IN PROCESS QUALITY CONTROL TESTS OF TABLETS,CAPSULES,etc...

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This presentation describes various Quality control tests of Tablets,Capsules,Injectables and Liquid orals.

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INPROCESS QUALITY CONTROL TESTS OF VARIOUS PRODUCTS: 

INPROCESS QUALITY CONTROL TESTS OF VARIOUS PRODUCTS T.Vani Chary

CONTENTS: 

CONTENTS In process quality control tests of TABLETS In process quality control tests of CAPSULES In process quality control tests of INJECTABELS In process quality control tests of LIQUID ORALS

IN PROCESS QUALITY CONTROL OF tablets: 

IN PROCESS QUALITY CONTROL OF tablets

EVALUATION OF DOSAGE FORMS : 

EVALUATION OF DOSAGE FORMS 1.General appearance : Size & shape Unique identification markings Organoleptic properties 2.Content uniformity test: The content uniformity test is used to ensure that every tablet contains the amount of drug substance intended with little variation among tablets within a batch.

30 Tablets are kept aside.: 

30 Tablets are kept aside . 10 tablets are assayed . 9 Tablets should have %limit of 85-115% If more than 1 Tablet has 85-115% then, 20 Tablets are assayed Not more than 1 Tablet should have 75-125%.

3.Hardness test or tablet crushing strength :: 

3.Hardness test or tablet crushing strength : It is defined as the force required to break a tablet in a diametric compression test. Tablet requires a certain amount of strength or hardness and resistance to friability to withstand mechanical shakes of handling in manufacture, packaging and shipping.

Five types of testers are used.: 

Five types of testers are used. Monsanto hardness tester or stokes hardness tester Strong cobb tester Pfizer tester- min 4kg Erweka tester Schleuniger or heberlein tester 4 . Friability test : Roche friabilator speed-25 rpm Allowable range : 0.5-1 %

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5. WEIGHT VARIATION: Take 20 tablets Weigh individually Determine the average weight of 20 tablets Compare individual tablet weight to average weight Not more than 2 of the individual weights deviate from the average weight by more than the percentage deviation and none deviates by more than twice that percentage. U.S.P LIMITS,I.P LIMITS.

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6. Disintegration test : For most tablets , the first important step towards formation of solution is breakdown of the tablet into smaller particles or granules , this process is known as disintegration . -Disintegration apparatus : 6 glass tubes- 3inch length 10 mesh screen at the bottom. Temperature : 37±2˚C Speed – 28-32 rpm .

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7. Dissolution test : Different types of dissolution apparatus : Basket type. Paddle type. Reciprocating paddle. Flow through cell. Paddle over disc. Cylinder with membrane. Reciprocating cylinder . Conditions maintained : Temperature : 37±0.5˚ C Speed : 25-150 rpm

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Procedure : Total tablets taken = 24 S1 : 6 tablets taken Acceptable: If all of the tablets are not less than (NLT) the monograph tolerance limit(Q)= ± 5%. If S1 fails S2 : Another 6 tables are taken Acceptable : If average of 12 tablets is ≥ Q & no tablet is less than Q-15% If S2 fails S3 : 12 tablets taken Acceptable : No tablet less than Q & not more than 2 tablets = Q-15%. USP limit for dissolution : NLT 75% of tablet dissolve in 45 min.

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IN-PROCESS CONTROL OF CAPSULES

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1)RAW MATERIALS : The gelatin of the capsule shells should be assayed for various physical properties like bloom strength, viscosity , etc ….

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2) MOISTURE PERMEATION TEST : : The degree & rate of moisture penetration is determined by packaging the dosage unit together with a color revealing dessicant pellet Expose the packaged unit to known relative humidity over a specified time Observe the dessicant pellet for color change Any change in color indicates absorption of moisture By measuring pre test weight & protest weight of pellet, amount can be calculated.

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3)CONTENT UNIFORMITY: 10 capsules are taken and subjected to assay. 9 of 10 capsules should be in the range of ±15%( 85-115%) and 10 th Capsule in the range of 75-125%. If 2 Capsules are beyond ± 15% range . Then, 20 tablets are assayed. All capsules should be in the range of ± 25%(75%-125%.)

WEIGHT VARIATION:: 

WEIGHT VARIATION: FOR HARD CAPSULES: Weigh 20 capsules individually, and determine the average weight. The individual weights should be within the limits of 90%and 110%of the average weight. If not all of the capsules fall within the limits , weigh the 20capsules individually remove the contents of each capsule with the aid of a small brush Weigh the emptied shells individually

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net weight of contents(individual) = the weight of shell -respective gross weight. Determine the average net content from the sum of the individual net weights. Then determine the difference between each individual net content and the average net content Limits: Not more than 2 of the differences are greater than 10%of the average net content No case is the difference greater than 25% wt range.

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If more than 2, but not more than 6capsules deviate from the average between 10%and 25%, determine the net contents of an additional 40capsules, determine the average content of the entire 60capsules Determine the 60deviations from the new average Limits: Not more than 6of the 60capsules does the difference exceed 10%of the average net content No case does the difference exceed 25%

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FOR SOFT CAPSULES: Proceed as directed under Hard Capsules, but determine the net weight of the contents of individual capsules as follows. Weigh the capsules individually Then cut & open the capsules remove the contents by washing with a suitable solvent Allow the solvent to evaporate from the shells at room temperature Weigh the individual shells calculate the net contents.

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BLOOM STRENGTH OF GELATIN: Gelatin is weighed into water to typically create a 6.67% solution in standard Bloom bottles The mix is then stirred and keep it for 3 hours at room temperature. Bottles are placed in a 65°C bath for 20 minutes Allow the Bloom jars to cool for 15 minutes at room temperature, They are then conditioned for 16 hours in 10°C water bath.

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When conducting a gelatin bloom test , The bloom jar is centered with the probe just above the sample surface. The probe penetrates the gelatin to a target depth of 4 mm at a speed of 0.5 mm/s, and then retracts. The peak force is the gel strength in Grams Bloom Chemical tests like purity, microbial properties, and limits for heavy metals like arsenic, ash content should be determined. The colorants should also be checked for purity, limits for heavy metals, color properties, dye content, subsidiary dye content and color value.

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IN PROCESS QUALITY CONTROL OF INJECTABLES

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Environmental control pH Viscosity Osmolality (occasionally) Conductivity measurement Temp for heat sterilized product Volume filled Leakage test Clarity test Pyrogen test Sterility tests

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1.EVIRONMENTAL CONTROL: Traffic control: A carefully designed arrangement to control and minimize the traffic Personnel should be permitted to enter aseptic areas only after following rigidly prescribed procedures Surface disinfection Personnel: must be inherently neat, orderly, reliable and alert should be in good health

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Air control: HEPA (High Efficiency Particulate Air): It is composed of glass fibers and filters. It is 99.97% efficient, Removes particles of 0.3µm size & larger. Velocity is 100±20 ft/min.

2. pH MEASUREMENT:: 

2. pH MEASUREMENT: 2 different types of methods used in the measurement of pH. 1.Dip a piece of pH paper into the sample. 2.pH meter pH meter

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Viscosity and consistency directly relates with stability of solutions. Viscosity is measured by viscometer. The personnel working in the filling area should have complete control on filling equipments. 3.VISCOSITY: 4. CONTROL ON VOLUME FILLED:

5. OSMOLALITY (Occasionally):: 

5. OSMOLALITY (Occasionally): Osmolality is a count of the number of particles in a fluid sample. The osmolality of a solution can be measured using an osmometer. The most commonly used instrument in modern laboratories is a freezing point depression osmometer freezing point depression osmometer

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Measured by using conductometer. It is also necessary measure the conductivity of the vehicle used in sterile preparations. The conductivity of the pure water is 0.055 µS/cm (micro-Siemens/cm). 6. CONDUCTIVITY MEASUREMENT:

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It is important to maintain the constant temperature during heat sterilization of products. The temperature changes may cause some undesirable changes like change in potency, change in isotonicity etc. The temperature can be determined normal thermometer, digital thermometer. 7. TEMPERATURE FOR HEAT STERILIZED PRODUCTS:

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A) VISUAL INSPECTION B) BUBBLE TEST C) DYE TEST 8.LEAKAGE TEST: Leakage test is employed to test the package integrity. By Three Methods:

9.CLARITY TESTING:: 

9.CLARITY TESTING: Clarity testing is carried out to check the particulate matter in the sample. It is practically impossible that every unit of lot is perfectly free from visible particulate matter, that is, from particles that are 30 to 40 µm and larger in size. USP limits for large volume infusions: Particle Size Particles limit 10µm and larger/ml 50 25µm and larger/ml 5

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I) VISUAL INSPECTION BY NAKED EYE: II)INSTRUMENTAL METHODS: each injectable is inspected visually against white and black backgrounds. The white background aids in detection of dark colored particles. The light or reflective particles will appear against the black back ground. also called as the particles count method particles counting may be based on any one of the following principles: change in electrical resistance light absorption light scattering.

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10.STERILITY TEST: The test method for sterility of the product: 1 .Membrane filtration 2. Direct inoculation of the culture medium

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1.Membrane filtration Solutions to be examined must be introduced and filtered under aseptic conditions All steps of this procedure are performed aseptically in a Class 100 Laminar Flow Hood pore size of 0.45  m effectiveness established in the retention of micro-organisms the size of filter discs is about 50 mm in diameter

2.DIRECT INOCULATION:: 

2.DIRECT INOCULATION:

11.PYROGEN TEST:: 

11.PYROGEN TEST: Main test: group of 3 rabbits are taken preparation and injection of the product: warming the product dissolving or dilution duration of injection: not more than 4 min the injected volume: not less than 0.5 ml per 1 kg and not more than 10 ml per kg of body mass determination of the initial and maximum temperature all rabbits should have initial T: from 38.0 to 39.8  C

The Result of Pyrogen Test: : 

The Result of Pyrogen Test: No.of Rabbits Individual Tempt. rise (°c) Tempt. Rise in group (°c) Test 3 rabbits 0.6 1.4 Passes If above not passes 3+5 = 8 rabbits 0.6 3.7 Passes If above test not passes perform the test again If above test not passes, the sample is said to be pyrogenic

LAL TEST:: 

LAL TEST: Limulus amebocyte lysate (LAL) test to detect or quantify endotoxins of gram-negative bacterial origin reagent: amoebocyte lysate from horseshoe crab ( Limulus polyphemus ). LAL reacts with bacterial endotoxin . It involves 3 methods: Gel clot method Turbidimetric method Chromogenic method

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IN-PROCESS CONTROL OF LIQUID ORALS

These are of two types:: 

These are of two types: 1.Monophasic liquids Ex:Solutions,Syrups,Elixirs,etc. 2.Biphasic liquids Ex:Emulsions,Suspensions

1. MONOPHASIC LIQUIDS:: 

1. MONOPHASIC LIQUIDS: CLEAN AND PURIFIED VEHICLE (WATER): Quality control technicians test the water frequently to ensure that it is clean and pure before the syrup is made. The syrup is also thoroughly filtered before filling in bottles. LIGHT TRANSMITTANCE TEST: A light transmittance meter is a newer tool that is used to check syrup color. In a light transmittance meter, a syrup sample is checked for color by passing light through the sample. The percent of light transmission is compared to light transmission rates set for different grades.

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VISUAL INSPECTION: The ingredients and the final products are carefully examined for purity and for appearance. Physical appearance of products for patient adherence and compliance is critical so it should be Good looking, Elegant in appearance. pH MEASUREMENT: The measurement and maintenance of pH is also very important step in the Quality control testing. Generally there are 2 different types of methods used in the measurement of pH. The simplest and cheapest is to dip a piece of pH paper into the sample. By using pH meter (for greater accuracy)

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DETERMINATION OF SUCROSE CONCENTRATION (FOR SYRUPS ONLY): If the concentration of Sucrose in the syrup is very high it may crystallize the syrup, less sucrose concentrations give favor for the microbial growth. For the determination sucrose in syrup, HPLC and UV -spectroscopy are used. DETERMINATION OF ALCOHOL CONCETRATION (FOR ELIXIRS ONLY): Elixir usually contains 5 to 40% alcohol. Distillation, Specific gravity.

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BIPHASIC LIQUIDS: 1.EMULSIONS 2.SUSPENSIONS

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1.DETERMINATION OF VISCOSITY: Determination of viscosity is done to assess the changes that might take place during aging. The viscometers used are cone and plate viscometers , Brookfield viscometer . 2.DETERMINATION OF PARTICLE SIZE: It is performed by optical microscopy and Coulter counter apparatus.

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3. DETERMINATION OF PHASE SEPERATION(for emulsions): Phase separation may be observed visually or by measuring the volume of the separated phases. Or by subjecting the emulsions to various stress conditions like boiling, temperature variations ,etc,.

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4.STABILITY OF SUSPENTIONS: SEDIMENTATION METHOD : The measurement of sedimentation volume is the most important parameter in the evaluation of stability of suspensions. RHEOLOGICAL METHOD : The viscosity of the suspension is studied at different time intervals by using a good quality of viscometer

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ELECTRO KINETIC METHOD : The determination of surface electric charge or zeta potential of suspension is helpful to find out the stability of suspension. MICROMERITIC METHOD : The stability of a suspension depends on the particle size of the dispense phase. A change in particle size distribution & crystal habit may be studied by microscopy & counter coulter method.

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1. The Theory and practice of Industrial pharmacy : LEON LACHMAN , HERBERT A.LIEBERMAN , JOSEPH L.KANIG References 2.Modern pharmaceutics Gilbert S. Banker Christopher T. Rhodes 3.The science and practice of pharmacy Remington 4.Pharmaceutical dosage forms: Disperse systems by Herbert A. Lieberman, Martin M. Rieger , Gilbert S. Banker 5.INDIAN PHARMACOPOEIA Images : www.google.com