Quality control test for containers and closure Pratik Ghive

Quality control test for containers and closure Pratik Ghive covers all aspects in details in sample language with animated images of containers for better understanding

1. QUALITY CONTROL TEST FOR CONTAINERS NAME: PRATIK GHIVE CLASS: M PHARM FIRST YEAR [QA] SUBJECT: PRODUCT DEVELOPMENT AND TECHNOLOGY TRANSFER GUIDED BY : Dr. RASHMI TRIVEDI COLLEGE NAME: SMT.KISHORITAI BHOYAR COLLEGE OF PHARMACY KAMPTEE

2. Contents Packing materials Quality control test for containers

3. Packaging Material Any material that is used for packaging of products for their distribution and sale is said to be packing material. Secondary packing:- used to cover primary packs e.g. cartons, boxes, etc. Primary packing:- comes in direct contact with the product e.g. bottles, vials,

4. Different types of materials used for container Glass container Plastic container Metal container Different types of materials used for closures Rubber closures Plastic closures Metal closures Different types of materials used for secondary packaging Paper Cartons/cardboards

5. Quality control test for glass containers 1.Chemical resistance test a)Powdered attack test b)Water attack test 2. Hydrolytic resistance tes t 3. Arsenic test 4. Thermal shock test 5. Internal bursting pressure test

6. Powdered glass test It is done to estimate the amount of alkali leached from the powdered glass,which happens at elevated temperatures Sample containers are rinsed with purified water and dried The containers are grinded in a mortar to a fine powder and passed through sieve no. 20 & 50 10 gm of the sample is washed with acetone and dried 50 ml of purified water is added to the dried sample and autoclaved at 121°C 30 min and cooled and decanted The decanted liquid is titrated with 0.02N H2SO4 using methyl red as indicator

7. Sample with methyl red indicator

8. Water attack test This test is for type II glass. The principle involved in this is whether the alkali leaches from surface of container. The container is rinsed thoroughly with high purity water. It is then filled with water upto 90% of its capacity It is then autoclaved at 121°C for 30 min. Then it is cooled and liquid is decanted Decanted liquid is titrated with 0.02N H2SO4 using methyl red as an indicator The volume of H2SO4 consumed is recorded and compared with  limitsv

9. Hydrolytic resistance test The test is directly related to the stability of pharmaceuticals packed in it. Test 1: Type I and Type II glass containers to distinguish from Type III glass containers Test 2: Type I and Type II glass containers where it is necessary to determine whether the high hydrolytic resistance is due to the chemical composition or the surface treatment

10. Test 1 Each container is rinsed at least three times with CO2 free water and filled with the same to their filling volume Vials and bottles are covered and autoclaved at 100°C for 10 mins. and the steam is allowed to displace from the vent cork The temp. is risen from 100°C to 121°C over 20 mins. The temp. is maintained at at 121°C to 122°C for 60 mins. The temp. is lowered from 121°C to 100°C over 40 min. venting to prevent  vaccum The containers are removed from autoclave, cooled and the liquids are combined in a conical flask and the volume is measured. This test solution is titrated with 0.01M HCl using methyl red as an indicator (methyl red is red in alkaline pH and pink in acidic) A blank titration is performed with water and the difference between the titration represents the volume of HCI consumed by the test solution

11. Test 2 Rinse the container twice with water and fill completely with 4% v/v solution of Hydrofluoric acid and allow to stand at room temperature for 10 mins Empty containers and rinse 5 times with water. Rest procedure are same as in test 1.

12. Arsenic test This test is for glass containers intended for aqueous parenteral. The inner and outer surface of container is washed with fresh distilled water for 5 min. containers are covered and autoclaved at 100°C for 10 mins. The temperature is risen from 100°C to 121°C over 20 mins. The temperature is maintained at 121°C to 122°C for 60 mins. The containers are cooled and the liquids are combined and volume measured.

13. 10 ml from the final combined volume is pipetted out and to it 10 ml of HNO3 is added and dried in an oven at 130°C 10 ml of hydrogen molybdate is added and refluxed for 25 mins It is cooled and absorbance is measured at 840nm A Blank test is performed with 10 ml hydrogen molybdate Limits:- The absorbance of the test solution should be less than the absorbance obtained using 0.1 ml of arsenic standard solution (10 ppm)

14. Thermal shock test Sample container is placed in upright position in tray and the tray is immersed in hot water for a given time The container is then transferred in cold water bath and temp. should be controlled. Cracks are examined before and after test (45°C temp. difference should be there)

15. The amount of thermal shock a bottle can withstand is based on construction Small bottles - 60°C to 80°C Pint bottles - 30°C to 40°

16. 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. Test Chamber

17. Quality control test for plastic containers Leakage test Collapsibility test Clarity of aqueous extract Water vapour permeability test Transparency test

18. L eakage Test 10 containers are filled with water and fitted with intended closures They are kept inverted at room temperature for 24 hours The test is said to be passed if there is no sign of Leakage from any container Plastic containers kept inverted

19. Collapsibility test This test is applicable to containers which are to be squeezed in order to remove the contents. A container by collapsing inward during use, yield at least 90% of its normal contents at the required rate of flow at ambient temperature. Collapsibility tester

20. Clarity of aqueous extract A suitable container is taken at random, and unlabeled, unmarked and non-laminated portions is selected These portions are cut into strips, none of which has a total surface area of 20 cm² Strips are washed free from extraneous matter by shaking them with at least two separate portions of distilled water for about 30 secs. The processed sample is taken in to the flask, previously cleaned with chromic acid and rinsed with distilled water 250 ml of distilled water is added to the flask, covered and autoclaved at 121°C for 30 mins. The extract is cooled and examined. It should be colourless and free from turbidity.

21. Water vapour permeability test 5 containers are filled with nominal volume of water and heat sealed with an aluminium foil, poly ethylene laminate or other suitable seal Then each container is weighed and allowed to stand (without any overwrap) for 14 days at a relative humidity of 60+5% and a temperature between 20 and 25°C Containers are reweighed (the loss in weight in each container is not more than 0.2%)

22. 5 containers are filled to their normal capacity with dil. suspension as per IP 1996 The cloudiness of suspension is observed when viewed through the container and compared with a similar container filled with water

23. Quality control test for metal containers The metals commonly used for construction of containers are aluminum, tin plated steel, stainless steel, tin and lead. Test: Take 50 empty tubes filled with ointment base, sealed and kept overnight. A metal bacteriological filter assembly is fitted with 4.25cm filter paper of suitable porosity and heated to melting range of ointment base. Base from all tubes squeezed at certain rate and extruded base is collected. Walls of the filter and filter paper is washed with 3 successive quantities of each of 30 ml, of chloroform, and filter paper is allowed to dry. Filter paper is then examined under oblique lighting using a magnifying glass.

24. Each metal particle detected on filter paper is given a score as follows Particles 1mm and above : 50 Particles 0.5mm but less than 1mm : 10 Particles 0.2mm but less than 0.5mm : 02 Particles less than 0.2 : nil

25. References Roop Khar, S. P. Vyas, Farhan Ahmad, Gaurav Jain, Lachman/Liberman's The Theory and Practice of Industrial Pharmacy 4th edition CBS publishers 2 Sahil Jasuja and Mahesh Kataria ., 2013. Quality Control Testing of Packaging Materials. Pharmatutor , Pharmacy Infopedia. The Indian Pharmacopoeia Commission Ghaziabad, Indian Pharmacopoeia 2007 volume I, pg. no. 363-371. United States Pharmacopoeia 2007, volume I pg. no. 661. 5 Lachman Leon, Liberman H. A. and Kaing J. L., 2013. The Theory and Practice of Industrial Pharmacy. 3rd edition. New Delhi: CBS Publishers & Distributors Pvt. Ltd. Pg. no. 711-732.