1.0 PURPOSE
It is established to provide a proper procedure for sterilizing different products in Autoclaving section (INJECTABLES).
2.0 SCOPE
It is applicable in Autoclaving section (INJECTABLES).
3.0 RESPONSIBILITY
Maintenance officer (Mechanical / Electrical)
Maintenance Supervisor (Mechanical / Electrical)
4.0 PROCEDURE
The Autoclave Injectables with instrument is handled in the following way.
5.0 MAINTENANCE
5.1 MONITORING OF MACHINE MAINTENANCE:
Time to time check each and every part of Autoclave Injectables according to the maintenance schedule.
Check the following parts carefully.
vSteam Valve
vTemperature Controller
vThermocouples
vDoor Gaskit
vSafety Valve
vLubrication & Adjustment of Handle rods.
This activity is then documented in the form Machinery & Equipment Maintenance Log
Check the Autoclave 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:
the pressure should be maintained slowly to the desired pressure through out the process.
Increase and release the pressure gradually to the desired temperature.
At the end of the process slowly release the steam pressure.
Check the Autoclave’s safety valves, pressure gauges etc, time to time to meet any kind
of abnormality during operations.
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