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Vekaria M.Pharm -III (QA) Roll no. 10MQ18Slide 2: In process quality control procedure are usually rapid and simple test or inspection that are performed when the manufacturing of the product batch is in process. It is done to minimize human error or to detect the error if and when it does occur; to pinpoint the responsibility to the personnel involved in each unit operation of the entire processLarge volume parenteral: Large volume parenteral A parenteral dosage form can be defined as a sterile drug product which is presented in the form of solution, suspension, emulsion, or reconstituted lyophilized powder, suitable for administration by injection . These are of two type 1) LVP (> 100 mL ) 2) SVP (< 100 mL )IPQC TEST: IPQC TEST pH Clarity Test Pyrogen Test Steility Test Bacterial Endotoxin test Leaker TestpH: pH Checking the bulk solution, before filling for drug content, pH, color, clarity and completeness of solution The pH of a formulation must be considered from following standpoint: 1) the effect on the body when the solution is administered 2) the effect on stability of the product 3) the effect on container-closure systemClarity Test: Clarity Test The preparations intended for parenteral use should be free form particulate matter and should be clear when inspected visually. Two methods are described by USP according to the filled volume of the product to be tested. LVP's - a filtration followed by microscopical examination procedure is used. SVP's - a light obscuration based sensor containing electronic liquid-borne particle counter system is used. for LVP’s Limit- NMT 50 particles of 10µm and NMT 5 particles of the 25µm per mL Pyrogen Test : Pyrogen Test It is performed by using rabbits as test animals. Initially 10 ml/kg body weigh of animal is injected through rat vein at 37±2C within ten minutes from start of administration. Temperatures are recorded at 1, 2 and 3 hours after injection. Limit :- 1) the rise in temperature of individual rabbit is NMT 0.6C and sum is NMT 1.4 c 2) any one rabbit shows a rise in temperature of 0.6C and sum is more then 1.4cSlide 8: Test is repeated using 5 rabbits. The requirements are met if 3 out of 8 rabbits shows an individual rise in temperature of NMT 0.6C and sum of maximum rise in temperature of 8 rabbits is NMT 3.7CSteility Test: Steility Test The sterility test is done using direct transfer and membrane filtration techniques. Membrane filtration technique is suitable for liquids, soluble powders with bacteriostatic or fungi static properties, oils, creams and ointments. direct transfer is performed by aseptic transfer of specified volume from test container. Fluid thioglycollate (30 to 35) for Anaerobic Soybean-casein digest (20 to 25) for AerobicBacterial Endotoxin test : Bacterial Endotoxin test LAL (Limulus Amebocyte Lysate ) test is used to detect endotoxin that may be present. The USP reference standard contains 10,000 USP endotoxins per vial. The LAL reagent is used for gel-clot formation. The test is performed using stated amounts of volumes of products, standard, positive control, negative control of endotoxin . The tubes are incubated at 37±1C FOR 60±2 minutes. When the tubes are inverted at 180C angle, formation of firm gel confirms positive reaction.Leaker Test : Leaker Test The test is intended to detect incompletely sealed ampoules so that they may discarded. Leaker usually are detected by producing a negative pressure within an incompletely sealed ampoules , usually in vacuum chamber 0.5-1.0% methylene blue Vacuum sharply released after 30 min.References: References Hanna SA, Quality Assurance. In: Avis KE, Lieberman HA, Lachman L, editors. Pharmaceutical dosage forms:Parenteral Medications.2nd ed. Vol. 1. Newyork : Marcel Dekker; 1996. pg no. 1-65 The Theory and practice of indusrial pharmacy, Lieberman HA, Lachman L, 3 rd edition, pg no. 673-75 USP 24-NF 19, pg no. 1930-32, United States Pharmacopoeial Convention, Rockville, MD, 2000 Sidney H. Willing; “Good Manufacturing Practices for Pharmaceuticals” 5 th edition; Marcel Dekker Inc.;109Thank you : Thank you You do not have the permission to view this presentation. In order to view it, please contact the author of the presentation.