1. IPQC TESTS FORPARENTRALSMOSES.MM.PHARMACY256212886050GUIDED BY: Dr. NIRMALADept. of PharmaceuticsPresented By:

2. Introduction to Parentrals: What are parentrals? Greek para = "beside" and enteron ="intestine", because it bypasses theintestines. 3. Parentrals are the dosage form for conveying drugby means of injection through the skin or mucousmembrane.Parenteral drugs are administered directly into theveins, muscles or under the skin, or more specializedtissues such as the spinal cord.Circumvents the highly efficient first line body defensethat is skin and mucous membrane.Thus they should be free from microbial contaminationand should have high purity. 4. Definition: Parenterals are Sterile Pyrogen-free & Free from particulate matterwhich are injected into the internal bodycompartment. 5. Quality Assurance: It is the sum total of the organizedarrangements with the objective ofensuring that the products will be ofthe quality required for their intendeduse. 6. GMP: Is that part of Quality Assuranceaimed at ensuring that the productsare consistently manufactured to aquality appropriate to their intendeduse. 7. Quality Control: Is that part of GMP concerned withsampling, specification & testing,documentation & release procedureswhich ensure that the necessary &relevant tests are performed & theproduct is released for use only aftera.scertaining its quality. 8. In Process Quality Control IPQC means controlling theprocedures involved in manufacturingof the dosage forms starting from rawmaterial purchase to dispatch of thequality product in ideal packaging. It monitors all the features of theproduct that may affect its quality andprevent errors during processing. It is the activity performed between QAand QC. 9. Importance: To minimize human errors. Provides accurate, specific and definitedescription of the procedure to beemployed. It is a planned system to identifymaterials, equipments processed andoperations. Is to detect the errors if and when it doesoccurs. Is to enforce the flow of manufacturingand packing operations according toestablished routes and practice. 10. IPQC For Parenterals: Each filled vials and ampoules aresubjected to inspection for particles,volume, cap or seal conditions. Assay: Drug content Clarity test: For particulate matter byVisual methodCoulter counter methodFiltration method/Microscopic countmethodLight blockage method 11. Continued.. Conductivity test Fill volume Leak test: Dye bath test Liquid loss test High voltage test Spark test 12. Continued.. Sterility test:Membrane filtration methodDirect inoculation method Pyrogen test:Testing on RabbitsLimulus Amoebocyte Lysate (LAL) test pH Label check Pass ability of Parenteral preparationthrough needle(Viscosity) 13. Drug Content: Assay: Assay is performed according to themethod given in the monograph of thatparenteral preparation in thepharmacopoeia. Assay is done to check the quantity ofmedicament present in the parenteralpreparation. 14. Clarity test: VISUAL INSPECTION BY NAKEDEYE: Each injectable is inspected visuallyagainst White and Black Backgrounds. The White backgroud aids in detectionof dark colored particles. The light reflective particles will appearagainst the Black background. 15. Coulter Counter method The sample solution is added to anelectrolyte solution which is drawnthrough a small orifice. As particle passes through the orifice itdisplaces its own volume of electrolyte. Particle detected by the increase inelectrical resistance. Voltage pulses are proportional to theparticle size. Particles below 0.2m can also bedetected. 16. Limits for detection of subvisible Particulate matter as prescribed in USPParticle size SVP LVP10m3000/container12/ml25m 300/container 2/ml 17. Microscopic count method Membrane filter and microscopes areused. 18. Light blockage/Obstructionmethod This method uses an electronic counter thatproduces a light beam of high intensity. The solution is allowed to pass under thisbright light. A shadow is formed if a particle is present. The particles are counted by the no. ofshadows.Limits for subvisible particulate matter as prescribed in USPParticle size SVP LVP10m6000/container25/ml20m 600/container 3/ml 19. Leakage Test Ampoules are subjected to this test. Leakage test not done for vials andbottles. 1. using methylene blue solution/Dye bathtest 2. spark test 20. Leakage test (with methylene bluesolution) The ampoules are immersed in vacuumchamber consisting of 1% methyleneblue solution A vacuum of about 27 (inch) Hg iscreated for about 15 to 30 min This causes the solution to enter theampoules with defective sealing. The vacuum is released and ampoulesare observed. If a leakage is present, the solution in theampoules appear blue color. 21. Spark test The machine uses high precisionelectrodes to inspect the fullcircumference of the containers,including the closure zone. All containers are presented inividually tothe electrodes. Any moisture that has penetratedthrough capillary forces in a crack,pinhole or just weak glass is registeredas a change in resistance. All products with a measured voltagehigher than a defined maximum valueare separated from the good products. 22. High Voltage Leak Dectection 23. Advantages of HVLD test Vials and ampoules also can betested. High accuracy of inspection. High speed of processing. 24. Sterility Test Sterility testing attempts to reveal thepresence or absence of viable micro-organismin a sample number ofcontainers taken from batch ofproduct. Based on results obtainedfrom testing the sample a decision ismade as to the sterility of the batch. Sterility testing is made after theproduct exposition to the one of thepossible sterilization procedures. 25. Principle Sterility test is based on the principlethat when micro-organisms aresupplied with nutrient medium andwater, and incubated at favorabletemperatures, they multiply. The presence of micro organisms canbe identified by turbidity in the clearmedium. 26. Culture Media The culture media used for sterilitytest must be capable of promoting thegrowth of a wide range of microorganisms. Types of media- 1. Fluid thioglycollate medium (foranaerobic bacteria). 2. Soyabean-casein digest medium (foraerobic bacteria and fungi). Incubation of media: 14 days at 30-35oC 27. Fluid Thioglycolate MediumIngredients Quantity for 1000 mlL-cysteine 0.5 gSodium chloride 2.5 gDextrose 5.5 gAgar 0.75 gYeast extract 5.0 gPancreatic digest of casein 15.0 gSodium thioglycollate 0.5 gResazurin (0.1% fresh1.0 mlsolution)Distilled water Upto 1000 ml 28. Soyabean-casein DigestMediumIngredients Quantity for 1000 mlPancreatic Digest of casein 17 gPeptic digest of soyabeanmeal3 gSodium chloride 5 gDibasic potassium phosphate 2.5 gDextrose 2.5 gDistilled water Upto 1000 ml 29. Minimum sample size related toBatch sizeNo. of items in the batch Min. No. of itemsrecommended to be testedInjectable preparationsa) upto 100 containers 10% or 4 containerswhichever is greaterb) 101-500 containers 10 containersc) >500 containers 2% or 20 containerswhichever is lessOphthalmic and other non Injectable preparationsa) upto 20 containers 5% or 2 containers whicheveris greaterb) >200 containers 10 containers 30. No. of items in the batch Min. No. of itemsrecommended to be testedSolidsa) 50 containers 2% or 20 containerswhichever is greater 31. For injectable preparationsQuality of each container Min. Quality to be used foreach culture mediumFor liquidsa) 100 ml NLT half the containersFor solidsa)