Test for the secondary material , containers ,closures with their detail description.

1. PRESENTED BY _ KARISHMA PRAKASH FUSE
PRESENTATION ON –
QUALITY CONTROL TEST FOR CONTAINERS,CLOSURES AND
SECONDARY PACKAGING MATERIAL
Subject- PRODUCT DEVELOPMENT AND TECHNOLOGY
TRANSFER
DEPARTMENT OF PHARMACEUTICAL QUALITY ASSURANCE

2. • Packaging is the process by which the pharmaceuticals are suitably packed so that they should
retain their therapeutic effectiveness from the time of packaging till they are consumed .
• Pharmaceutical packaging means of Providing protection , presentation, Identification,
Information and convenience to encourage compliance with a course of therapy.
• Any material that are used for packaging of the product for their distribution and sale is said to be
packaging material.
Packaging type
• Primary packaging is the material that first envelops the product and hold it .usually the smallest
unit of distribution or use and package which is direct contact with the content.
• Secondary packaging is outside the primary packaging – used to group primary packages together
• Tertiary packaging used for bulk handling, warehouse storage and transport.
Common form of palletized unit load that packs tightly into container.

3. • Secondary packaging designates the packaging used to group various pre-packaged products
together.
• It is not in direct contact with actual product .
• Its use and application usually differ distinctly from those of primary packaging.

4. 1. Branding & Display – Secondary packaging plays a vital role in the marketing strategy
surrounding the product. This is especially relavent in case of display packaging.
2. Logistics – secondary packaging serves to group several products together for ease of handling
transport and storage this means that secondary packaging must be able to,
• Contain relatively large volume of primary packaged product.
• Transport the product safely to the retailer or consumer destination.
• Keep the primary packaging in its original condition during storage .

5. Paper and boards
Cartons
Corrugated fiberboard
• The dimensions should be appropriate to withstand the stress during transportation.
• It should not affect the primary packaging.
• It should have sufficient strength to hold the material. Thickness should be appropriate to have
mechanical strength.

6. Dimensions • The physical dimensions of the given paper
board is taken and recorded .
Grammage • A test piece of suitable size (10×10 cm) is
cut and weighed . The grammage of the
sample is determined by Grammage –
104×w/a × b
w – weight in grams
a - length
b - breadth
Thickness • Measured with a micrometer.
• Thickness is related to grammage of paper
and its bulk density. It directly influences the
Physical property of the paper like stiffness,
varnishing & cutting
• Acidity in paper may be caused by the
presence of residual chemical left in the pulp

7. Surface pH
• A drop of distilled water is placed on the top
of the test piece and the electrode of pH
meter is placed in the drop touching the
paper .
• The reading is taken after 2 min.
pH After Extraction • Cut the 1gm of paper & place in a 100 ml
flask, fitted with condenser ,add 20ml of
boiling distilled water in small portions. Till
the paper is wet . Add 50ml of distilled water.
Reflux and digest with occasional shaking at
95 to 1000c for 1 hr. Cool to 40 to 450C remove
condenser and shake, cool in water bath .
Determine the pH of the supernatant with pH
meter.

8. Moisture content • Conditioned specimen is weighed and heated
to a constant weight to expel the moisture.
The difference of the two weights gives the
moisture content of the paper.
%moisture – 100 (A – B ) /B
A – Original weight
B – Weight after drying
Ash Content • Take about 1g of specimen and make it in to
shreds and place in a previously weighed
crucible
( C ). Heat carefully over a burner till completely
charred. Transfer the crucible into a muffle
furnace at 8000c until all the carbonaceous matter
are burnt off. Cool in desiccator, weigh and repeat
the experiment to a constant weight ( D ) .
% Ash – 100 (C-D)/D

9. Cobb Test • This measures the mass of water absorbed by
1cm2 of the test piece in a specified time under
a head of 1cm of water. It is determined by
weighing before and after exposure to the
water, and usually quoted in g/m2
Alkalinity • Place about 5gm (w) of accurately weighed
sample , cut into pieces in a stoppered flask
containing 250 ml of 0.02N HCL. Allow to stand
for 1hr with occasional shaking ,Decant and
titrate a measured quantity (v) against 0.1N
NaOH using methyl orange as indicator.
Carry out blank (B) .
% Alkalinity – 1250 (B-A) × N /v×w
A – Sample reading
B – Normality of NaOH
Folding Endurance • Fold the test piece back and forth until rupture
occur.
Tensile strength • The maximum tensile force per unit width that
a paper or a board will withstand before
breaking.

10. Tear Strength • The mean force required to continue the
tearing of an initial cut in a single sheet of
paper.
• F/T
Burst strength • The maximum uniformly distributed pressure,
applied at right angle to a surface that a test
piece of paper & board will stand under
condition of test.
Density • For rigid cellular material.
Puncture resistance • Energy required to make initial Puncture
Rub resistance • Resistance of printed test piece to withstand
rubbing against another similar test piece .
Roughness or smoothness • Important for printability of paper.
Ink Absorbancy • Determination of ink absorbancy by K & N ink

11. Compression This method is used to access the strength of
erected package.
Carton opening force • The method is used to hold the flat carton as
delivered ,by its creases between thumb and
first finger press.
Coefficient of friction • Both static and kinetic coefficients of friction
are determined by sliding the specimen over
itself under specific test conditions.
Crease Stiffness • This involves testing a carton board piece and
folding it through 900, It will then try to recover
its position when bending force is removed.
Joint shear strength • This is a method of testing glued lap scam on
the side of a carton for strength of the adhesive
using a tensile testing machine.

12. 1. Powdered glass test:
Done to estimate amount of alkali leached from the powdered glass, which
usually happens at elevated temperatures.
• Sample containers are rinsed with purified water and dried .
• The container are grinded in a mortar to a fine powder and pass through sieve no.20 & 50
• 10gm of sample is washed with acetone and dried.
• 50 ml of purified water is added to the dried sample and autoclaved at 1210C for 30min and
cooled and decanted.
• The decanted liquid is titrated with 0.02N H2SO4 using methyl red as indicator .

13. 2. Hydrolytic resistance of glass containers:
• Each container is rinse at least three times with CO2 free
water and filled with same to their filling volume.
• Vials and bottles are covered and autoclaved at 1000C
for 10mins.
• The temperature is risen from 1000C to 1210C over
20mins.
• The temp. is maintained at 1210C to 1220C for 60
Mins.
• The containers are cooled and the liquids are
combined and volume measured.
• It is titrated with 0.01M HCl using methyl red as an
indicator.

14. 3. Arsenic test
• The test is for glass containers intended for aqueous parenterals.
• The inner and outer surface of container is washed with fresh
Distilled water for 5min.
• Then similar steps are followed as performed in the hydrolytic test ,
Previously described . Till obtaining final combined solutions .
• 10ml from the final combined volume is pipetted out an to it 10ml
of HNO3 is added and dried in an oven at 1300C.
• 10ml of hydrogen molybdate is added and refluxed for 25 mins.
• It is cooled and absorbance is measured at 840nm.
• The absorbance of the test solution should be less than the absorbance
obtained using 0.1ml of arsenic standard solution .
(10ppm)

15. 1. Leakage test:
• 10 containers are filled with water and fitted with intended closures.
• They are kept inverted at room temp. for 24 hrs.
• The test is said to be passed if there is no sign of leakage from
any container.
2. 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 flow at ambient temperature.

16. 3. Clarity of aqueous extract
• A suitable container is taken at random, and unlabeled,
Unmarked and non-laminate portion is selected.
• These portion is cut into strips,non of which has total
surface area of 20 cm2
• The stripes are washed free from extraneous matter by
shaking them with at least two separate portions of distilled water for
About 30secs.
• The processed sample is taken into the flask. Previously cleared with
chromic acid and rinsed with distilled water .
• 250ml of distilled water is added to the flask, covered & autoclaved at 1210C for 30mins.
• The extract is cooled and examined . It should be colorless and free from turbidity .

17. Preparation of sample:
• The closures are washed in 0.2% w/v of anionic surface agents for 5 mins
• Rinsed 5 times with distilled water and 200ml water is added.
• Subjected to autoclave at 1190C to 1230C for 20-30mins covering with aluminum foil.
• Cooled and solution is separated from closures (solution A).
1. Residue on evaporation
• 50ml of solution A is evaporated to dryness on a water bath and dried at 1050C.
• The residue weighs not more than 4mg

18. 2. Sterilization test:
• The closures used for the preparation of the sample solution shall not
soften or become tacky and there shall be no visual change in the closure.
3.pH of aqueous extract:
• To 20ml of solution A,0.1ml of bromothymol blue solution is added
• NMT 0.3ml of 0.01M NaOH or 0.8ml of 0.01M HCl is rqd, to change the color
of the solution to blue or yellow respectively.

19. 4. Self Stability Test
• Pierced ten times with hypodermic needle.
• Immersed in 0.1% methylene blue solution and subjected
to a pressure of about 27 Kpa
• Restored to ATM pressure and made to stand for 30mins.
• Traces of colored solution should not be found.

20.  http://www.pharmatutor.org/articles/the-pharmaceutical-packaging-article
https://www.slideshare.net/mobile/AnupriyaNR/quality-control-on-secondary-packaging-materials.
https://www.slideshare.net/mobile/SanathoibaSingha/quality-control-tests-for-pharmaceutical-
containers-closures-and-secondary-packing.
http://www.rgpv.ac.in
http://www.glocaluniversity,edu.in
www.Wikipedia.com