ORAL DOSAGE FORM SOPs

1.0 PURPOSE

To provide the guidelines for Rules to be followed in Microbiology Lab.

2.0 SCOPE: 

This SOP is to be applied at the time of Rules to be followed in Microbiology Lab.

5.0  PROCEDURE:

5.1  MICROBIOLOGY LAB        

5.1.1  Wear clean laboratory coat or apron during the work in laboratory

5.1.2  Should not eat or drink in the laboratory.  Do not use laboratory glass wares for drinking or eating

5.1.3  Always keep your fingers, pencils, paper etc., out of your mout.

5.1.4  Keep clean as possible, in handling of equipment’s such as microscope, balance etc.

5.1.5  Use good permanent markers for labelling on the glassware’s to be autoclaved are to be kept in water bath. 

5.1.6  In case culture is spilled, inform your instructor immediately. Follow instruction for cleaning; wash your hand with soap and IPA

5.1.7  At the end of the experiment, keep the equipment’s to their place.

5.1.8  Clean the worktable with disinfectant solution (i.e., IPA70%) before and after use.

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1.0 PURPOSE

To provide the guidelines for Sampling Handling and storage of Microbiological sample.

2.0 SCOPE: 

This SOP is to be applied at the time of Sampling Handling and storage of Microbiological Sample in the microbiology Lab.

5.0 PROCEDURE:

5.1 The reliability of the analysis and interpretation of the results exclusively depend on the process of sampling/sample preparation. Hence it is very important that the sample should be uniform, homogenous and a true representative of the entire Lot/Batch size.

5.2 The sample for microbiological examination should be collected in clean sterilized bottles of neutral glass of capacity about 500ml wide mouth provide with ground stoppers.

5.3 All the sampling equipments used like plungers, can cutters, spatulas, cotton swabs, aluminium foil & etc. should be sterilized before use.

5.4 Sampling should be undertaken under aseptic conditions and care should be taken to see that good sanitation and hygienic conditions are maintained

5.5 COLLECTION OF WATER SAMPLE FOR MICROBIOLOGICAL EXAMINATION

• Hands should be cleaned with disinfectant before sampling. 
• Bottle should be sterilized either by hot air oven at 160 ^oC for one hour or in autoclave at15 ± 0.5 psi gauge pressure at 121^oC for minimum 15 minutes then wrapped with Aluminum foi

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1.0 PURPOSE

This describe the procedure to provide the guidelines for Preparation of Disinfectant solution

2.0 SCOPE: 

This procedure is to be applied at the time Guidelines for Preparation of Disinfectant Solution in the laboratory

5.0 PROCEDURE:

5.1   Disinfectant used for cleaning

        Dettol -2.5%

        Savlon -1.5%

         Lysol     -0.6%

         IPA       -70%

5.2    Preparation of Disinfectant solution

          Savlon -1.5% (1ltr)

5.3    Take 500 ml purified water add 15 ml savlon solution and make up 1000 ml with purified water. Mix well the solution and use within a day.

Dettol -2.5% (1Ltr)

5.4    Take 500 ml purified water add 25 ml Dettol solution and make up 1000 ml with purified water. Mix well the  solution and use within a day.

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1.0 PURPOSE

To provide the guidelines for Environmental Monitoring in Microbiology, Production Area.

2.0 SCOPE: 

This SOP is to be applied at the time of Environmental Monitoring in Microbiology, Liquid Section, Production Area

5.0 PROCEDURE:

5.1 Pre-Incubation Check – Prepare Soybean Casein Digest Agar (SCDA) and prepare plates. Before using the plates check pre incubation status. For this incubate all the plates at 32.5⁰C for 4 hrs for any growth. Reject those plates which show any of the following characters: microbial growth, uneven  media layer, dehydration of media.

5.2 Validation Of Scda Plates – Check the plates for their growth promoting property by keeping a   sensitivity control and for sterility by keeping a sterility control as follows:

5.3 Sensitivity Control (Positive control): Select the plate randomly from prepared lot and expose in a non-sterile area for 30 minutes. Incubate at 22.5⁰C for 72 hrs followed by 32.5 ^oC for 48 hrs. Record  the results after 3 days and 5 days of incubation

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1.0 PURPOSE

To lay down a procedure for operation and cleaning of Colony Counter.

2.0 SCOPE: 

This procedure is applicable to the operation & cleaning of Colony Counter in Microbiology laboratory

5.0 PROCEDURE:

5.1 Operation:

5.1.1    Connect the plug to the main power socket and switch ON the power supply.

5.1.2    Connect the auto maker to the instrument from the left side.

5.1.3    Reset the inverted petri dish on the graduated glass plate.

5.1.4    Focus the magnifying lens.  Reset the automatic counter, by pressing the ‘RESET’ button.  The counter   should read ‘0000’.

5.1.5    Remove the cap of the probe and touch the marking point of the probe on the petri-plate where a bacteriological colony is located. Press the probe gently.

5.1.6    The counter will register a count with a beep as each colony is marked on the petri-plate. Continue till all the colonies are thus counted.

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1.0 PURPOSE

To Provide a procedure for preparation and usage of 70% v/v isopropyl Alcohol solution.

2.0 SCOPE: 

Covers the preparation and usage of 70%v/v Isopropyl Alcohol solution (IPA) in Microbiology/Manufacturing area.

5.0 PROCEDURE: 

5.1 Measure required quantity Alcohol and freshly collected purified water in 70:30(IPA: H2O) ratio. See examples   in given table for reference,

PREPARATION OF 70% IPA v/v

5.2      transfer the prepared 70% v/v IPA Solution into a clean bottle.

5.3      Tightly close the lid of the bottle.

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1.0 PURPOSE

To Provide a procedure for cleaning and sanitization of Microbiology lab.

2.0 SCOPE: 

This SOP is applicable for the cleaning and sanitization of area and equipment in Microbiology lab.

5.0 PROCEDURE: 

5.1  Use the disinfect solution as mentioned in Annexure-1 for a week and use other disinfectant solution for another week on rotational basis.

5.2  The rotation of the disinfectant solution should be such that the disinfectant having one active ingredient should be rotated with another ingredient disinfectant.

5.3 Rotation of disinfectant shall be done in the beginning of every week i.e. every Monday. If Monday is a holiday then rotation shall take place on Tuesday. If any unavailability of validated disinfectant stock, then the available validated disinfectant shall be used until the availability of stock.

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1.0 PURPOSE

To Provide a procedure for cleaning, operation and calibration of micropipette.

2.0 SCOPE: 

Covers the procedure for routine cleaning, operation and calibration of micropipette.

5.0 PROCEDURE:                     

5.1 CLEANING OF MICROPIPETTE:

5.1.1    Clean the Micropipette with lint free cloth.

5.1.2    Sanitize the Micropipette with wet lint free cloth soaked in disinfectant and wipe with 70% Isopropyl     alcohol.

5.2 OPERATION OF MICROPIPETTE:

5.2.1    Adjust the required volume to be pipette out by rotating the pluger cap.

5.2.2    Insert the tip of appropriate capacity into the probe of Micropipette.

5.2.3    Hold the Micropipette (Vertical position) in such a way that the palm and four fingers are covered the  body of pipette and the thumb must be on the plunger cap.

5.2.4    Press the plunger cap with the help of thumb up to the first lock and introduce the Micropipette probe with tip into the solution and release the thumb to suck the required volume of solution.

5.2.5    Press the plunger cap with the help of thumb “fully” to deliver the sucked solution.

5.2.6    Press the tip ejector with help of thumb to remove the tip.

5.3 CALIBRATION OF MICROPIPETTE:

5.3.1     Take 50 ml beaker, which has been previously washed & dried

1.0 PURPOSE

To lay down a procedure for operation and cleaning of LAB Refrigerator.

2.0 SCOPE: 

This procedure is applicable to operation & cleaning of refrigerator in Microbiology laboratory

5.0 PROCEDURE: 

5.1       OPERATION:

5.1.1    Insert the power plug to the main power socket

5.1.2    Switch On the mains supply and then follow by the Main of the Refrigerator

5.1.3    Set the thermostat control knob to ‘NORMAL’ position (60)

5.1.4    Adjust the Set Temperature on the ‘‘Temperature controller’’ by using the UP and DOWN arrows.

5.1.5    Load the refrigerator with the items to be stored between 2°C - 8°C or desired Temperature

5.1.6    Monitor the temperature once a day and record in Annexure-II

5.1.7     Maintain record for the materials stored in the refrigerator in the Refrigerator Storage Log Book as per Annexure –I

PURPOSE

This SOP is to lay down procedure for the cleaning and operation of Laminar Air Flow       workstation

SCOPE: 

This SOP has be applicable to microbiology department for the cleaning and operation of Laminar Air Flow workstation

5.0 PROCEDURE:                       

5.1 METHOD

5.1.1 Switch on the UV lamp and airflow half an hour before starting the work Red indicator will glow and air will start to come out from the HEPA filters.

5.1.2 Switch off the UV lamp after minimum 30 minutes.

5.1.3 Press the switch cum indicator of “Light”. Red indicator and tube lights will glow.

5.1.4 Check and ensure that the manometer reading is as per the specified limit (0.5 inches of water)

5.1.5 Perform the microbiological testing under the Laminar Airflow Workstation

5.1.6 After completion of testing, clean the working table with 70% Isopropyl Alcohol

5.1.7 Switch off the ‘’Light” at the end of the testing for the day.

5.1.8 Press the switch cum indicator of “UV”. Red indicator and UV lights will glow.

5.1.9 Switch on the UV lamp for minimum 30 minutes.

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