SOP FOR OPERATION OF CENTRIFIGUE MACHINE

1.0          Objective:

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

2.0          Scope:

               This SOP covers operating procedure of Centrifuge .

3.0          Responsibility:

               Junior Research officer/ Research Officer/ Microbiologist: Responsible for operation of the instrument as per procedure.

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

4.0          Procedure:

4.1                       Open the lid of the instrument. Fill the material in tubes. The volume of each tube should be equal. Load the tubes in instrument’s test tube stand. If all tubes are not filled up with material, please put the filled test tubes on opposite sides, so as to maintain the balance.

4.2                       Connect the three-pin plug to the mains. Switch the mains ON.

4.3                       Switch the instrument ON.

4.4                     Regulate the speed control knob from minimum to maximum gradually till desired speed is reached.

4.5                       The desired time duration for the test can be adjusted with the help of timer knob.

4.6                       Now wait till the operation of centrifuge is over.

4.7                       When the timer will reach to ’00’, the function will stop automatically.

4.8                       Allow the centrifuge to reach at stop position and read the speed meter indicating “00”.

4.9                       Open the lid, remove the test tubes and observe the result.

4.10                   After completion of work switch ‘OFF’ the instrument and the mains.

SOP FOR OPERATION AND CALIBRATION OF HEATING BLOCK

1.0          Objective:

               The objective of this Standard Operating Procedure is to lay down the procedure for operating and calibration of Heating Block.

2.0          Scope:

               This SOP covers operating and calibration of Heating Block

3.0          Responsibility:

               Microbiologist: Responsible for operation, calibration and maintenance of the instrument. Maintain the required record.

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

4.0          Procedure:

4.1          Ensure that the instrument is visibly clean and free from dust.

4.2      Switch ‘ON’ the mains switch. Switch on the power switch of the instrument and observe that the LED of Temperature indicator displays the ambient value.

4.4          Press ‘SET TEMP.’ key (Red Button) to pre-set the desired performance parameter.

4.5        The LED shall display the lat setting. Turn the setting knob clockwise for decrement until the LED displays the desired set value. Use the second knob for fine setting if required. Depress (Release) the SET key.

4.6          The LED shall regain to display the ambient value of the chamber.

4.7          Now the unit will automatically perform to attain the set temperature with the on and off of the heater.

4.8         The heater selection (heater capacity) switch is provided having positioned 37°, 45°and 75° or High.

4.9        Select the switch initially at HIGH to attain the set point quickly. Turn it to LOW soon the display is reaching near to the set point for fine and accurate control, Thus to prevent the shooting up the temperature from the set value.

4.10      Select the LOW position if the set point is nearing the ambient for accurate and fine performance.

5.0          Calibration:

5.1          Operate the instrument as per above procedure.

5.2      Set the temperature knob at desire temperature at which temperature you want to calibrate.

5.3          Place a calibrated thermometer of appropriate range in the chamber of the heating block.

5.4          Set the three different temperature and note down the constantly result for a period of 60   minutes at interval of 15 minutes.

5.5          Note down the temperature in the calibration format .

5.6                    Acceptance Criteria: ↑± 1.0 ° C for Set Temperature

6.0                    Routine maintenance:

6.1          Clean the instrument with dry cloth.

SOP FOR OPERATION AND CALIBRATION OF ANTIBIOTIC ZONE READER

1.0          Objective:

               To provide written procedure for operation and calibration of Antibiotic Zone Reader.

2.0          Scope:

               This SOP covers the operation and calibration of Antibiotic Zone Reader.

3.0          Responsibility:

               Microbiologist: Responsible for operation, calibration and maintenance of the instrument. Maintain the required record.

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

4.0          Procedure:

4.1          Ensure that the instrument is visibly clean and free from dust.

4.2          Switch ‘ON’ the mains switch.

4.3         Turn the left side drum to its maximum clockwise position, so that Zero Marking on the scale of the right side drum coincides with the Zero marking on the Vernier scale.

4.4         Keep the Petri-dish on the Aluminum plate and rotate it manually; so that one end of the Zone image touches the Mark Line on the Prism.

4.5       Now turn the left-side drum slowly, in anti-clockwise position, till the other end of the Zone image touches the Mark Line on the Prism.

4.6         Note the reading directly on the Right side drum scale. The scale is marked from 0 to 35 mm with each division of 0.2 mm and the Vernier scale is marked with each division of 0.02 mm.

5.0          Calibration:

5.1          Operate the instrument as per above procedure.

5.2          Put the standard coin in the appropriate place on antibiotic zone reader.

5.3          Measure the zone of standard coin and compare with the standard coin result and observed result.

5.4         Record the result in the calibration format 

6.0                    Routine maintenance:

6.1                    Clean the instrument with dry cloth.

6.2                    Clean glass & lance with dry cloth or tissue paper.

SOP FOR ENTRY AND EXIT PROCEDURE IN STERILE AREA

1.0          Objective:

               To provide written procedure for entering into Microbiology Sterile Area.

2.0          Scope:

               This standard operating procedure covers Microbiology Sterile Area 

3.0          Responsibility:

               Microbiologist: Awareness about the procedure. 

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

4.0          Procedure:

4.1          Remove the apron & footwear, keep it them to out side the sterile area.

4.2          Spray your hands with antiseptic solution provided.

4.3          Enter the change room , wear clean footwear, apron, cap, nose mask and surgical gloves.

4.4          Then enter in sterile room. Disinfect hands with 70 % IPA and allow it to dry.

4.5          Perform the work as per the respective procedure.

4.6          After completion of the work, clean the hands with 70 % IPA, dry the hands.

4.7        Enter the change room and remove gloves, nose mask, cap and apron, keep it in the respective place.

4.8          Remove the footwear and come out of the sterile area.

4.9          Wear the out side footwear and apron.

5.0          Precaution:

5.1          Do not enter in microbiology sterile area with out side footwear and apron.

SOP FOR OPERATION AND VALIDATION FOR LAMINAR AIR FLOW HOOD

1.0             Objective:

                  To provide written procedure for operation and validation of  Laminar Air Flow Hood.

2.0             Scope:

                  This SOP covers the operation and validation (in-house) of  Laminar Air Flow Hood.

3.0             Responsibility:

                  Microbiologist: Responsible for operation, validation and maintenance of the instrument. Maintain the required record.

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

4.0             Procedure:

4.1             Switch on the mains.

4.2             Switch on the Ultra Violet light for 30 minutes before beginning of the work.

4.3             Switch on the Laminar flow at least 15 minutes before beginning of the work.

4.4             Ensure that Ultra Violet light is off during working period.

4.5             Check the pressure of Nanometer, lend of the Red liquid indicator. It should be between 5 - 15 mm.

4.6             Record the Ultra Violet lamp usage and pressure of Nanometer in the Ultra Violet lamp usage log book 

4.7             Switch off the instrument once the work completed.

4.8             Clean the interior surface of the Laminar with 70 % IPA before and after the analysis.

5.0             Validation:

5.1             Check the performance of the HEPA filter by the following methods:

5.1.1          DOP test             : To be performed by external agency.

5.1.2          Particulate count : To be performed by external agency.

5.1.3          Velocity measurement: To be performed by external agency.

                  Frequency           : Once in a year

5.1.4          Plate count method:

5.1.4.1       Expose Soya bean casein digest agar and Sabouraud  Chloramphenicol Agar plates (in

                  duplicate) to air flow for 2 hours.

5.1.4.2       Incubate Soya bean Casein Digest Agar plate at 35- 37° C for 24 hours and Sabouraud Chloramphenicol Agar plate at 20-25° C for 72 to 120 hours.

5.1.4.3     Observe the plate and count the no. of colonies found. Record the observations in the            Laminar flow validation log book 

5.1.4.4       Acceptance Criteria:  Not more than 1 cfu per plate/2 hour.

5.1.4.5       Frequency: Once in a month.

6.0                          Routine maintenance:

6.1                          Clean the instrument with dry cloth and LAF bench with Isopropyl alcohol.

6.2                          Check the level of the red liquid.

6.3                          Clean the tube of ultraviolet light with dry cloth.