Category: QC SOP

SOP Title-Operation of Rotary Shaker

 

 

• OBJECTIVE

To lay down a procedure  for  operation of Rotary Shaker.

• SCOPE

This SOP is applicable for operation of Rotary Shaker located at Quality Control,

 

• RESPONSIBILITY
• QC personal shall be responsible for implementation of
• QC Head – shall be responsible for compliance of this procedure.

 

• PROCEDURE
  • Precautions:
    • Always connected the shaker three pin power plugs.
• First operate the unit without samples place on the plate form.
• Operation Procedure
  • Connect the power to the main switch.
  • Press the mains to put ON to the shaker.
  • Red pilot lamp will glow as power is available for the Unit.
  • Time will starts blinking indicate 00.
  • In this mode the shaker can be start and used by passing the timer ON without timer.
  • For Using the shaker in “ Time Mode” press the  “SET TIME”
  • It will show “00”
  • Here desired time can now be selected by pressing “SET TIME” Switch.
  • The shaker now is ready to operate in “Timer Mode”.
• Cleaning:
• Daily clean the instrument with clean and dry lint free cloth to remove the dust.

 

• ABBREVIATION(s)

Abbreviation	Full Description
SOP	Standard Operating Procedure
QC	Quality Control
QA	Quality Assurance

 

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

 

SOP Title-Operation of Pin Hole Tester

 

• OBJECTIVE

To lay down a procedure for operation of Pin Hole Tester.

• SCOPE

This SOP is applicable for operation of Pin Hole Tester located at Quality Control laboratory.

 

• RESPONSIBILITY
• QC Personal shall be responsible for implementation of procedure.
• QC Head shall be responsible for compliance of this procedure.

 

• DEFINITION(s)

Not Applicable

 

• PROCEDURE
  • Operation Procedure
• Ensure the cleanliness of the instrument.
• Switch on the main power supply.
• After glowing the light, Wait for 5 minutes to get full glow of light in chamber.
• Examine the testing PVC/Blister foil by keeping on the surface of the instrument for any pin holes on the sample through naked eyes.
• Switch off the main power supply.
• After Completion record the operation activity as per format.
• Cleaning:
  • Daily clean the Instrument with clean and dry cloth.

 

• ABBREVIATION(s)

Abbreviation	Full Description
SOP	Standard Operating Procedure
QC	Quality Control
PVC	Poly Vinyl Chloride

 

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

 

SOP Title-Operation of High Performance Liquid Chromatography (HPLC)

 

• OBJECTIVE

To lay down a procedure  for  operation of High Performance Liquid Chromatography.

• SCOPE

This SOP is applicable for operation of High Performance Liquid Chromatography located at Quality Control Department.

MAKE: Shimdhzu

 * RESPONSIBILITY

• QC personal shall be responsible for implementation of
• QC Head – shall be responsible for compliance of this procedure.

 

• PROCEDURE :
  • Operation Procedure :
    • Switch “ON” the mains power supply.
    • Switch on the instrument.
    • Initialization the Instrument.
    • Wait for few minute to initialization the instrument.
    • Instrument screen display.
  • Rom check ——————   ok
  • Ram Check ——————   ok
  • Conditioning ——————  ok
  • Seeking Home —————— ok
  • Checking Wave —————— ok
  • Checking Energy—————— ok
  • User Name —————— Admin
  • Login Pass-ID-No——————00000
  • D₂ Lamp Energy ——————-on
  • Press Five Times (0) Key for the (Log) Screen.

The Screen Display OK, Use the (F2) Key, For Display Menu.

Then Press the (F5) Key For Display Method On System Screen.

• Software Operation: Start the Computer “LC solution” icon Display on Desktop.
  • Setting Analytical Conditions:
    • Double Click “LC Solution” icon on the Desktop.
• Click Instrument 1 or 2 or 3 or 4 for Real Time Analysis.
• Enter User ID and Password then Click OK.
•   Go to file →New method File.
• Click Data Acquisition in Toggle Assistant Bar located in the left side of the Window and Click the Instrument Parameter icon.
• Maximize the Instrument Parameters View window. Here we can select either normal mode or advance mode.
• Enter the analytical conditions in the respective modules and click Download.
• The save as window will open and give the name for Method. Select the path for the particular project  in this project method, data and batch name should come .Method name having the extension of *.lcm.
• Minimize the Instrument Parameter Window.
• Check the LC Status whether it is in Ready mode or not .If it is in Ready mode, System is Ready for sample Analysis.
• Creating Single Run:
  • Check the baseline stability in the chromatogram window for UV detector, click Acquisition →Plot Start. After checking the baseline, Acquisition → Plot top.
  • Click Data Acquisition in Toggle Assistant Bar located in the left side of the Window.
  • Single Run Window will open. Enter the sample name and Sample ID.
  • Current Method will open automatically otherwise open the required method.
  • Enter the Data File name and select auto increment if required.
  • Select the Background file for background correction and enter the Data Description for reporting purpose.
  • Enter the set vial number, tray number and injection volume of the
  • Click Advance for selecting the report format file.
  • Select Report and open the required report template.
  • Click ok and click Start to start the run.
• Creating Batch:
  • Click the Window → Show Window →Batch Table.
  • Select File → New Batch.
  • Right Click the mouse and select Table Easy setting.
  • Select Batch Table: New for New Batch and Append for add the sequence With exiting batch.
  • Select Standard →Enter the Starting Vial Number and Ending Vial number, Enter the tray, enter the Repetition, and Enter Injection Volume and Data Name. Follow the same for Unknown.
  • All the Information will be set in the batch tab.
  • Change or modify the necessary parameters such as Sample ID, Sample Name, Injection Volume, Vial Number, Tray No etc.,
  • File →Save Batch File As and enter the batch name in the respective Project
  • Here the Batch name having the extension of *.Icb
  • Click Batch Start in the Toggle Assistant Bar to start the sequence.
• Processing of Data:
  • Click the data Analysis icon in the Toggle Assistant Bar.
  • That data analysis window will open in the Post run Analysis Window.
  • Open the data from the Toggle Data Explorer bar.
  • Click Analyze icon in the Toggle Assistant Bar. Data Analysis Window Will open.
  • In Integration Tab, enter or check the necessary width, slop, drift value.
  • In Performance Tab, enter the calculation method, unretained peak time and column length. Click  Apply and OK.
  • Click Wizard icon from the Toggle Assistant Bar.
  • Compound Table Wizard 1/5 window will open. Check the necessary width, slop, drift value.
  • Click the Program icon in this table. Integration time program window will Open along with the current data name. Do the necessary integration and click Stimulate and OK.
  • Right click the mouse in the chromatogram window and select the manual Integration tool bar for addition integration icon.
  • Click Next to go for Compound Table Wizard 2/5.Click the select column in this window for naming the peak and click Next for Compound Table Wizard 3/5.
  • Enter the number in the # of calibration Levels, select fit type linear, enter the unit in this window and click Next for Compound Table Wizard 4/5.Check the necessary parameters in the window and click Next for Compound Table Wizard 5/5.

• Enter the peak name in the Name column in this window and give the concentration of the Samples in the conc1, conc2…column and click Finish.
• Right click the mouse in the chromatogram window and select Proper ties. Select the required peak top commands like area, RT, height etc.,
• Click View in the compound Table view. Click Apply to Method in the Toggle Assistant Bar. Save Method As window will open.
• Click Save and Click Yes to over write the method name. Select Method Parameters Window will open.
• To know the run table, to know RT, Area, Height etc., select Result in the compound Table view. To add more parameters right click the mouse in this table and select Table Style, double click the parameters which located in the right side of the window.

• Report Generation:
• Click the Top icon in the Toggle Assistant Bar and select the Report Format icon.

*  Blank Report Format will open.

• Select Item →Common→ Sample Information. Draw a square in the report format.
• Select Item →LC/PDA Common→ Chromatogram. Draw a square in the report format.
• Select Item →LC/PDA Common→ Peak Table. Draw a square in the report format.
• File →Save Report Format File As→ Give the name of the Report Format.
• To Add or modify any parameter, Double click the mouse in the respective filed and the necessary changes and then Save the report format. Open the data and drag the data and drop in the report format filed to get the report.
• To take the print outs of chromatograms and its report table: (Batch Run)
  • Create a report as mentioned in the above mentioned procedure.
  • After proper integration of peaks, open the Batch.
  • Check the Report Output column and open the report format file in the Report format file column.
  • Process the Batch for printouts.
• Washing Procedure:
  • Reverse Phase Chromatography:
• Off the D2 Lamp and wash the column with water about 30 Minutes.
• Then wash the column with mixture of water and strong organic solvent, used in mobile    phase in (50: 50) ratio about 30 minutes.
• Store the column in acetonitrile or in methanol.
• Normal Phase Chromatography:
• Wash the column with strong solvent used in mobile phase.
• Store the column in isopropyl alcohol.
• Procedure for Shutdown the Instrument:
  • Before shutdown the system, rinse the auto sampler at suitable solvents And purge the pump.
  • Switch off the system sequentially system and controller.
• Cleaning:
  • Daily clean the instrument, computer with clean and dry lint free cloth to remove the dust.
  • Before switching off the instrument Rinse and Purge the Auto injector with Water: methanol(50:50) mixture.
  • Clean the plunger head by flushing water through the cleaning tubes.
  • Sample Vials: Open the cap. Discard contents of vials. Rinse the vials and     caps with tap water. Then rinse with mild detergent solution. Finally rinse with purified water with tap water. Then rinse with mild detergent solution. Finally rinse with purified water and dry the vials in the Glass-ware drying oven.

 

• ABBREVIATION(s)

Abbreviation	Full Description
SOP	Standard Operating Procedure
QA	Quality Assurance
QC	Quality Control
HPLC	High Performance Liquid Chromatography
RT	Retention Time
ID. No.	Identification Number

 

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

 

SOP Title-Operation of Hot Plate

 

• OBJECTIVE

To lay down a procedure for operation of Hot Plate.

• SCOPE

This SOP is applicable for operation of Hot Plate located at Quality Control Laboratory.

• RESPONSIBILITY
• QC Personal shall be responsible for implementation of procedure.
• QC Head shall be responsible for compliance of this procedure.

 

• PROCEDURE

5.1  Precautions:

• Avoid the direct heating of ether, chloroform, alcohol or any other flammable solvents on  the hot plate.
• Do not touch the Hot Plate with bare hands. Always use heat resistant hand gloves.
• Do not over heat any solution on the Hot plate.

• Operation Procedure:
  • Check and ensure the instrument is clean & suitable for starting the operation.
  • Switch ON the main power supply and then switch ‘ON’ the power supply of the instrument.
  • Rotate to adjust the temperature controller knob and set required temperature with the help of knob provided on the front panel of the instrument.
• Rotate to adjust the thermostat to control the desire temperature from Regulator, to the temperature range 50° C to 300°  C. 
• Place the container with solution at the middle of the hot plate on the wire gauge.
• After completion of operation switch ‘OFF’ the knob. And switch OFF the main switch.
• Cleaning:
  • Daily clean the instrument with clean and dry lint free cloth to remove the dust.

 

 

• ABBREVIATION(s)

Abbreviation	Full Description
SOP	Standard Operating Procedure
QC	Quality Control

 

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

 

SOP Title-Operation of Gas Chromatography (GC)

 

• OBJECTIVE

To lay down the procedure for  Operation of Gas Chromatography.

• SCOPE

This SOP is applicable to Operation of Gas Chromatography in Quality Control laboratory.

• RESPONSIBILITY
• QC personnel shall be responsible for implementation of this procedure.
• QC Head /designee shall be responsible for compliance of this procedure.

 

• OPERATION PROCEDURE :
  • Operation of Gas Chromatography :

5.1.1   Check whether sufficient pressure is in zero air, hydrogen and nitrogen gas in the respective cylinders and on gas purification unit.

5.1.2   Check the tubes carrying gases are connected to the main instrument at their proper inlets.

5.1.3 Connect the required column between the injection port and detector.

5.1.4   Open the valves of Nitrogen, Zero air and Hydrogen at the gas purification unit.

5.1.5  Set the gas flow rate of Hydrogen, Zero air 5 kg/cm².and Nitrogen 6 kg/cm²

5.1.6  Switch on the power supply to the instrument and press power ON from right side of instrument.

5.1.7   Also switch on the Head space from back side of it.

5.1.8   Mean while switch on the computer, which is connected with instrument.

5.1.9  Double click the GC solution software icon from the desktop. Then select operation.

5.1.10  Click the instrument 1 icon. The login menu will appears, input user ID than password than click ok.

5.1.11  Check the system on icon, than select the desired method form following manner.

Click file menu→Open method file→Select local disk D→Open GC method file→Select desired method file→than click open →than click the download parameters from real time window.

5.1.12  Click the instrument monitor icon from toolbar.

• Operation of Head space :
• 5.2 Creation of new method :                       
• 5.2.1.1 To enter in method mode, press MET key on the left side of the front screen.

5.2.1.2    The key MET will light and than enter method number 1,2 or 3 etc. & method kind C by pressing up, down, left and right keys.

5.2.1.3   Then press down key and enter analysis time (It is 5 minute greater than GC method.) by pressing left or right key.

5.2.1.4  Than press down key and enter Oven conditioning Temperature by pressing left or right keys.

5.2.1.5 Then press down key to change the incubation time inside the oven by pressing left and right keys (It is 5 minute less than analysis time).

5.2.1.6  Then press down key to reach the syringe conditioning temperature by pressing left and right keys.

5.2.1.7   Then press down key regular to reach at the end of method mode than press the enter key to save the method.

5.2.1.8   At last press MET key again to exit from method mode.

5.2.2    Creation of new sequence :

5.2.2.1 To enter in sequence mode, press SEQ key on the left side of the front screen.

5.2.2.2  Press down key and enter method number, which is created previously in method mode by pressing left and right keys.

• Press down key to enter the vial position on the sample tray that is defined as first sample and last sample, for example first sample-1.0 and last sample-1.3.
• At last press right key regular to select the END. When END will blink then press enter key.
• Press SEQ key again to exit the sequence mode.

• 5.2.3 Run the Head Space :

5.2.3.1             Put sample in vials sealed tightly with septa on the sample tray at suitable position, which is defined in headspace method.

5.2.3.2             When GC status will ready on the instrument monitor than click the batch processing menu at real time window and enter the vial NO., Sample name, Sample ID, then method file and data file.

• Save the batch processing at desired folder in local disk D.
• Go on head space main menu and select automatic run by pressing down key and enter in automatic run mode than press down key when drag will complete press START key and click start button from monitor simultaneously.

 

• Switch Off the instrument :

5.3.1   Before switching off the instrument, open the cooling method file from GC method and then click on “down load parameter”. This will cool off instrument.

• When GC status will ready than click “GC system off” then switch off all power switches.
• Close all the knob and regulator from gas purification unit. Also close the valve of all cylinders.

 

7.0                   ABBREVIATION(s)

Abbreviation	Full Description
QC	Quality Control
QA	Quality Assurance
SOP	Standard Operating Procedure.
GC	Gas chromatography
No.	Number
RT	Retention time

 

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

 

SOP Title-Operation of Centrifuge Apparatus

 

• OBJECTIVE

To lay down a procedure for operation of Centrifuge Apparatus.

• SCOPE

This SOP is applicable for operation of Centrifuge Apparatus located at Quality Control Laboratory.

 

• RESPONSIBILITY
• QC personal shall be responsible for implementation of
• QC Head – shall be responsible for compliance of this procedure.

 

• PROCEDURE :
  • Precautions :
    • Do not open the lid during high speed. First of all control speed and then open the lid of  instrument.
    • Check the bottom level screw is properly fixed.
    • Before starting the mains switch ensure that all switches / knob are at ‘OFF’ or normal position.
    • Check and ensure that the cotton is place in the bottom of each tube compartment.
  • Operation Procedure
    • Open the upper lid by releasing the lock and lifting up lid.
    • Place the centrifuge tube in the compartment provided for it.
    • Balance the compartment by keeping centrifuge tube in opposite direction.
    • The compartment is designed in such a way to place six centrifuge tubes at a time.
    • Place equal volume of the sample quantity in each tube for balancing the machine.
    • Switch ‘ON’ the mains.
    • Adjust the required RPM speed by the knob provided on the front panel of the Instrument. The display will show speed of the centrifuge machine.
    • After specified time, RPM knob brings to set ‘0‘, so the motor will stop. Open the lid  &   remove the tubes from centrifuge.
  • Cleaning:
    • Daily clean the instrument with dry and lint free cloth.
    • Daily clean the inside of the instrument with wet cloth and then with dry cloth.

 

• ABBREVIATION(s)

Abbreviation	Full Description
SOP	Standard Operating Procedure
QC	Quality Control
QA	Quality Assurance

 

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

           

SOP Title-Operation of Alarm System

 

• OBJECTIVE

To lay down a procedure for Operation of Alarm System.

• SCOPE

This Procedure is applicable for Operation of Alarm system connected to stability chambers and incubators in quality control department.

 

•  RESPONSIBILITY
• QC Executive & above designee shall be responsible for following the procedure  as per   SOP.

• Maintenance personnel shall be responsible for following the procedure and rectify the problem.
• Security officer/designee shall be responsible for following the procedure as per SOP.
• QC Head- Review and compliance of this SOP.

 

• PROCEDURE :
  • OPERATION PROCEDURES OF ALARM SYSTEM :
    • Switch on the main power supply.
    • Red light should blink on indicator in screen of alarm system and alarming system will      switch ON.
    • Alarm system is connected to stability chambers and incubators.
• Concern serial number of alarming system will siren in case of malfunctioning of set temperature & RH limit of all connected stability chambers & temperature limit of
• QC personal/service floor personal shall attend to that particular equipment for which the alarming indicator is blinking and inform maintenance technician to rectify the problem.
• Blinking of concern serial no. of alarming system will stop after the maintaining the required temperature & RH limit within set limit.
• Inform to maintenance department if in case the activity is concern with electrical issues.
• Security officer/designee in night shift & company holiday shall attend alarm and inform to QC head/designee/Technician for further necessary action.
• Maintenance personnel available on service floor shall follow the procedure from point no.5.1.5 in case of sirening of alarm system.

Note: If buzzer sound of humidity chamber is not acknowledged, information regarding the breakdown shall be passed on to any of the authorized person mentioned in the list as per the Annexure.

 

 

• ABBREVIATION(s)

Abbreviation	Full Description
SOP	Standard Operating Procedure
QA	Quality Assurance
QC	Quality Control
ALS	Alarm System

 

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

 

SOP Title-Management of HPLC/GC Column

 

 

• OBJECTIVE

To lay down the procedure for Management of chromatographic column to be followed in QC Department.

• SCOPE

This SOP is applicable to Management of chromatographic column used for HPLC/GC  in Quality Control laboratory.

• RESPONSIBILITY
• QC personnel shall be responsible for implementation of this procedure.
• QC Head /designee shall be responsible for compliance of this procedure.

 

• PROCEDURE :
• Precaution
• Ensure that mobile phase is properly filtered using 0.45µ filters and suitably degas before its use.

• Do not cross the maximum temperature (in case of GC columns) and minimum temperature (in case of HPLC column) of column specification of manufacture.

• Always close inlet and outlet of columns by using end cap, when not in use.
• Handle column carefully to prevent it from any mechanical shock.
• Do not store HPLC column in buffer.
• Mobile phase pH should not cross its recommended values.
• Read the instruction regarding column packing before handling the column.
• Qualify every column prior to use.
• Always labeled the column immediately after receiving.
• Procurement
• Based on the requirement of QC Department shall raise the Indents for purchase of chromatographic column from the authorized sources.

• Receipt and Issuance 
• On the receipt of new column QC Executive, Sr.Executive/designee is responsible for checking the physical condition of column such as dimension, end caps, labels, and damage.
• On the  receipt of new column verify the column with purchase indent and tally the serial number, make etc of the column with the respective Certificate Of Analysis.
• Unique identification numbering of new Liquid chromatographic column shall be done as per below mentioned procedure.

QC/LC/YY/ZZZ

Where;

QC      –           Quality Control

LC       –           Liquid Chromatography

YY      –           Last two digit of the current calendar year

ZZZ     –           Serial Number (Starts from 001)

• Unique identification numbering of new Gas chromatographic column shall be done as per below mentioned procedure.

QC/GC/YY/ZZZ

Where;

QC      –           Quality Control

GC      –           Gas Chromatography

YY      –           Last two digit of the current calendar year

ZZZ     –           Serial Number (Starts from 001)

• After receiving of column maintain record in column receiving log as per format .
• If the column performance passes the column performance criteria then only column can be used for routine analysis.

• If column fails the system suitability criteria then immediately reject the column and sent to purchase department.
• Handling and Usage :
• Always store the column as per recommended solvent by its manufacturer. Unless otherwise specified follow In-House column washing instructions.
• Routinely monitor the column performance by its theoretical plate count or System  Suitability parameter.

• Reverse phase columns shall be kept in mixture of Acetonitrile: water. (90:10).
•  If the eluent is having buffer then always wash the column with water before its storage.

• Silica Cyno, Amino columns are shipped in n-Hexane or n-Heptane by its manufacturer. when such column are to be used for slightly polar eluent than column should be washed with ethanol or Isopropanol before equilibration with mobile phase.

•  Always increased or decreased the flow rate gradually to avoid pressure shock to the stationary phase in column.

•  Pre conditioning and post conditioning shall be provided to GC column.
• Before starting any analysis pre condition the GC column above 10˚C of product .
• Column shall be flushed properly after the analysis is complete. The solvent used for flushing should be miscible.

 

• Performance of Column :
•  Qualify the column as per the party COA or with the product for which column is  dedicated.
•  COA of column shall be attached with the column performance record.
• Maintain HPLC/GC Column Usage logbook.
• Maintain list of HPLC/GC column.
• Maintain HPLC/GC column performance record.

 

•  Storage of Column :
• Short Term Storage:
• For overnight storage, keep the mobile phase flowing at 0.2 to 0.4 ml/min. this is very helpful when using complex mobile phase (buffers and ion-pairing reagents), as it reduces equilibration time to few minutes rather than an hour or more.
• Long Term Storage :
• If intended mobile phase has buffer, then first wash the column with same   mobile phase composition without buffer. Then flush it with water and store the column in 90%  Acetonitrile or Methanol.
• Column Maintenance: The column shall be flushed properly after the analysis is complete. The solvent used for flushing shall be miscible. The Column flushing  procedure for HPLC column is as follows:
•  Reverse phase HPLC columns:
• Before starting the analysis flush the column with water, then switch over to mobile phase and saturate the column with mobile phase and perform the analysis.

• After completion of analysis, run the mobile phase for about 10 minutes. Switch over to water and wash the column with water for about 30 minutes at the flow rate 1.0 ml per minutes/as per specified STP.
• Switch over to Methanol/Acetonitrile (used in mobile phase as per specified STP) and wash the column with methanol/Acetonitrile (used in mobile phase as per specified STP) for about 30 minutes.

• Set the flow to 0ml/minute after completion of washing and remove the column from the system. Put the end plug and keep the column at respective place.

•  Normal  phase HPLC columns:
• After completion of analysis, run the mobile phase for about 10 minutes.
• If Hexane is used in the mobile phase , switch over to 100% Dichloromethane.
• Wash the column for about 60 minutes at flow rate 1.0 ml/minute.
• If hexane is not used in the mobile phase, switch over to 100 % Methanol.
• Wash the column with Methanol for about 30 minutes at the flow rate of 1.0    ml/minute.
• Switch over to 100 % Dichloromethane and wash the column for about 30 minutes.
• Set the flow to 0 ml /minutes after completion of washing and remove the column from the system. Put the end plug and keep the column at the respective place.

 

•   Re-Generation Procedure for HPLC Column:
• Re-Generation procedure for Reversed phase (C₁₈, C₈, & Phenyl) :
• Wash the column with Hot water (40ᵒC), inject 50 µl x 4 DMSO (Dimethyl sulfoxide) injections for a flow rate 0ml/min. up to 30 minutes.
• Then wash with 1.0ml/min up to 30 minutes of solvents mentioned in the following    order-
• Methanol (100%)
• Isopropanol (100 %)
• Dichloromethane (100%)
• Hexane (100%)
• Dichloromethane (100%)
• Isopropanol (100 %)
• Chloroform (100%)
• Methanol (100%)

 

• Re-Generation procedure for Normal phase (Silica & CN) :
• Wash the column with flow 1.0ml/min up to 30 minutes of solvents mentioned in the following order:
• Heptane (100%)
• Chloroform (100%)
• Acetone (100%)
• Ethanol (100%)
• Water (100%)

 

•  Re-Generation procedure for ION Exchange Column:
• Wash column with flow 1.0ml/minutes up to 30 minutes of solvents mentioned in the following order-

• Buffer wash – 5X as concentrated as that is used previously.
• Distilled water
• Acid wash – 0.5 M H₃PO_4, 01 M H₂SO₄ or 1.01 M HNO₃
• Distilled water
• Chelating wash: 0.1 M Disodium EDTA
• Distilled water
• Methanol wash: To remove absorbed organics from the bonded organic phase.
• Distilled water

 

• DISCONTINUATION AND DISPOSAL :-
•  Maintain the column regeneration record as per define format.
• If System suitability parameters are within limits than reuse the column.
•  If system suitability parameters are out of limit than discard the column and mention that the column is discarded in column usage logbook.
• Dedicated columns can be used till it meets the requirements of system suitability of respective method.
• Columns with high back pressure and not complying system suitability parameter should be discarded with the approval of Head quality.
• Column should be labeled as “Not to use” and stored separately from other columns.
• While discarding, column performance shall be evaluated for system suitability parameter.

 

 

• ABBREVIATION(s)

Abbreviation	Full Description
QC	Quality Control
QA	Quality Assurance
SOP	Standard Operating Procedure
No.	Number

 

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