schedule. Check the following parts carefully.
vElectric motor
vElectric Starter
vV, Belt
vBearing and Shafts
vBushes
vFilling Cylinder
vFilling Nozzles
vWorm and Gears

This activity is then documented in the form Machinery & Equipment Maintenance Log Check the Ampoule Filling machine condition time to time to find any kind of problem during operation.
All the monitoring record is filed and kept by the Maintenance Supervisor.
5.2 EMERGENCY / BREAKDOWN MONITORING:

Maintenance Manager receives Maintenance Work Order duly signed by the section incharge of the concerned machinery or equipment.
Maintenance Work Order is assigned a number according to the receiving in the Maintenance Reference Register.
Maintenance Manager assigns the maintenance work to the concerned personal
After the completion of work the section incharge signs the completion of Work Order.
All the record is filed and kept by the Maintenance Supervisor.
6.0 PRECAUTIONS:

Care should be taken while lighting burner to prevent any fire accidents.
Always wear protective gloves when handling the dry heat sterilizer.
Lubricate the required parts regularly.