ORAL DOSAGE FORM SOPs

1.0  PURPOSE

       This describes the procedure to provide the guidelines of Gram’s staining

2.0  SCOPE: 

       This SOP is to be applied at the time of Gram’s Staining

5.0  PROCEDURE:

5.1   Prepare a thin suspension of the culture to be identified using n-saline or distilled water.

5.2   Prepare a heat fixed smear of suspension on a glass slide.

5.3   Treat the smear with crystal violet for one minute.

5.4   Wash the slide with distilled water.

5.5   Treat the slide with Gram’s Iodine for one minute.

5.6   Wash the slide with distilled water.

5.7   Decolorize with 95% ethanol. Add alcohol drop by drop till the crystal violet fails to Come out from the smear.

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1.0 PURPOSE

To describe the procedure for fumigation in Microbiology Laboratory.

2.0 SCOPE: 

This procedure is to be applied at the time of Fumigation in Microbiology Laboratory.

5.0 PROCEDURE:

5.1  Frequency for fumigation is once in a week or if the microbial count exceeds the limits in Microbiology testing area.

5.2  At the end of the shift, after the completion of all the activities of Microbiology laboratory Fumigation is done.

5.3  Prepare freshly 20 % v/v Virosil solution or 1.5 % v/v (for critical area) in DM water.

5.4  Ensure that the Fogging Machine is clean and free from dust and discard the previous Solution.

5.5  Fill the tank of the fogging machine with the above solution.

5.6  Plug the power cord control of the instrument to the 230 V AC mains and switch on the power supply

5.7  Close the doors of the area where fogging is being done and stay outside.

5.8  Keep the fogger on till it forms sufficient fog in the area, and then shift to another area.

5.9  After fogging the disinfectant solution, switch off the fogging machine

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1.0 PURPOSE

To lay down a procedure for the operation and cleaning of BOD incubator

2.0 SCOPE: 

This SOP is applicable for the operation of BOD incubator (20-25 ⁰C) to the Microbiology Laboratory.

5.0 PROCEDURE:

5.1  Ensure the incubator is properly connected to the power supply

5.2  Switch ON the main switch and then the cabinet switch.

5.3  Set the required temperature at 22.5 ⁰C by pressing the soft keys UP and DOWN arrows.

5.4  Monitor the Temperature daily as per following procedure.

5.5  Temperature shall be recorded which is displayed on LCD of controller of incubator.

5.6  Observe the temperature shown on the digital display. The temperature should not differ by ±2.5⁰C

5.7  Temperature of incubator having online printer shall be recorded in printout chart.

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1.0 PURPOSE

This SOP provides the Procedure for handling of Spillage in Microbiology laboratory.

2.0 SCOPE: 

This SOP is to be applied at the time of Handling of spillage in Microbiology Laboratory

5.0 PROCEDURE:

5.1 Personnel working in the laboratory should be aware of handling the media, pathogenic cultures and chemicals carefully to avoid spillage and contamination.

5.2 At the time of spillage, Microbiologist/Lab Asst should immediately inform to house keeping persons for clearing the spillage.

5.3 The worker is instructed to put on the gloves and mask while cleaning pathogenic plates and broth.

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1.0 PURPOSE

To describe the procedure for cleaning procedure of glassware’s in Microbiological Lab.

2.0 SCOPE: 

This SOP is to be applied at the time of Cleaning Procedure of glassware’s in Microbiology lab.

5.0 PROCEDURE:

5.1  Wear face mask and gloves during washing.

5.2  Remove the media and culture waste into a container by spatula or by direct pouring and destroy the used media and culture waste by autoclaving

5.3  Dip all the glass wares in a container containing disinfectant solution of 2.5% Dettol ,1% teepol or 1.5% Savlon for 1 hr.

5.4  Decant the treated solution from all the glassware.

5.5  Soak all the glassware in soap solution for 30 minutes.

5.6  Clean the glassware with proper brushing & scrubbing.

5.7  Clean all the glassware under running tap water.

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1.0 PURPOSE

This document details the procedure for the Autoclave Validation

2.0 SCOPE: 

This procedure is applicable for Autoclave Validation in the microbiology laboratory

5.0 PROCEDURE:

5.1  METHOD

5.1  Pressure Gauges, Temperature indicators and sensors of the instrument shall be Calibrated.

5.2  Temperature distribution, penetration inside the instrument shall be calibrated with the help of  Data Logger.

5.3  Prepare the SCDM media; transfer 100 ml in each test tube. Add Bacillu Stearothermophilus strip into test tubes. Autoclave test tubes at 121⁰C at 15 lbs.

5.4  After autoclaving cool the media then add Bacillus stearothermophilus strip into SCDM as a  positive control.

5.5  Keep one test tube of SCDM as a Negative control.

5.6       Incubate all Test tubes in incubator at 55⁰C to 60⁰C for 5 to 7 days

5.7       Observe results on daily basis and add to data sheet.

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1.0 PURPOSE

This document details the procedure for Precaution and cleaning after handling of culture in MLT Room.

2.0 SCOPE: 

This SOP is to be applied at the time of Precaution and cleaning after handling of culture in MLT Room.

5.0 PROCEDURE:

5.1  Check and ensure that the surroundings and surface of the equipment is clean and ensure place is suitable for starting the operation.

5.2  Before using the equipment disinfect the interior surface of the work station by wiping thoroughly with 70% IPA. Wipe the hands thoroughly.

5.3  Wear another (secondary0 sterile gloves before starting work.

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1.0 PURPOSE

This document details the procedure for Handling of out of specification result in Microbiology Laboratory.

2.0 SCOPE: 

This SOP is to be applied at the time of Handling of Out of specification in Microbiology laboratory.

5.0 PROCEDURE:

5.1  Microbiologist shall inform in charge-Microbiology in case of any out of specification Result.

5.2  In charge -Microbiology shall check the corresponding negative control. If negative control show microbial growth, all test result shall be invalidated.

5.3  If negative control shows no microbial growth, in charge-Microbiology shall initiate the Out of Specification investigation report on

5.4  The serial number of the Out of Specification Investigation Report shall be generated

INVESTIGATION TO BE CARRIED OUT IF ACTION LIMITS FOR MICROBIAL ANALYSIS ARE EXCEEDED OR THE PATHOGENS DETECTED

• Note down the colony characteristics of the bacteria / fungi observed and carry out Identification as per SOP If the test is showing the presence of pathogens, confirm it with confirmatory test.
• Report the results to the In charge Microbiology.
• Re sampling can be as per situation observed
• Inform the respective customer / Quality Assurance department by sending a written communication.

INVESTIGATION TO BE CARRIED OUT IF ACTION LIMITS FOR ENVIRONMENT MONITORING ARE EXCEEDED

• Note down the colony characteristics of the bacteria / fungi observed and carry out identification as per SOP Compare the isolate characteristics with In house isolate data. Report if any different type of isolate found

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1.0 PURPOSE

To lay down a procedure for the operation and cleaning of microscope

2.0 SCOPE: 

This procedure is applicable to the Microbiology Laboratory

5.0 PROCEDURE:

5.1 Switch on the instrument by using ‘ON /OFF’ switch.

5.2 Set the required brightness through brightness control.

5.3 Position the slide on the stage with the sample to be observed on the upper surface of the slide

5.4 Adjust the slide to bring into the exact center of the light source.

5.5 Low magnification objective lens shall be focused first followed by high magnification lens on the center of the sample.

5.6 Turn the coarse adjustment knob to adjust the stage.

5.7 While observing through the ocular bring the object into focus by adjusting with the coarse knob. By using fine adjustment knob, focus the sample for better resolution.

5.8  Adjust the diaphragm lever to reduce or increase the light intensity to produce the clear and sharp image.

5.9  Once the image is visible, adjust the slide for the targeted item in the image

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1.0 PURPOSE

To define the operation of the instrument for better and error free use of the same.

2.0 SCOPE: 

This procedure is applicable to mix the solution or to dissolve the various substance in to solvent

5.0 PROCEDURE:

5.1       Switch “ON” the mains.

5.2       Switch “ON” the instrument.

5.3       Red light will glow.

5.4       Put the test tube on the rubber pad.

5.5       Set the speed with the help of the knob

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