1. 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. 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 1250cm 2.  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 0 c 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: 1. autoclave 2. Oven 3. Extraction container : ampoules, test tube of type 1 glass. 4. 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 cm 2. transfer to extracting container. Add 20ml extracting medium.  Autoclave at 121 0 c 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 0 c 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.