WFI distribution system, Purpose

WFI distribution system, The purpose of this procedure is to provide directions for operating the WFI Distribution System

WFI distribution system, Scope

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

Definitions / Abbreviation:

[][]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 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 distribution 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.
[][]There is one electrical panel for the distribution system. The PLC panel has 110V power in it. Precautions should be taken to avoid contact with the 110V power line. The remainder of the panel is at 24V.
[][]The panel inside is installed a VFD. It has an external power. It is unsafe to open the panel with power (415V) ON. Only knowledgeable service technicians should operate the VFD.

System Description

[][]Distribution skid and distribution piping will contribute to WFI distribution system.
[][]Distribution skid
[][]Distribution pump, system, sampling valves, instruments and control panel will be mounted on skid. The skid frame is constructed from 304 grade stainless steel.

Pump:

[][]Pump will be designed and selected according to cGMP requirement for velocity, flow and contact parts. Pressure gauge at the discharge will monitor the pressure.

Three way Pneumatic valve:

[][]Flow diverter valves are provided at the supply line and return line of distribution system. If conductivity of water is greater than the set point of conductivity transmitter provided at supply & return line of distribution system, drain port of this valve will open and in turn will not allow quality deteriorated water to go to the point of use & to the system.

Distribution Piping

[][]The whole distribution system is fabricated and installed as per cGMP. Distribution system is fabricated out of SS316L tubes and tube fittings (sanitary type). The distribution loop consists of 5 user points. The user point valves are zero dead leg valves. Orifice plates are provided at each point of use to maintain specific flow. The return line of distribution system is connected back to the top of the storage tank with the spray ball provided inside the tank.

Operation of WFI Plant

[][]Starting Procedure of WFI Distribution 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 screen will appear.

[][]Over the window Touch this[ENTER] key

[][]Press Enter on that screen . After that a screen will appear

[][]Over the screen Press on “Parameter set” for Parameter Set.

[][]Press on “Alarm” for Alarm check

[][]Press on “Control Flow” for ON the system

[][]Press on Press on “Parameter set” for Parameter Setting. After pressing on this key will show a screen.

[][]Press on BACK for return of the previous screen

Automatic Operation:

[][]After parameter setting, Back to previous screen and Press on “Control Flow”. If there is no need to parameter setting avoid the above procedure .After pressing the Control Flow key a screen will appear.

Two option will show the screen

1.0 “Automatic Cycle”

2.0 Press on “Manual cycle”

[][]Press on the “Automatic cycle” for on the system in automatic operation.

Manual operation:

[][]After parameter setting, Back to previous screen and Press on “Control Flow” for ON the system for manual operation. If there is no need to parameter setting avoids the above procedure  . After pressing the ‘Control Flow’  will be shown. If the system is on in Automatic mode must off the system. Press on the Manual cycle for on the system in manual mode. After that ON Pump (PU300), ON WFI inlet valve in WFI tank.

Check during operation

[][]Check that there is no unusual noise or vibration. Stop and investigate if found.
[][]The Operational Log Sheet (Annexure – I) of WFI distribution 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 Atomatic mode then stops the system by pressing on the key Automatic cycle. Then power off by turning to off position in circuit breaker.
[][]Manual Operation: At first turn off the circulating pump and WFI inlet valve from distribution loop. After that stops the system by pressing on the key Manual cycle. Then power off by turning to off position in circuit breaker.

Annexure

Annexure I Operational log Sheet of WFI Distribution System

WFI Generation and Distribution, Purpose:

WFI Generation and Distribution, The purpose of this SOP is to define the Maintenance of WFI Generation & Distribution System manufactured by Watertown in order to ensure its smooth & trouble-free operation.

WFI Generation and Distribution, Scope:

This Standard Operating Procedure applies to the WFI Generation & Distribution system manufactured by Watertown, which is located at the Utility area (roof top) of Cephalosporin Block of XX Pharmaceuticals Ltd.

Definitions / Abbreviation:

[][]SOP: Standard Operating Procedure
[][]WFI: Water For Injection
[][]HMI: Human Machine Interface
[][]PTFE: Poly Tetra Fluro Ethin

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

Operators/Technician

[][]To perform 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 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:

[][]Use Personal Protective Equipment during handling of any kind of chemical.
[][]Be careful about the hot water and steam line.

Maintenance Schedule:

[][]The maintenance schedule of WFI generation and distribution system is given below:

Daily maintenance

[][]Check for any leakage in steam line or WFI line.

After 800 hrs.

[][]Check and clean the filter/strainer.
[][]Check and clean the steam traps.
[][]Check the safety valve.
[][]Clean the storage tanks.

After 8000 hrs.

[][]Check the PTFE gaskets on the membrane valve and replace it if necessary.
[][]Check the diaphragm valves and change the diaphragm if it is necessary.
[][]Check the gaskets of heat exchangers.
[][]Check the mechanical seals of pump.
[][]Change the vent filter cartridge.

Annexure:

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

ETP Operation, Purpose:

ETP Operation, The purpose of this SOP is to define the standard operating procedure of Effluent Treatment Plant of XX Pharmaceuticals Ltd.

ETP Operation, Scope:

This Standard Operating Procedure applies to the Effluent Treatment Plant of XX Pharmaceuticals Ltd.

Definitions / Abbreviation:

[][]SOP: Standard Operating Procedure.
[][]ETP: Effluent Treatment Plant.
[][]PPE: Personal Protective Equipment.
[][]PAC: Poly Aluminum Chloride.
[][]MGF: Multi Grade Filter.
[][]ACF: Activated Carbon Filter.

Responsibilities:

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 regular checking of the critical components.

Operators

[][]To operate the ETP according to this SOP.

Manager, Engineering

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

Manager, Quality Assurance

[][]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:
[][]Handle the chemicals by wearing PPE.
[][]Ensure all the utilities before doing any operation.

System Description:

[][]The capacity of ETP is 12000 Ltr/hr. The effluents from the Solid and Liquid block come into the neutralization and equalization tanks respectively via bar screen chambers. In the bar screen chamber the floating material or solid material is filtered. A dosing of lime is provided in the neutralization tank if pH correction is needed.

[][]Also, the effluents are aerated in these tanks with air which is provided by the blowers. After being neutralized in the neutralization tank the effluents goes to equalization tank and then the effluent is transferred to flocculation tank through effluent transfer pumps.
[][]A dosing of PAC is provided in flocculation tank to flocculate all the effluents. Poly electrolyte dosing is provided in the transferring pipe of effluents from flocculation tank to lamella. After lamella the effluent is passed to the aeration tank.
[][]In aeration tank the effluents are aerated with air. A dosing of NaOH is provided if it is necessary. There is a buffer tank after aeration tank where one kg of urea will be provided after every 3 months of operation.
[][]There is a line under the buffer tank to transfer the sludge to underground sludge tank and then to sludge pit by sludge transfer pump.
[][]Clear water from buffer tank is stored in the clear water tank. There are two pumps to transfer the clear water to final storage tank through MGF and ACF. One pump is used at a time.

Operating Procedure:

Starting of ETP:

[][]Perform backwash of Multi Grade Filter for 15 minutes and Active Carbon Filter for 15 minutes daily before starting the plant by clean water.
[][]Switch ON the main breaker.
[][]Switch On the Blower A/B, effluent transfer pump 1/2 (alternative), Clean water transfer pump 1/2 (alternate) and keep the position of each switch in Auto mode. The dosing pumps of lime, PAC and polyelectrolyte are synchronized with the effluent transfer pumps. When the effluent transfer pumps are switched on those dosing pumps are started and vice versa. The dosing pump of NaOH is started manually when necessary.
[][]There are two float switches in the equalization and clear water tanks. When the equalization tank level will be high the effluent transfer pump will be switched on automatically and effluents will be transferred to flocculation tank.
[][]At that time, the Polyelectrolyte, PAC and lime dosing will be started automatically. If the equalization tank level becomes low, the pump will be switched off automatically.
[][]If the clean water tank level becomes high, the clean water transfer pump will be switched on and effluent transfer pump will be switched off automatically. When the level of clean water tank becomes low the clean water transfer pump will be switched off and effluent transfer pump will be switched on automatically.
[][]The effluent is transferred from flocculation tank to clear water tank via lamella, aeration tank and buffer tank by overflow of each tank.
[][]The blowers are changed over automatically after 10 minutes of operation if the main switch remains in Auto position.
[][]After 8 days of operation switch ON the sludge transfer pump to transfer the sludge to the sludge pit.

During operation:

[][]During operation fill up the operational log sheet (Annexure – I) on every hour.
[][]Check the dosing tank level.

Stopping procedure:

[][]Switch OFF the effluent transfer pumps and blowers.
[][]Switch OFF the clear water transfer pumps.
[][]Switch OFF the dosing pumps.

Annexure:

Annexure – I: Daily Operational Log Sheet of ETP.

WFI Distribution, Purpose:

WFI Distribution, The purpose of this SOP is to define the sterilization procedure of WFI distribution system in automatic mode.

WFI Distribution, Scope:

This Standard Operating Procedure applies to the WFI Distribution system manufactured by Watertown, China located at the Utility area  of XX Pharmaceuticals Ltd.

Definitions / Abbreviation:

[][]SOP: Standard Operating Procedure.
[][]WFI: Water For Injection.
[][]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.
[][]To inform WFI user departments not to open the valves during sterilization.

Operators

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

Manager, Engineering

[][]To ensure that the operation of WFI 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:
[][]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.

[][]Inform the respective departments i.e. Production, Microbiology, Quality Control not to open any valve of distribution line during sterilization.
[][]Ensure at least 40% water level is present in the WFI storage tank before doing sterilization.

System Description:

[][]The WFI distribution system is sterilized at a temperature of 121⁰C. WFI is heated up by using industrial steam. Heated WFI is circulated for 1 hour. After completing the sterilization distribution line is cooled down. The cooling temperature is 90⁰C. Chilled water is used to cool the WFI.

Sterilization Procedure:

Prestart check:
[][]Ensure minimum 3 bar industrial steam pressure before starting sterilization.
[][] Chilled water temperature has to be less than 10⁰C.
[][]Close all the valves of distribution line.
[][]Starting of Sterilization system in automatic mode:
[][]Open the steam inlet valve manually before starting sterilization.
[][]Switch on the main breaker to supply electrical power of 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 a page will be displayed on HMI and 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 Sterilization:

[][]During sterilization WFI is circulated through the distribution line at minimum 121oC.
[][]Fill up the log sheet (Annexure – I) during sterilization after every 20 minutes.
[][]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.”

After Sterilization:

[][]Drain all the water from the user points.
[][]Fill up the WFI storage tank with fresh WFI by running WFI Generation system.

Sterilization Frequency:

[][]The sterilization of WFI loop will be performed every 30 days.
[][]If the plant remains closed for any long vacation, then the distribution system will be sanitized.

Annexure:

Annexure – I: Operational Log Sheet of Sterilization of WFI distribution system.

Storage Tanks Cleaning, Purpose:

Storage Tanks Cleaning, The purpose of this SOP is to define the cleaning procedure of all the intermediate storage tanks and final storage tanks of PW and WFI generation and distribution systems of XX Pharmaceuticals Ltd.

Storage Tanks Cleaning, Scope:

This Standard Operating Procedure applies to the intermediate and final storage tanks of PW and WFI generation and distribution systems  of XX Pharmaceuticals Ltd.

Definitions / Abbreviation:

[][]SOP: Standard Operating Procedure.
[][]WFI: Water For Injection.
[][]PW: Purified Water.

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 cleaning of the tanks.
[][]To ensure that the operators are responsible to carry out the cleaning and fill up the logbook.

Operators/technician

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

Manager, Engineering

[][]To ensure that the cleaning procedure of all the storage tanks are done properly.

Manager, Quality Assurance

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

Procedure:

Precautions:

[][]All 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:
[][]Use Personal Protective Equipment during handling of any kind of chemical.
[][]Be careful about handling of toxic chemicals.
[][]Be careful when climbing using a ladder to reach at the top of the tank.

Cleaning Procedure:

[][]The cleaning procedure of intermediate and final storage tanks of both PW and WFI generation and distribution systems are stated below:
[][]Open the tip of the tank about 2 hours before cleaning.
[][]Close the inlet valve of the tank.
[][]Open the discharge valve at the bottom of the tank and make the tank empty.
[][]Wash the inside wall and ground floor of the tank with bleaching powder with the help of nylon brush.
[][]Spray fresh water into the wall thoroughly to remove dirt from the wall.
[][]Clean the level sensor of the tank.
[][]Drain out the dirty water.
[][]After successful completion of the cleaning procedure, dry inside of the tank.
[][]Storage tank is now ready for use.
[][]After cleaning of PW intermediate and final storage tanks record the cleaning in the Annexure – I. Also, for WFI storage tank record the cleaning in the Annexure – I
[][]The tanks will be cleaned after 800 hrs of operation of the plant.

Annexure:

N/A

WFI Distribution System Sterilization, Purpose:

WFI Distribution System Sterilization, The purpose of this SOP is to define the sterilization procedure of WFI distribution system in manual mode.

WFI Distribution System Sterilization, Scope:

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

Definitions / Abbreviation:

[][]SOP: Standard Operating Procedure.
[][]WFI: Water For Injection.
[][]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 WFI user departments not to open the valves during sterilization.

Operators

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

Manager, Engineering

[][]To ensure that the operation of WFI 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:
[][]Be careful about 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 sterilization.
[][]Ensure at least 40% water level in the WFI storage tank before doing sterilization.

System Description:

[][]The WFI distribution system is sterilized at a temperature of 121⁰C. WFI is heated up by using industrial steam. Heated WFI is circulated for 1 hour. After completing the sterilization distribution line is cooled down. The cooling temperature is 90⁰C. Chilled water is used to cool the WFI.

Sterilization Procedure:

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

Starting of Sterilization 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 a page will be displayed on HMI and 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 WFI return 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 drain valve.
[][]Press the “Sanitization OFF” button to start the sterilization.
[][]Wait until the temperature of WFI increases up to 121⁰C. When the temperature reaches at 121⁰C, close the steam inlet valve and condensate outlet valve.
[][]Circulate the WFI through the distribution loop for an hour.

Sterilization Period:

[][]During sterilization WFI is circulated through the distribution line at 121 ⁰C. If the temperature drops then open the steam inlet and condensate outlet valve to heat up the WFI.
[][]Fill up the log sheet (Annexure – I ) during sterilization every 20 minutes.

 Cooling Period:

[][]After completion of sterilization, switch OFF all the steam valves.
[][]Switch ON the pneumatic valves of cooling water in and cooling water out by pressing the ON button on HMI.
[][]Cool down the temperature of WFI less than 90 deg.C. Fill up the log sheet (Annexure – I ) during total sterilization period on every 20 minutes.
[][]After cooling down close all the valves and distribution pump.
[][]Switch off the UPS.
[][]Switch off the circuit breaker.

After Sterilization:

[][]Drain all the water from the user points.
[][]Fill up the WFI storage tank with fresh WFI by running WFI Generation system.

Sterilization Frequency:

[][]The sterilization of WFI loop will be performed every 30 days.
[][]If the plant remains closed for any long vacation, then the distribution system will be sanitized.

Annexure:

N/A

HEPA Filters Numbering, Purpose:

HEPA Filters Numbering, The purpose of this SOP is to define the procedure for the establishment of identification number of G4, F5, F7, F9 and HEPA filters of any machine (except HVAC system) of XX Pharmaceuticals Ltd.

HEPA Filters Numbering, Scope:

The G4, F5, F7, F9 and HEPA filters of any machine of all area of XX Pharmaceuticals Ltd are covered by this SOP.

Definitions / Abbreviation:

[][]N/A

Responsibilities:

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

Engineering Person

[][]To fill up the request form (Annexure – 1) to get the ID of filters of newly installed machines.
[][]To inform validation (engineering) department if there is any replacement of filters.

Engineering (Validation) Department

[][]To give the ID of filters.

Functional Head

[][]To ensure that all the filters of machines are numbered according to this SOP and any Inclusion or Exclusion will be reported to the Validation (Engineering) department within 7 days of Inclusion/Exclusion.

Quality Assurance

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

Procedure:

Filter Numbering

[][]Filters 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. (See the Annexure – I )
[][]BBB: 3 digits numerical code to indicate the machine. (See the Annexure – II)
[][]CCCC/CCC: 4/3 characters to indicate the grade and type of filter (see Annexure – I). First 2/3 characters indicates the grade of filters and last character indicates the type of filter (bag type, flat type etc.).
[][]XXX: Three digits numerical code to indicate the sequential number of the same type of filter of that machine.
[][]For an example, a flat type HEPA filter of grade H14 of Dispensing booth of production area of Solid Block will be numbered according to the following way:

SPRD – 030 – H14F – 001

[][]001 =Sequential Number for that filter

[][]H14F=H14 Grade and Flat type HEPA filter.

[][]030=Numerical code of dispensing booth

[][]SPRD=Solid Production Area

[][]All G4, F5, F7, F9 and HEPA filters of Machines 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 ID numbers of filters will be maintained by the validation (Engg.) department.

[][]To get the ID of newly installed filters, 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 Filter is replaced with a new one, the ID of previous one will be used for the new filter. For this, the respective engineering person will inform the validation (engineering) department and validation engineer will update the Filter list with the newly fitted one and replacement will be noted in the remarks section.

[][]If any filter of new grade (which is not in the list of Annexure – I) is installed, the Annexure – I will be updated by handwriting of Manager, QA with signature and date. The new grade filter will be added on the next version of 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 filters.
Annexure–III: Register of filters.

Gas Generator, Purpose:

Gas Generator, The purpose of this SOP is to define the operation and maintenance of the 1500 KW gas generator of XX Pharmaceuticals Ltd.

Gas Generator, Scope:

This SOP applies to the Cummins generator of capacity 1500 KW (Model: QST30-G4) which is located at General block 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 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.

Head of Engineering

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

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.
[][]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.
[][]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.
[][]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.
[][]Check whether the Gas pressure is 10 psi or not.
[][]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.
[][]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

[][]Reduce the load gradually to the range of 0 – 50 kW.
[][]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.

Maintenance Interval with Maintenance action to be taken

Daily Maintenance

[][]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 leaks.
[][]Check the amount of lubricating oil in the sump.
[][]Check the lubricating oil pressure at the panel display.
[][]Check the battery charge level.
[][]Check the air inlet filters.
[][]Drain air tank moisture and sediment.
[][]Inspect the engine fan blades.
[][]Inspect the drive belt.
[][]Check the intercooler and the coolant radiator for debris.
[][]Inspect and check the generator load and power factor.
[][]Check the voltage and frequency frequently

Weekly Maintenance

[][]Repeat Daily Check.
[][]Check Fuel lines and connections.
[][]Check for adequate fresh air to engine.
[][]Check hose and connections.
[][]Check 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.
[][]Inspect operation under load.
[][]Check for any unusual sounds.
[][]Terminals and connections normal color.
[][]Check if doors closed securely.

Monthly Maintenance

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

After every 2500 Hours

[][]Tapped adjustment.
[][]Change lubricating oil.
[][]Change the lubricating oil filters.
[][]Change spin on filter.
[][]Change Air filter.

After every 16000 hours

[][]Change lubricating oil.
[][]Change the lubricating oil filters.
[][]Change spark plug cables.
[][]Clean/replace Gas filters and check/replace fuel hoses.
[][]Clean/replace air filter elements.
[][]Check for any leakage on engine, line and drains.
[][]Check crankcase venting valve and the crankcase pressure.
[][]Check/replace of all engine compensators.
[][]Check pumps and heat exchangers/radiator/cooling tower.
[][]Check engine starting battery, starting motor/starting system.
[][]Check/adjust valve clearances.
[][]Check engine safety controls, protection.

[][]Visually check turbocharger.
[][]Check push roads, cylinder head valve springs and valve heights.
[][]Check engine support, base rail level and anti-vibration pads
[][]Check air intake/exhaust system.
[][]Check engine governor.
[][]Check for any vibration or noise of engine
[][]Check cable termination.
[][]Check Genset control panel and instruments.
[][]Check performance and parameters of Genset during operation.

After every 32000 Hours

[][]Overhauling of engine
[][]Ensure that the turbocharger impeller and the turbocharger compressor casing are cleaned
[][]Ensure that the alternator, the starter and the turbocharger are checked
[][]Check the turbocharger bearing clearance.
[][]Check the exhaust restriction.
[][]Check the valves settings.
[][]Check, adjust and replace the ignition system spark plugs.
[][]Check vibration damper.
[][]Clean Turbocharger compressor wheel and diffuser.

After every 64000 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 1500 KW gas generator
Annexure-II: Log sheet for 1500 KW gas generator

Filter cleaning procedure, Purpose:

Filter cleaning procedure, The purpose of this SOP is to define the cleaning procedure of filters of various process machines of Production, Product Development and Warehouse departments.

Scope:

This Standard Operating Procedure applies to the fluid bed dryers, coating machines, dust collectors of tablet compression machine, laminar air flow unit, dispensing and sampling booths of production, product development and warehouse department which are located of XX Pharmaceuticals Ltd.

Definitions / Abbreviation:

[][]FBD: Fluid Bed Dryer.
[][]HEPA: High Efficiency Particulate Air.
[][]EHS: Environment Health and Safety.
[][]PPE: Personal Protective Equipment.
[][]SOP: Standard Operating Procedure.
[][]W.C: Water column (pressure unit).
[][]PD: Product Development.
[][]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 to the technician for cleaning the filters.
[][]To check that the filters are properly cleaned/changed.
[][]To check that the log book is properly filled.

Technician

[][]To clean/change the filters when necessary.

Head of Engineering

[][]To ensure filters are cleaned/changed according to the SOP.

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:
[][]Use all Personal Protective Equipments such as goggles, masks, hand gloves etc. during cleaning/changing the filters.
[][]Disconnect the electrical power before opening the filters.
[][]Ensure all utilities before doing any kind of cleaning/changing task.

Cleaning and Changing procedure:

[][]Filters of FBD: There are five types of filters in FBD such as pre filter, medium filter, HEPA filter, product retaining filters and the cartridge filters of dust collector.
[][]To clean the cartridge filters and pre filters following procedures are followed:

Dismantle the filter from the filter housing.

[][]Clean the filters using compressed air at a pressure of 1-2 bar.
[][]Then take the filters to the filter cleaning area  and keep the filters drowning in the potable water for 2-3 hours.
[][]Then take out the filters from the water and partial drying is done by blowing compressed air at a pressure of 1-2 bar.
[][]After that, dry the filters under the sunlight.
[][]Finally, compressed air is used after sunlight to remove any dirt from the filters.
[][]Fix the filter into the filter housing.
[][]The pre filters are cleaned after every 15 days. An exchange is only required, if dirt is visible or any part of the filter is worn out.
[][]The cartridge filters are cleaned if the differential pressure is equal to or more than 4 in. of W.C. An exchange is only required, if dirt is visible or the differential pressure does not decrease after cleaning or any part of the filter is worn out.
[][]The medium filters and HEPA filters of inlet air handling unit are checked on every 3 months. Change the filters if the differential pressure is equal to or more than 4 in. of W.C.
[][]The product retaining filters are cleaned through production SOP.
[][]Filters of Coating machine: There are four types of filters in the coating machine such as: pre filter, medium filter, HEPA filter and cartridge filters of dust collector
[][]The cleaning procedure of pre filter and cartridge filter of dust collector is as same as it is described in the previous section The filters are cleaned after every 15 days. An exchange is only required, if dirt is visible or any part of the filter is worn out.
[][]An exchange of the filters is only required, if dirt is visible or the differential pressure does not decrease after cleaning or any part of the filters is worn out.
[][]The medium filter and HEPA filters of inlet air handling unit are checked every 3 months. Change the filters if the differential pressure is equal to or more than 4 in. of W.C.
[][]Filters of Dust Collector of Tablet Compression machine: They are cleaned using compressed air at a pressure of 1-2 bar after each batch of operation. Full cleaning (as per the procedure described in the previous section is done after 5 batches of operation.

Filters of Dispensing and Sampling Booth:

[][]There are pre filter, medium and HEPA filters in dispensing and sampling booths.
[][]The pre filters are cleaned on every month according to the procedure described in the previous section.
[][] The medium filters are cleaned using compressed air at a pressure of 1-2 bar when the differential pressure across the filter is equal to or more than 250 Pa.
[][]An exchange is only required, if dirt is visible or the differential pressure does not decrease after cleaning or any part of the filter is worn out.
[][]The HEPA filters are changed when the differential pressure across the filter is equal to or more than 400 Pa.

Filters of Laminar Air Flow unit of Dialysis Fluid area:

[][]There are two types of filters in the Laminar Air Flow unit such as: Pre filter and HEPA filter.
[][] The cleaning procedure of pre filter is as same as it is described in the previous section .
[][]The pre filter will be cleaned after every 15days.
[][]The HEPA filter will be checked on every month and will be changed if the differential pressure exceeds 250 Pa.
[][]An exchange is only required, if dirt is visible or any part of the filters is worn out.
[][]The filter integrity test (PAO test) of all the HEPA filters will be performed on every year.
[][]The filters will be changed in case of failure to meet the acceptance criteria of this test.
The technician will fill up the log books of filter cleaning/changing after cleaning or changing the filters.

Annexure:

Annexure – I: Log book of cleaning the filters of process machines
Annexure – II: Log book of changing the filters of process machines

Color Coding, Purpose:

Color Coding, The purpose of this SOP is to define the color coding procedures of utility lines  of XX Pharmaceuticals Ltd.

Color Coding, Scope:

This SOP covers the color coding procedure of utility lines in Production, PD, QC and Microbiology area of of XX Pharmaceuticals Ltd.

Definitions / Abbreviation:

[][]SOP: Standard Operating Procedure.
[][]PW: Purified Water
[][]CA: Compressed Air
[][]WFI: Water For Injection
[][]Elec: Electric line
[][]PoW: Potable water
[][]HW: Hot potable water
[][]NT: Nitrogen line
[][]PD: Product Development
[][]CWFI: Cold Water For Injection

Engineering (Validation) Department

[][]Preparing the SOP and revise it when necessary.
[][]Identification of the utility lines with the assistance of Engineering persons.

Engineering (Maintenance)

[][]To put on the labels on respective utility lines.

Respective department

[][]To ensure that the labels are properly maintained.
[][]To inform the engineering department if any label is torn or harmed by any means.

Head of Engineering

[][]To ensure that all the utility lines are properly labeled.

Head of Quality Assurance

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

Annexure:

N/A

Procedure:

Cleaning and Changing procedure:

[][]The list of utility lines which are to be marked is as follows:
[][]Purified water Potable water
[][]Cold Water For Injection
[][]Hot potable water
[][]Water for injection
[][]Compressed air Pure steam
[][]Nitrogen line
[][]Electric cable

The color coding procedure of each line is described below:

Purified water:

[][]All Purified Water lines must be tagged using an arrow head, Dark green colored tag. The length and width of the tag will be 18 cm and 3.0 cm respectively. “PURIFIED WATER” must be written in the middle of the tag and the font would be Cambria, bold, and black color on white background as well. The sample of the tag is shown below:

Potable Water:

[][]All Potable Water lines must be tagged using an arrow head, light green colored tag. The length and width of the tag will be 18 cm and 3.0 cm respectively. “POTABLE WATER” must be written in the middle of the tag and the font would be Cambria, bold and black color on white background as well.

Hot Potable Water:

[][]All Hot Potable Water lines must be tagged using an arrow head, light green colored tag and it will be surrounded by a red color band along its periphery. The length and width of the tag will be 18 cm and 3.0 cm respectively. “HOT POTABLE WATER” must be written in the middle of the tag and the font would be Cambria, bold black color on white background as well.

Water For Injection:

[][]All WFI lines must be tagged using an arrow head, dark green colored tag and it will be surrounded by a red color band along its periphery. The length and width of the tag will be 18 cm and 3.0 cm respectively. “WATER FOR INJECTION” must be written in the middle of the tag and the font would be Cambria, bold and black color on white background as well.

Compressed air:

[][]All Compressed Air lines must be tagged using an arrow head, dark blue colored tag. The length and width of the tag will be 18 cm and 3.0 cm respectively. “COMPRESSED AIR” must be written in the middle of the tag and the font would be Cambria, bold and black color on white background as well.

Pure Steam:

[][]All Pure Steam lines must be tagged using an arrow head, ash colored tag. The length and width of the tag will be 18 cm and 3.0 cm respectively. “PURE STEAM” must be written in the middle of the tag and the font would be Cambria, bold and black color on white background as well.

Nitrogen:

[][]All Nitrogen lines must be tagged using an arrow head, light blue colored tag. The length and width of the tag will be 18 cm and 3.0 cm respectively. “NITROGEN” must be written in the middle of the tag and the font would be Cambria, bold and black color on white background as well.

Electric line:

[][]All electric lines must be tagged using an arrow head, red colored tag. The length and width of the tag will be 18 cm and 3.0 cm respectively. “ELECTRIC CABLE” must be written in the middle of the tag and the font would be Cambria, bold and black color on white background as well.

Cold Water For Injection:

[][]All Cold Water For Injection lines must be tagged using an arrow head, dark green colored tag and it will be surrounded by a light blue color band along its periphery. The length and width of the tag will be 18 cm and 3.0 cm respectively. “WATER FOR INJECTION” must be written in the middle of the tag and the font would be Cambria, bold and black color on white background as well.

Chilled Water:

[][]All Chilled water lines must be tagged using an arrow head, blue colored tag. The length and width of the tag will be 18 cm and 3.0 cm respectively. “CHILLED WATER” must be written in the middle of the tag and the font would be Cambria, bold and black color on white background as well.

Pure Steam condensate:

[][]All Pure Steam condensate lines must be tagged using an arrow head, dark green colored tag and it will be surrounded by a yellow color band along its periphery. The length and width of the tag will be 18 cm and 3.0 cm respectively. “PURE STEAM CONDENSATE” must be written in the middle of the tag and the font would be Cambria, bold and black color on white background as well.

[][]All the tags will be put on the utility lines by the respective engineer.
[][]The tag will be maintained properly by the respective departmental persons. If the tag is torn or harmed by any means, the engineering department must be informed to replace it.