ICHAPPS

Ondansetron Hydrochloride, Model of pack:2ml, Packing:Ampl  Ondansetron Hydrochloride , ONDITAL AMPOULES

Piroxicam - 20mg, Model of pack:2ml, Packing:Ampl Piroxicam - 20mg , RELAXENE - 20 AMPOULES

Tramadol Hydrochloride - 100mg, Model of pack:2ml, Packing:Ampl Tramadol Hydrochloride - 100mg , TRAMOTAL – 100 AMPOULES

Methylcobalmin - 500 mcg, Model of pack:1ml, Packing: AmplKeywords: Methylcobalmin - 500 mcg , VITABALMIN - 500 AMPOULES

Measure 42.5 ml of Strong Ammonia Solution (Ammonia) and transfer slowly,  into a 100 ml volumetric flask. To the above said volumetric flask, add sufficient distilled water to mark, to dilute the Strong Ammonia Solution. Keep the lid to close the volumetric flask and shake gently to mix the solution. Transfer the prepared solution into a suitable container and label with all necessary details. Keep the solution at cool place. The resultant solution is having the concentration of about 10% w/w. Strong ammonia solution , Measuring cylinders, Distilled water, volumetric flask

Measure 95.0 ml of Absolute alcohol  and transfer slowly,  into a 250 ml Glass stoppered bottle. To the above said glass stoppered bottle, add 5.0 ml of distilled water. Keep the lid to close the glass stoppered bottle and shake gently to mix the solution. Transfer the prepared solution into a suitable container and label with all necessary details. The resultant solution is having the concentration of 95.0% v/v. Absolute alcohol , Glass stopered flask, Measuring cylinders , Distilled water

Pour about 75 ml of Distilled water into a 250 ml capacity beaker. Weigh 10.0 grams of Barium Chloride LR and transfer slowly, into above said beaker, through it‘s side walls, while gentle mixing, by using a glass rod. Transfer prepared solution into a 100 ml volumetric flask, by using a glass funnel. Rinse the beaker and funnel with few ml of Distilled water, and allow to add into the contents of volumetric flask. Make up the volumetric flask to mark with Distilled water, remove the funnel, keep the lid to close the volumetric flask and shake gently to mix the solution. Transfer the prepared solution into a suitable container and label with all necessary details. The resultant solution is having the concentration of 10.0% w/v. Barium Chloride , Distilled water, Glass rod, Glass funnel, Calibrated Analytical Balance

Measure 137 ml of Hydrochloric acid LR and transfer into a 250 ml capacity beaker. Pour about 200 ml of distilled water into a 500 ml capacity beaker. Transfer slowly, through sidewalls of the beaker, 137 ml of Hydrochloric acid LR, into above said beaker, while gentle mixing by using a glass rod. Transfer prepared solution into a 500 ml capacity volumetric flask by using a glass funnel. Rinse the beakers and funnel with few ml of distilled water, and allow to add into the contents of volumetric flask. Make up the volumetric flask to mark with distilled water, remove the funnel, keep the lid to close the volumetric flask and shake gently to mix the solution. Transfer the prepared solution into a suitable container and label with all necessary details. The resultant solution is having the concentration of 10% w/w. Hydrochloric acid , Distilled water, Glass funnel, Measuring cylinders , volumetric flask

Take the sample (product diluted to 2-fold of MVD) 50?l each in endotoxin free tubes by micropipette fitted with disposable tip. Keep all the sets in duplicate for product positive and product negative. Add 50?l of reconstituted Control Standard Endotoxin diluted to 2? in positive tubes and 50?l of LAL reagent water in negative tubes. Add 100 ?l of reconstituted LAL reagent to each test tube in turn starting with negative control. Once prepared shake the rack of tubes to ensure mixing of the sample and lysate. Insert the tubes in heating block for incubation at 37°C + 1 for a period of 60 minutes. After incubation remove the test tubes and invert smoothly and note down the result as positive or negative. A positive test is defined as a firm clot that maintains its integrity upon inversion. Rest of the result considers as negative. Microbiology, Procedure, Endotoxin testing Materials , Endotoxins in Finished Product

Sampling shall be done for microbial analysis for regular batches as per SOP XXXXX. Sampling shall be done by microbiologist only for product validation by following the below procedure. Requirement Sterile Glass bottles / sterile polyethylene bags Sterile Spatula / Sampling Rod. Carry all the above items in a sampling kit for sampling. Shift the containers one by one to the sampling booth for sampling. Enter in the details the sampling booth register (for raw materials). Take out the container/bag from the sampling kit and note the Name of the sample, Batch no, Sampling date, Manufacture date, Expiry or retest date, Sampled by and Quantity sampled on the bottle/bag . Wear the gloves and mask and spray 70% IPA on the gloves and wait until it dry. Procedure, Microbiology , Raw material, microbial analysis

Pour about 75 ml of Glacial Acetic Acid into a 250 ml capacity beaker. Weigh 10.0 grams of Mercuric Acetate LR and transfer slowly, into above-said beaker, though it‘s sidewalls, while gentle mixing by using a glass rod. Transfer prepared solution into a 100 ml volumetric flask, by using a glass funnel. Rinse the beaker and funnel with few ml of Glacial Acetic Acid, and allow to add into the contents of volumetric flask. Make up the volumetric flask to mark with Glacial Acetic Acid , remove the funnel, keep the lid to close the volumetric flask and shake gently to mix the solution. Transfer the prepared solution into a suitable container and label with all necessary details. The resultant solution is having the concentration of 10.0% w/v. Mercuric Acetate , Glacial Acetic Acid , Glass funnel, Volumetric flask

Put off all the instrument and cover them with polyethylene sheet. Clean the area thoroughly including walls, ceiling, Doors and windows, light fixers with dry mop or vacuum cleaner. Start the cleaning of rooms from critical to non-critical area. Critical area includes LAF room, Buffer room and change rooms. After dry cleaning follow wet cleaning procedure as below. Prepare the disinfectant solution as per the current version of SOP No. xxxxx. Take the disinfectant solution in two bucket. And mark the bucket as 1 and 2. Enter into the LAF room through change room as per the current version of SOP no. xxxxx Microbiology , Spring Cleaning

Measure 10.6 ml of Nitric Acid LR and transfer into a 50.0 ml capacity beaker. Pour about 75.0 ml of distilled water into a 250 ml capacity beaker. Transfer slowly, through sidewalls of the beaker, 10.6 ml of Nitric Acid LR into above said beaker, while gentle mixing, by using a glass rod. Transfer prepared solution into a 100 ml volumetric flask by using a glass funnel. Rinse the beakers and funnel with few ml of distilled water , and allow to add into the contents of volumetric flask. Make up the volumetric flask to mark with distilled water, remove the funnel, keep the lid to close the volumetric flask and shake gently to mix the solution. Nitric Acid , Glass rod, Glass funnel, Beaker, Volumetric flask , Measuring cylinders

Pure cultures of Staphylococcus aureus xxxxxnas aeruginosa xxxxx Sterilized Conical flasks (250 ml capacity) Sterilized graduated pipettes (1 ml). Sterilized Petriplates. Sterilized test tubes (18 x 150 mm). Nutrient agar / Soya bean casein digest agar. Nutrient broth / Soya bean casein digest medium. Inactivating agent (Lecithin 0.5% with tween 20 4.0% / Sodium thiosulfate / Sodium thioglycollate) Microbiology, Procedure, Disinfectant Efficacy Test

Prepare soybean casein digest agar plate as per the current version of general test procedure No. GTP-210. Take the solidified agar plates in sterile Stainless Steel perticans and carry it to respective area for finger dab test. Wear sterile hand gloves, open the box and remove the plates. Carefully open the plate and touch the finger and thumb of operator/microbiologist on to the agar surface, who is directly in contact with product/ analysis. After completion, close the plate and mark it for identification. Bring it to microbiology lab and assign Analytical Reference No. as per current version of SOP No xxxxx Incubate the plate for not less than 48 –72 hours at 35 +2°C in incubator. Follow same procedure for fungi using Sabouraud dextrose agar and incubate them for not less than 5 days at 22 + 2°C. Observe the plate under colony counter and record the result in Annexure Procedure, Finger Dab Test , Microbiology

Measure 53.0 ml of Nitric Acid LR and transfer into a 100 ml capacity beaker. Pour about 200 ml of distilled water into a 500 ml capacity beaker. Transfer slowly, through sidewalls of the beaker, 53.0 ml of Nitric Acid LR (about 10ml on each attempt) into above said beaker, while gentle mixing, by using a glass rod. Transfer prepared solution into a 500ml volumetric flask by using a glass funnel. Rinse the beakers and funnel with few ml of distilled water, and allow to add into the contents of volumetric flask. Make up the volumetric flask to mark with distilled water, remove the funnel, keep the lid to close the volumetric flask and shake gently to mix the solution. Nitric Acid , Glass rod, Glass funnel , Beaker, Volumetric flask , Measuring cylinders

Pick the individual colonies from the previously exposed plates in which growth found. Purify the colonies, if necessary by streaking on to Soybean casein digest agar plate. Observe and record the morphological characters of the colonies such as shape, elevation, color and margins in Bacterial isolate identification as per annexure-I. Using sterile inoculating technique, inoculate the organism on two Soybean casein digest agar slants. Use one slant culture to determine the cultural characteristics and the other to repeat any of the tests, if necessary as stock. Make a smear of the colony by taking with a loop and subject it to Gram’s Staining procedure. Observe under a microscope and note the reaction, morphology   and arrangement of the cells. Procedure, Identification, Bacterial Isolate , Microbiology

Prepare Soybean Casein Digest agar (SCDA) and Sabouraud Dextrose Agar (SDA) as per current version of GTP No.- XXXXX. Aseptically dispense the media in Petri dishes. After solidification invert and incubate the plates for 24 hours at 35°C. Carry the plates in the Petri cans for plate exposing to the respective area. Follow the entrance procedure available at that place and enter into the respective area accordingly.  Mark the Plates as per Point No given in Appendix’s according to respective block before wearing gloves. Wear the hand gloves and clean the surface where plate has to be exposed by 70% isopropyl alcohol. Open the plate carefully and keep the lid beside. Expose the plate as per Appendix – I, II, III, IV, V, and VI layouts. Expose the plates for 120 minutes. After completion closes the plate by a lid. After exposing carry the plates in Petri cans to the microbiology lab. Environmental , Microbiology, Monitoring, Plate Exposing

Pour about 75 ml of Distilled water into a 250 ml capacity beaker. Weigh 10.0 grams of Potassium Iodide LR and transfer slowly, into above said beaker, through it‘s sidewalls, while gentle mixing by using a glass rod. Transfer prepared solution into a 100 ml volumetric flask, by using a glass funnel. Rinse the beaker and funnel with few ml of Distilled water, and allow to add into the contents of volumetric flask. Make up the volumetric flask to mark with Distilled water, remove the funnel, keep the lid to close the volumetric flask and shake gently to mix the solution. Transfer the prepared solution into a suitable container and label with all necessary details. Potassium Iodide, Glass funnel, Glass rod , Beaker, Volumetric flask

Connect power plug to the socket. Put ON the Mains on the control panel, temperature controller displays and the inside chamber motor ON. Set the thermostat at 5°C above the Set Temperature on the temperature controller. The Safety thermostat will cut off the mains contactor in case of overshoot of the temperature by 5°C. Set the Print time interval for 30 minutes on PC /Printer interface unit and connect the same to 80 column printer or to the PC for data communication. Put ON the Heating Switch on the Control Panel, Dry heater will be ON. Put ON the Cooling Switch on the Control Panel, Refrigeration condenser motor and compressor will be ON. Enter the temperature into Temperature Monitoring record as per Annexure – I. The temperature should not vary? 1°C against the set temperature Procedure, Operation, Calibration, BOD Incubator, Microbiology

Pour about 75 ml of Distilled water into a 250 ml capacity beaker. Weigh 1.70 grams of Silver Nitrate LR and transfer slowly, into above said beaker, through it‘s sidewalls, while gentle mixing by using a glass rod. Transfer prepared solution into a 100 ml volumetric flask, by using a glass funnel. Rinse the beaker and funnel with few ml of Distilled water, and allow to add into the contents of volumetric flask. Make up the volumetric flask to mark with Distilled water, remove the funnel, keep the lid to close the volumetric flask and shake gently to mix the solution . Transfer the prepared solution into a umber colored glass container and label with all necessary details. The resultant solution is having the concentration of 1.7 % w/v. Silver Nitrate , Glass funnel, Beaker, Distilled water, Glass rod

Connect power plug to the socket. Put ON the Mains on the control panel, Orange lamp inside it glows and temperature controller as well as the PC / Interface displays and the inside Incubator motor ON. Put ON the heating switch on the control panel, Dry heater will ON and green indicator lamp glows. Set the required temperature on the temperature controller by pressing increment and decrement key, which will display the Setpoint. Set the safety thermostat at 5° above the Set temperature on the temperature controller. The safety thermostat will cut off the Mains contractor in case of overshoot of the temperature by 5°C with a beep sound alarm. Set the temperature by pressing up or down key and decrement key. Now the bottom display (green digital) will show the set temperature and the top display (Red digital) will show the actual temperature. Procedure, Cleaning, Bacteriological , Incubators , Microbiology

Pour about 75 ml of Distilled water into a 250 ml capacity beaker. Weigh 5.0 grams of Silver Nitrate LR and transfer slowly, into above-said beaker, through its sidewalls, while gentle mixing by using a glass rod. Transfer prepared solution into a 100 ml volumetric flask, by using a glass funnel. Rinse the beaker and funnel with few ml of Distilled water, and allow to add into the contents of volumetric flask. Make up the volumetric flask to mark with Distilled water, remove the funnel, keep the lid to close the volumetric flask and shake gently to mix the solution. Transfer the prepared solution into a suitable container and label with all necessary details. The resultant solution is having the concentration of 5.0% w/v. Silver Nitrate , Glass funnel, Beaker, Distilled water , Glass rod

Check the water level before starting the autoclave. If the level is down, then add purified water up to the level mark. Open the door at non-sterile area and load the necessary items to be sterilized as per Appendix – I / appendix –II as required. Place the autoclave indicator strips at different places in the autoclave for each cycle to indicate the proper sterilization by color differentiation of the strip. Close the door using the radial locking handles clockwise till it is tight. Set the thermograph recorder. Switch on the system to record the temperature cum time of each cycle. Switch on the mains to supply t he power followed by the toggle switch located in the control panel to activate the heat generator. Set the multi port-operating valve in slow exhaust position and allow the steam to build in the outer jacket till the pressure reaches 14-17 PSI. Operation, Cleaning, Calibration, Double Door Autoclave , Microbiology

Connect power plug to the socket. Put ON the Mains on the control panel, Orange lamp inside it glows and temperature controller as well as the PC / Interface displays and the inside Incubator motor ON. Put ON the heating switch on the control panel, Dryheater will ON and green indicator lamp glows. Set the required temperature on the temperature controller by pressing increment and decrement key, which will display the Setpoint. Set the safety thermostat at 5° above the Set temperature on the temperature controller . The safety thermostat will cut off the Mains contractor in case of overshoot of the temperature by 5°C with a beep sound alarm. Set the temperature by pressing up or down key and decrement key. Now the bottom display (green digital) will show the set temperature and the top display (Red digital) will show the actual temperature. Procedure, Operation, Cleaning, Calibration, Microbiology , Hot Air Oven

Pour about 75 ml of distilled water into a 250 ml capacity beaker. Weigh 5.0 grams of Sodium Hydroxide Pellets LR and transfer slowly, into above said beaker, through it‘s sidewalls, while gentle mixing by using a glass rod. Transfer prepared solution into a 100 ml volumetric flask by using a glass funnel. Rinse the beaker and funnel with few ml of distilled water, and allow to add into the contents of volumetric flask. Make up the volumetric flask to mark with distilled water, remove the funnel, keep the lid to close the volumetric flask and shake gently to mix the solution. Transfer the prepared solution into a suitable container and label with all necessary details. The resultant solution is having the concentration of 5.0% w/v. Sodium Hydroxide Pellets , glass funnel, sidewalls, glass rod

Check the water level before starting the autoclave. If the level is down, then add purified water upto the level mark. Open the door and load the necessary items to be sterilized as required. Place the autoclave indicator strips at different places in the autoclave for each cycle to indicate the proper sterilization by color differentiation of the strip. Close the door using the radial locking handles clockwise till it is tight. Switch on the mains to supply the power followed by the toggle switch located in the control panel to activate the heat generator. Operation , Cleaning, Calibration, Single Door Autoclave , Microbiology

Pour about 75 ml of distilled water into a 250 ml capacity beaker. Weigh 10.0 grams of Sodium Hydroxide Pellets LR and transfer slowly, into above said beaker, through its sidewalls, while gentle mixing by using a glass rod. Transfer prepared solution into a 100 ml volumetric flask by using a glass funnel. Rinse the beaker and funnel with few ml of distilled water, and allow to add into the contents of volumetric flask. Make up the volumetric flask to mark with distilled water, remove the funnel, keep the lid to close the volumetric flask and shake gently to mix the solution. Transfer the prepared solution into a suitable container and label with all necessary details. The resultant solution is having the concentration of 10.0% w/v. said beaker, glass funnel, Beaker, Calibrated Analytical Balance

Pour about 75 ml of distilled water into a 250 ml capacity beaker. Weigh 20.0 grams of Sodium Hydroxide Pellets LR and transfer slowly, into above said beaker, though it‘s sidewalls, while gentle mixing by using a glass rod. Transfer prepared solution into a 100 ml volumetric flask by using a glass funnel. Rinse the beaker and funnel with few ml of distilled water, and allow to add into the contents of volumetric flask. Make up the volumetric flask to mark with distilled water, remove the funnel, keep the lid to close the volumetric flask and shake gently to mix the solution. Transfer the prepared solution into a suitable container and label with all necessary details. The resultant solution is having the concentration of 20.0% w/v. SODIUM HYDROXIDE , PREPARATION, distilled water, volumetric flask

Connect the power plug to the socket. Check the manometer reading initially that oil level at zero. Put on the power switch to start up. Manometer reading should not be less than 10mm water gauge scale while laminar airflow is running Enter the details of manometer reading in Annexure –I. There are four switches and a pressure manometer at the left side panel of the instrument. Switch (1) for air flow. Switch (2) for tube light. Switch (3) for Exhaust. Switch (4) UV light. Put ON the switch (1) to start the airflow and manometer no –2 will show the reading of Airflow. Put ON switch (2) to start normal light. Put on the Switch (3) for Exhaust and the manometer No –1 will show the reading of the exhaust. Put on the Switch (4) for UV Light. Operation, Microbiology , Calibration , Cleaning

Connect the power plug to the socket. Check the manometer reading initially that oil level at zero. Put on the power switch to start up. Manometer reading should not be less than 10mm water gauge scale while laminar airflow is running. Enter the details of manometer reading at Annexure –I. Two switches are present at right below of the instrument. Switch (1 - Red) for air flow Switch (2 - Green) for tube light. Put ON the switch (1 -Red) to start the airflow and manometer will show the reading of Airflow. Put ON switch (2 -Green) to start normal light. Enter the working hours of the instrument in Vertical Flow Ceiling Suspended laminar logbook as per Annexure Operation, Microbiology , Calibration, Suspended, Vertical, Suspended Laminar

Measure 28.5 ml of Sulphuric acid LR and transfer into a 100 ml capacity beaker. Pour about 200 ml of distilled water into a 500 ml capacity beaker. Transfer slowly, through sidewalls of the beaker, 28.5 ml of Sulphuric acid LR (about 10ml on each attempt) into above said beaker while gentle mixing by using a glass rod. Transfer prepared solution into a 500ml volumetric flask by using a glass funnel. Rinse the beakers and funnel with few ml of distilled water, and allow to add into the contents of volumetric flask. Make up the volumetric flask to mark with distilled water, remove the funnel, keep the lid to close the volumetric flask and shake gently to mix the solution. Transfer the prepared solution into a suitable container and label with all necessary details. The resultant solution is having the concentration of 10% w/w. PREPARATION, SULPHURIC ACID , distilled water, volumetric flask

Connect the power plug to the socket. Check the manometer reading initially that oil level at zero. Put on the power switch to start up. Two switches are present at right below of the instrument. Switch (1 - Red) for air flow. Switch (2 - Orange) for UV light. Switch (3 - Green) for tube light. Put ON the switch (1 -Red) to start the airflow and manometer will show the reading of Airflow. Manometer reading should not be less than 10mm water gauge scale while laminar airflow is running. Enter the details of manometer reading in Annexure -I Put ON switch (3 -Green) to start normal light. Put ON switch (2 -Orange) to start UV light. Operation, Cleaning, Calibration, Garment Cabinet , Microbiology

Switch on the instrument using the RED switch which is on the front of the instrument. Set the desired time for sonication from 0.00 minutes to 9.59 minutes by using the upward arrow keys on the micro timer panel. Start/Stop the sonication by pressing the RED color round toggle key. Pour Demineralized water in the ultrasonic bath . Drain the water in the ultrasonic bath daily or whenever any material is spilled or whenever the color of water changes. Ensure the water level at the time of sonication to avoid the floating of the bottles used. Ultrasonic Bath , micro timer panel, sonication , soft cloth

Entry Procedure with Gowning. Push the door to enter into the first change room. Remove the apron, cap and foot ware and keep them in respective cupboard. Take a sterile gown from the Garment storage cabinet and wear a sterile gown, close the zipper up to neck and put a head guard. Check that the gown is properly set or not in a mirror. Wear the booties and tuck the gown in the booties and tie it as required and Cross the Changeover bench. Enter into secondary change room by pushing the door. Disinfectant the hands with a disinfectant solution provided. Gowning , Procedure, Controlled, Microbiology

Operation and Calibration of (Vacuum pump Arunvac AVB 50) his procedure is applicable for the Vacuum pump Arunvac, AVB 50 used in the Quality Control department. It is the responsibility of all the personnel involved in the analysis using of the equipment. SOPs: Core procedure: Calibration of Equipment PRELIMINARY CHECK: Before switching on the vacuum pump check the oil level through the view glass. Vacuum pump , Arunvac AVB, calibrated

Basic Operation: Before using the Vacuum oven, check the validity of calibration. Switch on the instrument by the “MAINS” switch on the control panel of the instrument. The control panel consists of Microprocessor based Temperature controller, Three heat control switch (Rotatory switch) to control heating rate control, Fuse, Vacuum gauge. To set the desired temperature press set key on Microprocessor based Temperature controller until SP is displayed. Press enter. Usage of  “Three heat control switch” – based upon he target set temperature he rotator. switch should be set as follows. Temperature controller , Microprocessor, instrument , Vacuum

Before using ensure the validity of calibration. Switch on the power. Switch on the normal light and open the front door pulling towards the front side to keep the TLC plates. Place the TLC plate in UV chamber horizontally on the base of the chamber. Switch on the particular nm wavelength light i.e. 254 nm or 365 nm light at which the TLC is to be viewed. Do not expose to UV light while handling the UV cabinet , use always normal light only while operations. Switch of the power after the completion of the test. UV Cabinet , salicylate, Core Procedure , salicylate  Operation and Calibration of UV Cabinet Advance

Prepare the disinfectant solution as per the current version of SOP No. xxxxx... Take the disinfectant solution in two buckets and mark the bucket as 1 and 2. Enter into the Laminar airflow room through change rooms as per the current version of SOP no.xxxxx... While cleaning dip the non - fiber shedding mop in bucket No 1 containing a disinfectant solution and after each swab squiz the mop in bucket no. 2. Do not squiz the mop in the same bucket after swab. Clean the area daily with Dettol 2.5% or Savlon 2.5% in the following order, Floor of Laminar airflow room and the outer surface of Bio Safety Cabinet, vertical flow ceiling suspended laminar, media unloading table, trolley and Balance table. Procedure, Cleaning, Microbiology https://ichapps.com/qms/view/procedure-for-cleaning-of-microbiology-lab

Place the MAS –100 Air Sampler on a firm support. Press “ YES” to turn ON the MAS –100. After power – on, the MAS –100 displays the software with the current battery charge, followed by the most recent aspirated volume. Check the instrument battery. When the power unit is connected and the MAS –100 is in “Sleep Mode”, “Battery Charging” appears in the display and the red LED lights . Once the battery is fully charged it appears “Battery OK”. Open the perforated lid (With attached dust cover) by rotating to the right. Microbiology , Procedure, Operation, Calibration, Air Sampler

Ensure that the laminar airflow is working. Place a drop of sterile water/purified water on the grease free glass slide. Scrap a colony  (if growth is on solid media) or take a loopful from the suspension with the help of inoculating wire loop (nichrome/platinum) and Prepare a smear on the grease free glass slide by rotating the loop. Allow to air dry the smear and heat fix it by passing the slide gently through a flame. Flood/cover the smear with Gram’s Crystal violet solution for 1 min exactly. Rinse the stained slide with tap water and drain off excess. Flood the smear with Gram’s Iodine solution for 1 min. Procedure , Staining, Microbiology, microorganism

Ensure that the working area and balance are clean. Clean the weighing pan with a small brush if required. Adjust the spirit level of the balance to center by rotating the leveling knobs provided at the bottom if required. Connect the instrument to 230 volts A/C power supply and put on the power switch. Press and hold “ON/ OFF” button. Press the ‘TARE’ button before weighing; ensure that 0.0 gm is displayed on the digital display board if required grams can be changed into kg by pressing “F” key. Procedure , Operation, Calibration, Microbiology

C ALIBRATION OF PUMP: Accuracy of flow rate: Fill filtered water in the pump reservoir and purge the pump. Set the Flow rate of the pump to 1.0 ml/minute and ensure no air bubble is stuck up in the path. Take a clean 10 ml Class – A graduated cylinder. Note the time and immediately start collecting water into the 10 ml graduated cylinder. Calibration , Equipment, graduated cylinder, concentration

Preparation And Standardisation OR Re Standardisation Of Volumetric Solutions. Prepare and Standardise / Re-standardise (as per the schedule) the volumetric solutions as per the respective Standard Test Procedures and assign lot numbers as per the Standard Operating Procedure, “Coding System Followed In Quality Control Department”. Preparation , Standardisation, Re-standardisation , Volumetric

REAGENTS: Sodium hydroxide Solution (1 in 5): Dissolve 2 g of sodium hydroxide in 10 mL of purified water. 2N Sulfuric acid : Add slowly, with stirring, 60 mL of sulfuric acid to about 1020 mL of purified water, allow to cool to 25°C.6 7N Sulfuric acid : Add slowly, with stirring, 210 mL of sulfuric acid to about 1020 mL of purified water, allow to cool to 25°C. Potassium Iodide TS: Dissolve 16.5 g of potassium iodide in purified water to make 100 mL. Store in light-resistant containers. Stronger acid Stannous Chloride, TS: Dissolve 8 g of stannous chloride in 20 mL of hydrochloric acid. Store in glass containers, and use within 3 months. Silver diethyldithiocarbamate TS: Dissolve 1 g of silver diethyldithiocarbamate in 200 mL of pyridine from a freshly opened bottle or that which has been recently distilled. Store in light-resistant containers, and use within 30 days. Arsenic Trioxide Stock Solution: Dry arsenic trioxide at 105°C for 1 hour. Weigh accurately 132.0 mg into 1000 mL vo...

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Total aerobic microbial count is one type of microbiological purity testing, which is used to count the number of colony forming  unit present in an article complying with monograph standards. PREPARATION OF CULTURE MEDIA: Sodium hydroxide 1N: Dissolve 4.0 g of sodium hydroxide in water to make 100 mL. Hydrochloric Acid 1N: Dissolve 8.5 ml of Hydrochloric Acid in water to make 100 mL. Soyabean-Casein Digest Broth Medium (SCDM)/ Soyabean-Casein Digest Agar(SCDA)/ Plate Count Agar(PCA): Reconstitute  dehydrated media as directed by the manufacturer and sterilize in an autoclave at 121°C for 20 minutes. AEROBIC MICROBIAL , General Testing Procedure

BASIC OPERATION : Switch ‘ON’ the main for LC-10 pump. Switch ‘ON’ the main for auto injector. Switch ‘ON’ the main for UV vis detector. Switch ‘ON’ the system controller and the computer. After switching ‘ON’ all the components, finally switch ‘ON’ the computer. Default screen appears on the respective screen modules. Double click on the (Shimadzu class VP) icon in the screen. Double click on Instrument 1 icon. Here for the beep sound, which indicates the communication between the system and the software. OPERATING PROCEDURE FOR LC-10AVP PUMP Open the drain valve of the pump.  Press the purge key.  Ensure that there are no air bubbles in the flow line and press purge/pump key to stop purging.  Close the drain valve of the pump. Operation, Calibration , Shimadzu, GRADIENT

Pest Control: Company shall make a contract with a competent agency to carry out the pest and rodent control operations. To control pest, the following chemicals shall be used. Human Resource shall monitor the Pest Control program and co-ordinates the activity with the authorized service contractor Pesticides activity shall not be carried out inside the production areas. Only areas outside the building along the walls shall be sprayed. Pesticide materials shall not be taken inside Raw Material and Packing materials warehouse, Manufacturing and Quality Control areas. Administration, Fly Control , Pest Rodent

Potassium Tetra oxalate, 0.05 M (pH 1.68 at 25°C):  Dissolve 3.1525 g of KH3(C2O4)2. 2H2O in purified water to make 250 mL. Potassium  Biphthalate,  0.05 M (pH 4.01 at 25°C):  Dissolve  2.5300 g of  KHC8H4O4,  previously dried at  110°C for 1 hour, in purified water to make 250 mL. Equimolal Phosphate, 0.05 M (pH 6.86 at 25°C): Dissolve 0.8825 g of anhydrous disodium hydrogen phosphate  (Na2HPO4) and 0.8475 g of potassium dihydrogen phosphate  (KH2PO4), each previously dried at 120°C for 2 hours, in purified water to make 250 mL. STANDARDIZATION , General Testing Procedure, potassium dihydrogen