SOP for Preventive Maintenance of Instrument

1.0 OBJECTIVE

To lay down a procedure for the Preventive Maintenance of Instruments.

2.0 SCOPE

This SOP is applicable for preventive maintenance of Laboratory instrument (other than HPLC) in Quality Control, Pharmaceutical Manufacturing.

3.0 RESPONSIBILITY

Officer/ Executive - Quality Control

4.0 ACCOUNTABILITY

Manager – Quality Control.

5.0 PROCEDURE

5.1 General Precaution/ Safety:

5.1.1 Switch OFF the instrument before the starting of preventive maintenance
5.1.2 After preventive maintenance is over, switch ON the instrument and check the voltage supply.

5.2 Analytical Balance

5.2.1 Clean the weighing pan with the help of a lint-free cloth.
5.2.2 Check the door for free movement. Clean the door path, if required with the help of a lint-free cloth soaked in Methanol and wipe immediately with the help of dry lint free cloth.
5.2.3 Open the cover of the equipment and check all the connector and rectify any loose contact if observed. Clean the PCB with a vacuum cleaner and lint free cloth soaked in carbon chloride. Check the voltage on power supply card. Remove all the dust from the instrument using a vacuum cleaner. Close the cover of the equipment and insure proper leveling of the equipment.
5.2.4 Close the cover the instrument and check proper start up of the instrument.

5.3 UV Spectrometer

5.3.1 Open the cover of the instrument and clean the instrument with the help of lint free cloth soaked in Methanol / Isopropyl alcohol and wipe immediately with dry lint free cloth and clean all PCBs with the help of vacuum cleaner. Check all the connector for proper contact and rectify any loose connection if observed. Check the voltage on power supply card.
5.3.2 Clean the sample compartment with the help of lint free cloth.
5.3.3 Check the UV and Tungsten lamp for ignition.
5.3.4 Check and cleaned the optical system.
5.3.5 Check the filter wheel and it drive mechanism for jerk free operation and rectify it if required.
5.3.6 Close the cover of the instrument.

5.4 Fourier Transform Infrared Spectrophotometer (FTIR)

5.4.1 Open the cover of the instrument. Clean the instrument with the help of lint free cloth soaked in Methanol / Isopropyl alcohol and wipe immediately with dry lint free cloth.
5.4.1 Check all wiring connection. Check all the connector and rectify my loose connection if observed.
5.4.3 Clean the PCBs with the help of vacuum cleaner. Check reference voltage on the power supply card. Check and clean the optical supply.
5.4.4 Clean the fan inside the cabinet with free cloths.
5.4.5 Clean sample compartment with dry lint free cloth.
5.4.5 Close the cover of the instrument and check proper start up of the instrument.

5.5 Polarimeter

5.5.1 Clean the instrument with the help of lint free cloth soaked in Methanol / Isopropyl Alcohol and wipe immediately with dry lint free cloth.
5.5.2 Open the cover of the instrument. Clean the sample compartment with lint free cloth. Check all the reference voltage on power board. Check all the connector and rectify any loose connection if observed.
5.5.3 Check and clean the cabinet fans.
5.5.4 Check the cover of the instrument and check for proper startup of the instrument.

5.6 Gas Chromatography

5.6.1 Clean the instrument with the help of lint free cloth soaked in Methanol /Isopropyl alcohol and wipe immediately with dry lint free cloth.
5.6.2 Open the cover of the instrument. Clean the instrument with a vacuum cleaner, lint free cloth. Clean all the PCBs with a vacuum cleaner. Check all the reference voltage on power board. Check all the connector and rectify any looses connection if observed.
5.6.3 Check the gas line for leakage and rectify if found.
5.6.4 Check and insure proper ignition of the flame.
5.6.5 Check injector for proper needle insertion and syringe movement.
5.6.6 Close the cover of the instrument and proper start up of the instrument.

5.7 Melting Point Apparatus

5.7.1 Clean the instrument with the help of lint free cloth wipe immediately with dry lint free cloth.
5.7.2 Check and clean PCB. Check all the connector and rectify any looses connection if observed.
5.7.3 Check and cleaned measuring slots in the cell interior.

5.8 Auto Titrator

5.8.1 Clean the instrument with the help of lint free cloth soaked in Colin solution and wipe immediately with dry lint free cloth.
5.8.2 Check all the fitting tubes. Check all the connector and rectify any loose connection if observed.
5.8.3 Check the burette movement.
5.8.4 Check stirrer motor for proper operation.

5.9 Leak Test Apparatus

5.9.1 Clean the instrument with the help of lint free cloth soaked in Methanol / Isopropyl Alcohol and wipe immediately with dry lint free cloth.
5.9.2 Check the leveling leg screw of the equipment and ensure leveling of the instrument.
5.9.3 Check and insure proper spindle mounting.
5.9.4 Check and insure proper operation of speed adjusting knob.

5.10 Muffle Furnace

5.10.1 Clean the instrument with lint free cloth.
5.10.2 Check the temperature controller and sensor for proper operation. Check the heating elements and insure it proper connection.
5.10.3 Check the furnace compartment for damage of firebrick and rectified if required.

5.11 Vacuum Oven

5.11.1 Clean the instrument with the help of lint free cloth soaked in Methanol / Isopropyl Alcohol and wipe immediately with dry lint free cloth.
5.11.2 Check the door for proper closing and sealing. Check the gasket of the door.
5.11.3 Check the vacuum pump and replace the oil, if required. Check the vacuum tubing.
5.11.4 Check the heater connection and insure proper working of thermostat /temperature controller.

5.12 Autoclave

5.12.1 Clean the instrument with the help of lint free cloth soaked in Methanol / Isopropyl Alcohol and wipe immediately with dry lint free cloth.
5.12.3 Check wiring connection. Check and insure proper sequencing of input/output of the PLC. Check the safe line of the instrument.
5.12.4 Check the door for proper closing and inter locking. Check the gasket of the doors.
5.12.5 Check the boiler heater. Check safety valve of the boiler.
5.12.6 Check vacuum pump and rectify any leakage if required.

5.13 General Procedure

5.13.1 Record the observation preventive maintenance log (Reference annexure –I).
5.13.2 Inform the discretion observed, if any, to QC – Manager.
5.13.3 Preventive maintenance shall be performed at every three-month ± 15 days.
Related: Qualification of Systems and Equipments in Pharmaceuticals

6.0 ABBREVIATIONS

6.1 SOP - Standard Operating Procedure
6.2 PLC - Programming Logic Controller
6.3 PCB - Printed Circuit Board
6.4 UV - Ultra Violet

ANNEXURE-I 

Format No. ____________

PREVENTIVE MAINTENANCE SCHEDULE CUM REPORT Instrument        : Instrument No. : Frequency        : Quarterly
S. No.	Check point	Preventive Maintenance Schedule Cum Report
Preventive Maintenance Done On
Signature/ Done By
Remark
Next due on
Checked By

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