Preventive Maintenance of Rapid Cooling Steam Sterilizer
1.0 Objective
To lay down a procedure for the Preventive Maintenance of Rapid Cooling Steam Sterilizer.
2.0 Scope
This Standard Operating Procedure is applicable for Preventive Maintenance of Rapid Cooling Steam Sterilizer to be followed at formulation plants
3.0 Responsibility
3.1 Officer / Executive Engineering shall be responsible for the execution of this procedure.
3.2 Engineering Manager shall be responsible for the implementation of this SOP.
3.3 Head QA/designee shall be responsible for the compliance of this SOP
4.0 Abbreviations and Definitions
SOP : Standard Operating Procedure etc
No : Number
QA : Quality assurance
Qty : Quantity
ER : Engineering
5.0 Procedure
5.1 General Conditions
5.1.1 Refer the master plan of preventive maintenance.
5.1.2 Equipment shall be available for preventive maintenance.
5.1.3 Clean oil / grease stains & remove unwanted material, spares after Completion of work.
5.2 Precautions
5.2.1 Use necessary safety wears, while doing the work.
5.2.2 Ensure covers & guards are properly fixed.
5.3 Procedure for Preventive Maintenance of Steam Sterilizer (Autoclave).
5.3.1 Ensure that electrical supply is in off position in main panel and display “Under Maintenance” Board on the panel board.
5.3.2 Switch OFF the drive unit and inform all the concerned.
5.3.3 Operator or above has to ensure and verify the check points for the preventive maintenance as shown in the Annexure-1 &2.
5.3.4 After the completion of preventive maintenance, check the machine for smooth operation.
5.3.5 Remove “Machine under Maintenance” Board on the panel board after completion of the Maintenance.
5.3.6 The operator / technician who perform the job will enter his name / sign in “Done By” Column and
responsible Engineer/ Officer and Officer – Production will put sign in “Checked by” column.
5.3.7 Half yearly maintenance will include the jobs of Quarterly maintenance.
5.3.8 Quarterly Preventive Maintenance is to be carried out as per the following check points.
5.3.8.1 Check all the nuts and bolts for any looseness if loose tighten it.
5.3.8.2 Check the compressed air line for any leakage.
5.3.8.3 Check the condition of the gaskets for physical damage and replace them if required.
5.3.8.4 Check the vacuum line for any leakage.
5.3.8.5 Check the Steam line for any leakage.
5.3.9 Half Yearly Preventive Maintenance is to be carried out as per the following check points.
5.3.9.1 Overhaul the Vacuum pump & replace the bearings if required.
5.3.9.2 Check all electrical connections for any loose connections, burned contacts, signs of Overheated wires etc.
5.3.9.3 Check all interlocking.
5.3.9.4 Overhaul the electrical panel.
5.3.9.5 Check all the pneumatic valves.
6.0 Forms and Records
6.1 Quarterly Preventive Maintenance Check List of Rapid Cooling Steam Sterilizer- Annexure-1
6.2 Half Yearly Preventive Maintenance Check List of Rapid Cooling Steam Sterilizer Annexure-2
7.0 Distribution
7.1 Master copy – Documentation Cell (Quality Assurance)
7.2 Controlled copies – Engineering Department
