Category: Engineering SOP

SOP Title: Operation of Air Conditioning Plant

 

1. Objective:

To lay down a procedure for the Operation of Air Conditioning Plant.

2. Scope:

This procedure is applicable for the Operation of Air Conditioning Plant installed at site.

 

3. Responsibility:

3.1 Engineering Department: To prepare and review the SOP. To follow the procedure laid down   for the Operation of Air Conditioning Plant as per this SOP.

3.2 Quality Assurance Department: To review and approve the SOP and Annexes. To ensure the compliance to the SOP.

4. Accountability:

Head, Engineering Department / Head, Quality Assurance Department.

5. Procedure:
   • Definitions:

5.1.1  Engineering Associate: Executive or Operator of Engineering Department trained to perform duties as per this SOP.

• Preventive Maintenance: Maintenance activity performed to ensure that the equipment will function smoothly and to avoid breakdowns. These activities are performed as per predefined frequency.

 5.2.    Operational Procedure:               

	Safety Precautions/Instructions:
5.2.1	Wear appropriate Personal Protective Equipment while operating the Air Conditioning Plant.
5.2.2	Ensure all the electrical connections are properly earthed. Ensure the power plug of the Air Conditioning Plant is fixed in the socket properly.
5.2.3	Inspect electrical cables and connectors for any sign of damage.
5.2.4	Ensure that the ON/OFF push button is working properly.
5.2.5	Check for any leakages.
5.2.6	Do not leave the compressor for the first 15 minutes after starting.
	Operation:
5.2.7	Check the oil level in the compressor.
5.2.8	Check the pulley belt Tension.
5.2.9	Check the chiller water line valve is open.
5.2.10	Check the condensate water supply line valves of Air Conditioner Compressor are open.
5.2.11	Solenoid switch should be “ON” position.
	Sequence of operations:
5.2.12	Switch “ON” the main electric line located on the electric panel board located in the utility section.
5.2.13	Start the cooling tower fan by pressing Green push button.
5.2.14	Start the condensate pump by pressing Green button.
5.2.15	Start the chiller pump and wait for two or three minutes to circulate the water in all lines.
5.2.16	Start the Air Conditioner Compressor by pressing Green button and then the toggle switch in clock wise direction and wait for one or two minutes, for knocking sound, if knocking sound is there, close the unit immediately and verify the sound and restart the Air Conditioner Compressor until there is no sound.
5.2.17	Put “ON” the Low Pressure switch located on panel board in clock wise direction.
5.2.18	Make sure that the required temperature is maintained and temperature of delivery pipe is correct (8 ºC to 12º C).
5.2.19	Check the pressure of condensate which should be remained within the limit and air conditioning plant smooth working.
	Shutdown of Air Conditioning Plant:
5.2.20	While stopping the plant, unload the compressor by pressing toggle switch in anti clockwise direction of Low Pressure on the panel board.
5.2.21	Switch “OFF” the toggle switch in anti clockwise direction of the solenoid valve.
5.2.22	Switch off the main electrical supply.
	Preventive Maintenance:
5.2.23	Perform the Preventive Maintenance as per Annexure.
5.2.24	Affix the “Preventive Maintenance Status Label” on the Air Conditioning Plant as per SOP.
5.2.25	If Preventive Maintenance activity is outsourced, the observations are to be transcribed in the Annexure and external party certificate to be attached.
	Action Plan During Breakdown of Air Conditioning Plant:
5.2.26	If any breakdown occurs, inform Head of the Department and Quality Assurance Department. Put the tag “Equipment Under Maintenance, Do Not Start” and inform the Service Engineer for rectification.

6. Abbreviation:

Abbreviation	Expansion
UTL	Utility
º C	Degree Celsius
AC	Air Conditioner
FRP	Fibreglass Reinforced Plastic

  

*Note – Ready to use SOP available in “DOWNLOAD” Section.

 

SOP Title: Heating, Ventilation and Air Conditioning System (HVAC)

 

1. Objective:

To lay down a procedure for the Operation of Heating, Ventilating, and Air Conditioning (HVAC) System for the respective unit in different user sections.

2. Scope:

This procedure is applicable for the Operation of Heating, Ventilating, and Air Conditioning (HVAC) System for the respective unit in different user sections.

3. Responsibility:

3.1 Engineering Department: To prepare and review the SOP. To follow the procedure laid down   for the Operation of Heating, Ventilating, and Air Conditioning System as per this SOP.

3.2 Quality Assurance Department: To review and approve the SOP and Annexes. Ensure the compliance of the SOP.

4. Accountability:

Head, Engineering Department / Head, Quality Assurance Department.

5. Procedure:
   • Definitions:

5.1.1   Engineering Associate: Executive or Operator of Engineering Department trained to perform duties as per this SOP.

5.1.2 Preventive Maintenance: Maintenance activity performed to ensure that the equipment will function smoothly and to avoid breakdowns. These activities are performed as per predefined frequency.

 5.2.    Operational Procedure:              

	Safety Precautions/Instructions:
5.2.1	Wear appropriate Personal Protective Equipment while operating the Heating, Ventilating, and Air Conditioning System.
5.2.2	Ensure all the electrical connections are properly earthed. Ensure the power plug of the Heating, Ventilation and Air Conditioning System is fixed in the socket properly.
5.2.3	Inspect electrical cables and connectors for any sign of damage.
5.2.4	Ensure that the ON/OFF push button is working properly.
	Operation:
5.2.5	Start the circulation of water system pump by pressing Green push button of the starter.
5.2.6	Ensure that the supply of chilled water to AHU/HVAC is indicated by the pressure gauge.
5.2.7	Put ON the chiller plant by pressing toggle switch on the panel board.
5.2.8	Ensure that the chilled water inlet temperature of the cooling coil is in the range of 8 0C -12 0C.
5.2.9	Switch ON the Miniature Circuit Breaker.
5.2.10	If the above steps are performed satisfactorily, switch ON the main switch of the AHU/HVAC by pressing Green button of the starter.
5.2.11	Put ON the respective De-Humidifier by rotating Green knob in clockwise direction by manual mode.
5.2.11	Wait till the orange indicator light beeps. (This will energize Fan motors, Bed drive motor and Reactivation electric heaters).
	Shut Down of HVAC System:
5.2.12	Put OFF the respective dehumidifier by rotating Green knob in to anticlockwise direction in OFF mode.
5.2.13	Wait for five minutes until the electrical heater cools down to lower temperature of the heater.
5.2.14	Switch OFF the starter by pressing the Red bottom of starter.
5.2.15	Switch OFF the Miniature Circuit Breaker.
5.2.16	Put OFF the chiller plant by pressing toggle switch located on the PLC board.
5.2.17	Stop the chilled water circulation by switching off water pump located in the utility room.
	Preventive Maintenance:
5.2.18	Perform the Preventive Maintenance as per Annexure.
5.2.19	Affix the “Preventive Maintenance Status Label” on the Heating, Ventilation and Air Conditioning System as per SOP.
5.2.20	If Preventive Maintenance activity is outsourced, the observations are to be transcribed in the Annexure and external party certificate to be attached.
	Action Plan During Breakdown of Heating, Ventilation and Air Conditioning System:
5.2.21	If any breakdown occurs, inform Head of the Department and Quality Assurance Department. Put the tag “Equipment Under Maintenance, Do Not Start” and inform to Service Engineer for rectification.

 

6. Abbreviation:

Abbreviation	Expansion
UTL	Utility
PLC	Programmable Logic Controller
0C	Degree Celsius
AHU	Air Handling Unit
HVAC	Heating, Ventilation and Air Conditioning
PM	Preventive Maintenance

  

*Note – Ready to use SOP available in “DOWNLOAD” Section.

 

SOP Title: Operation of De-Humidifier

1. Objective:

To lay down a procedure for the Operation of De-Humidifier.

2. Scope:

This procedure is applicable for the Operation of De-Humidifier installed in the Engineering Department.

 

3. Responsibility:

3.1 Engineering Department: To prepare and review the SOP. To follow the procedure laid down   for the Operation of De-Humidifier as per this SOP.

3.2 Quality Assurance Department: To review and approve the SOP and Annexes. To ensure the compliance of the SOP.

4. Accountability:

Head, Engineering Department / Head, Quality Assurance Department.

5. Procedure:
   • Definitions:

5.1.1   Engineering Associate: Executive or Operator of Engineering Department trained to perform duties as per this SOP.

• Preventive Maintenance: Maintenance activity performed to ensure that the equipment will function smoothly and to avoid breakdowns. These activities are performed as per predefined frequency.

 5.2.    Operational Procedure:              

	Safety Precautions/Instructions:
5.2.1	Wear appropriate Personal Protective Equipment while operating the De-Humidifier.
5.2.2	Ensure all the electrical connections are properly earthed. Ensure the power plug of the De-Humidifier is fixed in the socket properly.
5.2.3	Inspect electrical cables and connectors for any sign of damage.
5.2.4	Ensure that the ON/OFF push button is working properly.
5.2.5	Check for tripping through thermostat, motor over load tripping and motor over load tripping.
5.2.6	Check for overload relay tripping.
	Operation:
5.2.7	Before starting the De-Humidifier, make sure that all filter accessorises are clean.
5.2.8	Check that the Damper for fresh air inside, react air out, by pass air duct and process air out are open.
5.2.9	Check the belt tension of the blower motor.
5.2.10	Check the chiller water line valves are open.
	Sequence of operations:
5.2.11	Put the MCB “ON” located on the panel board and check the three-phase power which is indicated by Red, Yellow and Blue lamps.
5.2.12	Voltage must be maintained in between 380 to 440 volts.
5.2.13	Before putting the system “ON” ensure that the blower MCB is in “OFF” position and only bed drive motor is started.
5.2.14	Now put “ON” the heater by pressing Red rocker switch located on the panel board and then  keep the system continuously running till the reading temperature reaches to 150 ºC and Air Cooling Temperature is below 12 º C.
5.2.15	Open the MCB door box and switch “ON” the blower system.
	Shut Down of De-Humidifier:
5.2.16	While stopping the De-Humidifier the heater Red rocker switch button should be switched “OFF” before 15 minutes to shut down the plant.
5.2.17	After 15 minutes stop the system.
	Preventive Maintenance
5.2.18	Perform the Preventive Maintenance as per Annexure.
5.2.19	Affix the “Preventive Maintenance Status Label” on the De-Humidifier as per SOP.
5.2.20	If Preventive Maintenance activity is outsourced, the observations are to be transcribed in the Annexure, and external party certificate to be attached.
	Action Plan During Breakdown of De-Humidifier
5.2.21	If any breakdown occurs, inform Head of the Department and Quality Assurance Department. Put the tag “Equipment Under Maintenance, Do Not Start” and inform to Service Engineer for rectification.

 

6. Abbreviation:

Abbreviation	Expansion
MCB	Miniature Circuit Breaker
UTL	Utility
º C	Degree Celsius
ID	Identification
PM	Preventive Maintenance

  

*Note – Ready to use SOP available in “DOWNLOAD” Section.

 

SOP Title: Operation of Reciprocating Liquid Chiller Plant

1. Objective:

To lay down the procedure for the Operation of Reciprocating Liquid Chiller Plant.

2. Scope:

This procedure is applicable for the Operation of Reciprocating Liquid Chiller Plant installed in the Engineering at site to provide cool Air.

 

3. Responsibility:

3.1 Engineering Department: To prepare and review the SOP. To follow the procedure laid down   for the Operation of Reciprocating Liquid Chiller Plant as per this SOP.

3.2 Quality Assurance Department: To review and approve the SOP and Annexes. To ensure compliance to the SOP.

4. Accountability:

Head, Engineering Department / Head, Quality Assurance Department.

5. Procedure:
   • Definitions:

5.1.1   Engineering Associate: Executive or Operator of Engineering Department trained to perform duties as per this SOP.

• Preventive Maintenance: Maintenance activity performed to ensure that the equipment will function smoothly and to avoid breakdowns. These activities are performed as per predefined frequency.

 5.2.    Operational Procedure:              

	Safety Precautions/Instructions:
5.2.1	Wear appropriate Personal Protective Equipment while operating the Reciprocating Liquid Chiller Plant.
5.2.2	Ensure that all the electrical connections are properly earthed and the power plug of the Reciprocating Liquid Chiller Plant is fixed in the socket properly.
5.2.3	Inspect electrical cables and connectors for any sign of damage.
5.2.4	Ensure that the ON/OFF push button is working properly.
5.2.5	Check for the any leakages of oil and leak test of gases.
5.2.6	Do not leave the compressor for the first 15 minutes after starting.
	Operation:
5.2.7	Check for the oil level through side glass of the compressor. This should be at half mark as seen through the visible glass.
5.2.8	Check the chillers water line valve is open.
5.2.9	Heater should be in ‘ON’ position.
5.2.10	Switch on Chiller plant by operating toggle switch located on PLC board.
5.2.11	After preset delay of 3 minutes circuit indicates OK.
5.2.12	Compressor will start depending on set temperature and actual entering water temperature.
5.2.13	Oil pressure switch is closed within six seconds and will continue to run.
5.2.14	Low Pressure switch is bypassed for 45 seconds during the compressor starts.
5.2.15	Liquid Line Solenoid Valve will be opened to clear refrigeration circuit.
5.2.16	Depending upon the set temperature & cooling range.  The time of delay between closing should be one minutes each.
	Shutdown Reciprocating Liquid Chiller Plant :
5.2.17	Move the toggle switch towards left which will followed by pump in down mode, unloading the compressor and switching off the display and finally shutdown of the system.
	Preventive Maintenance:
5.2.18	Perform the Preventive Maintenance as per Annexure.
5.2.19	Affix the “Preventive Maintenance Status Label” on the Reciprocating Liquid Chiller Plant as per SOP.
5.2.20	If Preventive Maintenance activity is outsourced, the observations are to be transcribed in the Annexure and external party certificate to be attached.
	Action Plan During Breakdown of Reciprocating Liquid Chiller Plant:
5.2.21	If any breakdown occurs, inform the Head of the Department and Quality Assurance Department. Put the tag “Equipment Under Maintenance, Do Not Start” as per SOP and inform the Service Engineer for rectification.

6. Abbreviation:

Abbreviation	Expansion
QAD	Quality Assurance Department
EGD	Engineering Department
UTL	Utility
PLC	Programmable Logic Controller

  

*Note – Ready to use SOP available in “DOWNLOAD” Section.

 

Title: Operation and Preventive Maintenance of Reverse Osmosis (RO) &  (EDI) System_

 

1. Objective:

To lay down procedure for Operation and Preventive Maintenance of Reverse Osmosis (RO) & Electro De-Ionizer (EDI) plant for generation of the purified water.

2. Scope:

This SOP is applicable for Operation and Preventive Maintenance of Reverse Osmosis (RO) & Electro De-Ionizer (EDI) system located in the Purified Water Generation System.

3. Responsibility:

Engineering Department: To follow the procedure for operation and preventive maintenance of the RO and EDI system.

Quality Assurance Department: To ensure compliance of the procedure for water system and to review and approve the procedure.

4. Accountability:

Head Engineering and Head Quality Assurance Department

5. Procedure:

5.1  Definitions:

Reverse Osmosis: Reverse Osmosis is a process in which external pressure is applied to reverse the natural flow of pure solvent (osmosis) through semi permeable membrane to get pure form of solvent (water).

Electro deionization: Electro deionization is a water treatment technology that utilizes electricity, ion exchange membranes and resin to deionised water and separate dissolved ions (impurities) from water.

Preventive Maintenance: Maintenance activity performed to ensure that the equipment will function smoothly and to avoid breakdowns.

Engineering Associate: Any personnel or operator of Engineering Department trained to perform duties as per this SOP.

5.2 Procedure:

	Operation of RO Plant
5.2.1	Before Starting of the RO Plant Ensure that: 1. Treatment of raw water using sodium hypochlorite solution in the sump complies with the given specifications, 2.  Sufficient water is available in raw water storage tank (overhead tank), 3.  Ensure sufficient quantity (about 20 litters) of Antiscalent solution i.e. Sodium Metabisulphite has been prepared (75 gm of sodium metabisulphite dissolved in 45 litres of purified water).
5.2.2	Open the raw water valve located outside the PW generation area which allows water flow from the overhead tank.
5.2.3	Open the valve located after treated water motor by rotating the handle in anticlockwise direction and check that water is coming out from the RO system outlet.
5.2.4	Put ON the Main Circuit Breaker located near the entrance of water system.
5.2.5	Ensure that the valve located after high pressure pump is in open position by checking the red colour handle which should be downward.
5.2.6	Put ON the Treated Raw Water Pump and check whether clear water is discharged from RO outlet.
5.2.7	Ensure that the red, yellow and blue indicator are lit and working.
5.2.8	Start the High Pressure Pump by pressing the green button on the RO panel.
5.2.9	Check flow meter reading which should be between 225 to 275 litres per hour.
5.2.10	Simultaneously check the Pressure Dial reading as following: LEFT Pressure Gauge- for product water it should be at about 100 psi, RIGHT Pressure Gauge- for Raw water it should be at about 75 psi.
5.2.11	Switch ON the Antiscalent Electrical switch for sodium metbisulphite dosing.
5.2.12	Next put ON the RO UV switch followed by stabilizer (indicates glowing of red colour indicator).
5.2.13	Discharge the product water for 5 minutes and then connect the pipe to the RO Water Storage Tank.
	Operation of Electro Deionization (EDI) Plant
5.2.14	Ensure that the water level in RO Water Storage Tank is at least upto the level of stainless steel pipeline.
5.2.15	Open the valve of RO Water Storage Tank located on the pipeline after RO Water Storage Tank.
5.2.16	Switch ON the Conductivity Meter and UV lamp followed by stabilizer of EDI System (indicated by red colour indicator).
5.2.17	Put ON the Starter of EDI motor by pressing green colour button on the panel to start the EDI plant.
5.2.18	Simultaneously check for water coming out from the EDI outlet/discharge.
5.2.19	Switch ON the EDI System Indicator Panel which indicates Ampere (output current) and Volt (output voltage).
5.2.20	Check the flow rate of water in the flow meter and ensure that: Flow rate of product water is in between 100 to 200 litres per hour (LPH) and flow rate of concentrated water is less than 5 litres per hour.
5.2.21	Check conductivity in the Conductivity Meter which should be less than 2.5 µS/cm.
5.2.22	Monitor the working of pressure gauges, flow meters conductivity, electrical indicators, ampere, voltage etc during operation of water system.
	Procedure for EDI shut down
5.2.23	Put OFF the starter of EDI motor.
5.2.24	Put OFF the Conductivity Meter followed by UV Lamp.
5.2.25	Turn OFF/close the valve of RO water storage tank.
	Procedure for EDI shut down
5.2.26	Putt OFF High Pressure Pump by pressing red button on RO panel.
5.2.27	Put OFF the Antiscalent electrical switch.
5.2.28	Put OFF UV followed by Treated Raw Water Pump.
5.2.29	Finally switch OFF the main circuit breaker and close the raw water valve.
	Preventive Maintenance of RO and EDI
5.2.30	Perform the Preventive Maintenance as per Annexure.
5.2.31	If Preventive Maintenance activity is outsourced, the observations are to be transcribed in the Annexure and external party certificate to be attached.
	Records
5.2.32	Record the details of RO and EDI operation in the format specified as per Annexure.
5.2.33	Maintain the burning hours record of UV lamp as per Annexure.

 

6. Abbreviation:

Abbreviation	Expansion
SOP	Standard Operating Procedure
QA	Quality Assurance
HOD	Head of Department
EDI	Electro Deionization
RO	Reverse Osmosis
UV	Ultra Violet
psi	Pond per Square Inch
µS/cm	Micro Siemens per Centimetre
PW	Purified Water

 

*Note – Ready to use SOP available in “DOWNLOAD” Section.

 

 

SOP Title: Sanitization of PW Storage and Distribution System

1. Objective:

To lay down a procedure for the Sanitization of PW Storage and Distribution System.

2. Scope:

This procedure is applicable for the Sanitization of Purified Water Storage Tank and Distribution loop line at site.

3. Responsibility:

3.1 Engineering Department: To prepare and review the SOP. To follow the procedure laid down   for the PW Storage and Distribution System as per this SOP.

3.2 Quality Assurance Department: To review and approve the SOP and Annexes. To ensure

compliance of the procedure.

 

4. Accountability:

Head, Engineering Department / Head, Quality Assurance Department.

5. Procedure:
   • Definitions:

5.1.1   Engineering Associate: Executive or Operator of Engineering Department trained to perform duties as per this SOP.

 

5.2.    Operational Procedure:              

	Safety Precautions/Instructions:
5.2.1	Wear appropriate Personal Protective Equipment while sanitization of   PW storage and distribution system.
5.2.2	Check whether all the instruments in the line are under calibrated state and functioning properly.
5.2.3	Ensure that the water level in the PW storage tank is at least 2/3 of the capacity.
5.2.4	Check the operation of spray ball by opening the lid of PW storage tank.
5.2.5	Inform the User Departments before sanitization of the system and close all the user points of PW during sanitization procedure.
	Hot water sanitization of PW Storage and Distribution System:
5.2.6	Thermal approaches to system sanitization include periodic circulating of hot water at 80°C -85°C for 45 minutes.
5.2.7	Start the boiler and open the steam valve to the PW water tank.
5.2.8	Check the pressure of steam on the pressure gauge (should be maintained below 1.5 kg/cm2).
5.2.9	Open the steam valve of the steam jacketed purified water tank.
5.2.10	Wait till the temperature of the PW storage tank reaches to 80°C -85°C.
5.2.11	Open the re-circulatory pump of the water system and circulate the hot water continuously for 45 minutes.
5.2.12	After 45 minutes drain the hot water through all the users points for 10 minutes (i.e. till all the hot water gets drain out completely).
5.2.13	Close all the user points of the loop and close the steam valve from the boiler.
5.2.14	After completion of sanitization, intimate Quality Control Department to collect the purified water sample by sending “Water Sample Intimation Slip” as per Annexure to Quality Control Department.
5.2.15	Water Sample Intimation Slip containing two copies (One original and one Carbon copy.
5.2.16	After water sample analysis, Quality Control Department sends the carbon copy of “Water Sample Intimation Slip” with result to Engineering Department and original copy retains with Quality Control Department.
5.2.17	Record the sanitization details in the prescribed format as mentioned in Annexure.
5.2.18	Start the water system after receiving water analysis report satisfactory.
	Frequency
5.2.19	Perform the Sanitization Procedure for Water System after every fortnightly.

 

6. Abbreviation:

Abbreviation	Expansion
QAD	Quality Assurance Department
EGD	Engineering Department
°C	Degree Celsius
PW	Purified Water
NMT	Not More Than
w.r.t.	With Respect To

  

*Note – Ready to use SOP available in “DOWNLOAD” Section.

 

SOP Title: Preventive Maintenance of Equipment

1. Objective:

To lay down a procedure for Preventive Maintenance Programme for the Equipment and to ensure that Preventive Maintenance of the Equipment is performed in order to maintain the efficiency of the equipment.

2. Scope:

This procedure is applicable to all critical equipment installed at site.

3. Responsibility:

3.1 Engineering Department: To prepare and review the SOP. To follow the procedure laid down   for the Preventive Maintenance of the Equipment as per this SOP.

3.2 Functional Department: To assist the execution of Preventive Maintenance activity and review the same as per SOP.

3.3 Quality Assurance Department: To review and approve the SOP and Annexure. To ensure compliance of the procedure.

 

4. Accountability:

Head, Engineering Department / Head, Quality Assurance Department.

5. Procedure:
   • Definitions:

5.1.1 Engineering Associate: Executive or Operator of Engineering Department trained to perform duties as per this SOP.

• Preventive Maintenance: Maintenance activity performed to ensure that the Equipment will function smoothly and to avoid breakdowns. These activities are performed as per predefined frequency.

 5.2.    Operational Procedure:              

	Safety Precautions/Instructions:
5.2.1	Wear appropriate Personal Protective Equipment while operating equipment.
5.2.2	Ensure all the electrical connections are properly earthed. Ensure the power plug of the all equipment is fixed in the socket properly.
	Operation:
5.2.3	Prepare a list of the equipments as per Annexure to be included in the Preventive Maintenance Programme based on the assessment of criticality and need for Preventive Maintenance.
5.2.4	Prepare the ‘Annual Preventive Maintenance Programme’ as per Annexure. Based on the Annual Preventive Maintenance Programme prepare a Preventive Maintenance Checklist. Refer Preventive Maintenance Checklist of current approved SOP prepared for equipment.
5.2.5	Submit Annual Preventive Maintenance Programme to the Functional Department for review.
5.2.6	Review the Annual Preventive Maintenance Programme and send back to Engineering Department.
5.2.7	Submit the Annual Preventive Maintenance Programme list to Quality Assurance Department for review and approval.
5.2.8	Review and approve the ‘Annual Preventive Maintenance Programme’.
5.2.9	Plan the ‘Activity Chart’ for the month as per Annexure and submit to the Functional Department to confirm the availability of the equipment/machine for Preventive Maintenance.
5.2.10	Review the ‘Activity Chart’ for any changes; confirm the availability of the equipment/machine for Preventive Maintenance and communicate to Engineering Department.
5.2.11	Sign the “Activity Chart” and returned back the chart to the Associate Engineering for execution.
5.2.12	Update the Status Label of equipment as “Equipment Under Maintenance Do Not Start”.
5.2.13	Perform the Preventive Maintenance jobs as defined in the Preventive Maintenance Checklist and complete the work sheet.
5.2.14	In case of any other job carried out other than the defined jobs, enter the same in the worksheet under the heading ‘ANY OTHER JOBS’ as per Annexure.
5.2.15	Inform Quality Assurance in case of any unplanned maintenance activities are performed.
5.2.16	Sign the completed work sheet and hand over to the relevant department person for review.
5.2.17	Review and comment on the observations & actions if necessary. Sign the document and hand it over to Associate Engineering.
5.2.18	File the executed check list in the Preventive Maintenance folder of the respective equipment.
5.2.19	Update the Preventive Maintenance Status Labels as per Annexure and Preventive Maintenance Schedule.
5.2.20	During the execution of Preventive Maintenance if any repair or any major modification needs to be done, make a detailed assessment as per Annexure “Job Order For Unplanned Maintenance”.
5.2.21	Initiate a Change Control based on the above Job Order Assessment done for the particular equipment.
5.2.22	If there are any changes in the Preventive Maintenance Procedure, Frequency and Tolerance limit, then initiate a change control as per the current edition.
5.2.23	Initiation of change control is not required in case of Like to Like changes i.e. Change Parts, Bearings, Gearbox, Gaskets, Filters, Belts, Valves and other electrical components or parts if purchased from Original Equipment Manufacturer / Local Supplier without any hardware modifications.
5.2.24	If any major spare part of the machine is replaced enter the same in the work sheet.
5.2.25	Execute the Preventive Maintenance of the equipment as per the frequency and date mentioned in the schedule. If the Preventive Maintenance is not performed within 7 days after the date mentioned in the schedule, it shall be justified and informed to QA Department with proper documentation system.
5.2.26	If new equipment is installed in any department, then incorporate the new equipment in the next edition of Annual Preventive Maintenance Programme.

 

6. Abbreviation:

Abbreviation	Expansion
SOP	Standard Operating Procedure
QAD	Quality Assurance Department
EGD	Engineering Department
UTL	Utility

  

*Note – Ready to use SOP available in “DOWNLOAD” Section.

 

SOP Title: Cleaning of Pre-Filter of MLT Laminar Air Flow Unit

                                                                  

1. Objective:

To lay down procedure for the cleaning of Pre-filters of Laminar Air Flow Unit located in the MLT Room in Microbiology Section of Quality Control Department.

2. Scope:

This procedure is applicable for the cleaning of Pre-filters of Laminar Air Flow Unit placed in the MLT Room in Microbiology Section of Quality Control Department.

3. Responsibility:

3.1 Engineering Department: To prepare and review the SOP. To follow the procedure laid down   for the cleaning of Pre-filters of Laminar Air Flow as per this SOP.

3.2 Quality Assurance Department: To review and approve the SOP and Annexure. To ensure compliance of the procedure.

 

4. Accountability:

Head, Engineering Department / Head, Quality Assurance Department.

5. Procedure:
   • Definitions:

5.1.1   Engineering Associate: Executive or Operator of Engineering Department trained to perform duties as per this SOP.

 

   5.2.    Operational Procedure:               

	Safety Precautions/Instructions:
5.2.1	Wear appropriate Personal Protective Equipment while cleaning of pre-filters of Laminar Air Flow.
5.2.2	Ensure all the electrical connections are properly earthed.
5.2.3	Inspect electrical cables and connectors for any sign of damage.
5.2.4	Ensure that the ON/OFF push button is working properly.
5.2.5	Use proper maintenance tools while cleaning of Pre-filters of Laminar Air Flow Unit.
5.2.6	Ensure that a trained person is carrying out the cleaning activity.
5.2.7	Inform to the user department before the start of cleaning activity.
5.2.8	Switch Off the LAF unit before removing the filter.
	Operation:
5.2.8	Inform and get the clearance from the QC department for cleaning of Pre-filter of Laminar Air Flow.
5.2.9	Remove the filters from filter body assembly by loosening front side safety cover (net).
5.2.10	Clean the filter as per Annexure.
5.2.11	Pack the cleaned filters in the polyethylene covers and transfer them to the Laminar Air Flow Unit of MLT Room.
5.2.12	Inspect the filters visually for any damage and cleanliness.
5.2.13	Re-fix the filter, check the gasket and tighten all the nut and bolts.
5.2.14	Record all the details in “Cleaning Check List for Pre-filters of Laminar Air Flow Unit” as per Annexure.
5.2.15	Update the “Cleaning Status Label” as per Annexure and attach it to the Laminar Air Flow Unit.
5.2.16	In case any filter is found to be damaged then wash the damage filter and dry the same. After drying, separate the metal housing and filter media. Enclose in polyethylene bags separately and dispose of in the designated scrap yard.
	Cleaning Frequency:
5.2.17	Every Fortnight ± 2 Days.

 

6. Abbreviation:

Abbreviation	Expansion
UTL	Utility
cm	Centimetre
kg	Kilogram

 

*Note – Ready to use SOP available in “DOWNLOAD” Section.

 

SOP Title: Cleaning of Reverse Osmosis Membrane

 

1. Objective:

To lay down a procedure for the Cleaning of Reverse Osmosis Membrane.

2. Scope:

This procedure is applicable for the Cleaning of Reverse Osmosis Membrane installed in the RO Unit in Engineering Department.

3. Responsibility:

3.1 Engineering Department: To prepare and review the SOP. To follow the procedure laid down   for the Cleaning of Reverse Osmosis Membrane as per this SOP.

3.2 Quality Assurance Department: To review and approve the SOP and Annexes. To ensure compliance to the SOP.

4. Accountability:

Head, Engineering Department / Head, Quality Assurance Department.

5. Procedure:
   • Definitions:

5.1.1   Engineering Associate: Executive or Operator of Engineering Department trained to perform duties as per this SOP.

 

5.2.    Operational Procedure:              

	Safety Precautions/Instructions:
5.2.1	Wear appropriate Personal Protective Equipment while cleaning the Reverse Osmosis Membrane.
5.2.2	Material Safety Data Sheet for chemicals to be used is collected and used in case of any emergency.
5.2.3	Do not run the pump in dry condition.
	Requirements
5.2.4	Five plastic tanks of 50 litres capacity.
	Operation:
5.2.5	Collect the 500 litres of purified water for cleaning of RO Membrane in the RO storage tank.
5.2.6	Put the inlet (suction) pipe of cleaning of RO membrane pump in chemical cleaning tank.
5.2.7	Close the valve of high pressure pump by rotating handle in to clockwise direction.
5.2.8	Turn the valve (blue colour) located near discharge side of cleaning of RO membrane pump in to anticlockwise direction.
5.2.9	Turn the valve located near discharge side of cleaning of RO membrane pump in to anticlockwise direction.
5.2.10	Connect the cleaning of RO membrane pump to mains.
5.2.11	Fill the purified water cleaning tank No. 1 with 50 litres of water.
5.2.12	Put ON the cleaning of RO membrane pump and recycle this water through RO membrane for 60 minutes, at the end of 60 minutes stop pump & drain the Purified cleaning tank.
5.2.13	Wash tank with RO water, then rinse with Purified water.
5.2.14	Fill the chemical cleaning tank NO. 2 with 50 litres of purified water, 200 gm of Sodium Hydroxide, 200 gm EDTA Disodium salt and 200 gm Sodium Lauryl Sulphate. Mix the solution properly.
5.2.15	Put ON the cleaning of RO membrane pump and then recycle this solution for 60 minutes through the RO membrane.
5.2.16	At the end of 60 minutes stop pump and drain the chemical cleaning tank.
5.2.17	Wash tank with RO water, then rinse with purified water.
5.2.18	Fill the cleaning tank NO.1 with 50 litres of purified water.
5.2.19	Put ON the cleaning of RO membrane pump, recycle the purified  water through the RO membrane for 60 minutes, at the end of 60-minuets stop pump and then drain purified cleaning tank.
5.2.20	Wash tank with RO water, then rinse with purified water.
5.2.21	Fill the chemical cleaning tank No. 3 with 50 litres of purified water and 200 ml of Hydrochloric Acid. Mix the solution of properly.
5.2.22	Put ON the cleaning of RO membrane pump and then recycle this solution for 30 minutes through the RO membrane.
5.2.23	At the end of 30 minutes stop pump and drain the chemical cleaning tank.
5.2.24	Wash tank with RO water, then rinse with purified water.
5.2.25	Fill the cleaning tank No.1 with 50 litres of purified water, put ON the cleaning of RO membrane pump & recycle the purified water through the RO membrane for 60 minutes, at the end of 60 minutes stop pump and then drain cleaning tank.
5.2.26	Wash tank with RO water, then rinse with purified water.
5.2.27	Fill the chemical cleaning tank No.4 with 50 litres of purified water and 200 ml of Formaldehyde. Mix the solution properly.
5.2.28	Put ON the cleaning of RO membrane pump and then recycle this solution for 30 minutes through the RO membrane.
5.2.29	At the end of 30 minutes stop pump and drain the chemical cleaning tank. Wash tank with RO water, then rinse with purified water.
5.2.30	Fill the cleaning tank No.1 with 50 litres of purified water, put ON the cleaning of RO membrane pump; recycle the purified water through the RO membrane for 60 minutes, at the end of 60 minutes stop pump and then drain cleaning tank.
5.2.31	Wash tank with RO water, then rinse with purified water.
5.2.32	Fill the cleaning tank No.1 with 50 litres of purified water, put ON the cleaning of RO membrane pump; recycle the purified water through the RO membrane for 60 minutes, at the end of 60 minutes stop pump and then drain cleaning tank.
5.2.33	Wash tank with RO water, then rinse with purified water.
5.2.34	Fill the chemical cleaning tank No. 5 with 50 litres of purified water and 200 gm of Citric acid. Mix the solution properly. Put ON the cleaning of RO membrane pump and then recycle this solution for 30 minutes through the RO membrane.
5.2.35	At the end of 30 minutes stop pump and drain the chemical cleaning tank. Wash tank with RO water, then rinse with purified water.
5.2.36	Fill the cleaning tank No. 1 with 50 litres of purified water, put ON the cleaning of RO membrane pump; recycle the purified water through the RO membrane for 60 minutes, at the end of 60 minutes stop pump and then cleaning tank.
5.2.37	Wash tank with RO water, then rinse with purified water.
5.2.38	After completion of the RO membrane, send Water Testing Intimation Slip to QC Department as per Annexure.
5.2.39	Update the “Cleaning Record of Reverse Osmosis Membrane” as per Annexure.
	Cleaning Frequency:
5.2.40	Once in 3 month or when the output of product water quality decreases (conductivity increases > 1.0 µS/cm).

6. Abbreviation:

Abbreviation	Expansion
UTL	Utility
PPE	Personnel Protective Equipment
RO	Reverse Osmosis
QC	Quality Control
gm	Gram
µS/cm	Micro Simon Per Centimetre
>	Greater Than
EDTA	Ethylene Di-amine Tetra Acetic Acid

 

*Note – Ready to use SOP available in “DOWNLOAD” Section.

 

SOP Title: Calibration of Magnehelic Gauge

1. Objective:

To lay down a procedure for Calibration of Magnehelic Gauge in the facility.

2. Scope:

This procedure is applicable for the Calibration of Magnehelic Gauge installed in the different sections or areas in the facility to monitor/indicate pressure or pressure differential in the area or system/equipment.

3. Responsibility:

3.1 Engineering Department: To prepare and review the SOP. To follow the procedure laid down   for the calibration of Magnehelic Gauge as per this SOP.

3.2 Quality Assurance Department: To review and approve the SOP and Annexes. To ensure compliance of the procedure.

3.3 Concerned Department: To assist in the calibration activity and monitor the routine measurement  of the gauges.

 

4. Accountability:

Head, Engineering Department / Head, Quality Assurance Department.

5. Procedure:
   • Definitions:

5.1.1   Engineering Associate: Executive or Operator of Engineering Department trained to perform duties as per this SOP.

5.1.2  Preventive Maintenance: Maintenance activity performed to ensure that the equipment will  function smoothly and to avoid breakdowns. These activities are performed as per predefined frequency.

 5.2.    Operational Procedure:              

	Safety Precautions/Instructions:
5.2.1	Wear appropriate Personal Protective Equipment while operating the Magnehelic Gauge.
5.2.2	Take clearance from the Concerned Department Head for execution of calibration activity for Magnehelic Gauges.
5.2.3	Carry all the necessary instruments/items safely to the respective area.
5.2.4	Ensure that the Magnehelic Gauges are in working condition and free from any sign of damage.
	Calibration
5.2.5	Frequency: Once in a Year or After any breakdown.
5.2.6	Remove the Magnehelic Gauge and its tubing properly from the platform.
5.2.7	Keep the Magnehelic Gauges in vertical position.
5.2.8	Before starting calibration set the deflection needle on zero with the help of a screw driver.
5.2.9	Connect the tubing of the Reference Gauge and Magnehelic Gauge to pressure port.
5.2.10	Ensure that there is no leakage in the set up by applying some pressure.
5.2.11	Set the pressure in the Magnehelic Gauge by rotating the screw knob at different values as 0, 02, 04, 06, 08 and 09 (or at minimum of 5 calibration points to cover the specified limit) etc and allow stabilising for at least one minute each time. Record the reading shown in the Reference Gauge against each set parameter after stabilizing.
5.2.12	The reading on the gauge to be calibrated should be within the specified tolerance (± 2 % of Full Scale).  Record both readings on the calibration record as specified in Annexure.
5.2.13	Repeat this procedure for each gauge to be calibrated.
5.2.14	If the readings are within the acceptance criteria, affix the Calibration Status Label duly signed by the responsible person or external party (in case of outsource calibration).
5.2.15	If the reading is outside the acceptance criteria refer the manufacturer’s handbook or replace gauge as required.
	Documentation
5.2.16	Record the details of calibration in Annexure.
5.2.17	If calibration activity is outsourced, the observations are to be transcribed in the Annexure, calibration certificate and pertinent data to be attached.
	Action plan during Breakdown of Magnehelic Gauge
5.2.18	If any breakdown occurs, inform the Head of the Department and Quality Assurance Department immediately. Put the tag “Equipment Under Maintenance, Do Not Start” and inform to Service Engineer for rectification.

 

 

6. Abbreviation:

 

Abbreviation	Expansion
SOP	Standard Operating Procedure
QAD	Quality Assurance Department
EGD	Engineering Department
UTL	Utility

 

*Note – Ready to use SOP available in “DOWNLOAD” Section.