QC TEST FOR C, C, SPM.pptx
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This document outlines quality control tests for various pharmaceutical packaging materials including containers, closures, and secondary packaging. It describes tests for glass, plastic, metal and rubber containers to test properties like chemical resistance, hydrolytic resistance, sterility and leakage. Tests are also described for closures to evaluate sterility, fragmentation, self-sealability and extractable substances. Finally, common tests for secondary packaging materials like paper and board are mentioned including moisture content, folding endurance and burst resistance.
QC TEST FOR C, C, SPM.pptx
- 1. 1 MBS
- 2. CONTENT 2 MBS 1. QC Test for Containers 2. QC Test for Closures 3. QC Test for Secondary Packaging Materials
- 3. QUALITY CONTROL TEST FORCONTAINERS 3 MBS Different types of container materials. 1. Glass Container 2. Plastic Container 3. Metal Container 4. Rubber
- 4. Quality Control Test for Glass Containers 4 MBS 1. Chemical Resistance Test a) Powdered Glass Test b) Water Attack Test 2. Hydrolytic Resistance Test 3. Arsenic Test 4. Thermal Shock Test 5. Internal Bursting Pressure Test
- 5. 1. Chemical Resistant Test a) Powdered Glass Test: It is done to estimate the amount of alkali from powdered glass with happen at elevated temperature. When glass is powdered, leaching of alkali is enhanced, which can be titrated with 0.02N sulphuric acid using methylred as an indicator. Step 1 • Preparation of glass specimen Step 2 • Washing the specimen 5 MBS
- 6. 10g of specimen/sample + 50ml oh highly purified water.Autoclave it at 121C. Test Container Vol. of 0.02N H2SO4(ml) Powdered Type I 1.0 Glass Test Type III 8.5 Type N.P 15 6 MBS Cool it and deacant solution in another flask again add 15ml water and decant solution Titrate the decant solution with 0.02N sulphuric acid using indicator and record the volume Limits:
- 7. b) Water Attack Test: This test is for Type II glass. The principle involve in this is whether the alkali leaches from surface of container. Rinse thoroughly container with high purity water. Fill it by 90% of it’s capacity with water. Autoclave it at 121C ̊ for 30 minutes. Then it is cooled and liquid is decanted Decanted liquid is titrated with 0.02N Sulphuric acid using methylred as an indicator The volume of sulphuric acid consumed is recorded and compare with limits 7 MBS
- 8. Test 8 MBS Container Vol. of 0.02N H2SO4(ml) WaterAttack Test Type II 1.0 Size(ml)-100 0.7 Less than 100 0.2 Limits: 2. Leakage Test: Drug filled container is placed in contained filled with colored solution (methyleneblue) and autoclave at 121̊C for 1 0 min. under pressure. Later on the container are observed whether colored get entered in container or not.
- 9. 3. Hydrolytic Resistant Test This test is only for unused glass container. At 100C ̊ for 10 min. allow to rise temp. to 121̊C for 60 m i n . Low down temp to 100̊C. Cool it Rinse the container with CO2 free water for 3 times. fill till a particular vol. autoclave it Specific amount of liquid solution is titrated with 0.01N HCL using methylred as an indicator. Perform the blank with water and difference between the titration represents vol. of HCL consumed by test liquid 9 MBS
- 10. Limits 10 MBS
- 11. C ̊ for 30 min. & cool it Cool the solution and determine absorbance at 840nm. Perform blank. Wash inner and outer surface of container with D.W. for 5 min. Test solution is same as that of hydrolytic resistant test (50ml) Pipette out 10 ml and add 10ml of nitric acid on the water bath maintaing the temperature. Dry residue in oven at 130 & add hydrogen molybdate & refux for 25 min. 4. Arsenic Test 11 MBS
- 12. Limits: The absorbance of test solution should not exceedthe absorbance of arsenic standard solution of 10ppm. The test bottle is filled with water and placed inside test chamber 5. Internal Bursting Pressure Test Instrument used American glass research increment pressure tester. The internal pressure automatically raised by series of increment at set time Bottle are checked at preselected pressure level until container finally burst. 12 MBS
- 13. 6. Thermal Shock Test Step 1 • Place sample container in upright position in tray & immersed tray in hot water for a given time. Step 2 test.(45 • Transfer the container in cold water bath temp. should be controlled. Examine cracks before & after C ̊ temp. difference should be there.) Step 3 • The amount of thermal shock a bottle can withstand is based on construction. 13 MBS •Small bottles- 60 - 8 0 ̊C • Pint bottles- 30-40 ̊C
- 14. Quality Control test for Plastic Container Leakage test Collapsibi lity Transpare ncy Water vapour permeabilit y test Bacteriolog ical test 14 MBS
- 15. Quality Control Test for Metal Container • Take 50 empty tubes filled with ointment base, sealed & kept overnight Step 1 Step 2 • A metal bacteriological filter assembly fitted with filter paper & heated to melting range of ointment base. • Base from all tubes squeezed at certain rate & passed through filter under vaccum. further wash with CHCL3 and observed for particles. Step 3 15 MBS
- 16. Observations 16 MBS Particles 1mm and above 50 Particles 0.5mm to 1mm 10 Particles 0.2mm to 0.5mm 2 Particles less than 0.2mm Nil Total score 62 Limits : Lot of tube passes test if total score is less than 100. Lot of tubes fails if total score is above 150 If it is between 100 – 150 test is repeated again with 50 more tubes
- 17. Quality Control Test for collapsible tubes Quality Control Test for collapsible tubes Leakage Test Power of Adhesion Flexibility Product compatibility 17 MBS
- 18. Quality Control Test for Strip and Blister packing 3/4th of water is poured in desiccator. Strip and Blister were placed inside desiccators and vaccum is applied Later on strips, blisters were taken out. water present over the outer surface were wiped out. The content of strips and blisters were removed and presence of moisture was checked If there is no leakage, content will not be wetted. It indicate perfect sealing. 18 MBS
- 19. QUALITY CONTROL TEST FORCLOSURES 1. Sterility Test 2. Fragmentation Test 3. Self-Sealability 4. pH of aqueous extract 5. Light AbsorptionTest 6. Reducing Substance 7. Residue on Evaporation 8. Penetrability 19 MBS
- 20. Preparation of sample solution Wash closure in 0.2%w/v of anionic surfactant for 5 min. Rinse 5 times with D.W. and add 200ml water. Further subjected to autoclave and covering with Al foil. Allow to cool and separate solution from closure 20 MBS
- 21. 1. Sterility Test Closures are subjected for sterilization ByAutoclaving at 64-66 C & pressure 0.7kPa Further testing is carried out by using culture media. 21 MBS 21
- 22. Take 12 clean vials and place closures containing 4ml of water Allow to stand for 16 hrs. Use hypodermic needle to inject 1ml of water into the vial & remove 1ml of air. Carry this operation for 4 times with new needle each time. Pass the water present in vial through a filter with pore size of 0.5µm No. of fragments of 22 MBS closure retain should be as per the limits 2. Fragmentation Test Limit: No. of fragments – NMT 10(in case of butyl rubber) No. of fragments –NMT 15
- 23. 3. Self-Sealability Fill 10 vials with nominal volume of water and place closures. Pierce cap for 10 times at different sites with hypodermic needle Immerse vials in 0.1%w/v solution of methylene blue under pressure Keep the container immersed for 30 minutes Wash the vials & none of vials should contain traces of color solution 23 MBS
- 24. 4. pH of Aqueous Extract Take 20ml of sample solution and add 0.1ml of bromothymol blue Add 0.01M of NaOH till color change from Blue to Yellow. Volume required is measured LIMITS: Vol. of NaOH – NMT 0.3 ml If HCL is used –NMT 0.8 ML 5. Light Absorption Test It must be done within 4 hr of preparing sample solution. It is filtered and its absorbance is measured at 220nm to 360nm. Blank is done without closure and absorbance must be NMT-2.0 24 MBS
- 25. 6. Reducing Substance 20ml of sample solution + 1M sulphuric acid 20ml of sample solution + 0.002M Potassiumpermagnet Boil for 3 min. and cool it. Add 1 Kg of Potassiumiodide Treat the solution with Na thiosulphate using starch solution as indicator. Blank Titration is done and difference of sample and blank should be NMT-0.7ml 25 MBS
- 26. 7. Residue on Evaporation 26 MBS The 50ml of sample solution is evaporated at 105̊C. Residue obtained should be NMT 4mg. 8. Penetrability This is to measure the force required to make a hypodermic needle penetrate easily through closure. It is measured by using piercing machine. The piercing force must not exceed a stated value, the hypodermic needle can get damage as a result of undesirable hardness of closure.
- 27. QC TEST FOR SECONDARY PACKAGING MATERIALS 27 MBS The test pieces of paper and board are taken for test to be carried out in standard condition a) Temperature: 23C̊ ± 1 C ̊ b) Relative Humidity: 50% ± 2% 1. Moisture Content 2. Folding Endurance 3. Air Permeability 4. Tensile Strength 5. Stiffness 6. Burst Resistance
- 28. REFRENCES 28 MBS 1. Pharmaceuticals Packaging Technology,Taylor and Francis by Dean D.A, Evans E.R fifth edition page no. 188-189. 2. “Packaging”; Cooper and Gunn’s Tutorial Pharmacy, sixth edition, CBS publicashers page no. 139-140
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