SOP FOR OPERATING PROCEDURE OF STABILITY CHAMBER

1.0           Objective:

            The objective of this Standard Operating Procedure is to lay down the procedure for  

            Operation of the Stability Chamber.

2.0              Scope:

            This SOP covers operating Procedure of Stability Chamber.

3.0              Responsibility:

            Junior Research Officer, Research Officer: Responsible for operation of the Stability   Chamber as per procedure.

            QA Officer/QA Manager: Review the records and governing the document 

4.0       Procedure for Stability Chamber:

4.1       Connect the 15Amp three pin plugs to the mains supply.

4.2              Ensure that the earthing is grounded correctly to avoid the sudden shock hazards.      

4.3              Ensure that the front door and inner door is in lock position.

4.4              Switch ON the main and observe that the mains indicator glows on the front panel.

4.5              Give Water Connection to water inlet of reservoir pot.

4.6              Now set the required dry temperature & % R.H as per your requirement.

            Provided on control panel having 3 different modes.

5.0       Procedure for Controller:

5.1       Switch on the cooling system for lower temperature. A compressor positioning switch is  

(1)     Off mode: Between the range of 10⁰C.Above ambient to 60⁰ C & 10% R.H. Above ambient to 95% R.H.

(2)       On Mode: Below 10⁰C of ambient temperature.

(3)      Auto mode: Deleted.

6.0           Note: When the water level of water tank will go down to the normal level the buzzer will

Ring and supply connection to boiler heater will get disconnected.

7.0       Note down the temperature in the Temperature record in LOG BOOK.

7.0              Calibration Frequency: Yearly

8.0              Routine Maintenance:

8.1       Clean the Stability Chamber every week and wipe with clean duster.

SOP FOR OPERATING PROCEDURE FOR PRESERVATION OF SAMPLE ANALYSIS

1.0                  Objective:

             The objective of this standard Operating Procedure is to lay down the procedure for

             Storage of analysis sample

2.0                  Scope:

             This SOP covers operating procedure for storage of analysis sample.

3.0                  Responsibility:

HOD: Proper checking of sample and storage of sample.

QA Officer/QA Manager: Review the records and governing the document.

4.0                  Procedure:

After receiving the sample from “Sample Registration area”, check the integrity of sample, type of sample, test requirement, quantity of sample, storage condition etc..

After that preserve the sample under specified condition as per the requirement of test standard.

 To protect from contamination/cross contamination, light, environment effect and

  Maintain integrity of sample, Sample stored at following temperature and place.

Parameter to be studies	Preservation Temperature	Preservation Place
1. Microbiological parameter	4°C ± 2°C	Refrigerator
2. Chemical parameter	4°C ± 2°C	Refrigerator
3. Elements parameter	25°C ± 2°C	Room temperature
4. Pesticides parameter	4°C ± 2°C	Refrigerator

SOP FOR PROCEDURE FOR HANDLING AND DESPOSAL OF RETAIN SAMPLE

1.0                  Objective:

              The objective of this standard Operating Procedure is to lay down the procedure for

              Handling and DESPOSAL of Retain Samples.

2.0                  Scope:

              This SOP covers operating procedure for handling and desposal of retain sample

3.0                  Responsibility:

Retain sample-handling personnel

              Responsible for collection, storage and disposal of sample.

QA Officer/QAM: Review the records and governing the document.

4.0                  Procedure:

4.1                Collection and Receipt:

4.1.1        Sample of each booking Number shall be collected from the sample receiving area by who is handling retain sample. 

4.1.2        After collected the sample, enter all the required details of sample in retain sample register. Segregate all the sample by product wise i.e. Raw material, finished product (Tablet, Capsule, Syrup etc.) water and waste water, soil sample and solid waste.

4.1.3        Personnel who receiving the sample will check the appearance of sample, booking number and integrity of packing.

4.1.4        Keep the sample in corrugated box by month wise.

4.1.5        Store the samples at 25°C ± 1°C for 3 months from the date of receipt.

4.1.6        Retain sample shall be checked if complaint from Sponsor.

4.2            Destruction:

4.2.1    The retain samples shall be destroyed after 3 months from the date of receipt.

4.2.2        Destruction of retain sample shall be recorded in the retain sample register.

 4.2.3        Procedure for Destruction:

Strip/Blister of tablet or capsule shall be defoiled and shall be put in disposal container containing water. Foil, Carton shall be cut into pieces then put into the dustbin. Bottle shall be empty in waste disposal container. Label of the same shall be cut into pieces and then put into dustbin and destroy the bottle. Raw material destroys in waste disposal container containing water.  Water sample destroy directly in drainage and waste water, soil sample & solid waste sample destroy in hazardous waste container.       

4.2.4  After destroy the material container shall be send to effluent treatment plant   

at ETP PLANT

SOP FOR OPERATION AND CALIBRATION OF TABLET DISSOLUTION APPRATUS

1.0       Objective

The objective of this Standard Operating Procedure is to lay down the procedure for operating the Tablet Dissolution Apparatus Model No TDT-08L.

2.0       Scope

This SOP covers operating procedure of Tablet Dissolution Apparatus Model No TDT-

08L

3.0       Responsibility

Jr. Research Officer, Research Officer: Responsible for operation, calibration and maintenance of the instrument as per procedure.

Head of Department: Responsible for calibration and maintenance, timely as per schedule.

QA Officer/QA Manager: Review the records and governing the document.

4.0       Procedure

4.1       Ensure the instrument is Clean & Free from Dust

4.2       System Start Up

4.2.1    Switch ON The ETC-11L instrument by pressing the power button

4.2.2    Now, Switch ON the Power switch provided on rear side of TDST-08L the instrument will initialize by displaying a power flash screen, which will flash once.

4.2.3    After the power flash screen will be displayed showing the last protocol no selected, RPM, Bath temperature, and temp by external probe.

4.2.4    Raise the instrument by pressing the lift UP Key provided in the front panel TDT-08L.

4.2.5    Remove the bath Top Plate and fill the bath with R.O or distilled water till the bottom of the inlet Nozzle. Once the tube of the inlet nozzle is filled with water, ensure the priming of the pump. Then fill water till the level marked. Place the bath top plate and tighten the

plate retaining Knob

4.2.6    Place the test vessels filled with the media.

4.2.7    If required check the centering of the Test Vessel.

4.2.8    Set the test parameter as desired.

4.2.9    Parameter Setting:

RPM Setting:

In this parameter rotation per minute of the shaft are set from 25 to 200 RPM

Setting Of spindle RPM Press RPM key from front panel a RPM screen will be displayed than set the RPM by pressing UP/Down/Digit scroll key and enter to register the value. Than come out the RPM mode.

For starting and stopping of spindle rotation Press RPM key and than F1 for starting and F2 for Stopping

Temperature Setting:

In this parameter temperature of the bath is set from 30°C to 40°C

Press the TEMP key from the front panel a Temperature screen will be display than set the Temperature by using UP/Down/Digit scroll key and enter key to register the value. Than come out the Temperature mode. 

For Heater ON/OFF Press TEMP key and than F1 for Heater to be ON and F2 for Heater to be OFF.

Indication

If the temperature controller has started then the ONLED on the front panel and ETC-11L will glow.

If HEATER ON then the circulating pump will start by default

Run Time

To set the run time press TIME key from the front panel and set the time by pressing UP/Down/ Digit Scroll key and enter key to register the value. Than come out the time mode 

4.2.10  Lower the stirrer unit by pressing the down arrow key from the front panel. 

Press F1 Key (PREPARE) for starting of test, the temperature controller will be on.

4.2.11  To attain a constant temperature through out The vessel start the RPM with paddle attached to the spindle.

4.2.12  After getting the desired temperature at the lowest position of the stirrer unit (as per the method selected) the ready indication on the front panel will glow.

4.2.13  To View the individual jar temperature in between the test or prior to the test, from idle screen press F2 key to select jar probe.

Caution: If F1 key pressed to start the test and stirrer unit is not at the lowest position then an error indication will be display for 5 sec, Press down arrow key to park the stirrer unit at lowest position and rectify the error indicated.

4.2.14  To start the testing lift the stirrer unit and place the test sample in basket if using apparatus 1 and in jar if using apparatus2 than down the stirrer unit by pressing down key and start the test. 

5.0       Calibration:

5.1       CALIBRATION OF TEMPERATURE:

5.1.1    Set 37˚ C and measure the temperature using calibrated thermometer.

5.1.2    Of inside vessel at the following intervals : 30 minutes, 45 minutes, 1 hour, 2 hours, 4 hours.

5.1.3    Limit : The observed value should be between 36.5˚ C to 37.5˚ C.

5.1.4    Record the observations as given in the LOG BOOK.

5.2       CALIBRATION OF SPEED:

5.2.1    Set the speed as 50 RPM and measure the number rotations at the following time intervals :  30 minutes, 45 minutes, 1 hour, 2 hours, 4 hours.

5.2.2    Limit: ± 4 % of the set speed.

5.2.3    Record the observations as given in the LOG BOOK.

5.2.4    In the same way, set the speed as 100 RPM and measure the number rotations at the following time intervals: 30 minutes, 45 minutes, 1 hour, 2 hours, 4 hours.

5.2.5    Limit: ± 4 % of the set speed.

   5.2.6    Record the observations as given in the LOG BOOK.

5.3       WOBBLING :

5.3.1    Check the shaft paddle wobbling using wobble meter at different time intervals as follows: 30 minutes, 45 minutes, 1 hour, 2 hours, 4 hours.  (Limit : ± 2 mm from vertical axis) Record the observations as given in the LOG BOOK.

5.3.2    Check the basket wobbling using wobble meter at the following time intervals as follows: 30 minutes, 45 minutes, 1 hour, 2 hours, 4 hours.   (Limit : ± 2 mm of maximum allowable run out at the bottom).

5.3.3    Record the observations as given in the LOG BOOK.

5.4       DISTANCE BETWEEN THE BOTTOM OF THE VESSEL AND THE BASKET:

5.4.1    Measure the distance between the bottom of the vessel and the basket. Limit: 25 ± 2 mm.

5.4.2    Record the observations.

5.5       CENTERING OF DISSOLUTION VESSEL:

5.5.1    Using the centering device check whether the dissolution vessel is at center.

5.5.2    If it is not at the center, then adjust its position to the center.

5.6       Calibration Frequency: Monthly for above parameter

5.7       Calibration with USP calibrators:

5.7.1    Use the following dissolution calibrators:

1.         Disintegrating type Prednisone tablets.

Use current lot of the above tablets for calibration.

5.7.2    To be prepared and use dissolution medium as per catalog given with USP calibrators tablets specification from the source.

5.7.3    To set all the parameters e.g. RPM, Apparatus 1 or 2 (Basket or paddle), temperature and time as per given in specification.

5.7.4    After completion of USP calibrator calibration calculate the percentage and compare with Acceptance Criteria as per given in specification.

5.7.5    Enter the details of calibration record in LOG BOOK

5.8              Calibration Frequency: Yearly for USP calibrator tablet

6.0                    Routine maintenance:

6.1                    Disconnect the instrument from power supply.

6.2                    Remove the water from tank. Clean the water tank with dry cloth and replace the fresh distilled water.

6.3                    Clean the Basket –Paddle and Bowl with water and than dry cloth.

6.4                    Clean the instrument with dry cloth.

SOP FOR OPERATION AND CALIBRATION OF NEPHELOMETER

1.0       Objective:

            The objective of this standard Operating Procedure is to lay down the procedure for

            Operation and Calibration of Nephelometer.

2.0       Scope:

            This SOP covers operating and calibration of Nephelometer .

3.0       Responsibility:

            Jr. Research Officer, Research Officer: Responsible for operation, calibration and  

            maintenance of the instrument as per procedure.

            Head of Department: Responsible for calibration and maintenance, timely as per               

            schedule.

            QA Officer/QA Manager: Review the records and governing the document.

4.0       Procedure:

4.1       Switch ON the instrument (back side switch).

4.2              Open the lid of the sample compartment & insert a test tube filled with the distilled water

            into the sample compartment then close the lid.

4.3       Rotate the switch of “set 0” to get “0” on LCD.

4.4       Open the lid, replace the test tube of distilled water by Formazine Std .Solution, and close

            the lid.

4.5       Rotate the switch of “Set 100” to get “100” on LCD.

4.6      Take the reading of sample in same way after setting standard.

4.7      Switch of the instrument.

Note:   Wash the test tube with distilled water after taking result.

5.0       Calibration Procedure:

            Solution 1:- Weigh accurately 5.0 g of Hydrazine Sulphate in 500 ml volumetric flask

            and add distilled water to make up to the mark. Leave the mixture to stand for 4 hours.

            Solution 2:- Weigh accurately 50.0 g of Hexam-Ethlenetetramine in 500ml volumetric

            flask and add make up the volume up to the mark with distilled water.

            Mix the equal volume of solution 1 and 2 form Formazine Turbidity Concentrate   

            Allow to stand in a closed container at 25º C to 30º C for 48 hrs to produce insoluble 

            while turbidity corresponding to 4,000 NTU (This solution is stable for 2-3 Months).

            Formazine Standard -100 NTU :- Dilute 25 ml of  the Formazine Turbidity Concentrate 

            to one liter with turbidity free distilled water to obtain 100 NTU Formazine Standard  for     

            setting 100 of  the instrument. (This Solution should be prepared weekly)

6.0              Routine Maintenance:

6.1              Clean the instrument with dry cloth.

6.2              Clean sample tube with methanol and than with water.

6.3              Clean the sample holder with dry cloth.