Transcript Testing of packaging material

Prepared by :Paras Shah
Guided by :Dhaval sir
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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.
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.
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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.
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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.
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.
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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.
Biological test(systemic injection test):
 this test is designed to evalute systemic
responses to the extract of materials under
test following injection into mice.
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test animals : use healthy albino mice
weighing between 17 and 23 g.
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.
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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.
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.
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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.
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.
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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.
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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.
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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.
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If the final score is less than 100, then
sample pass the test.