SOPs

Atlas Copco Air Compressor , Purpose:

Atlas Copco Air Compressor , The purpose of this SOP is to define the standard operation and maintenance procedure of Atlas Copco Air Compressor and Air Dryer in order to ensure its smooth & trouble-free operation and generation of quality compressed air.

Atlas Copco Air Compressor , Scope:

This Standard Operating Procedure applies to the Atlas Copco Air Compressor (Model: ZT 75) and Air Dryer (Model: CD185+) which is located at the Utility area of Solid Block of XX Pharmaceuticals Ltd.

Definitions / Abbreviation:

[][]Air Compressor: An air compressor is a device that converts power (usually from an electric motor) into kinetic energy by compressing and pressurizing the ambient air.

Responsibilities:

[][]The roles and responsibilities are as follows:

Engineering (Validation) Department

[][]Preparing the SOP and revise it when necessary.

Engineering (Maintenance) Department

[][]To provide necessary support for smooth operation & maintenance of the system.
[][]To ensure that the operators are responsible to carry out the operation and maintenance work and regular checking of the critical components and logbooks.
[][]To develop a list of spare parts based on the manufacturer’s recommendations and to forward the list to the Planning and Procurement department with a request to place order as required.

Operators

[][]To operate the Air Compressor according to the SOP.
[][]To fill up the logbooks related to the air compressor.
[][]To do the maintenance according to the check list.

Manager,  Engineering

[][]To ensure that the operation and maintenance of air compressor are done properly.
[][]To approve any maintenance/plans related to the compressor.

Manager, Quality Assurance

[][]To ensure overall implementation of this SOP.

Procedure:

Precautions:

[][]All operation and maintenance work must be done safely in accordance with the requirements of the Plant Safety Statement and the safety notices around the plant. Specific attention must be paid to the following:
[][]Never touch any piping or components of the compressor during operation.
[][]Use only the correct type and size of hose end fittings and connections. When blowing through a hose or air line, ensure that the open end is held securely.

[][] A free end will whip and may cause injury. Make sure that a hose is fully depressurized before disconnecting it.
[][]Do not apply the air to skin or direct an air stream at people. Never use the air to clean dirt from your clothes. When using the air to clean equipment; do so with extreme caution and wear eye protection.
[][]Persons switching on the machines shall take adequate precautions to ensure that there is no one checking or working on the machine.
[][]Never operate the machine when there is a possibility of taking in flammable or toxic fumes, vapors or particles.

[][]Never operate the machine below or in excess of its limit ratings.
[][]Keep all bodywork doors shut during operation.
[][]All maintenance work shall only be undertaken when the machine has cooled down.
[][]Before removing any pressurized component, effectively isolate the machine from all sources of pressure and relieve the entire system of pressure.
[][]Never use flammable solvents or carbon tetrachloride for cleaning parts. Take safety precautions against toxic vapors of cleaning liquids.
[][]Never use a light source with open flame for inspecting the interior of a machine, pressure vessel, etc.
[][]Make sure that no tools, loose parts or rags are left in or on the machine.
[][]Do not walk or stand on the roof of the unit.

System Description:

The Atlas Copco Air Compressor and Air Dryer manufactured by Atlas Copco has a capacity of 10.4 m3/min.
[][] Air drawn through an air filter is compressed in low-pressure compressor element and discharged to the intercooler.
[][]The cooled air is further compressed in high-pressure compressor element and discharged through silencer and after coolers.
[][]A check valve is provided downstream of the silencer.
[][]The compressed air leaves the compressor via the air outlet.
[][]The compressor delivers oil-free, pulsation-free air.
[][]This is an air cooled type compressor which is facilitated with air filter, moisture trap, high pressure and low pressure safety valve, desiccant type dryer system etc.
[][]After being compressed in compressor the oil free compressed air will be stored in a receiver tank.
[][]Air will be dried in the desiccant type dryer and then distributed through pipe line to the different production facility.

Operating Procedure:

Operation of compressor:

[][]Initial Start-up of compressor:
[][]Tight up all the flanges, nuts and bolts as instructed in the instruction manual of the compressor.
[][]Check that the gear casing is filled with oil; the level should be in the middle of sight-glass.
[][]The electrical installation must be earthed and protected by fuses in all phases. An isolating switch must be provided.
[][]Switch on the voltage. Start the compressor and stop it immediately. Check for correct direction of rotation (Clockwise) while the motor is coasting to a stop.
[][]An arrow on the gear casing indicates the correct rotation direction. If the rotation direction is wrong, switch off the voltage and reverse two incoming electric lines.
[][]Check the rotation direction of the fan motor. If the rotation direction is wrong, switch off the voltage and reverse the motor’s electrical connection.

[][]Open the air outlet valve.

[][]Switch on the voltage and check that voltage on LED (2) lights up.
[][]Press start button (1). The compressor starts running and automatic operation LED (3) lights up.

Be careful about the following:

[][]When the compressor is stopped and automatic operation LED (3) is alight, the compressor may start automatically.
[][]If the start/stop timer is active, the compressor may start automatically, even if it was stopped manually.

During Operation:

[][]Daily check the display (2) for readings and messages. Normally, the main screen indicates the compressor outlet pressure, the status of the compressor and the functions of the keys below the display.
[][]Always check the display and remedy the trouble if alarm LED (3) is alight or blinks.
[][]Regularly check the actual compressor status by pressing the down key from the main screen.
[][]The Operational Log Sheet (Annexure – I) of air compressor and dryer will be filled up on every hour by the operator. Photocopy of all the approved forms will be used where easily applicable.

[][]For the cases where computer generated copies are relatively easy to handle, the exact format of the approved form can be used(except the approval sign) with the following notes as footer:
“This is a computer generated report. The format is as per the original approved form.”

Stopping Procedure:

[][]Frequently stopping the compressor using the emergency stop button may damage the compressor; only use the emergency stop button in case of emergency.

[][]Press the stop button (1): the compressor will stop and LED (2) will go out.
[][]Close the air outlet valve.
[][]To stop the compressor immediately, press emergency stop button (S2).

 Taking out of operation:

[][]Close the air outlet valve and stop the compressor.
[][]Switch off the voltage and disconnect the compressor from the mains.
[][]Shut down and depressurize all the parts.
[][]Drain oil and condensate circuits.
[][]Disconnect the compressor condensate piping from the condensate drain.

Operation of Air Dryer:

[][]Initial start-up
[][]To start up the dryer for the first time or after a long period of standstill, proceed as follows:
[][]Open the bypass valves of the dryer.
[][]Close the air supply from the compressor towards the dryer by closing the external inlet valve.
[][]Close the external outlet valve.
[][]Remove the silencers to prevent the silencers from getting clogged by the desiccant and wear a dust mask, safety glasses and ear protection. (This is only required at initial start-up or after the desiccant was replaced).
[][]Start the compressor and wait for pressure.
[][]Slowly open the external inlet valve.
[][]Check the connections of the dryer for air leaks and remedy if necessary.
[][]Switch the dryer on by putting main switch S1 in position I.
[][]Let the dryer operate for several hours with the external outlet valve closed.
[][]In case the silencers were removed, refit the silencers.
[][]Gradually open the external outlet valve.
[][]Close the bypass valves of the dryer.

Normal start

[][]If the dryer has not been used for more than 3 months, refer to previous section, In all other cases proceed as follows:
[][]Cut off the air supply from the compressor towards the dryer by closing the external inlet valve.
[][]Close the external outlet valve between the dryer and the dry air consumer.
[][]Start compressor and slowly open the external inlet valve.
[][]Switch the dryer on by putting main switch in position I.
[][]Gradually open the air outlet valve.
[][]Close the bypass valves of the dryer.
[][]Close the external inlet valve in case the compressor needs to be restarted. The high air speed in the start-up phase of the compressor may damage the desiccant.

Shutdown Procedure of Dryer:

[][]To stop the dryer, proceed as follows:
[][]Open the bypass valves of the dryer so that the application will still receive compressed air.
[][]Close the external inlet valve between the compressor and the dryer and the external outlet valve between the dryer and the dry air consumer.
[][]Let the dryer operate for a period without consumption, to depressurize the vessels.
[][]Switch off the dryer by putting main switch to position 0.
[][]If the dryer is stopped for a longer period, keep the external inlet and outlet valve closed to avoid the moisture from entering the dryer.
[][]Under no circumstances must compressed air be allowed to flow through the dryer when the electrical power is switched off. This will result in terminal failure of the desiccant material; causing regeneration will no longer be possible.

Maintenance Procedure:

Safety Instruction:

[][]Hang the Maintenance tag prior to any maintenance activity.
[][]Use protective clothing.
[][]Use proper tools.
[][]Isolate the system electrically and mechanically prior to maintenance.

General Instruction:

[][]Plan and procure spares and manpower prior to the maintenance works.
[][]Only trained personnel are to be engaged in maintenance work.
[][]After finishing the maintenance work, the area & the equipment should be cleaned & tagged out.
[][]Functional/operational checks are to be conducted after maintenance works have been done.
[][]Maintenance Log Book (Annexure – II) has to be filled up by the operator after performing scheduled maintenance.

Maintenance Program:

Daily Maintenance

[][]Clean the machine exterior and its surroundings.
[][]Check that condensate is discharged during loading.
[][]Check the oil level. Before starting, the level should be in the middle of the sight-glass.
[][]Check the display panel for information and service messages.

Weekly Maintenance

[][]Clean the inner side of the machine.
[][]Clean the air filters thoroughly.

Monthly Maintenance

[][]Check for possible leaks.

Quarter Yearly

[(3 months) Maintenance] [][]Check coolers, clean if necessary.

Maintenance after 2000 hrs

[][]Check for damaged wiring or loose connections.
[][]Replace the air filter cartridge.
[][]Replace the oil filter cartridge.
[][]Check/replace the cooling air inlet filter.
[][]Replace the inlet and outlet filter cartridges of Air Dryer.
[][]Change the lubricating oil.

Maintenance after 4000 hrs

[][]Tighten the bolted connections.
[][]Tighten all the connecting terminals in the switch cabinet/electric motor.
[][]Test the safety valve function.
[][]Replace the silencers of Air Dryer.

Maintenance after 8000 hrs

[][]Perform the maintenance as it is in the Yearly maintenance schedule.
[][]Replace worn parts.

Maintenance after 40000 hrs

[][]Replace desiccant of air dryer.
[][]Revision of inlet valves and actuator.
[][]Replace the check valves.

Other Maintenance

[][]Oil and Oil Filter Change Procedure
[][]Run the compressor until warm.
[][]Press stop button, wait until the compressor has stopped, press emergency stop button (S2) and switch off the voltage to the compressor.
[][]Remove filler plug. Drain the compressor sump by opening drain valve. Close the valve after draining.
[][]Drain the oil cooler by removing its drain plug and vent plug.
[][]Drain the oil of the compressor elements. Yellow-painted drain plugs are provided on both elements.
[][]Remove the oil filter. Clean the filter seat, oil the gasket of the new filter and screw it into place until the gasket contacts the seat. Then tighten by hand.
[][]Fill the compressor sump to the middle of the oil level sight-glass with oil as specified in “Oil specifications”. Reinstall the filler plug.
[][]Switch on the voltage. Unlock the emergency stop button.
[][]Run the compressor for a few minutes. Stop the compressor. If necessary, top up the gear casing with oil to the middle of the sight-glass.

Air Filter Cleaning Procedure:

[][]Stop the compressor and switch off the voltage to the compressor.
[][]Remove the filter.
[][]Clean the filter by passing compressed air through the filter.
[][]After carrying out the service actions of the related service plan, the service warning must be reset.

Annexure:

Annexure – I: Operational Log Sheet.
Annexure – II: Maintenance Log Book of Atlas Copco Air Compressor and Air Dryer.

Lupamat Air Compressor,Purpose:

Lupamat Air Compressor, The purpose of this SOP is to define the standard operation and maintenance procedure of Air Compressor manufactured by Lupamat in order to ensure its smooth & trouble-free operation and generation of quality compressed air.

Lupamat Air Compressor, Scope:

This Standard Operating Procedure applies to the Lupamat Air Compressor of Model – LKV 37/10MI, which is located at the Utility area of General Block of XX Pharmaceuticals Ltd.

Definitions / Abbreviation:

[][]Air Compressor: An air compressor is a device that converts power (usually from an electric motor) into kinetic energy by compressing and pressurizing the ambient air.

Responsibilities:

[][]The roles and responsibilities are as follows:

Engineering (Validation) Department

[][]Preparing the SOP and revise it when necessary.

Engineering (Maintenance) Department

[][]To provide necessary support for smooth operation & maintenance of the system.
[][]To ensure that the operators are responsible to carry out the operation and maintenance work and regular checking of the critical components and logbooks.
[][]To develop a list of spare parts based on the manufacturer’s recommendations and to forward the list to the Planning and Procurement department with a request to place order as required.

Operators

[][]To operate the Air Compressor according to the SOP.
[][]To fill up the logbooks related to the air compressor.
[][]To do the maintenance according to the check list.

Procedure:

Precautions:

[][]All operation and maintenance work must be done safely in accordance with the requirements of the Plant Safety Statement and the safety notices around the plant. Specific attention must be paid to the following:
[][]Never touch any piping or components of the compressor during operation.
[][]Use only the correct type and size of hose end fittings and connections. When blowing through a hose or air line, ensure that the open end is held securely. A free end will whip and may cause injury. Make sure that a hose is fully depressurized before disconnecting it.
[][]Do not apply the air to skin or direct an air stream at people. Never use the air to clean dirt from your clothes. When using the air to clean equipment; do so with extreme caution and wear eye protection.
[][]Persons switching on the machines shall take adequate precautions to ensure that there is no one checking or working on the machine.
[][]Never operate the machine when there is a possibility of taking in flammable or toxic fumes, vapors or particles.

[][]Never operate the machine below or in excess of its limit ratings.
[][]Keep all bodywork doors shut during operation.
[][]All maintenance work shall only be undertaken when the machine has cooled down.
[][]Before removing any pressurized component, effectively isolate the machine from all sources of pressure and relieve the entire system of pressure.
[][]Never use flammable solvents for cleaning parts. Take safety precautions against toxic vapors of cleaning liquids.
[][]Never use a light source with open flame for inspecting the interior of a machine, pressure vessel, etc.
[][]Make sure that no tools, loose parts or rags are left in or on the machine.
[][]Do not walk or stand on the roof of the unit.

System Description:

The air compressor manufactured by Lupamat has a capacity of 5.03 m3/min.
[][] Air drawn through an air filter is mixed with the oil and compressed in screw type compressor.
[][] The compressed air – oil mixture is then passed through the oil separator to separate the oil.
[][]This compressed air is discharged through silencer and after coolers.
[][]The compressed air leaves the compressor via the air outlet.
[][]This is an air cooled type compressor which is facilitated with air filter, moisture trap, high pressure and low pressure safety valve, desiccant type dryer system etc.
After being compressed in compressor the compressed air will be stored in a receiver tank.
[][]Air will be dried in the desiccant type dryer and then distributed through pipe line to the different production facility.

Operating Procedure:

Operation of compressor:

[][]Initial Start-up of compressor:
[][]Tight up all the flanges, nuts and bolts.
[][]Check the oil level inside the tank.
[][]The electrical installation must be earthed.
[][]Close the discharge valve before initial start – up.
[][]Switch on the voltage. Start the compressor by pressing Start Button and stop it immediately.
[][]Check for correct direction of rotation (Clockwise) while the motor is coasting to a stop.
[][]If the rotation direction is wrong, switch off the voltage and reverse two incoming electric lines.
[][]Check the rotation direction of the fan motor. If the rotation direction is wrong, switch off the voltage and reverse the motor’s electrical connection.

Start-up Procedure of compressor:

[][]Open the air outlet valve.
[][]Switch on the main circuit breaker.
[][]Press the Start button. The compressor starts running in automatic mode.

During Operation:

[][]Daily check the display for readings and messages. At the left middle of the main screen the line pressure, air / end pressure, air/oil temperature can be seen. At the middle of right side of the screen total working time, load working time information and the remaining time up to general service maintenance time.
[][]Always check the display and remedy the trouble if alarm is alight or blinks.
[][]The Operational Log Sheet (Annexure – I) of air compressor and dryer will be filled up on every hour by the operator.
[][]Photocopy of the all the approved forms will be used where easily applicable.
[][]For the cases where computer generated copies are relatively easy to handle, the exact format of the approved form can be used(except the approval sign) with the following notes as footer:
“This is a computer generated report. The format is as per the original approved form.”

Stopping Procedure:

[][]Press the stop button; the compressor will stop when the outlet pressure is under 1 bar.
[][]If the pressure does not come under 1 bar within 5 minutes the compressor will stop by giving a failure alarm “the compressor cannot be stopped”.
[][]Close the air outlet valve.
[][]Cut the electricity from the main power. When shutting down after a normal day operation, empty out any water that may have stayed within the air tank.
[][]To stop the compressor immediately, press emergency stop button.
[][]Frequently stopping the compressor using the emergency stop button may damage the compressor; only use the emergency stop button in case of emergency.
[][]The compressor cannot be started without resetting the emergency switch.

Operation of Air Dryer:

Starting Procedure

[][]Hold down on-off button for 3 seconds.
[][]With the first start, all leds on the front panel flash one by one.
[][]At first, the hot air gets into dryer, +4 °C or +8°C led flashes. Then refrigerating compressor starts to work and related led flashes.
[][]Condenser fan unit starts only if the refrigerating compressor is running and/or condenser fan temperature is higher than +30°C.
[][] It switches itself “stop” when condenser fan temperature gets lower than +20°C or refrigerating compressor stops.
[][]Cooling process continues until temperature gets down to +2°C and condenser motor stops. Dryer switches itself “STOP” and Because of thermal storage feature of heat exchanger, keeps the heat for a while.
[][]When the heat rises up to +4°C motor starts again. System continues in this way.

Stopping Procedure of Dryer:

[][]To stop the dryer, proceed as follows:
[][]Close the external inlet valve between the compressor and the dryer and the external outlet valve between the dryer and the dry air consumer.
[][]Switch off the dryer by pressing ON/OFF button.
[][]If the dryer is stopped for a longer period, keep the external inlet and outlet valve closed to avoid the moisture from entering the dryer.

Maintenance Procedure:

Safety Instruction:
[][]Hang the Maintenance tag prior to any maintenance activity.
[][]Use protective clothing.
[][]Use proper tools.
[][]Isolate the system electrically and mechanically prior to maintenance.

General Instruction:

[][]Plan and procure spares and manpower prior to the maintenance works.
[][]Only trained personnel are to be engaged in maintenance work.
[][]After finishing the maintenance work, the area & the equipment should be cleaned & tagged out.
[][]Functional/operational checks are to be conducted after maintenance works have been done.
[][]Maintenance Log Book has to be filled up by the operator after performing scheduled maintenance.

Maintenance Program:

Daily Maintenance

[][]Clean the machine exterior and its surroundings.
[][]Check that condensate is discharged during loading.
[][]Check the oil level. Before starting, the level should be in the middle of the sight-glass.
[][]Check the display panel for information and service messages.

Weekly Maintenance

[][]Clean the inner side of the machine.
[][]Clean the air filters thoroughly.
[][]Check for possible leaks.
[][]Clean the condenser unit of Air Dryer with compressed air.
[][]Clean the cooler surface.
[][]Check the tightness of v-belt.

After 3000 hrs

[][]Clean the air filter elements.
[][]Check the viscosity of the oil and change it if necessary.
[][]Check for oil leakage.

After 5000 hrs

[][]Check for damaged wiring or loose connections.
[][]Check and replace the air hoses if necessary.
[][]Check and replace the oil hoses.
[][]Clean the air/oil separator tank.

After 10000 hrs

[][]Clean the intake air filter and change it if necessary.
[][]Clean the intake control valve.
[][]Clean the intake control valve o-ring and rubber pad and change it if necessary.
[][]Clean the air/oil pipe gasket and change it if necessary.
[][]Check the V-belt and change it if necessary.

After 20000 hrs

[][]Replace the electric motor bearings if it is necessary.

Annexure:

Annexure – I: Operational Log Sheet.
Annexure – II: Maintenance Log Book of Air Compressor and Air Dryer.

Diesel Generator, Purpose

Diesel Generator, The purpose of this SOP is to describe the procedure of operation and maintenance of the 1000 KVA diesel generator which is installed in the Generator room of Solid Block of XX Pharmaceuticals Ltd.

Diesel Generator, Scope

This SOP applies to the Cummins generator of Model No.: QST30-G4 and capacity 1000 KVA which is located at General block of XX Pharmaceuticals.

Definitions / Abbreviation:

[][]EHS : Environment Health and Safety
[][]PPE : Personal Protective Equipment
[][]SOP : Standard Operating Procedure

Responsibilities:

[][]The roles and responsibilities are as follows

Engineering ( Validation) Department

[][]To prepare the SOP & revise it when necessary.

Engineering (Maintenance) Department

[][]To provide necessary support for smooth operation & maintenance of the system.
[][]To ensure that the operators are responsible to carry out the operation and maintenance work and regular checking of the critical components and logbooks.
[][]To develop a list of spare parts based on the manufacturer’s recommendations and to forward the list to the Planning and Procurement department with a request to place order as required
[][]Engage technician/mechanic/operator/supplier in repair and maintenance work

Operators

[][]To operate the generator according to the SOP.
[][]To fill up the logbooks related to the Generator.
[][]To do the maintenance according to the check list.

Procedure

Precautions:

[][]All maintenance work must be carried out safely in accordance with the requirements of the Plant Safety Requirements and the EHS safety notices must be displayed around the plant. Specific attention must be paid to the following:
[][]Personal protective equipment (PPE) and clothing appropriate to the job must be worn.
[][]Hearing protection must be used.
[][]Equipment must be electrically isolated and locked out where possible.
[][]Ensure the control panel is switched off before carrying out any check.
[][]Do not smoke when put fuel in the tank.
[][]Clean away fuel which has been spilt. Material which has been contaminated by fuel must be moved to a safe place.
[][]Do not make adjustment that doesn’t understand.
[][]Do not remove the filler cap or any component of the cooling system while the engine is hot and while the coolant is under pressure, because dangerous hot coolant can be discharged.
[][]Turbochargers operate at high speed and at high temperatures. Keep fingers, tools and debris away from the inlet and outlet ports of the turbocharger and prevent contact with hot surfaces.
[][]Use extreme care if emergency repairs must be made in adverse conditions.
[][]The fuel injector units are actuated by high pressure engine lubricating oil. Do not remove any component of the high pressure system while the engine oil is under pressure, because dangerous oil can be discharged.
[][]Maintenance activity must be carried out by trained technician/operators.
“Under Maintenance” be displayed in a prominent position on a machine, equipment or facility undergoing maintenance work.

Engine Starting Procedure

Pre-Start Check

[][]Before the engine is started the operator should understand fully the reason for the controls and their use. The following check should be done before engine start.
[][]Make a general visual inspection on the engine and alternator. Check if there is any breakage, crack, leakage or looseness.
[][]Check the battery electrolyte level-fill with distilled water as necessary.
[][]Check that there is sufficient coolant level and if necessary, add the correct coolant
[][]Check that there is sufficient lubricating oil in the sump & Viscosity and, if necessary add lubricating oil.
[][]Fill the fuel tank with fuel of the correct specification.
[][]Check the air filter and its connection.
[][]Check the all electrical connections are tight.
[][]Check the condition and tension of the fan end engine alternator belts-tighten as necessary.
[][]Check all hoses for loose connections or deterioration tighten or replace as necessary.
[][]Check the battery connection cables. Take care to tighten the loosened battery terminals with spanner and, cover with special substance and keep clean in order to avoid oxidation
[][]Take out foreign materials such as keys, tools, cleaning wool, papers etc. on the engine and the Alternator.

Engine Start

[][]Reset the emergency stop.
[][]Press the reset button.
[][]Start key turn to the “ON” Position.
[][]After start key turn to “ON” position following are checked:
[][]Check for any abnormal noise or vibration.
[][]Check for fluid leakage or leaks in the exhaust system.
[][]Check the control panel for indications of abnormal operations, particularly abnormally high temperature or low oil pressure. The oil pressure should be in the normal range within about 10 seconds of starting.
[][]Switch the alternator circuit breaker to “ON” (Handle Up).

Caution:

[][]Load can now be applied to the generating set (Normally 2-3 minutes wait from pressing the start button).
[][]The maximum step load can be 70%-100% of rated power depending on the generating set model. Typically we run 80% of rated load.
[][]Do not operate the engine at high speeds without a load.
[][]Do not overload the engine.

Engine Stopping Procedure

[][]Turn off the load by switching output circuit breaker to “OFF” (Handle Down).
[][]Allow the generating set to run without load.
[][]After 2-3 minutes the key turn to the “OFF” position.
[][]In case of an emergency where immediate shutdown is necessary, the emergency stop push button should be pushed immediately without discounting the load.

Preventive Maintenance Planning

[][]The preventive maintenance periods apply to average conditions of operation. The schedule which follows must be applied at the Interval (hours or months) which occur first.

Daily or every 20 Hours after

[][]Visually inspect engine, generator, transfer switch and Control panel.
[][]Clean the machine exterior and its surroundings.
[][]Ensure that the coolant is at the correct level.
[][]Check Oil, Water and fuel leaks.
[][]Check the amount of lubricating oil in the sump.
[][]Check the fuel level in the fuel tank.
[][]Check the lubricating oil pressure at the panel display.
[][]Battery charge level.
[][]Drain Fuel/Water separator.
[][]Inspect the engine fan blades.
[][]Inspect the drive belt.
[][]Drain water from the fuel pre-filter.
[][]Check the intercooler and the coolant radiator for debris.

Weekly Maintenance

[][]Repeat Daily Check.
[][]Fuel level in main tank.
[][]Fuel lines and connections.
[][]Adequate fresh air to engine.
[][]Check hose and connections.
[][]Battery charging alternator belts.
[][]Inspect the engine fan blades.
[][]Inspect the fan belt.
[][]Check oil level (Governor Housing).
[][]Check exhausts leakage.
[][]Tighten connections.
[][]Check Panel display.
[][]Tighten covers.
[][]Check output voltage and frequency
[][]Operation under load.
[][]No unusual sounds.
[][]Terminals and connections normal color.
[][]Doors closed securely.

Monthly Maintenance

[][]Repeat weekly check
[][]Clean the air filters.
[][]Check All fittings, Clamps, fasteners etc
[][]Check generator air outlet

After 6 Months or every 200 Hours

[][]Repeat weekly check
[][]Clean air filters
[][]Change, lubricating oil
[][]Change the lubricating oil filters.
[][]Change, lubricating oil filters
[][]Change, fuel filters
[][]Drain sediment from main tank
[][]Change, lubricating oil
[][]Check, antifreeze
[][]Governor lubricate with grease, bearing of the fan hub.
[][]Check operating alarms and safeties

After 12 Months or 800 Hours

[][]Repeat Maintenance after 200 Hours.
[][]Check and adjust if necessary, the antifreeze.
[][]Test the level of coolant conditioner and adjust if necessary.
[][]Check the condition of the drive belt.
[][]Change the engine lubricating oil.
[][]Change the canister of the lubricating oil filter.
[][]Change the air filter (or earlier if in extremely dusty conditions).
[][]Clean or renew the air filter element Check for damaged wiring or loose connections.
[][]Check radiator hoses for wear and cracks.
[][]Check exterior of radiator for obstructions.
[][]Clean engine.
[][]Generator rotor and stator with compressed air.
[][]Check water circulating pump.
[][]Check Circuit breakers and fuse holders.
[][]After 24 Months or 2,000 Hours
[][]Check the turbocharger bearing clearance
[][]Check the exhaust restriction
[][]Check the valves settings
[][]Check the injectors settings
[][]Check vibration damper
[][]Clean Turbocharger compressor wheel and diffuser.

After every 10000 hours

[][]Overhauling of full generator.
[][]Ensure that the turbocharger impeller and the turbocharger compressor casing are cleaned.
[][]Ensure that the alternator, the starter and the turbocharger are checked.

Annexure

Annexure-I: Maintenance logbook of 1000 KVA diesel generator
Annexure-II : Log sheet for 1000 KVA diesel generator

Purified Water, Purpose:

Purified Water  , The purpose of this SOP is to define the Automatic Operation of Purified Water Generation Plant manufactured by Watertown, China in order to ensure its smooth & trouble-free operation and generation of qualified purified water.

Purified Water, Scope:

This Standard Operating Procedure applies to the PW plant manufactured by Watertown, China, which is located at the Utility area (roof top) of Solid Block of XX Pharmaceuticals Ltd.

Definitions / Abbreviation:

[][]SOP: Standard Operating Procedure.
[][]PW: Purified Water.
[][]HMI: Human Machine Interface.
[][]RO: Reverse Osmosis.
[][]EDI: Electro De Ionizer.

Responsibilities:

[][]The roles and responsibilities are as follows:

Engineering (Validation) Department

[][]Preparing the SOP and revise it when necessary.

Engineering (Maintenance) Department

[][]To provide necessary support for smooth operation of the system.
[][]To ensure that the operators are responsible to carry out the operation and fill up the logbooks.

Operators

[][]To operate the PW plant according to the SOP.
[][]To fill up the logbooks related to the PW plant.

Manager, Engineering

[][]To ensure that the operation of PW plant are done properly.

Manager, Quality Assurance

[][]To approve the SOP.
[][]To ensure overall implementation of this SOP.

Procedure:

Precautions:

[][]All operational work must be done safely in accordance with the requirements of the Plant Safety Statement and the safety notices around the plant. Specific attention must be paid to the following:
[][]Use Personal Protective Equipment during handling of any kind of chemical.
[][]Be careful about the hot water and steam line.
[][]Ensure all the utilities before doing any operation.

System Description:

[][]The PW plant manufactured by Watertown has a capacity of 3000 L/hr. The plant has Raw water pretreatment and RO/EDI sections.
[][]In Raw water pretreatment portions the water is filtered through Multi Grade Filter and Active Carbon Filter respectively. After that, the water is softened with the softeners.
[][]There are two softeners of which one stands by while running another one. The softeners are regenerated by Brine solution. There are two dosing systems in pretreatment section.
[][]One is Clotech (NaClO) and another is Sodium Meta Bi Sulphite (SMBS) dosing.
[][]The NaClO dosing is used to add Chlorine which acts as a disinfectant. This chlorine is removed in the Active Carbon Filter.
[][]The SMBS dosing is used after active carbon filter to remove the remaining chlorine.
[][]After being softened, the water is treated through two stage Reverse Osmosis (RO) system and Electro De Ionizer (EDI).
[][]Finally, the purified water is stored in the PW storage tank.
[][]Two dosing systems are used in this section: Anti Silicant and NaOH dosing.
[][]NaOH dosing is used to control the pH and anti silicant dosing is used to reduce the silica from the water.

Operating Procedure:

[][]Automatic operation of PW plant:

Starting of PW plant:

[][]Switch on the main breaker to supply electrical power of the plant.
[][]Ensure compressed air and other utilities to run the plant.
[][]The HMI becomes ON and following screen will appear.
[][]Press Enter on that screen.
[][]Then the following screen will appear.
[][]Press “Parameter setting**” button to check the parameters and a box will appear for user ID and Password.
[][]Then the screen will appear to see the parameters. Press “setting2” to see the other parameter settings
[][]Then the screen will appear.
[][]Press the “Pretreatment Flowchart” button and screen for pretreatment flowchart will appear.
[][]Press the “Auto off” button. So, the system will be operated sequentially in automatic mode. In automatic mode the Multi Grade Filter and Active Carbon Filter will be reversely washed and then the RO will be washed.
[][]The softener will be regenerated automatically when the water flow rate is 100 Ton.

[][]After completing reverse washing normal production of PW will start.

During Operation:

[][]To see any alarm press the “Alarm status” button in . Following screen will appear:

[][]By pressing the button “ ” the alarms will be acknowledged and stored in the alarm history. All the alarms in the alarm history can be watched in the “History Alarm” section by pressing the Up and Down arrow.
[][]There is an online data logger which logs the conductivity of water after softener, 1st RO, 2nd RO and EDI.
[][]The real time curve can be seen by pressing the “Real Time Curve” button.
[][]The Daily Operational Log Sheet (Annexure – I) of PW plant will be filled up on every hour by the operator. Photocopy of all the approved forms will be used where easily applicable. For the cases where computer generated copies are relatively easy to handle, the exact format of the approved form can be used(except the approval sign) with the following notes as footer:

“This is a computer generated report. The format is as per the original approved form.”

Stopping procedure of PW plant:

[][]To stop the plant press “Auto on” button in the “Pretreatment Flowchart status” screen.
[][]Switch off the main breaker to cut the electricity.
[][]Close the line of compressed air and other utilities.

Annexure:

Annexure – I: Daily Operational Log Sheet of PW Plant.

Active Carbon Filter, Purpose:

Active Carbon Filter, The purpose of this SOP is to define the procedure of sanitization of Active Carbon Filter, RO and EDI of Purified Water Generation Plant manufactured by Watertown in order to ensure its smooth & trouble-free operation and generation of qualified purified water.

Active Carbon Filter, Scope:

This Standard Operating Procedure applies to the PW plant manufactured by Watertown, which is located at the Utility area (roof top) of Solid Block of XX Pharmaceuticals Ltd.

Definitions / Abbreviation:

[][]SOP: Standard Operating Procedure.
[][]PW: Purified Water.
[][]HMI: Human Machine Interface.
[][]ACF: Active Carbon Filter.
[][]RO: Reverse Osmosis.
[][]EDI: Electro De Ionizer.

Responsibilities:

[][]The roles and responsibilities are as follows:

Engineering (Validation) Department

[][]Preparing the SOP and revise it when necessary.

Engineering (Operation & Maintenance) Department

[][]To provide necessary support for smooth operation of the system.
[][]To ensure that the operators are responsible to carry out the operation and fill up the logbooks.

Operators

[][]To sanitize the ACF, RO and EDI according to the SOP.
[][]To fill up the logbooks.

Manager, Engineering

[][]To ensure that the operation of PW plant are done properly.

Manager, Quality Assurance

[][]To approve the SOP.
[][]To ensure overall implementation of this SOP.

Procedure:

Precautions:

[][]All operation work must be done safely in accordance with the requirements of the Plant Safety Statement and the safety notices around the plant. Specific attention must be paid to the following:
[][]Use Personal Protective Equipment during handling of any kind of chemical.
[][]Be sure that the steam line is insulated.
[][]Do not touch the hot water pipe line with bare hands.
[][]Check that there is no leakage in the steam or hot water line.
[][]Ensure all the utilities before doing any operation.
[][]Ensure that the water level in the water storage tank is at least 35%.

Framework Description:

[][]The PW plant made by Watertown has a limit of 3000 L/hr. The plant has Raw water pretreatment and RD/EDI areas.
[][] In pretreatment segment crude water is sifted through MGF and ACF separately.
[][] Then, at that point, this crude water is gone through the conditioner to lessen the hardness and is at long last treated with the RO and EDI to get the refined water of wanted determinations.
[][]The disinfection of ACF, RO and EDI is finished by utilizing heated water at a temperature of around 80°C.
[][] There are two hotness exchangers in pretreatment area and RO/EDI segment to create the boiling water with the assistance of modern steam.
[][]After disinfection of RO and EDI cooling is done at a temperature of 30 ± 5°C.

Automatic Sanitization Procedure:

Sanitization of ACF:

[][]Close the manual butterfly valve V47-03.
[][]Switch on the main breaker to supply electrical power of the plant.
[][]Ensure compressed air and other utilities to run the plant.
[][]The HMI becomes ON and following screen will appear.

Press Enter on that screen.

[][]Then the following screen will appear. Press “Parameter setting**” button to check the parameters sanitization and a box will appear for user ID and Password.
[][]Then the following screen will appear to see the parameters. Press “setting2” to see the other parameter settings.
[][]Then the screen will appear.
[][]Press the “Exit” button to go to the menu navigation page
[][]Press the “sanitization***” button and give user ID and password to go to the sanitization page.
[][]In the sanitization page press the “Auto ON” button for Automatic operation.
[][]In the sanitization page press “Carbon filter Sanitization” for sanitization of ACF.
[][]Then the following screen will appear. Press the “Carbon filter Sanitization OFF” button to start the sanitization automatically. Normally the sanitization temperature is approx. 80°C for a period of 60 mins.
[][]During sanitization fill up the operation log sheet (Annexure – I).
[][]Natural cooling procedure is used to cool the ACF after sanitization.

Sanitization of 1st stage RO:

[][]Close the manual butterfly valve V50-22.
[][]In the sanitization page (Figure 06) press the “RO I Sanitization” button. Then the following screen will appear. Press “RO I Sanitization OFF” button on that screen to sanitize the 1st stage RO automatically.
[][]The sanitization temperature of 1st RO is as 80 ± 3°C for 60 mins.
[][]After doing sanitization cooling is done at a temperature of 30 ± 5°C by flowing cooling water.
[][]Fill up the operational log sheet (Annexure – I) during sanitization.

Sanitization of 2nd stage RO:

[][]In the sanitization page (Figure 06) press the “RO II Sanitization” button. Then the following screen will appear. Press “RO II Sanitization OFF” button on that screen.
[][]Cooling procedure is as same as it is for 1st stage RO.

Sanitization of EDI:

[][]Close the manual diaphragm valve of bypass line of membrane contactor.
[][]In the sanitization page (Figure 06) press the “EDI Sanitization” button. Then the following screen will appear. Press “EDI Sanitization OFF” button on that screen.
[][]After sanitization RO and EDI are cooled down to 30°C ± 5°C by supplying cooling water.
[][]Fill up the operational log sheet during whole sanitization and cooling period.

Annexure:

Annexure – I: Operational Log Sheet for Sanitization of ACF, RO and EDI

Chiller Operation , Purpose

Chiller Operation, The purpose of this SOP is to define the operation and maintenance procedure of Chillers of XX Pharmaceuticals Ltd.

Chiller Operation , Scope

This SOP applies to the Chillers manufactured by Trane, USA which is located at the roof top area of Sterile and Sterile blocks of XX Pharmaceuticals Ltd.

Definitions / Abbreviation:

[][]EHS: Environment Health and Safety.
[][]PPE: Personal Protective Equipment.
[][]SOP: Standard Operating Procedure.
[][]AHU: Air Handling Unit.

Responsibilities:

[][]The roles and responsibilities are as follows

Engineering ( Validation) Department

[][]To prepare the SOP & revise it when necessary.

Engineering (Maintenance) Department

[][]To provide necessary support for smooth operation & maintenance of chillers.
[][]To ensure that the operators are responsible to carry out the operation and maintenance work and regular checking of the critical components and logbooks.
[][]To engage technician/mechanic/operator/supplier in repair and maintenance work.

Operators/Technician

[][]To operate the chiller according to the SOP.
[][]To fill up the logbooks related to the Chiller.
[][]To do the maintenance job according to the schedule.

Head of Engineering

[][]To ensure that the operation and maintenance of Chiller are done properly.
[][]To approve any maintenance/plans related to the Chiller.

Head of Quality Assurance

[][]To approve this SOP
[][]To ensure overall implementation of this SOP.

Procedure

Precautions:

[][]All maintenance work must be carried out safely in accordance with the requirements of the Plant Safety Requirements and the EHS safety notices must be displayed around the plant. [][]Specific attention must be paid to the following:
[][]Personal protective equipment (PPE) and clothing appropriate to the job must be worn.
[][]Equipment must be electrically isolated and locked out where possible.
[][]Ensure the control panel is switched off before carrying out any check.
[][]Maintenance activity must be carried out by trained technician/operators.
[][]“Under Maintenance” tag must be put while doing maintenance tasks.

System Description:

[][]Chiller is used to produce chilled water which is used in AHU’s cooling coil to cool the air. There are two chillers at the roof top area of Cephalosporin block and two at the roof top area of General Block. Each chiller has capacity of 250 Ton.
[][]The chiller works according to the Vapor Compression Refrigeration Cycle. There is an evaporator (heat exchanger) to chill the water by exchanging heat with the refrigerant. The refrigerant used in this system is R134a.

[][] The vapor refrigerant from the evaporator is sucked into the compressor and compressed to a higher pressure. There is a water cooled condenser to cool the refrigerant. The flow of refrigerant is controlled by using an expansion valve before entering into the evaporator.

Pre-Start Check:

[][]Check the power supply voltage within the utilization range.
[][]Verify that all refrigerant valves are “OPEN”.
[][]Check the chilled water.
[][]Check the Condenser water.
[][]Check cooling Tower water level.
[][]Check the fused-disconnect switch (es) that supplies power to the chilled water pump starter and the condenser water pump starter.
[][]Check all piping for leakage.
[][]Check the chilled water and condense water valve are “OPEN”.
[][]Visually inspect the chilled water pressure and condenser water pressure.
[][]Check the voltage of chiller.

Starting procedure:

[][]Following steps are followed to start the chillers
[][]Turn chiller circuit breaker (Panel Board) handle to “ON” Position.
[][]Start the chilled water pump
[][]Start Condenser water pump.
[][]Check the evaporator water flow.
[][]Check the condenser water flow.
[][]Start the cooling tower fan.
[][]After 10-30 Seconds Figure-I will be displayed.
[][]For checking condenser and evaporator circulating water we have to go to report option and check water flow.
[][]Touch the Report key and check water flow for condenser and chilled water circulating pump and oil temperature (Figure-II).
[][]After checking water flow, check the Setting of parameters.
[][]For setting parameter touch the” Setting” Key. Figure-III.
[][]Go back to Main screen menu and then touch the’ AUTO” key.
[][]After pressing the “AUTO” Figure-IV is displayed.

During Operation:

[][]Fill up the operational log book of chillers while the chillers are running on every 2 hours.

Stopping Procedure:

[][]At first Unlock the screen
[][]Touch the “STOP’’ key on screen.
[][]After stopping the chiller 5-10 minutes later
[][]Stop the condenser water pump.
[][]Stop chilled water circulating pump.
[][]Stop Cooling Tower Fan.

Chiller Preventive Maintenance Procedure:

[][]Use of a periodic maintenance program is important to ensure the best possible unit performance and efficiency.
[][]Fill up the maintenance log sheet of Chillers after doing maintenance.

Daily Maintenance

[][]Check the chiller’s evaporator and condenser pressures, and discharge oil pressure.
[][]Check the oil level in the chiller oil sump.
[][]Clean the chiller outside and surroundings.
[][]Check setting and operation of all controls and safety devices.

Weekly Maintenance

[][]Clean the environment of chiller room.
[][]Clean outside of the chillers, chilled water pumps.
[][]Clean outside of the condenser water pump.
[][]Check the electrical connection.

Monthly Maintenance

[][]Clean all water strainers in both the chilled and condensing water piping system.
[][]Measure the oil pressure drop. Replace oil filter if required.
[][]If operating conditions indicate a refrigerant shortage, leak checks the unit and confirm using soap bubbles.
[][]Repair all leaks.
[][]Check the motor bearing.
[][]Grease all pumps.

Annually Maintenance

[][]Check all isolators of pumps.
[][]Check starter contactors for wear and replace if required.
[][]Check motor winding insulation.
[][]Check motor amps draw.
[][]Clean condenser tubes.
[][]Check water pipeline for any leakage.
[][]Change the chilled water, refill with chemical.
[][]Change the condenser water.
[][]Check the evaporator and condenser flow switches.

Annexure

Annexure-I: Operational log sheet of Chillers
Annexure-II: Maintenance log sheet of Chillers

Operation & Maintenance of AHUS , Purpose

Operation & Maintenance of AHUS , The purpose of this SOP is to define the operation and maintenance procedure of Air Handling Units of Sterile Block of XX Pharmaceuticals Ltd.

Operation & Maintenance of AHUS , Scope

This SOP applies to all the AHUs which are located in the Sterile Block of XX Pharmaceuticals Ltd.

Definitions / Abbreviation:

[][]AHU: Air Handling Unit (AHU)
[][]EHS: Environment, Health and Safety.
[][]PPE: Personal Protective Equipment.
[][]SOP: Standard Operating Procedure.

Responsibilities:

[][]The roles and responsibilities are as follows

Engineering (Validation) Department

[][]To prepare the SOP & revise it when necessary.

Engineering (Maintenance) Department

[][]To provide necessary support for smooth operation & maintenance of AHUs.
[][]To check the log books.

Operators/Technician

[][]To operate the AHUs according to the SOP.
[][]To do the maintenance job according to the schedule.
[][]To fill up the operation and maintenance log book.

Head of Engineering

[][]To approve any maintenance/plans activities related to the AHUs.

Head of Quality Assurance

[][]To approve this SOP.

Procedure

Precautions:

[][]All maintenance work must be carried out safely in accordance with the requirements of the Plant Safety Requirements and the EHS safety notices must be displayed around the plant. [][]Specific attention must be paid to the following:
[][]Personal protective equipment (PPE) such as masks, safety glass, boots etc. appropriate to the job must be worn.
[][]Equipment must be electrically isolated and locked out where possible.
[][]Ensure the control panel is switched off before carrying out any check.
[][]Maintenance activity must be carried out by trained technician/operators.

Filters:

[][]Filtration is ordinarily positioned first in the AHU to keep every one of the downstream parts clean. Contingent on the grade of filtration required, regularly channels will be organized in (at least two) progressive manages an account with a coarse-grade channel gave before a fine-grade channel, or other “last” filtration medium.

[][] The coarse-grade channel is less expensive to supplant and keep up with, and in this manner safeguards the more costly channels.

Heating and/or cooling coil:

[][]Air taking care of Unit needs to give warming, cooling, or both to change the stockpile air temperature, and dampness level contingent upon the area and the application.

[][] Chilled water from the chiller is gone through a twisting container of the cooling curl, heat trade among water and air. Blades are appended to the cylinders effectively increment the surface for heat move to water from air.

[][]Boiling water from the high temp water age framework is gone through a twisting container of the warming loop, heat trade between boiling water and air.

[][]Blades are appended to the cylinders increment surface for heat move to air.

Blower/Fan/Motor:

[][]In the air handling unit fan/motor is used for supplying or extracts air from room. Depending on the size of AHU more than one fan/motor is installed.

Dampers:

[][]In AHU dampers are provided to control the flow of conditioned air to the room.

Pre-Start Check

[][]Check that the electrical connection is supplied.
Ensure that the chilled water is supplied to the cooling coil.
[][]Ensure that the hot water is supplied to the heating coil.
[][]All maintenance panels are to be closed and check all maintenance panels and locks for perfect position.
[][]Make sure that filters have been installed properly in their places.
[][]Make sure all filters media are installed in correct airflow direction.
[][]Starting Procedure
[][]Power ON for VSD.
[][]Press “Hand” Button.
[][]Press Start Button.

During Operation

[][]Check that there is no unusual noise or vibration. Stop and investigate if found.
[][]The Operational Log Sheet (Annexure – I) of AHUs will be filled up once a week by the operator. The reading of magnehelic gauges will be used to monitor whether the filter is blocked.

[][] If the pressure reaches the maximum limit as stated in the filters will be changed or cleaned according to the described procedure in that SOP.

[][] Photocopy of all the approved forms will be used where easily applicable. For the cases where computer generated copies are relatively easy to handle, the exact format of the approved form can be used(except the approval sign) with the following notes as footer:
“This is a computer generated report. The format is as per the original approved form.”

Stopping Procedure

[][]Press the Stop (Red) button.(See Figure-I)
[][]Power off for VSD.

Preventive Maintenance

[][]At first switch off power supply /isolate the AHU from power supply. The maintenance job is performed by trained personnel. “Under Maintenance” be displayed in a prominent position on a machine
[][]undergoing maintenance work.

Fan/Motor

[][]Check for soiling, corrosion, damage and tendency of excessive vibration.
[][]Check the electrical connection.
[][]Check that all bolts, nuts and flexible connection are securely fixed.
[][]Check that vibration isolator mounts is functioning well.
[][]Inspect for any obstructions or blockages at air intakes and discharges.
[][]Check fan bearing are secured and no undue noise by observe/listen using metal bar as a conductor.
[][]Check noise or knocking from bearing, replace both bearings.
[][]Check fan bearing and lubricate with grease.
[][]Check whether the fan impeller rotates freely.

Drive Belt

[][]Belts that are split or have frayed edges or any other sign of damage must be replaced in full set.
[][]Check the belt tension and alignment, retention and realign if necessary.
[][]Check drive belt, if damage replace belt.

Coil Section

[][]Ensure that coils are cleaned.
[][]Check for any leakage in coil.
[][]Ensure coil fins are not damage when performing dry/wet cleaning.

[][]Check that drain pan and drain trap are free from blockage and water accumulation at pan.

Filter Section:

[][]Disposable filters must be replaced each time when pressure drop reaches the indicated by dirty condition by magnehelic gauges. Washable filters must be cleaned periodically. For filters changing and cleaning procedure follow the SOP..

Dampers:

[][]Check for dirt accumulation, damage, and sign of corrosion.
[][]Clean with cloth or high pressure air.
[][]Check damper blade by turning manually or central control for smooth operation.

Preventive Maintenance Schedule

[][]During maintenance work the equipment must be electrically isolated. After performing maintenance works maintenance log book (as same as Annexure – II) has to be filled up by the operator.

Weekly Maintenance

[][]Check and clean fan
[][]Check Fan for excessive vibration.
[][]Check Fan belt.
[][]Check fan motor bearing.
[][]Check the functioning of auto actuator valves of chilled and hot water line.

Monthly Maintenance

[][]Check and Clean Motor.
[][]Check the belt drive tension.
[][]Check or replace V-belt condition.
[][]Check filter.
[][]Check nuts and bolts and tighten it if necessary.
[][]Grease the motor if necessary.

Quarter yearly Maintenance

[][]Check Vibrator Isolator.
[][]Check the electrical connection.
[][]Check the bearing for motor.
[][]Check drain trap clog.

Half Yearly Maintenance

[][]Check fan bearing.
[][]Check motor bearing.
[][]Check bolt and nut tighten.
[][]Check fin block.
[][]Check coil leakage.
[][]Check dirt accumulation of damper & Heater.
[][]Check sign of damage.
[][]Check position of damper.

Yearly Maintenance

[][]Servicing cooling coil and heating coil.
[][]Check/treat/repair corrosion of coil.
[][]Check/repair Electrical control box.
[][]Check/Replace Circuit Breaker.
[][]Check/replace internal lighting.

Annexure

Annexure-I: Differential Pressure Monitoring Log sheet of AHUs
Annexure-II: Maintenance Log Book of AHUs

HEPA Filter Cleaning , Purpose:

HEPA Filter Cleaning , The purpose of this SOP is to define the cleaning and changing procedure of G4, F7, F9 and HEPA filters of HVAC system of XX Pharmaceuticals Ltd.

HEPA Filter Cleaning , Scope:

This Standard Operating Procedure applies to the G4, F7, F9 and HEPA filters of HVAC system installed at Sterile and Solid Block of XX Pharmaceuticals Ltd.

Definitions / Abbreviation:

[][]SOP: Standard Operating Procedure
[][]AHU: Air Handling Unit
[][]G4 Filter: G4 filters are used as pre filters inside the AHUs and in low return line of rooms of HVAC system. This is also known as coarse graded filter
[][]F7 and F9 Filter: F7 and F9 filters are used as intermediate filters inside the AHUs of HVAC system. These are factory fabricated and mounted with galvanized steel or plastic frames
[][]HEPA: High Efficiency Particulate Air
[][]DOP: Di – Octyl Phthalate
[][]PAO: Poly Alpha Olefin

Responsibilities:

[][]The roles and responsibilities are as follows:

Engineering (Validation) Department

[][]Preparing the SOP and revise it when necessary.

Engineering (Maintenance) Department

[][]To provide necessary support for performing cleaning/changing operation smoothly.
[][]To ensure that the operators are responsible to carry out the operation and fill up the logbooks.

Operators/Technician

[][]To clean/change the filters according to the SOP.
[][]To fill up the log sheets.

Manager, Engineering

[][]To ensure that the cleaning/changing of filters are done properly.

Manager, Quality Assurance

[][]To approve the SOP.
[][]To ensure overall implementation of this SOP.

Procedure:

Precautions:

[][]All operation work must be done safely in accordance with the requirements of the Plant Safety Statement and the safety notices around the plant. Specific attention must be paid to the following:
[][]Do not open the doors of AHU while the motor is running.
[][]Do not wash the filters beside the AHUs.
[][]Use personal protective equipment and clothing as necessary at the time of performing cleaning/changing work.
[][]Be careful about the hot water line.

System Description

[][]In HVAC system, the filtration of air is done in three stages to remove the particulates from the air. The stages are: primary, secondary and tertiary stages.

Primary stage:

[][]Coarse graded filters are used in primary stage. The grade of this filter is G4. This type of filter is washable. This is also used in the low return duct line of AHUs. This type of filters are used to remove the coarse particles.

Secondary stage:

[][]After primary stage filtration the air is filtered in secondary stage filter inside the AHUs. Normally, the secondary stage filters are of F7/F9 graded. The bag type F7 filter is washable but cartridge and flat type F7 and F9 filters are not washable. They have to be replaced after being blocked with particles.

Tertiary stage:

[][]The air is finally filtered by the HEPA filters in tertiary stage. In some cases, filtration is done by the HEPA filters after secondary stage inside the AHU followed by terminal HEPA filter. Otherwise, HEPA filter is used only in the terminal of supply duct. These filters are neither washable nor cleanable rather than these are replaced or changed in case they fail the filter integrity test commonly known as DOP/PAO test.
[][]Monitor the differential pressure in the magnehelic gauge across the filters of AHUs in the log sheet.  If the differential pressure is beyond the set limit, then clean/change the filters.

Cleaning Procedure

[][]Cleaning of G4 and F7 (bag type) filters:
[][]Switch off the power of AHU and wait until the motor rotation is fully off.
[][]Open the door of the filter section and unmount the filter from its frame.
[][]Take the filter to the wash area at the roof top of both cephalosporin and general blocks.
[][]Wash the filter with water. Then, use any kind of non ionic cleaning agent to clean the filter.
[][]After cleaning the filters are dried.
[][]During cleaning a lot of dust may come out from the filters. So, use mask, goggles, hand gloves and other clothes to be safe from any harmful dust.
[][]After drying set the filters in the filter frame.
[][]The G4 filters of low return and inside the AHUs are cleaned once a week and every 15 days respectively for periodic maintenance. The F7 (bag type) filters are cleaned once a month.
[][]Fill up the log sheet (Annexure – I) after performing the activities.

Changing Procedure

[][]Changing of G4, F7, F9 filters:
[][]Both the G4 and F7 (bag type) filters are changed when filters cannot filter the air although it has been cleaned.
[][]Monitor the differential pressure across the filters. If the differential pressure across F7 (cartridge and flat type) and F9 filters is more than 500 Pa, the filters have to be changed. Both of these filters are changed once in a year for periodic maintenance.
[][]To change the filters follow the steps 1 to 2 of previous section.
[][]Take the filters to the dispose area.
[][]Destroy the filters in the dispose area abiding by the proper safety rules.
[][]Set a new filter.
[][]Fill up the log sheet (Annexure – II).

Changing the HEPA filters:

[][]The differential pressure across the HEPA filters (fitted inside the AHUs) is monitored. These filters are changed when the differential pressure exceeds 300 Pa.
[][]The integrity test (DOP/PAO) is performed at a defined interval for every HEPA filters. The filter is changed if it fails the test.
[][]To change the HEPA filters follow the previous steps
[][]After replacing the filter fill up the log sheet (Annexure – II).

Annexure:

Annexure – I: Log sheet for cleaning of G4 & F7 (bag type) filters.
Annexure – II: Log sheet for changing of G4, F7, F9 and HEPA filters.

Pure Steam, Purpose:

Pure Steam, The purpose of this SOP is to define the Operation of Pure Steam Generation System manufactured by Watertown in order to ensure its smooth & trouble-free operation and generation of qualified pure steam.

Pure Steam, Scope:

This Standard Operating Procedure applies to the pure steam generation system manufactured by Watertown, which is located at the Utility area (roof top) of Sterile block of XX Pharmaceuticals Ltd.

Definitions / Abbreviation:

[][]SOP: Standard Operating Procedure.
[][]PW: Purified Water.
[][]HMI: Human Machine Interface.
[][]PS: Pure steam.

Responsibilities:

[][]The roles and responsibilities are as follows:

Engineering (Validation) Department

[][]Preparing the SOP and revise it when necessary.

Engineering (Maintenance) Department

[][]To provide necessary support for smooth operation of the system.
[][]To ensure that the operators are responsible to carry out the operation and fill up the logbooks.

Operators

[][]To operate the system according to the SOP.
[][]To fill up the logbook.

Head of Engineering

[][]To ensure that the operation of PW plant are done properly.

Head of Quality Assurance

[][]To approve the SOP.
[][]To ensure overall implementation of this SOP.

Procedure:

Precautions:

[][]All operation work must be done safely in accordance with the requirements of the Plant Safety Statement and the safety notices around the plant. Specific attention must be paid to the following:
[][]The tank walls are hot. The water in the tank is at 80°C when the unit is operating. Contact with 80°C water will cause burning.
[][]Use Personal Protective Equipment during handling of any kind of chemical.
[][]Be careful about the hot water and steam line.
[][]Ensure all the utilities before doing any operation.

System Description:

[][]Pure steam is generated by heating the purified water. In this plant it is generated during the production of Water For Injection.
[][]So, the main control panel for WFI Generation system and PS is same. Purified water is converted to pure steam by exchanging the heat with the industrial steam in the heat exchanger.
[][]Then, the pure steam is supplied to the user point by opening the pneumatic valve PBV501. The capacity of steam generation is 250 Kg/hr.

Operating Procedure:

Starting of Pure steam generation:

[][]Switch on the main breaker to supply electrical power of the plant.
[][]Open the industrial steam inlet valve such that the pressure is within 3-4 bar.
[][]Ensure compressed air and other utilities to run the plant.
[][]Switch ON the UPS. In case of emergency stop, release the emergency stop switch.
[][]Then starting page will appear and press on HMI.
[][]Press Start on that screen
[][]Press User key. After that following screen will appear
[][]Press the “Parameter setting**” button to set the parameters. Following screen will appear:
[][]Give user ID and Password and press OK.
[][]Then the parameter setting screen will appear.
[][]Press on any reading (yellow marked) to change the value if required.
[][]Then press flow chart status on Figure V.
[][]Screen of WFI/PS generation flow chart will appear.
[][]Press the Auto On button to operate the plant automatically.

[][]Open the pneumatic valve PBV501 when the temperature of pure steam reaches the required temperature limit.

During operation:

[][]Check PS temperature.
[][]Check Pure Steam pressure.
[][]Check that there is no unusual noise or vibration. Stop and investigate if it is found.
[][]The Operational Log Sheet (Annexure – I) of PS generation will be filled up by the operator on hourly basis.

Stopping procedure:

[][]Close the PS valve (PBV501).
[][]Press the Auto Off to stop the plant.
[][]Then switch the power off by turning the circuit breaker to off position.
[][]Close the industrial steam inlet valve.

Annexure:

Annexure – I: Operational Log Sheet of pure steam generation system.