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.

SOP FOR DISPOSAL OF USED AND WASTE MICROBIOLOGICAL MEDIA

1.0          Objective:

               The purpose of this SOP is to provide guidelines for the Disposal of used & waste media in  microbiology laboratory.

2.0          Scope:

               This SOP covers  disposal of used and waste media from microbiology laboratory.

3.0          Responsibility:

            Microbiologist: Responsible for dispose the media as per guideline and maintain the necessary record.

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

4.0          Procedure:

4.1          Disinfect the glassware containing used media and other accessories used for                     microbiological testing as follows :

4.1.1       Used media: Pour 5 to 10 ml of 2 % v/v Phenol or 5 % v/v Dettol solutions to each of the glassware containing used media for disposal. Use the solutions alternately.

4.1.2       Allow to stand for 30 minutes.

4.2          Sterilize the glassware by autoclaving 15 lbs (at 121° C) for 30 minutes.

4.3       After the pressure in the autoclave is released, unload the glassware in hot condition                 and drain the liquid media in the washing area.

4.4          Wash the glassware .

4.5          After washing the destruction load, clean the washing area with 5 % v/v Dettol.

4.6          Wash the autoclave with 5 % v/v Dettol solution and then with tap water thoroughly before using the autoclave again.

4.7          Enter the details in disposal of microbiological media log book

4.8       CULTURE TUBES: Disinfect media tubes containing cultures by the above procedure            after the freshly sub-cultured is done and growth observed.

4.9    PIPETTES: Dip used pipettes in a cylinder or waste bin containing disinfectant. Allow                        to stand for 30 minutes and wash the pipettes.