cGMP and Regulatory Updates

1.0 SCOPE: To provide guidelines to ensure effective line clearance of the area and equipment. 2.0 RESPONSIBILITY: Operator, Production Officer. 3.0 PROCEDURE: 3.1 Ensure that the area is cleaned as per SOP: PRGN:xxx. 3.2 Ensure that Bottle washing machine is cleaned as per the SOP: PRCL:xxx/A; Point No: 3.1 for Batch change over/At the end of shift or is cleaned as per the SOP: PRCL:xxx/A; Point No: 3.2, for Product change over/Expiry of use before date. 3.3 Ensure that all containers, documents and labels of previous product / batch are removed and status board is updated. 3.4 Ensure that all the cervices and near by area is free from previous product. 3.5 Ensure that all the gloves and accessories of previous product/batch are removed. 3.6 Check the Temperature, Relative Humidity and the Differential Pressure of the cubicle and enter the same in the Batch Manufacturing Record. 3.7 Line clearance is given by Production Officer to start the next batch, after checkin...

1.0 SCOPE: To provide guidelines to ensure effective line clearance of the area and equipment. 2.0 RESPONSIBILITY: Operator, Production Officer. 3.0 PROCEDURE: 3.1 Ensure that the area is cleaned as per SOP: PRGN:xxx. 3.2 Ensure that Bottle drying machine is cleaned as per the SOP: PRCL:xxx/A; Point No: 3.1 for Batch change over/At the end of shift or is cleaned as per the SOP: PRCL:xxx/A; Point No: 3.2, for Product change over/Expiry of use before date. 3.3 Ensure that all containers, documents and labels of previous product / batch are removed and status board is updated. 3.4 Ensure that all the cervices and near by area is free from previous product. 3.5 Ensure that all the gloves and accessories of previous product/batch are removed. 3.6 Check the Temperature, Relative Humidity and the Differential Pressure of the cubicle and enter the same in the Batch Manufacturing Record. 3.7 Line clearance is given by Production Officer to start the next batch, after checking ...

1.0 SCOPE: To provide guidelines to ensure effective line clearance of the area and equipment. 2.0 RESPONSIBILITY: Operator, Production Officer. 3.0 PROCEDURE: 3.1 Ensure that the area is cleaned as per SOP: PRGN:xxx. 3.2 Ensure that the BOPP tape dispenser is cleaned as per SOP: PRCL:xxx/A 3.3 Ensure that all containers, documents and labels of previous product / batch are removed and status board is updated. 3.4 Ensure that all the cervices and near by area is free from previous product / batch. 3.5 Ensure that accessories of previous product/batch are removed. 3.6 Check the Temperature and Relative Humidity of the Packing hall and enter the same in the Batch Packing Record. 3.7 Line clearance is given by Production Officer to start the next batch, after checking the above-mentioned points, which is to be recorded in the Batch Packing Record (BPR). 3.8 After checking all above points and the BPR, Final Line Clearance should be given by In Process Quality Assuranc...

1.0 SCOPE: To provide guidelines to ensure effective line clearance of the area and equipment. 2.0 RESPONSIBILITY: Operator, Production Officer. 3.0 PROCEDURE: 3.1 Ensure that the area is cleaned as per SOP: PRGNxxx 3.2 Ensure that the Blister Pack Machine (240 SS) as per the SOP: PRCL:xxx/A; Point No: 3.1,for batch change over/at the end of shift or as per SOP: PRCL: xxx/A; Point No: 3.2,for product change over/expiry of use before date. 3.3 Ensure that all containers, documents and labels of previous product / batch are removed and status board is updated. 3.4 Ensure that all the cervices and near by area is free from previous product. 3.5 Ensure that all the PVC/PVDC/Aluminum foils, gloves and accessories of previous product/batch are removed. 3.6 Check the Temperature, Relative Humidity and the Differential Pressure of the cubicle and enter the same in the Batch Packing Record. 3.7 Line clearance is given by Production Officer to start the next batch, after checking the a...

1.0 SCOPE: Applicable to AF-90T capsule-filling machine manufactured by Pam Pharmaceutical and Allied Machinery Company Limited. 2.0 RESPONSIBILITY: Operator, Production officer. 3.0 PROCEDURE: FOR MACHINES HAVING CODE NUMBERS PRxxx AND PRxxy. 3.1 Verify the cleanliness of the area and the capsule-filling machine (AF-90T). Confirm that ‘CLEANED’ label is affixed to the machine. 3.2 Remove the ‘CLEANED’ label and affix the ‘EQUIPMENT IN USE’ label on the equipment. Affix the ‘CLEANED’ label in the BMR. 3.3 Switch ‘ON’ the main supply. 3.4 Release the ‘EMERGENCY’ switch. 3.5 Switch ‘ON’ the control panel by rotating the key provided in the control panel. 3.6 Open the compressed air valve and adjust the pressure, it should be 5 to 7 kg/sq.cm. 3.7 Check the vacuum on vacuum gauge; it should be 20 to 24 inch/Hg. 3.8 Press ‘ MAIN’ key, screen will display the following: 3.9 Press ‘Next screen’, screen will display the following: 3.10 Press ‘COUNT RESET’ prior to start a new batch. 3.11 Pr...

1.0 SCOPE: To provide guidelines to ensure effective line clearance of the area and equipment. 2.0 RESPONSIBILITY: Operator, Production Officer. 3.0 PROCEDURE: 3.1 Ensure that the area is cleaned as per SOP: xxxxx 3.2 Ensure that Bottle washing machine is cleaned as per the SOP: xxxxx; Point No: 3.1 for Batch change over/At the end of shift or is cleaned as per the SOP: xxxxx; Point No: 3.2, for Product change over/Expiry of use before date. 3.3 Ensure that all containers, documents and labels of previous product / batch are removed and status board is updated. 3.4 Ensure that all the cervices and near by area is free from previous product. 3.5 Ensure that all the gloves and accessories of previous product/batch are removed. 3.6 Check the Temperature, Relative Humidity and the Differential Pressure of the cubicle and enter the same in the Batch Manufacturing Record. 3.7 Line clearance is given by Production Officer to start the next batch, after checking the above-mentioned p...

1.0 SCOPE: To provide guidelines to ensure effective line clearance of the area and equipment. 2.0 RESPONSIBILITY: Operator, Production Officer. 3.0 PROCEDURE: 3.1 Ensure that the area is cleaned as per SOP: xxxxx. 3.2 Ensure that Bottle drying machine is cleaned as per the SOP: xxxxx; Point No: 3.1 for Batch change over/At the end of shift or is cleaned as per the SOP: xxxxxx; Point No: 3.2, for Product change over/Expiry of use before date. 3.3 Ensure that all containers, documents and labels of previous product / batch are removed and status board is updated. 3.4 Ensure that all the cervices and near by area is free from previous product. 3.5 Ensure that all the gloves and accessories of previous product/batch are removed. 3.6 Check the Temperature, Relative Humidity and the Differential Pressure of the cubicle and enter the same in the Batch Manufacturing Record. 3.7 Line clearance is given by Production Officer to start the next batch, after checking the above-mentioned ...

1.0 SCOPE: To provide guidelines to ensure effective line clearance of the area and equipment. 2.0 RESPONSIBILITY: Operator, Production Officer. 3.0 PROCEDURE: 3.1 Ensure that the area is cleaned as per SOP: xxxxxx 3.2 Ensure that the BOPP tape dispenser is cleaned as per SOP: xxxxxx 3.3 Ensure that all containers, documents and labels of previous product / batch are removed and status board is updated. 3.4 Ensure that all the cervices and near by area is free from previous product / batch. 3.5 Ensure that accessories of previous product/batch are removed. 3.6 Check the Temperature and Relative Humidity of the Packing hall and enter the same in the Batch Packing Record. 3.7 Line clearance is given by Production Officer to start the next batch, after checking the above-mentioned points, which is to be recorded in the Batch Packing Record (BPR). 3.8 After checking all above points and the BPR, Final Line Clearance should be given by In Process Quality Assurance Officer. 3.9 R...

1.0 SCOPE: To provide guidelines to ensure effective line clearance of the area and equipment. 2.0 RESPONSIBILITY: Operator, Production Officer. 3.0 PROCEDURE: 3.1 Ensure that the area is cleaned as per SOP: xxxxxx 3.2 Ensure that the Blister Pack Machine (240 SS) as per the SOP: xxxxaa; Point No: 3.1,for batch change over/at the end of shift or as per SOP: xxxxbb; Point No: 3.2,for product change over/expiry of use before date. 3.3 Ensure that all containers, documents and labels of previous product / batch are removed and status board is updated. 3.4 Ensure that all the cervices and near by area is free from previous product. 3.5 Ensure that all the PVC/PVDC/Aluminum foils, gloves and accessories of previous product/batch are removed. 3.6 Check the Temperature, Relative Humidity and the Differential Pressure of the cubicle and enter the same in the Batch Packing Record. 3.7 Line clearance is given by Production Officer to start the next batch, after checking the above-mentio...

PREPARATION: Dissolve 42 g of Sodium hydroxide in sufficient carbon dioxide-free water to produce 1000 ml. STANDARISATION: Weigh accurately about 0.5g of potassium hydrogen phthalate previously powdered and dried at 120°C for 2 hours. Dissolve it in 75 ml carbon dioxide free water. Add 0.1 ml phenolphthalein solution and titrate with prepared sodium hydroxide solution until a permanent pink colour is produced. Each ml of 1 M sodium hydroxide ≡ 0.2042 gm of potassium hydrogen phthalate. Perform a duplicate and calculate the molarity factor (MF). Note down the average value Calculation MF =W/ 0.2042 x V Where V = Volume of Sodium hydroxide consumed in ml. W = Weight of potassium Hydrogen phthalate in gram. Note : Restandardise before use. Store in bottle with well fitted suitable stoppers, which prevents access to atmospheric carbon dioxide. Discard the solution after 30 days. For storage and labeling follow the general procedure.

PREPARATION: Dissolve 18.6 g of disodium edetate in sufficient water to produce 1000 ml. Standardisation Weight accurately about 0.8 g of Granulated Zinc, dissolve by gentle warming in 12ml of diluted Hydrochloric acid and 0.1ml of bromine solution boil to remove the excess bromine, cool, add sufficient water to produce 200 ml. Pipette 20 ml in to a conical flask and nearly neutralize with 2 M sodium hydroxide. Add about 125 ml water and sufficient ammonia buffer pH 10 to dissolve the precipitate and add 5 ml in excess. Add 50 mg of mordant black II mixture and titrate with the prepared disodium edentate solution until the solution turns to green point. Each ml of 0.1M disodium edetate solution ≡ 0.00654g of Zinc Perform a duplicate and calculate the molarity factor (MF) Note down the average value Calculation MF =W x 20/200 x 0.00654 x V Where W = Weight of Zinc in gram. V = Volume of EDTA consumed in ml. Note: 1) Discard the solution after ...

PREPARATION: Dissolve 1.792 g of benzethonium chloride, previously dried to constant weight at 100° to 105°, in sufficient water to produce 1000 ml. Standardisation Dissolve 0.35 g of the dried substance in 30 ml of anhydrous acetic acid, add 6 ml of mercury(II) acetate solution and carry out potentiometric titration with 0.1M perchloric acid using 0.5ml of crystal violet solution as an indicator to the full colour change of indicator. Carry out a blank titration. Each ml of 0.1M perchloric acid VS is equivalent to 44.81 mg of C27H42ClNO2. Calculation MF = W/0.04481 x V Where W = Weight of Benzethonium chloride in g. V = Volume of perchloric acid consumed in ml. Note: 1) Discard the solution after 30 days. 2) Restandardise before use 3) For storage and labeling follow the general procedure

PREPARATION: Dissolve 6.85 g of mercury nitrate in 20 ml of 1M nitric acid and add sufficient water to produce 1000 ml. Standardisation Dissolve 15 mg of sodium chloride in 50 ml of water and titrate with the mercury nitrate solution determining the end point potentiometrically, using a platinum or mercury indicator electrode and a mercury-mercury(I) sulphate reference electrode. Each ml of 0.02M mercury(II) nitrate VS is equivalent to 2.338 mg of NaCl. Calculation ---------------- Note: 1) Discard the solution after 30 days. 2) Restandardise before use 3) For storage and labeling follow the general procedure.

PREPARATION: For a 0.1M solution Dissolve 29 g of zinc sulphate in sufficient water to produce 1000 ml. Standardisation To 20 ml add 5 ml of 2M acetic acid in a 500 ml conical flask dilute the prescribed solution to 200 ml with water and add about 50 mg of xylenol orange triturate and sufficient hexamine to produce a violet-pink colour. Add a further 2 g of hexamine and titrate with 0.1M disodium edetate VS until the colour changes to yellow. Each ml of 0.1M disodium edetate VS is equivalent to 6.54 mg of Zn. Calculation --------------- Note: 1) Discard the solution after 30 days. 2) Restandardise before use 3) For storage and labeling follow the general procedure.

Preparation Dissolve 25 g of sodium thiosulphate and 0.2 g of sodium carbonate in sufficient carbon dioxide-free water to produce 1000 ml. Standardisation To 20 ml of 0.0167M potassium bromate VS add 40 ml of water, 10 ml of potassium iodide solution and 5 ml of 7M hydrochloric acid. Titrate with the sodium thiosulphate solution using 1 ml of starch solution, added towards the end of the titration, as indicator. Each ml of 0.1M sodium thiosulphate VS is equivalent to 2.784 mg of KBrO3. Perform a duplicate and calculate the molarity factor (MF) Note down the average value Calculation ----------- Note: 1) Restandardise before use 2) Discard the solution after 30 days. 3) For storage and labeling follow the general procedure.

PREPARATION: Dissolve 4.2 g of Sodium hydroxide in sufficient carbon dioxide-free water to produce 1000 ml. STANDARISATION: Weigh accurately about 0.5g of potassium hydrogen phthalate previously powdered and dried at 120°C for 2 hours. Dissolve it in 75 ml carbon dioxide free water. Add 0.1 ml phenolphthalein solution and titrate with sodium hydroxide solution until a permanent pink colour is produced. Each ml of 0.1 M sodium hydroxide ≡ 0.02042 gm of potassium hydrogen phthalate. Perform a duplicate and calculate the molarity factor (MF). Note down the average value . Calculation MF = W/ 0.02042 x V Where V = Volume of Sodium hydroxide consumed in ml. W = Weight of potassium Hydrogen phthalate in gram. Note : Restandardise before use. Store in bottle with well fitted suitable stoppers which prevents access to atmospheric carbon dioxide. Discard the solution after 30 days.For storage and labeling follow the general procedure

Preparation Dissolve 17g of silver nitrate in sufficient chloride free water to produce 1000 ml. Standardisation Weigh accurately about 0.1g sodium chloride, previously dried at about 110º C for 2 hours and dissolve in 5 ml of water. Add 5 ml of glacial acetic acid, 50 ml of methanol and 0.15 ml of eosin solution. Titrate with silver nitrate solution with constant stirring to purple end point. Each ml of 0.1 M silver nitrate ≡ 0.005844 g of sodium chloride. Perform a duplicate and calculate the Molarity factor (MF) Note down the average value Calculation MF = W/0.005844 X V Where W = Weight of sodium chloride in gm. V = Volume of silver nitrate solution consumed in ml. Note: 1) Restandardise before use 2) Discard the solution after 30 days. Store in amber bottle with well fitted suitable stoppers which prevents access to atmospheric carbon dioxide.

PREPARATION: To 900 ml of glacial acetic acid add 8.5 ml of perchloric acid, mix, add 30 ml of acetic anhydride, dilute to 1000 ml with glacial acetic acid, mix and allow to stand for 24 hours. STANDARISATION: Wigth accurately about dissolve 0.35 g of potassium hydrogen phthalate in 50 ml of anhydrous acetic acid, warming gently if necessary. Allow to cool protected from the air and titrate with the perchloric acid solution using 0.05 ml of crystal violet solution as indicator. Each ml of 0.1M perchloric acid VS is equivalent to 20.42 mg of C8H5KO4. Perform a duplicate and calculate the molarity factor.(MF) Note down the average value . Calculation MF = W/ 0.02042 x V Where V = Volume of perchloric acid consumed in ml. W = Weight of potassium hydrogen phthalate in g. Note : Restandardise before use. Store in amber bottle with well fitted suitable stoppers which prevents access to atmospheric carbon dioxide. Discard the solution after...

PREPARATION: To 900 ml of glacial acetic acid add 8.5 ml of perchloric acid, mix, add 30 ml of acetic anhydride, dilute to 1000 ml with glacial acetic acid, mix and allow to stand for 24 hours. STANDARISATION: Wigth accurately about dissolve 0.35 g of potassium hydrogen phthalate in 50 ml of anhydrous acetic acid, warming gently if necessary. Allow to cool protected from the air and titrate with the perchloric acid solution using 0.05 ml of crystal violet solution as indicator. Each ml of 0.1M perchloric acid VS is equivalent to 20.42 mg of C8H5KO4. Perform a duplicate and calculate the molarity factor.(MF) Note down the average value . Calculation MF = W/ 0.02042 x V Where V = Volume of perchloric acid consumed in ml. W = Weight of potassium hydrogen phthalate in g. Note : Restandardise before use. Store in amber bottle with well fitted suitable stoppers which prevents access to atmospheric carbon dioxide. Discard the solution af...

PREPARATION: Dissolve 3.312 g of Lead nitrate in sufficient water to produce 1000 ml. STANDARISATION: Pipette 50 ml of the solution into a flask,add 50 mg of xylenol orange mixture and sufficient hexamine to produce a violet pink colour and titrate with 0.1 M disodium edetate to a lemon yellow end point. Each ml of 0.1M disodium edetate is equivalent to 0.03312 g of Lead nitrate Molarity factor:0.03312 x 50 x V/1000 x W Where V= Volume of 0.1M disodium edetate consumed in ml W= Weight of lead nitrate in g Note: 1) Restandardise before use 2) Discard the solution after 30 days. 3) For storage and labeling follow the general procedure.

PREPARATION: Dissolve 3.312 g of Lead nitrate in sufficient water to produce 1000 ml. STANDARISATION: Piptte 50 ml of the solution into a flask,add 50 mg of xylenol orange mixture and sufficient hexamine to produce a violet pink colour and titrate with 0.1 M disodium edetate to a lemon yellow end point. Each ml of 0.1M disodium edetate is equivalent to 0.03312 g of Lead nitrate Molarity factor : 0.03312 x 50 x V/1000 X W Where V = Volume of 0.1M disodium edetate consumed in ml. W = Weight of lead nitrate in g Note: 1) Restandardise before use. 2) Discard the solution after 30 days. 3) For storage and labeling follow the general procedure.

PREPARATION: Dissolve 40g of ferrous ammonium sulphate in a previously cooled mixture of 40 ml of sulphuric acid and 200ml of water,dilute with sufficient freshly boiled and cooled water to produce 1000ml . STANDARISATION: Pipette accurately 25.0ml of the solution into a flask,add 2 drops of 1,10-phenanthroline solution and titrate with 0.1M ceric ammonium sulphate until red colour is changed to pale blue.Each ml of 0.1M ceric ammonium sulphate is equivalent to 0.03921g of Fe(NH4)2(SO4)2,6H2O . Note : The molarity factor of volumetric solution should not differ by more than ± 5% of the Prescribed strength and the molarity should be determined with a precision of 0.2%. Restandardise after 15 days. Storage in amper bottle with well fitted suitable stoppers which prevent access to atmospheric carbon dioxide. Discard the solution after 30 days. For storage and labeling follow the general procedure.

PREPARATION: Dissolve 37.2 g of disodium edetate in sufficient water to produce 1000 ml. Standardisation Weight accurately about 0.8 g of Granulated Zinc, dissolve by gentle warming in 12ml of diluted Hydrochloric acid and 0.1ml of bromine solution boil to remove the excess bromine, cool, add sufficient water to produce 200 ml. Pipette 20 ml in to a conical flask and nearly neutralize with 2 M sodium hydroxide. Add about 125 ml water and sufficient ammonia buffer pH 10 to dissolve the precipiate and add 5 ml in excess. Add 50 mg of mordant black II mixture and titrate with the prepared disodium edentate solution until the solution turns to green point. Each ml of 0.1M disodium edetate solution ≡ 0.00654g of Zinc Perform a duplicate and calculate the molarity factor (MF) Note down the average value Calculation MF = W x 20/200 x 0.00654 x V Where W = Weight of Zinc in g. V = Volume of EDTA consumed in ml. Note: 1) Discard the solution after 30 days. 2) Resta...

Preparation Dissolve 7.612 g in sufficient water to produce 1000 ml Standardisation To 20 ml of 0.1M silver nitrate VS add 25 ml of water, 2 ml of 2M nitric acid and 2 ml of ammonium iron(III) sulphate solution R2 and titrate with the ammonium thiocyanate solution until a reddish yellow colour is obtained. Each ml of 0.1M silver nitrate VS is equivalent to 7.612 mg of NH4SCN. Perform a duplicate and calculate the molarity factor (MF) Note down the average value Calculation :-------------- Note: 1) Restandardise before use 2) Discard the solution after 30 days. 3) For storage and labeling follow the general procedure.

1.0 SCOPE: Applicable to AF-90T capsule-filling machine manufactured by Pam Pharmaceutical and Allied Machinery Company Limited. 2.0 RESPONSIBILITY: Operator, Production officer. 3.0 PROCEDURE: FOR MACHINES HAVING CODE NUMBERS xxxxx xxxxx 3.1 Verify the cleanliness of the area and the capsule-filling machine (AF-90T). Confirm that ‘CLEANED’ label is affixed to the machine. 3.2 Remove the ‘CLEANED’ label and affix the ‘EQUIPMENT IN USE’ label on the equipment. Affix the ‘CLEANED’ label in the BMR. 3.3 Switch ‘ON’ the main supply. 3.4 Release the ‘EMERGENCY’ switch. 3.5 Switch ‘ON’ the control panel by rotating the key provided in the control panel. 3.6 Open the compressed air valve and adjust the pressure, it should be 5 to 7 kg/sq.cm. 3.7 Check the vacuum on vacuum gauge; it should be 20 to 24 inch/Hg. 3.8 Press ‘ MAIN’ key, screen will display the following: 3.9 Press ‘Next screen’, screen will display the following: 3.10 Press ‘COUNT RESET’ prior to start a new ...

1.0 SCOPE: Applicable to Air Displacement unit manufactured by Pam Pharmaceutical and Allied Machinery Company Limited. 2.0 RESPONSIBILITY: Operator, Production officer. 3.0 PROCEDURE: 3.1 Verify the cleanliness of the area and the equipment. Confirm that CLEANED’ label is affixed to the air displacement unit 3.2 Remove the ‘CLEANED’ label and affix the ‘EQUIPMENT IN USE’ (LBPR:004) label on the equipment. Affix the ‘CLEANED’ label in the BMR. 3.3 Connect the equipment to the power supply point. 3.4 Ensure that the seal filter is fitted properly. 3.5 Enter the details in the ‘Equipment usage log’ 3.6 Switch ‘ON’ the starter. 3.7 In case of clogging of the filter bag. Switch of the machine and press the lever down and lift up for shaking of the filter bag. 3.8 At the end of batch / shift switch ‘OFF’ the machine. 3.9 Remove the ‘EQUIPMENT IN USE’ label and affix the ‘TO BE CLEANED’ label to the equipment. Destroy the ‘EQUIPMENT IN USE’ label. 3.10 Enter the ...

1.0 OBJECTIVE To lay down a procedure for handling of In-Process Samples and Finished Products out-of-specifications test results [except Microbiological Analysis] 2.0 SCOPE This SOP is applicable to Quality Assurance Department. 3.0 RESPONSIBILITY Head of Respective Departments 4.0 ACCOUNTABILITY Manager - QC 5.0 PROCEDURE 5.1 Any out-of-specification test result shall be investigated and documented. The investigation report shall include, 5.1.1 Errors in sampling, handling and storage of sample. 5.1.2 Error in Analysis. 5.1.3 Error in manufacturing (process related, non-process related and operator related). 5.2 In case investigation reveals out of specification result is due to manufacturing error, the batch shall be rejected. 5.3 In case investigation reveals that sampling is one of the reason for out of specification result, the repeat analysis shall be done on re-sample. 5.4 In case investigation reveals th...

1.0 OBJECTIVE To lay down procedure for spring cleaning of microbiology Lab. 2.0 SCOPE This SOP covers the procedure for spring cleaning of microbiology lab and is applicable to the Quality Control Department 3.0 RESPONSIBILITY Housekeeping supervisor 4.0 ACCOUNTABILITY Department Head 5.0 PROCEDURE 5.1 With the help of non-shedding mop or vacuum cleaner, clean the area in the following order, a. Ceiling , fixtures and walls. b. Outer surface of equipment’s i.e, LAF, incubator, autoclave, etc., c. Media preparation room d. Table top and chairs e. Flooring 5.2 Subsequently swab the area in the order given above with any of the following disinfectant solutions 2.5% Dettol solution or 2.5 % Fairgenol solution or 2.5 % Savlon solution or with 2.5 % Phenyl solution . 5.3 Clean the area in following order. a. Critical (LAF room) b. Change rooms c. Incubator room d. Med...

PRINCIPLE The bacterial endotoxin test or LAL test is the most sensitive and specific means available to detect and measure bacterial endotoxins, a fever producing by-product of gram negative bacteria commonly known as Pyrogen. The gram negative bacteria causes blood coagulation in Americal Horse Shoe Crab (Limulus Polyphemus) and clotting phenomenon was an enzyme-mediated response to endotoxin by components in the intercellular fluid of the circulating cells, the amebocyte. This phenomenon is exploited for estimating the concentration of bacterial endotoxins that may be present in or on the sample. The rate of reaction depends on the concentration of endotoxin, the pH and the temperature. The reaction requires the presence of certain bivalent cations, a proclotting enzyme system and clottable protein; these are provided by the lysate. As per BP Before carrying out the test for endotoxins on the preparation being examined, it is necessary to verify. 1. that the equivalent used does not...

OBJECTIVE Swab test is provided to determine compliance with the requirements given in the individual monograph / specifications. PRINCIPLE Swab test is the counting of total number of aerobic bacteria, yeasts and molds on any surface. PROCEDURE 1. A cotton Swab of Johnsons and Johnsons make is moistened with normal saline( 0.9 % NaCl) and placed in a suitable test tube or screw cap test tube. The mouth of the test tube is closed with a cotton plug and rapped with aluminum foil. 2. The test tube containing the swab is then sterilized by autoclaving at 121 OC , 15 psi, pressure for 15 min. 3. Alternatively pre sterilised cotton swab of HI- media make can also be used.In this case, moisten the swab with sterile normal saline before using the swab. 4. Wear handgloves and take out the swab carefully from the test tube and swab the surface to be checked. 5. The area of the swab should be approximately 10 Sq. cm. 6. Replace the swab immediatel...

OBJECTIVE The test for Identification of Pseudomonas aeruginosa is provided to determine compliance with the requirements given in individual monograph / specifications. PRINCIPLE Identification of Pseudomonas aeruginosa is the identification or detection of a pathogenic bacteria which may cause infection to human body. It can be identified by using specific differential media which support only the growth of Pseudomonas aeruginosa.’ REAGENT AND MEDIA A. 1 % w/v solution of N,NN’N’-Tetramethyl-p-phenylene diammonium dichloride (Reagent A) B. Cetrimide Agar Pancreatic Digest of Gelatin 20.0 g Magnesium Chloride 1.4 g Potassium Sulfate 10.0 g Cetrimide 0.3 g Agar 13.6 g Glycerol 10.0 mL Water 1000 mL Heat to boiling for 1 minute with shaking. Adjust the pH 7.0 +0.2. Sterilize the media an autoclave at 121 OC for 15 min. C. Cetrimide Broth Prepare the broth with the addition of all the ingredients specified in Cetrimide agar except the agar. D. Pseudomonas Agar Medium for detection of Hou...

OBJECTIVE The test for Escherichia coli is provided to determine compliance with the requirements given in individual monograph / specifications. PRINCIPLE This includes identification of Escherichia coli, a bacteria pathogenic to human body and causes infection of stomach. It is detected by using specific, differential media which supports growth of Escherichia coli. REAGENTS AND MEDIA 1. Kovac’s Reagent Dissolve 5 g of 4-Dimethylaminobenzaldehyde in 75 mL Amyl alcohol by warming on a water bath at 50 - 55 OC , cool and add 25 ml of Conc. Hydrochloric acid. Store between 2 - 10 OC protected from light or use readymade reagent. 2. Nutrient Broth Beef Extract 10.0 g Peptone 10.0 g Sodium chloride 5.0 g Water 1000 mL Dissolve with the aid of heat. Adjust to pH 8.0 - 8.4 with 5M Sodium Hydroxide and boil for 10 min. ...

OBJECTIVE The test for Identification of Salmonella species is provided to determine compliance with the requirements given in individual monograph / specifications. PRINCIPLE Identification of Salmonella species which is pathogenic bacteria causes disease in human body. It can be identified by using specific, differential media which only supports growth of Salmonella. REAGENTS AND MEDIA 1. Selenite F Broth Peptone 5.0 g Lactose 4.0 g Disodium Hydrogen Orthophosphate 10.0g Sodium Hydrogen Selenite 4.0 g Water 1000 mL Dissolve, distribute in sterile containers and sterilize by maintaining at 100 OC for 30 min. 2. Fluid Lactose Medium Beef Extract 3.0 g Pancreatic Digest of Gelatin 5.0 g Lactose 5.0 g Water 1000 mL Cool as quickly as possible after sterilization. pH after sterilization 6.9 ± 0.2 3. Fluid Selenite - Cystine Medium Pancreatic Digest of Casein 5.0 g Lactose 4.0 g Sodium Phosphate 10.0 g Sodium Acid Selenite 4.0 g L - Cystine 10.0 g Water 1000 mL Final pH 7.9 ± 0.2. Mix and...