Quality control test for packaging material ,qc test for glass,metal,rubber

quality control test of glass plastic rubber closure and secondary packaging material

1. 10/19/2018 Quality Control Test 1 QUALITY CONTROL TEST OF PACKAGING MATERIALS Sanjivani College of Pharmaceutical Education and Research, Kopargaon Prepared by Miss Unnati .M. Patel F.Y.M Pharm(PQA) Guided by Dr A.D.Kulkerni MPharm(Pharmaceutics)

2. 10/19/2018 2 CONTENT QC Test for Containers QC Test for Closures QC Test for Secondary Packaging Materials Quality Control Test

3. 10/19/2018 3 QUALITY CONTROL TEST FOR CONTAINERS Quality Control Test Different types of container materials. Glass Container Plastic Container Metal Container Rubber

4. 10/19/2018 Quality Control Test 4 Quality Control Test for Glass Containers Chemical Resistance Test Powdered Glass Test Water Attack Test Hydrolytic Resistance Test Arsenic Test Thermal Shock Test Internal Bursting Pressure Test

5. 10/19/2018 Quality Control Test 5 Chemical Resistant Test 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.

6. 10/19/2018 Quality Control Test 6 Test Container Vol. of 0.02N H2SO4(ml) Powdered Glass Test Type I Type III Type N.P 1.0 8.5 15 Limits:

7. 10/19/2018 Quality Control Test 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 121 ̊C 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

8. 10/19/2018 Quality Control Test 8 Test Container Vol. of 0.02N H2SO4(ml) Water Attack Test Type II Size (ml)-100 Less than 100 1.0 0.7 0.2 Limits: 2. Leakage Test: Drug filled container is placed in contained filled with colored solution ( methyleneblue ) and autoclave at 121 ̊C for 10 min. under pressure. Later on the container are observed whether colored get entered in container or not.

9. 10/19/2018 Quality Control Test 9 3. Hydrolytic Resistant Test This test is only for unused glass container . At 100 ̊C for 10 min. allow to rise temp. to 121̊C for 60 min. Low down temp to 100 ̊C. 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

10. 10/19/2018 Quality Control Test 10 Limits

11. 10/19/2018 Quality Control Test 11 Wash inner and outer surface of container with D.W. for 5 min. Dry residue in oven at 130 ̊C for 30 min. & cool it & add hydrogen molybdate & refux for 25 min. Cool the solution and determine absorbance at 840nm. Perform blank. Pipette out 10 ml and add 10ml of nitric acid on the water bath maintaing the temperature. Test solution is same as that of hydrolytic resistant test (50ml) 4. Arsenic Test

12. 10/19/2018 Quality Control Test 12 Limits : The absorbance of test solution should not exceed the absorbance of arsenic standard solution of 10ppm. 5. Internal Bursting Pressure Test Instrument used American glass research increment pressure tester. The test bottle is filled with water and placed inside test chamber The internal pressure automatically raised by series of increment at set time Bottle are checked at preselected pressure level until container finally burst.

13. 10/19/2018 Quality Control Test 13 6. Thermal Shock Test Small bottles- 60 - 80 ̊C Pint bottles- 30-40 ̊C

14. 10/19/2018 Quality Control Test 14

15. 10/19/2018 Quality Control Test 15 Quality Control Test for Metal Container

16. 10/19/2018 Quality Control Test 16 Observations 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. 10/19/2018 Quality Control Test 17 Quality Control Test for collapsible tubes

18. 10/19/2018 Quality Control Test 18 Quality Control Test for Strip and Blister packing

19. 10/19/2018 19 QUALITY CONTROL TEST FOR CLOSURES Sterility Test Fragmentation Test Self-Sealability pH of aqueous extract Light Absorption Test Reducing Substance Residue on Evaporation Penetrability Quality Control Test

20. 10/19/2018 20 Preparation of sample solution Quality Control Test

21. 10/19/2018 21 1. Sterility Test Quality Control Test

22. 10/19/2018 22 2. Fragmentation Test Limit: No. of fragments – NMT 10(in case of butyl rubber) No. of fragments –NMT 15 Quality Control Test

23. 10/19/2018 23 3. Self-Sealability Quality Control Test

24. 10/19/2018 24 4. pH of Aqueous Extract 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 Quality Control Test

25. 10/19/2018 25 6. Reducing Substance Quality Control Test

26. 10/19/2018 26 7. Residue on Evaporation The 50ml of sample solution is evaporated at 105 ̊C. 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. Quality Control Test

27. 10/19/2018 27 QC TEST FOR SECONDARY PACKAGING MATERIALS Quality Control Test The test pieces of paper and board are taken for test to be carried out in standard condition Temperature: 23 ̊C ± 1̊C Relative Humidity: 50% ± 2% Moisture Content Folding Endurance Air Permeability Tensile Strength Stiffness Burst Resistance

28. 10/19/2018 28 REFRENCES Quality Control Test Pharmaceuticals Packaging Technology,Taylor and Francis by Dean D.A, Evans E.R fifth edition page no. 188-189. “Packaging”; Cooper and Gunn’s Tutorial Pharmacy, sixth edition, CBS publicashers page no. 139-140

29. 10/19/2018 29 Quality Control Test