DOUBLE DOOR STERILIZER CABINET TYPE

1. PURPOSE

It is established to provide a procedure for proper sterilization of empty ampoules and Vials.

2. SCOPE

It is applicable in Injectables & Dry Powder manufacturing section.

3. RESPONSIBILITY

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

4 PROCEDURE

The Dry Heat Sterilizer (Cabinet Type) with instrument is handled in the following way.

5. MAINTENANCE

MONITORING OF MACHINE MAINTENANCE:

Time to time check each and every part of Double Door Sterilizer according to the maintenance schedule.
Check the following parts carefully.
 Electric motor
 Electric Heater
 V , Belt
 Shaft and Bearing
 Blowers
 Magnetic Contactor
 Temperature Controller
 Thermo couples
 Timer
 Door Seals
This activity is then documented in the form Machinery & Equipment Maintenance Log
Check the Double Door Sterilizer condition time to time to find any kind of problem during operation.
All the monitoring record is filed and kept by the Maintenance Supervisor.
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.
PRECAUTIONS:
Never open the door of the sterilizer during running condition.
Never open the door of the sterilizer in the sterile area until the doors in the non sterile area is properly locked and closed.
Always wear protective gloves when handling the dry heat sterilizer.