SOPs

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.

Boiler, Purpose:

Boiler, The purpose of this SOP is to define the standard operation and maintenance procedure of Boiler in order to ensure its smooth & trouble-free operation and generation of steam.

Boiler, Scope:

This SOP is applicable to Cochran Diesel / Gas Boiler which is located at the ground floor of Sterile Block of XX Pharmaceuticals Ltd.

Definitions / Abbreviation:

[][]Boiler: A boiler is a closed vessel in which water is heated; steam is generated and superheated from any combination of heat from combustible fuels or electricity.
[][]EHS: Environment Health and Safety.
[][]PPE: Personal Protective Equipment.
[][]SOP: Standard Operating Procedure.
[][]TDS: Total Dissolved Solids.

Responsibilities:

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

Validation (Engineering) Department

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

Engineering Department

[][]To provide necessary support for smooth operation & maintenance of boiler.
[][]To ensure that the operators are responsible to carry out the operation and maintenance work and regular checking of 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 Boiler according to the SOP.
[][]To fill up the logbooks related to the Boiler.
[][]To do the maintenance according to the check list.

Manager, Engineering

[][]To ensure that the operation and maintenance of the Boiler.
[][]To approve any maintenance/plans related to the Boiler.

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:
[][]Personal protective equipment (PPE) and clothing appropriate to the job must be worn.
[][]Ensure the control panel is switched off before carrying out any maintenance.
[][]Maintenance activity must be carried out by trained technician/operators.
[][]No unauthorized person is allowed to do any kind of operation or maintenance to the boiler.
[][]The cover doors must be kept closed during operation.
[][]The safety mechanism of the machine must be checked by the operator for reliability in each and every working day.
[][]“Under Maintenance” be displayed in a prominent position on a machine, equipment or facility undergoing maintenance work.

Pre-start Check

[][]To ensure the permanent ventilation of the boiler house (Excluding doors and windows) is capable of supplying sufficient air for combustion and to keep the boiler house cool.
[][]Check all mechanical connections are properly tightened and have not worked loose in transit.
[][]Check direction of rotation of burner fan motor.
[][]To ensure oil / Gas is present.
[][]To ensure fuel / Gas valve is “OPEN”.
[][]To ensure water level in the feed water tank is enough.
[][]To ensure the burner switch on the control panel is OFF.
[][]To ensure feed water pump valve is “OPEN”
[][]To ensure that the fuel / Gas selector switch has selected OIL.
[][]To ensure that the gas isolating valves are closed and the oil isolating valves are open.
[][]The boiler feed pump should be filled with water on its suction side.
[][]The boiler should be filled with softened water.
[][]Ensure the fuel / Gas filters are clean.

Starting Procedure

[][]Main switch turn to “ON” position.
[][]Switch on the feed water pump selector switch (No.1 or No.2 for respective pump selection).
[][]Turn feed water pump control switch to “AUTO” position from “OFF” position.
[][]Turn burner control switch to “LOW” position from “OFF” position.
[][]When boiler steam pressure reaches up to (6.5-7) bar then turn burner control switch to “LOW” position from “OFF” position.

During Operation

[][]All boiler gaskets, valve stuffing boxes and valve gaskets are to be checked periodically during the boiler heat-up.
[][]The boiler pressure gauge should be observed during this heat-up period.
[][]Water analysis after every 12 hours of operation. If feed water is found to be hard any time, stop the boiler immediately. Drain the water from the service tank.
[][]Regenerate the softener and fill up the feed water tank then restart the boiler.
[][]Any excessive sound coming from motors or any moving part.
[][]All valves, joints, head-hole and manhole covers are leak tight.
[][]The water level is correct and steady.
[][]Steady steam pressure is maintained.
[][]Check Safety valve.
[][]Check fuel pressure.
[][] The Operational Log Sheet (Annexure – I) of boiler 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.”

Boiler Stopping Procedure

[][]Turn burner control switch to “OFF” position.
[][]Turn feed water pump control switch to “OFF” position.
[][]Fuel / Gas valve is off.
[][]In case of an emergency where immediate shutdown is necessary, the emergency stop push button should be pushed immediately.

Preventive Maintenance Planning

[][]During maintenance works 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. The schedule which follows must be applied at the Interval which occurs first.

Daily Maintenance

[][]Ensure that the fuel filters are clean.
[][]Check the water level.
[][]Clean the viewing glass
[][]Check the operating pressures.
[][]The boiler feed pump should be filled with water on its suction side.
[][]The boiler should be filled with softened water.
[][]Check the quality of feed water.
[][]Check the safety valve.

Weekly Maintenance

[][]Clean the flame sensor & viewing glasses.
[][]Check the water level is properly controlled.
[][]Check the low level & extra low level alarms by reducing the water level.

Monthly Maintenance

[][]Clean igniter assembly.
[][]Drain the feed water tank to remove the sediment.
[][]Clean the burner nozzle & ignition electrodes.
[][]Check oil / Gas leaks.

Quarterly Maintenance

[][]Clean electrical contacts of all relays & tighten loose connection if any.
[][]Check the water pump seal non-return valve.
[][]Check & clean the furnace if required.
[][]Service burner unit.
[][]Check door and furnace seals.
[][]Visual check of refractory’s.
[][]Check control panel.
[][]Set-up combustion.
[][]Check safety interlocks.
[][]Drain & clean the water service tank.
[][]Check the feed water pump.
[][]Check the seals of the feed water pump.
[][]Clean the blower fan blades

Half Yearly Maintenance

[][]Check the valves for leakages; lap them if found leakage.
[][]Lubricate the bearing of water pump.
[][]Check the sealing of Manhole, head holes & clean out door of smoke box.

Annually Maintenance

[][]Check the burner position, adjust if required.
[][]Clean the boiler tubes with brush.
[][]Clean the combustion chamber.
[][]Overhaul the valves.
[][]Check the door refractory for any damage, repair if necessary.
[][]Check the door seal to make sure that there is no gas leakage.
[][]Clean the water side of the boiler thoroughly.

Annexure:

Annexure – I: Operational Log sheet of Boiler.
Annexure – II: Maintenance Log sheet of Boiler.

Dehumidifier Operation and Maintenance, Purpose:

Dehumidifier Operation and Maintenance, The purpose of this SOP is to define the operation and maintenance procedure of dehumidifiers of HVAC systems of Sterile and Solid of XX Pharmaceuticals Ltd.

Dehumidifier Operation and Maintenance, Scope:

This Standard Operating Procedure applies to the dehumidifiers of HVAC system installed at Sterile and Solid Block of XX  Pharmaceuticals Ltd.

Definitions / Abbreviation:

[][]AHU: Air Handling Unit.

[][]Dehumidifier: A dehumidifier is an equipment of HVAC system which reduces the level of humidity in the air. This basic dehumidification process uses a special humidity absorbing material called a desiccant, which is exposed to the air to be conditioned.

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.

Operator

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

GM, Engineering

[][]To ensure that the system is operated properly.

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 touch the steam line with bare hands.
[][]Perform any kind of maintenance after switching off electrical power and also after cooling of hot pipe line.
[][]Use personal protective equipment and clothing as necessary at the time of performing maintenance work.
[][]Put the “UNDER MAINTENANCE” tag on an easily visible place of the equipment before performing maintenance.

System Description

[][]In an HVAC system a dehumidifier is used to reduce the humidity of air. There are various ways to dehumidify the air. Desiccant type dehumidifier is commonly used in HVAC system of pharmaceutical industry.
[][]A chemical (normally silica gel) is used as a desiccant which adsorbs the moisture in the air. The air to be conditioned is passed through the bed of silica gel which adsorbs the moisture.
[][]This silica gel is again regenerated using the heated air. The heated air is produced by using steam in the heat exchanger or by electrical heater.

Pre-start check

[][]Check that the related AHU of the dehumidifier is switched on.
[][]The steam pressure in the steam header should be between 2 to 4 bar.

Starting Procedure

[][]Switch on the main circuit breaker.
[][]Check the power indicating light.
[][]Turn the selector switch to “MANUAL” mode to run the dehumidifier using manual mode. “AUTO” position is selected to run the dehumidifier in automatic mode.

During Operation

[][]During operation, the indicating light “OPERATION” becomes on.
[][]Check the rotational direction of motor and bed of silica gel. It should be in clockwise direction.
[][]Check if there is any alarm in the alarm indicator and resolve it.

Stopping Procedure

[][]Turn the selector switch to off (O) position to switch off the dehumidifier.
[][]Switch off the main circuit breaker.

Preventive Maintenance of Dehumidifier

[][]Perform any kind of maintenance after switching off the electrical power and cooling of electrical heater.
[][]Fill up the log book after performing preventive maintenance (according to Annexure – I and Annexure – II).
[][]Perform preventive maintenance according to the following schedule:

Monthly

[][]Check the filters and clean if necessary.

Half yearly

[][]Check the rotor drive and clean with compressed air if it is necessary.
[][]Check that the rotor sealing is in the right position and not damaged.

Yearly

[][]Check the rotor bearing.
[][]Check the rotor surface.
[][]Check the motors for any abnormal sound.

After 3 years

[][]Change the silica gel.

Annexure:

Annexure – I: Log sheet for preventive maintenance of Dehumidifier

Chilled Water Circulating Pumps , Purpose:

Chilled Water Circulating Pumps , The purpose of this SOP is to define the operating procedure of chilled water and cooling water circulating pumps of HVAC system of XX Pharmaceuticals Ltd.

Chilled Water Circulating Pumps , Scope:

This Standard Operating Procedure applies to the chilled and cooling water circulating pumps installed at the roof top area of Sterile Block of XX Pharmaceuticals Ltd.

Definitions / Abbreviation:
VSD: Variable Speed Driver.

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.

Operator

[][]To operate the system according to the SOP.

Manager, Engineering

[][]To ensure that the system is operated properly.

Manager, Quality Assurance

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

Annexure:

N/A

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.
[][]In HVAC system, chilled water is used to cool the air inside the AHUs. This chilled water is produced in chiller and circulated from chiller to heat exchanger of AHUs through pumps. This acts as a closed loop.
[][]In cooling tower, the cooling water is circulated from cooling tower to the condenser of chiller through pumps.

Pre-start check

[][]Ensure that pipeline is filled with water. If there is not sufficient water, the pump may be damaged.

Starting Procedure

For VSD
[][]Switch on main circuit breaker to give electrical power to VSD.
[][]Press the  “HAND” button and then press the Green button on VSD to start the pumps.

[][]Press the green button to start the pump. During operation check for any alarm (RED indicating light)
#Stopping Procedure
#For VSD
[][]Switch off the pump by pressing the red button on VSD.
[][]Switch off the main circuit breaker.
[][]For Star Delta connection
[][]Press the RED button to switch OFF the pump.
[][]Switch off the main circuit breaker.

Cooling Tower , Purpose

Cooling Tower , The purpose of this SOP is to define the operation and maintenance procedure of Cooling Towers of XX Pharmaceuticals Ltd.

Cooling Tower , Scope

This SOP applies to the cooling towers, installed at the roof top area of Solid and Sterile Blocks of XX Pharmaceuticals Ltd.

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 cooling towers.
[][]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.
[][]To engage technician/mechanic/operator/supplier in repair and maintenance work.

Operators/Technician

[][]To operate the cooling tower according to the SOP.
[][]To do the maintenance job according to the schedule.

Head of Engineering

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

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 be displayed in a prominent position on a machine, equipment or facility undergoing maintenance work.

Pre-Start Check

[][]Inspect all wiring connections to be sure they are clean and tight.
[][]Check the power supply voltage within the utilization range.
[][]Check cooling Tower basin water level.
[][]Check the fused-disconnect switch(es) that supplies power to the condenser water pump starter.
[][]Start Condenser water pump.
[][]Start the cooling tower fan.
[][]Check all piping for leakage.
[][]Check the condense water valve are “OPEN”.
[][]Visually inspect the condenser water pressure.
[][]Check condense water modulating butterfly valve position.
[][]Check the condense water line make-up water tank water level.

[][]Starting procedure
[][]Power ON for VSD.
[][]Press “Hand” Button.
[][]Press Start Button.

Stopping Procedure

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

Preventive Maintenance schedule

[][]Use of a periodic maintenance program is important to ensure the best possible unit performance and efficiency. Fill up the Annexure – I and II after completing the maintenance tasks accordingly.

Daily Maintenance

[][]Check the condense water pressure,
[][]Check cooling towers basin water level.
[][]Clean the cooling towers outside and surroundings.

Weekly Maintenance

[][]Current drawn by the fan motor.
[][]Check cooling tower fan rotation.
[][]Unusual noise, vibration, and so forth.

Monthly Maintenance

[][]Check and clean strainer.
[][]Clean Fan blade.
[][]Check the Belt tension.
[][]Clean the Internal side of the cooling Tower.
[][]Check and adjust sump water level.
[][]Check and adjust blow-down.
[][]Inspect water distribution.
[][]Clean the cooling towers Fins.
[][]Change the cooling water, refill with chemical.
[][]Grease the cooling tower motor.
[][]Clean the Y-strainer of chilled water and condenser water line.

Annually Maintenance

[][]Check/clean all parts of cooling tower.
[][]Clean cooling tower basin.
[][]Clean cooling tower fins.
[][]Check setting and operation of all controls and safety devices.
[][]Check starter contactors for wear and replace if required.
[][]Check motor winding insulation.
[][]Check motor amps draw.
[][]Check and adjust the water flow.
[][]Change the water of chilled water line.

Annexure

Annexure-I: Maintenance Log sheet of Cooling Tower

HVAC System Filters Numbering, Purpose:

HVAC System Filters Numbering, The purpose of this SOP is to define the procedure for the establishment of identification number of terminals/filters of HVAC system of XX Pharmaceuticals Limited.

HVAC System Filters Numbering, Scope:

All types of filters, diffusers and return risers/grilles of HVAC system of both Solid and Sterile Blocks are covered by this SOP.

Definitions / Abbreviation:

[][]HVAC: Heating Ventilation and Air Conditioning.
[][]HEPA: High Efficiency Particulate Air.
[][]AHU: Air Handling Unit.

Responsibilities:

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

Engineering Person(related to HVAC)

[][]To fill up the request form (Annexure – 1) to get the ID of newly fitted filters/diffusers/return grilles.
[][]To inform validation (engineering) department if there is any replacement of terminals/filters.

Engineering (Validation) Department

[][]To give the ID of filters/diffusers/return grilles.
[][]To maintain a register for terminals/filters of HVAC system.

Functional Head

[][]To ensure that all the terminals/filters of HVAC system are numbered according to this SOP and any inclusion or exclusion is reported to the Validation (Engineering) department.

Head of Quality Assurance

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

Procedure:

[][]Supply Diffuser and Filter Numbering
[][]Filters will be numbered using the following convention:
[][]AAAA – BBBB – CCC – XXX
Where,
[][]AAAA/AAA/AA: 4/3/2 characters to indicate the area of the plant.
[][]BBB/BB/B: 3/2/1 characters to indicate the diffuser and filter.
[][]For a diffuser and filter combination the code will be ‘DF’. If there is a swirl diffuser and filter, the character will be ‘SDF’.
[][]For a supply terminal without filter, the code will be only ‘D’ for diffuser. Only ‘F’ is used for the filters inside the AHUs.
[][]CCCC/CCC: 4/3 characters to indicate the grade and type of filter.
[][] First 2/3 characters indicate the grade of filters and last character indicates the type of filter (bag type, flat type etc.).
[][]The character will be 000 in case of having no filter with the supply diffuser.
[][]XXX: Three digits numerical code to indicate the sequential number of the same type of filter in an area.
For an example, a terminal flat type HEPA filter of grade H13 of Production Area of Sterile Block will be numbered according to the following way:

SPRD – DF – H13F – 001

001=Sequential Number for that area

H13F=H13 Grade and Flat type filter.

DF =Diffuser and Filter

SPRD=Sterile Production Area

Return Grille/Riser, Filter and Exhaust Grille Numbering

[][]All diffusers and return grilles of HVAC system of the plant will be numbered using the following convention:
AAAA – BBB – CCC – XXX
Where,
AAAA/AAA/AA: 4/3/2 characters to indicate the area of the plant.
[][]BBB: 3 characters of which first 2 characters indicate either low return riser or high return.

[][]Last character indicates filter or grille. ‘RR’ or ‘HR’ is used to indicate the low return riser and ceiling return respectively. ‘

[][]F’ and ‘G’ is be used for last character to indicate the filter and grille correspondingly. For exhaust grille the code will be 2 letters ‘EG’.
[][]CCC: 3 characters to indicate the filter grade and type of filter.

[][]If there is no filter in the return, the character will be 000.
[][]XXX: Three digits numerical code to indicate the sequential number of the same type of terminals/filters of a particular area.
[][]For an example, a low return riser of production area of general block with a G4 bag type filter is identified according to the following way:

PRD – RRF – G4B – 001

001=Sequential Number.

G4B=Filter grade and type

RRF =Low return riser with filter

PRD=Solid Block Production Area

[][]All terminals/filters of HVAC system will be tagged containing ID number. Format of filter identification tag is as follows:

[][]ID Number##

[][]The length and height of the box is 4.0 inch and 0.4 inch respectively. Arial font of size 10 shall be used for all the letters.
[][]A register of Terminal/Filter ID will be reserved in the validation (Engineering) department. (See Annexure – III).

[][]To get the ID of newly installed filters/terminals, the request form for ID (Annexure – II) will be filled up by the respective engineers and sent to the validation (engineering) department. Validation department will provide the sticker of ID and photocopy of the request form after giving new ID.
[][]If a Terminal/Filter is replaced with a new one, the new ID no. will be provided and the previous ID no. will not be used again.
[][]If any filter of new grade (which is not listed in the Annexure – I) is installed, the new filter will be added in the Annexure – I by handwriting of Head of QA with signature and date without reviewing the whole SOP. The Annexure – I will be added on the next version of this SOP.
[][]Photocopy of all the approved forms will be used where easily applicable. For the cases where computer generated copies are relatively easier 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”

Annexure:

Annexure-I : Code for Grade and Type of Filters.
Annexure-II : Request Form for ID Number of New Terminal/Filter of HVAC system.
Annexure-III : Register of Terminal/Filter of HVAC system.