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Testing of packaging material

Testing of packaging material. Prepared by :Paras Shah Guided by :Dhaval sir. Packaging is science, art and technology of enclosing or protecting products for distribution, storage, sale and use. Generally glass, metal and plastic containers are used for the packaging of drug products.

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Testing of packaging material

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  1. Testing of packaging material Prepared by :Paras Shah Guided by :Dhaval sir

  2. Packaging is science, art and technology of enclosing or protecting products for distribution, storage, sale and use. • Generally glass, metal and plastic containers are used for the packaging of drug products. • Testing of such packaging material is required to prevent its interaction with drug produts.

  3. Testing of plastic container Physico chemical test: • Leakage test: fill ten container with water, fit with closures. Keep them inverted at room temperature for 24 hrs. there are no signs of leakage from any container. • Collapsibility test: sqeeze the container in order to remove the contents. it should yield at least 90% of its nominal content.

  4. Clarity of aqueous extract: select unlabeled, unmarked portion of container having surface area of 1250cm2. • Cut portion and wash with dist. Water. • Then transfer it to the flask. Add 250ml dist. Water. Cover the flask with beaker and autoclave at 121 0c for 30 min. • Cool and examine the extract. It is called aqueous extract. It is free from turbidity.

  5. Light absorption: light absorption of extract using water as a blank is not more than 0.08 in the range of 220 to 240nm. • Ph: take 10 ml of extract and blank. Add 1ml of 0.1% w/v solution of pot. Chloride.determine the ph. The difference in ph of the two solution is not more than 1.5.

  6. Non volatile matter: evaporate 50 ml of the extract on water bath. • Dry the residue. And weigh. • Repeat the operation using water as a blank. • The difference in weight does not exceed 15mg. Heavy metal: transfer 20ml of the extract into the cylinder. Adjust the ph 3 with 1M acetic acid. Dilute with water up to 35ml. Add 10ml of freshly prepared hydrogen sulphide solution. Dilute with water to 50ml and mix.

  7. In another cylinder take 2ml of std. lead solution. And follow the same procedure. • Any brown colour produced within 10 min. in the cylinder of the extract is not more intense then that in the cylinder containing the lead std. solution. • Buffer capacity: titrate 20ml extract of ph 7 with 0.01M HCL.determine the end point potentiometrically. • Repeat the test with 20ml blank. The difference between volume is not more than 10ml.

  8. Biological test(systemic injection test): • this test is designed to evalute systemic responses to the extract of materials under test following injection into mice. • test animals : use healthy albino mice weighing between 17 and 23 g.

  9. Apparratus: • autoclave • Oven • Extraction container : ampoules, test tube of type 1 glass. • Extracting media: • Sodium chloride injection • 5%v/v solution of ethanol in sodium chloride. • Polyethylene glycol • Vegetable oils.

  10. Preparation of extract : take portion of plastic container having surface area 1250 cm2. transfer to extracting container. Add 20ml extracting medium. • Autoclave at 121 0c for 30 min. • Allow to cool at room temperature and shake. • Procedure: inject the extract intracutaneously into 5 mice.

  11. Observe the animals after injection at the interval of 24, 48 and 72 hrs. • If two or more animals die , then samples fail the test. Plastic container for opthalmic preparation: • Eye irritation test: • Extracting media : sod. Chloride injection, vegetableoils.

  12. Test animals: select healthy albino rabbits having no visible eye irritation. • Procedure: use three albino rabbits for each extract to be examined. • Instil about 100µl of the sample extract into one eye and 100µl dist. Water into other eye. • Examine the eyes 24,48,72hrs, after instillation.

  13. If the irritation is observed, then sample fail the test. Testing of glass container: Glass container intented for injectable preparations may be ampoules,vials or bottles. Hydrolytic resistance test: Take 10 ampoule of 5ml capacity. Rince twice with dist. Water. Then fill the ampoule with dist. Water.

  14. Autoclave them at 121 0c for 20 min.So alkali leached from container into water. • Now titrate this 50ml dist.water with 0.01MHCL using methyl red as an indicator measure the end point. • End point of the test should not be more than 1.3 in case of type 1or 2 glass and 13.6 In case of type 3 glass.

  15. Test of metal container: metal collapsible tube comply the following test. • Take 50 tubes. Clean the tube by vibration. Fill the tube with molten base. Allow to cool over night. • Assemble metal filter on perforated plate. Heat it at melting temp. of the base. • Press the tubes over the filter. Spread over it.

  16. Examine the filter paper under oblique lighting with aid of magnifying glass to measure particle size from 0.2mm to 1mm. And score it as follow. • 1mm or above – 50 • 0.5mmto 1mm – 10 • 0.2mm to 0.5mm – 2 • Less than 0.2mm – nil.

  17. If the final score is less than 100, then sample pass the test.

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