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.

Purified Water System Sanitization, Purpose:

Purified Water System Sanitization , The purpose of this SOP is to define the sanitization procedure of purified water distribution system in automatic mode.

Scope:

Purified Water System Sanitization , This Standard Operating Procedure applies to the PW Distribution systems manufactured by Watertown, which is located at the Utility area (roof top) of both Solid and Sterile Blocks of XX Pharmaceuticals Ltd.

Definitions / Abbreviation:

[][]SOP: Standard Operating Procedure.
[][]PW: Purified Water.
[][]HMI: Human Machine Interface.
[][]PQ: Performance Qualification.

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.
[][]To inform PW user departments not to open the valves during sanitization.

Operators

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

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 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:

[][]Be careful about the hot water and steam line.
[][]Ensure all the utilities before doing any operation.
[][]Do not touch the steam and hot water line with bare hands.
[][]Do not open any valve of distribution line during sanitization.
[][]Ensure at least 40% water level in the PW storage tank before starting sanitization.

System Description:

[][]There are two distribution systems of purified water in cephalosporin and general block. There is a shell and tube type heat exchanger in distribution loop to sanitize the system.
[][]During sanitization, purified water is heated using industrial steam at a temperature of 80–90⁰C. Then, this hot water is circulated through distribution loop for a period of 60 minutes.
[][]Cooling is done after sanitization at a temperature of 40⁰C using chilled water.

Sanitization Procedure:

Prestart check:

[][]Ensure minimum 3 bar industrial steam pressure before starting sanitization.
[][]Chilled water temperature has to be less than 10⁰C.
[][]Close all the valves of distribution line and inform all the PW user departments not to open the valve during sanitization period
[][]Check the water level in the PW storage tank. It has to be minimum 40%.

Starting of Sanitization system in automatic mode:

[][]Switch on the main breaker to supply electrical power of the plant.
[][]Ensure compressed air and other utilities to run the plant.
[][]Switch ON the UPS. In case of emergency stop, release the emergency stop switch.
[][]Switch ON the UPS. In case of emergency stop, release the emergency stop switch.
[][]Then starting page will appear and press on HMI.
[][]Then the following screen will appear. Press “Control flow”.

[][]Press the “Sanitization OFF” and give user ID and password.

[][]Press the “Sanitization OFF” again to start the system in automatic mode.

During Sanitization:

[][]During sanitization PW is circulated through the distribution line at a temperature of 80–90⁰C. After cooling the sanitization will be automatically stopped when the water temperature decreases to 40⁰C.
[][]Fill up the log sheet (Annexure – I) at 30 minutes interval after starting the cycle of sanitization.

Sanitization Frequency:

[][]After successful completion of chemical and microbiological tests of PQ (phase-1, phase-2 and phase-3 study) of PW system, the sanitization frequency has been finalized to 14 days interval.
[][]If the plant remains closed for any long vacation, then the distribution system will be sanitized.
[][]The distribution loop of General Block will either be sanitized prior to cephalosporin block’s loop or will be sanitized both at a time.

Annexure:

Annexure – I: Operational Log Sheet of Sanitization of PW distribution system

Purified Water Generation Plant, Purpose:

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

Purified Water Generation Plant, Scope:

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

Definitions / Abbreviation:

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

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.

Operators

[][]To operate the PW plant according to the SOP.

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 careful about the hot water and steam line.
[][]Ensure all the utilities before doing any operation.

Operating Procedure:

[][]Manual 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 following screen will appear to see the parameters. Press “setting2” to see the other parameter settings.
[][]Then the following screen will appear.
[][]Press the “Pretreatment Flowchart” button and screen for pretreatment flowchart will appear.
[][]Press the “Manual off” button. In Manual mode the Multi Grade Filter and Active Carbon Filter will be reversely washed and then the RO will be washed by manually on Valve and pump. The softener generation also will be done manually.
[][]Reverse Washing of Multi grade filter:
[][]Active carbon filter reverse washing:
[][]Softener Regeneration:
[][]Manual Operation In RO:
[][]Press on RO Flow chart on Screen and will show following screen
[][]After 5-10 min on pump PU51-01,PU51-02,PU52
[][]Do reverse washing as it is stated for 3 minutes.
[][]Then open the valves XV51-09, XV51-06, XV52-10, XV52-09, XV52-06 and XV60-01.
[][]During Operation:
[][]To see any alarm press the “Alarm status” button in Figure 05. 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 in Figure 05.

Stopping procedure of PW plant:

[][]To Stop Pump PU51-01,PU51-02,PU52
[][]To stop valves.
[][]After that press “Manual on” button in the “Pretreatment Flowchart status” screen (Figure 05) for stopping manual mode.
[][]Switch off the main breaker to cut the electricity.
[][]Close the line of compressed air and other utilities.

Annexure:

N/A

Purified Water Generation, Purpose:

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

Purified Water Generation, Scope:

This Standard Operating Procedure applies to the PW Generation and Distribution systems manufactured by Watertown. The Generation system of purified water is located at the utility area (roof top).

Definitions / Abbreviation:

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

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 maintenance of the system.
[][]To ensure that the operators are responsible to carry out the maintenance tasks and fill up the logbooks.

Operators

[][]To perform the maintenance of the system according to the SOP.
[][]To fill up the logbooks.

Manager, Engineering

[][]To ensure that the maintenance 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 careful about the hot water and steam line.
[][]Ensure all the utilities before doing any operation.
[][]Hang the Maintenance tag prior to any maintenance activity.

System Description:

[][]The PW is produced from feed water through various processes. In pretreatment portion the feed water is passed through the MGF, ACF, softener and 5 micron cartridge filter. Then the pretreated water is passed through 1st and 2nd stage RO and finally through EDI. In RD/EDI section there is another 5 micron cartridge filter after 1st RO.

[][] There are four chemical dosing systems in PW Generation system such as chlorine dosing, SMBS dosing, Anti Scalant dosing and pH correction dosing. There is a PW storage tank of capacity 5000L in Solid Block.

[][]Also, there is a PW Distribution loop in the Liquid Block which contains a 3000L PW storage tank. There is a user point in the PW distribution loop system of Solid to supply the PW in the PW storage tank of Liquid Block.

Maintenance Procedure:

[][]Filter Cleaning procedure: The cartridge filter is cleaned when the filter is blocked and the pressure rises. Normally, an alarm is generated on the PLC due to high pressure (greater than 0.3MPa).
The cartridge filter is dismantled from the filter housing. Then wash the filter by passing the normal water through the filter in backward direction.
[][]Sanitize the ACF after every 14 days according to the SOP.
[][]Sanitize the 1st RO, 2nd RO and EDI after 6 months according to the SOP.
[][]Sanitize the PW distribution system after every 14 days according to the SOP.
[][]Clean the dosing tanks on every 2 weeks. At first, empty the dosing tank and wash it by PW.
[][]The maintenance schedule of PW Generation and Distribution system is given below:

[][]Daily maintenance
>>Check for any leakage.
[][]Bi monthly
>>Clean the dosing tanks.
[][]Monthly
>>Shoot clean for panel board.
[][]Yearly
>>Tighten all the nuts and bolts.
>>Check all electrical connections.
[][]After two years
>>Change the gasket of the valves.
>>Check the pneumatic pipes and change if it is necessary.
>>High pressure (greater than 0.3 MPa) across the cartridge pre filter
>>Wash the cartridge pre filter.

Annexure:

Annexure – I: Maintenance Log Sheet of PW Generation and Distribution system

Purified Water Distribution System , Purpose:

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

Purified Water Distribution, Scope:

This Standard Operating Procedure applies to the PW Distribution systems manufactured by Watertown, which is located at the Utility area (roof top) of both General and Cephalosporin Blocks of XX Pharmaceuticals Ltd.

Definitions / Abbreviation:

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

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 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 careful about the hot water and steam line.
[][]Ensure all the utilities before doing any operation.

System Description:

Both the Generation and Distribution system of PW plant has been installed by Watertown. In PW distribution system purified water is circulated by a booster pump. There are a flow transmitter and a conductivity transmitter in the return line of PW which show the flow rate and conductivity of PW. The system can be operated using both the manual and automatic mode.

Operating Procedure:

[][]Automatic operation of PW Distribution system:

Starting of PW Distribution system:

[][]Switch on the main breaker to supply electrical power of the plant.
[][]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.
[][]Then the following screen will appear. Press “Control flow”.
[][]Press the “Automatic Cycle OFF” and give user ID and password.
[][]Press the “Automatic Cycle OFF” again to start the system in automatic mode. When the system is started, the “Automatic Cycle OFF” turns into “Automatic Cycle ON” and the booster pump becomes ON.

During Operation:

[][]To see any alarm press the “Alarm” in Figure 02.
[][]By pressing the “ ” the alarms will be acknowledged and stored in the alarm history.
[][]Press the “Parameters Set” to see and change the set parameter.
[][]The Daily Operational Log Sheet (Annexure – I and II) of PW distribution system 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 of PW distribution system:

[][]Press the “Automatic Cycle ON” of on HMI. The booster pump will shut down.
[][]Switch OFF the UPS.
[][]Switch OFF the main circuit breaker.
[][]In case of emergency press the emergency switch.

Manual operation of PW distribution system:

[][]Starting of PW distribution system:
[][]Follow the steps of one to five of section
[][]Press the “Manual Cycle OFF” and give user ID and password on HMI (figure 02). Again press the “Manual Cycle OFF” and it turns to “Manual Cycle ON”.
[][]Switch ON the booster pump, pneumatic valves of vent filter and return line by pressing the ON button of each component on HMI.

Stopping procedure of PW distribution system:

[][]Switch off the booster pump and pneumatic valves of vent filter and return line.
[][]Press the “Manual Cycle ON”.
[][]Switch OFF the UPS.
[][]Switch OFF the main circuit breaker.
[][]In case of emergency, press the emergency switch.

Annexure:

Annexure – I: Operational Log Sheet of PW Distribution system

Reverse Washing, Purpose:

Reverse Washing, The purpose of this SOP is to define the Reverse washing of MGF, ACF and regeneration of softener of PW Generation system in manual mode.

Scope:

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

Definitions / Abbreviation:

[][]SOP: Standard Operating Procedure.
[][]PW: Purified Water.
[][]HMI: Human Machine Interface.
[][]MGF: Multi Grade Filter.
[][]ACF: Active Carbon Filter.

Responsibilities:

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

Engineering (Validation)

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

Engineering (Maintenance) Department

[][]To provide necessary support for smooth operation of the system.

Operators

[][]To operate the PW plant according to the SOP.

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 careful about the hot water and steam line.
[][]Ensure all the utilities before doing any operation.

Operating Procedure:

Manual Reverse Washing of MGF:
[][]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.
[][]Press the “Pretreatment Flowchart” button and screen for pretreatment flowchart will appear.
[][]Press the “Manual off” button and give USER ID and Password.
[][]On Valve by pressing on Valve position on screen (figure-05) XV44-04, XV44-05, and XV20-02.
[][]Set frequency (0-50Hz) PU30B/PU30A.
[][]ON Pump by pressing on pump position.
[][]After 5-10 min off the pump by pressing on pump position.
[][]On valve by pressing on valve position on screen XV44-01, XV44-03.
[][]Pump ON.
[][]Reverse washing of MGF is performed for 10 minutes. Depositing and observe washing of MGF is performed for 2 minutes and 5 minutes respectively.

Active Carbon Filter Reverse Washing:

[][]OFF Valve XV44-03
[][]ON Valve XV44-02
[][]ON Valve XV45-04,XV45-05
[][]After 5-10 min Pump off.
[][]On Valve XV45-01,XV45-03
[][]After 0-10 min OFF valve XV45-03
[][]On Valve XV45-02
[][]After 5-10 min will go to softener operation.
[][]The time for reverse washing, depositing and observe washing is as same as MGF.

Softener Regeneration:

[][]For back washing of softener A ON the valve XV50-04A and XV50-05A. Backwashing will be performed for 10 minutes.
[][]After backwashing during regeneration ON the valves XV50-01A, XV50-15, XV50-14A, XV50-03A. Regeneration will be performed for 50 minutes.
[][]For observe washing ON the valves XV50-01A, XV50-03A. Observe washing will be performed for 50 minutes.
[][]Backwashing, regeneration and observe washing procedure of softener B is same as softener B.

Reverse Washing of RO:

[][]Press on RO Flow chart on Screen and will show following screen
[][]After 5-10 min on pump PU51-01,PU51-02,PU52
[][]On valve XV51-07, XV51-05, XV52-06, XV52-07 and XV52-05.

Annexure:

N/A

Purified Water Distribution System, Purpose:

Purified Water Distribution System, The purpose of this SOP is to define the sanitization procedure of purified water distribution system in manual mode.

Purified Water Distribution System, Scope:

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

Definitions / Abbreviation:

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

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 according to the SOP.
[][]To inform PW user departments not to open the valves during sanitization.

Operators

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

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:
[][]Be careful about the hot water and steam line.
[][]Ensure all the utilities before doing any operation.
[][]Do not touch the steam and hot water line with bare hands.
[][]Do not open any valve of distribution line during sanitization.
[][]Ensure at least 35% water level in the PW storage tank before doing sanitization.

System Description:

[][]There are two distribution systems of purified water in cephalosporin and general block. There is a shell and tube type heat exchanger in distribution loop to sanitize the system. During sanitization, purified water is heated using industrial steam at a temperature of 80⁰C. Then this hot water is circulated through distribution loop for a period of 60 minutes. Cooling is done after sanitization at a temperature of 40⁰C using chilled water.

Sanitization Procedure:

Prestart check:

[][]Ensure minimum 3 bar industrial steam pressure before starting sanitization.
[][]Chilled water temperature has to be less than 10⁰C.
[][]Close all the valves of distribution line and inform all the PW user departments not to open the valve during sanitization period.
[][]Check the water level in the PW storage tank. It has to be minimum 35%.
[][]Open the steam inlet valve manually before starting sanitization

Starting of Sanitization system in manual mode:

[][]Switch on the main breaker to supply electrical power of the plant.
[][]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 “ENTER” on HMI.
[][]Then the following screen will appear. Press “Control flow”.
[][]Press the “Manual Cycle OFF” and give user ID and password.
[][]Press the “Manual Cycle OFF” again to start the system in manual mode.
[][]Open the vent valve and PW inlet valve of storage tank and switch ON the distribution pump by pressing the ON button on HMI.
[][]Open the pneumatic valve of steam inlet and condensate outlet of heat exchanger. See the next figure:

#Open the valves and start the pump

#Open the valves to start sanitization.

[][]Press the “Sanitization OFF” button to start the sanitization.
[][]Wait until the temperature of PW increases up to 80⁰C. When the temperature reaches at 80⁰C, close the steam inlet valve and condensate outlet valve.
[][]Circulate the PW through the distribution loop for an hour.

[][]Cool down the temperature of PW less than 40 deg.C. Fill up the log sheet during sanitization on every 30 minutes.
[][]After cooling down close all the valves and distribution pump.
[][]Switch off the UPS.
[][]Switch off the circuit breaker.
[][]Sanitization Frequency:
[][]Initially, the sanitization will be performed after every 20 days.
[][]Sanitization frequency will be finally determined after completion of phase – 3 of performance qualification of PW.
[][]If the plant remains closed for any long vacation, then the distribution system will be sanitized.

Annexure:

WFI generation system operation, Purpose

WFI generation system operation, The purpose of this procedure is to provide directions for operating the WFI generation System.

WFI generation system operation, Scope

This SOP applies to the WFI generation system which is located at the roof top area of XX Pharmaceuticals Ltd.

Definitions / Abbreviation:

[][]SOP: Standard Operating Procedure.
[][]HMI: Human Machine Interface

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

Operators/Technician

[][]To operate the WFI generation system 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:

[][]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 burns.
[][]The piping system is under pressure .Causing an open in the systems pressurized piping without taking suitable precaution may release medium pressure (60+psig).
[][]Running the pump without water in it will burn out the motor after only a few seconds, and it may cause the pump to seize as well.

Operation of WFI generation Plant

[][]Starting Procedure of WFI Generation System:
[][]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 Start on that screen.
[][]Press User key. After that following screen will appear
[][]Press on Press on “Parameter set” for Parameter Setting. After pressing on this key will show the following screen.

Automatic Operation:

[][]After parameter setting, Back to previous screen and Press on “flow chart status”. If there is no need to parameter setting avoid the procedure.After pressing the flow chart status key following figure will be shown below. After that Press on the “Auto” for on the system in automatic operation.

Manual operation:

After parameter setting, Back to previous screen and Press on “Flowchart Status” for ON the system for manual operation. If there is no need to parameter setting avoids the procedure. After pressing the flowchart status key figure-III will be shown. If the system is on in Automatic mode must off the system. Press on the “Manual” for on the system in manual mode. After that ON Pump (PU01), ON valve PASV501, PASV201, and PDMV402.Other controlling Valve operate Operator according to the condition of the system.

Check during operation

[][]Check WFI Temperature.
[][]Check Steam pressure.
[][]Check that there is no unusual noise or vibration. Stop and investigate if found.
[][]The Operational Log Sheet (Annexure – I) of WFI generation system will be filled up 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 WFI distribution System

Automatic Operation:

[][]if plant is running on Automatic mode then stops the system by pressing on the key Auto. Then power off by turning to off position in circuit breaker.

Manual Operation:

[][]At first turn off the pump. After that stop valve PASV50, PASV201, and PDMV402. The system stop by pressing on the key Manual. Then power off by turning to off position in circuit breaker.

Annexure

Annexure-I: Operational Log sheet of WFI Generation System.