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Premium member Presentation Transcript PowerPoint Presentation: VARIOUS IN-PROCESS QUALITY CONTROL OF DOSAGE FORMS (INJECTABLES & ORAL LIQUIDS) BY, SANKEERTHI HEPSIBA.B PHARMACEUTICAL ANALYSIS & QUALITY CONTROL. 8/26/2012 1PowerPoint Presentation: What Do You Mean By “IPQC” …? IPQC is concerned with providing accurate , specific , & definite descriptions of the procedures to be employed, from, the receipt of raw materials to the release of the finished dosage forms. 8/26/2012 2PowerPoint Presentation: VARIOUS IN PROCESS QUALITY CONTROL OF DOSAGE FORMS (INJECTABLES ) VARIOUS IN-PROCESS QUALITY CONTROL OF DOSAGE FORMS: (INJECTABLES) 8/26/2012 3PowerPoint Presentation: 1.Environmental control 2.pH 3.Viscosity 4.Osmolality (occasionally) 5.Conductivity measurement 6.Temp for heat sterilized product 7.Volume filled 8.Leakage test 9.Clarity test 10.Pyrogen test 11.Sterility tests 8/26/2012 4PowerPoint Presentation: 1.EVIRONMENTAL CONTROL: Traffic control: A carefully designed arrangement to control traffic. and minimize the Personnel should be permitted into aseptic areas only after following rigidly prescribed procedures. Surface disinfection Personnel: must be inherently neat, orderly, reliable and alert. should be in good health . 8/26/2012 5PowerPoint Presentation: 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. 8/26/2012 6PowerPoint Presentation: 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 8/26/2012 7PowerPoint Presentation: 3.VISCOSITY: 1.Viscosity and Consistency directly relates with stability of solutions. 2.Viscosity is measured by Viscometer. 4.CONTROL ON VOLUME FILLED: The personnel working in the filling area should have complete control on filling equipments. 8/26/2012 8PowerPoint Presentation: 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 8/26/2012 9PowerPoint Presentation: 6.CONDUCTIVITY MEASUREMENT: 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). 8/26/2012 10PowerPoint Presentation: 7. TEMPERATURE FOR HEAT STERILIZED PRODUCTS: 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 . 8/26/2012 11PowerPoint Presentation: 8.LEAKAGE TEST: Leakage test is employed to test the package intensity. A) VISUAL INSPECTION By Three Methods: B) BUBBLE TEST C) DYE TEST 8/26/2012 12PowerPoint Presentation: 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 the particles that are 30 to 40 µm and larger size. USP limits for large volume infusions: Particle Size Particle Limit 10 µm & larger/ml 50 25 µm & larger/ml 5 8/26/2012 13PowerPoint Presentation: 1.VISUAL INSPECTION 2.INSTRUMENTAL METHODS: Each injectable is inspected visually against white & black backgrounds. The white backgrounds aids in detection of dark colored particles. The light or reflective particles will appear against the black backgrounds. A lso known 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. 8/26/2012 14PowerPoint Presentation: 10.STERILITY TEST: The test method for sterility of the product: 2. Direct inoculation of the culture medium 1.Membrane Filtration 8/26/2012 15PowerPoint Presentation: 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 . P ore size of 0.45µm E ffectiveness established in the retention of micro-organisms the size of the filter discs is about 50mm in diameter. 8/26/2012 16PowerPoint Presentation: 2.DIRECT INOCULATION:: 8/26/2012 17PowerPoint Presentation: 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 rise (°c) 8/26/2012 18PowerPoint Presentation: 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 If above not passes 3+5= 8rabbits 0.6 0.6 1.4 3.7 Passes Passes If above not passes , perform the test again. If above test not passes ,the sample is said to be pyrogenic. 8/26/2012 19PowerPoint Presentation: LAL TEST:: LAL TEST: Limulus amebocyte lysate (LAL) test to detect or quantify endotoxins of gram-negative bacterial . Origin reagent: A moebocyte lysate from horseshoe crab ( Limulus polyphemus ). LAL reacts with bacterial endotoxin . It involves 3 methods: Gel clot method Turbidimetric method Chromogenic method 8/26/2012 20PowerPoint Presentation: IN-PROCESS CONTROL OF LIQUID ORALS 8/26/2012 21PowerPoint Presentation: These are of two types: 1.Monophasic liquids Ex:Solutions,Syrups,Elixirs,etc. 2.Biphasic liquids Ex:Emulsions,Suspensions 8/26/2012 22PowerPoint Presentation: 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. 8/26/2012 23PowerPoint Presentation: 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) . 8/26/2012 24PowerPoint Presentation: 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. 8/26/2012 25PowerPoint Presentation: BIPHASIC LIQUIDS: 1.EMULSIONS 2.SUSPENSIONS 8/26/2012 26PowerPoint Presentation: 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. 8/26/2012 27PowerPoint Presentation: 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,. 8/26/2012 28PowerPoint Presentation: 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. 8/26/2012 29PowerPoint Presentation: 5.ELECTRO KINETIC METHOD : The determination of surface electric charge or zeta potential of suspension is helpful to find out the stability of suspension . 6.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. 8/26/2012 30PowerPoint Presentation: REFERENCES 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 8/26/2012 31PowerPoint Presentation: THANK YOU 8/26/2012 32 You do not have the permission to view this presentation. In order to view it, please contact the author of the presentation.