1. Presented By Guided By:
Mahesh K. Shinde Dr. R. J. Dias
HOD, Dept. of Pharmaceutics
M.Pharm -II nd sem.
 
SINHGAD INSTITUTE OF PHARMACEUTICAL SCIENCES, LONAVALA
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2. Packaging material for :
 Solid dosage form
 Liquid dosage form
 Sterile products
 Ophthalmic dosage form
 Transdermal drug delivery system
 Transnasal drug delivery devices
2

3. Glass Bottles
• type III glass and NP glass is used.
• Transparent and Amber coloured glass
bottle
• It have strong and rigid
• Impermeable to water vapors
Plastic Bottle :
• Bottles made from polyethylene (HDPE),
Polypropylene , Polystyrene .
• It is light weighted and non breakable.
3

4. Blister packaging:
The primary component of a blister pack is a cavity
or pocket made from a formable web, usually a
thermoformed plastic and a backing
membrane or a "lidding" seal of aluminum foil
The most basically Polyvinyl chloride (PVC) used
for forming cavity or pocket.
Others materials used - polychloro-trifloro-ethylene
- cyclic olefin copolymers
for moisture prevention
4

5. Strip Packaging
1. Strip packs present an alternative form of pack
for a unit dosage.
2. This pack consists of one or two plies, made from
regenerated cellulose, paper, plastic, foil or combination
of these
3. The use of high barrier material like aluminum foil or
saran-coated film with excellent seal formation for
moisture-sensitive products.
4. cellophane film -.
-when transparency required.
5

6. Tests of strip and blister packaging
1) Leakage testing and package integrity testing
Dip the packages in the pot containing the colored water and place the pot in the
vacuum chamber.
Apply the vacuum for strip packages and for blister packs for 30 sec
.
Return to the atmospheric pressure and remove the pot from the vacuum
chamber.
Examine the package for ingress of the water in to the package
2) Pinholes and package integrity
Pinholes are the common features of aluminum foil.
It can be detected by water vapor permeation. High water vapor permeation
indicates the high numbers of the pinholes.
6

7. Pouches
Plastic Pouches :
1. Made from strong LDPE film
2. With a re-sealable strip at the top, easy to
open and close
Plastic Pouches
3. It have Waterproof, tide proof, air proof and
non-poisonous property .
Especially suitable for hospital and clinic
Aluminum pouches :
1. It have tear strip facility
Aluminium pouches
2. It offers excellent barrier properties to the
moisture, gas and light
7

8. Solids-Rectal (Suppository) :
1) Aluminum Foil
• Offers the highest possible protection against
moisture, oxygen, and light,.
• the aluminum suppository package takes the shape
of individual doses .
• Aluminum foil quality offers protection even under the most
difficult climatic conditions.
• It serves Child resistant due to Non-transparent material
• Excellent appearance
• Have an easy opening feature with a peelable system, and
tearing
8

9. 2) Laminates for suppositories :
• It is made of Polyolefine, Aluminum, P.E. .
• It gives protection from moisture, gas
,vopours,light
• The product is smooth, easy to tear, shape well,
particularly suitable for temperature & humidity-
sensitive suppository,
• It directly contacts suppository medicines, no
abnormal toxicity, no physical and chemical
matrix effects occurred
9

10. Solids (Inhalation) Dry-Powder Inhaler :
• It is made of plastics such as polyethylene (HDPE),
Polypropylene , polystyrene .
How to use:
1. Hold the base of the inhaler firmly and open the
inhaler by turning the mouth piece in the direction of
the arrows.
2. Take a capsule out of the blister strip and
. Place the capsule into the capsule cavity .
3. Close the mouthpiece back to the closed position
4. Press the bottom buttons with thumb and index
finger at the same time . So that capsules are
puncture & powder is dispersed .
5. Insert the mouthpiece of the inhaler completely into
your mouth, behind your teeth and on your tongue.
Close your lips tight round the mouthpiece And
Breathe in rapidly but steadily, as deeply as you
can. 10

11. - Glass Or Plastic Bottle
- Bottle With Spray Pump
1)Capacity: 50ml
2) Material: Bottle-polyethylene terephthalate;
Sprayer-polypropylene
3) Spray output: 0.05ml-0.20ml
4) Bottle is tough , excellent strength and have
gas
& aroma barrier
5) Used for body spray, oral spray, anti-bacterial 11

12. Bottle With Dropper Assembly :
• Dropper assemblies can be supplied
with
coloured caps
• glass type II is used
• Dropper glass is of Sodalime
glass(type III) and Neutral glass(type
I).
• Bottle capacity is from 2 to 100ml
• pipettes are up to 120mm in length
12

13. Collapsible tubes :
• It is made of metals like aluminum , tin and lead
and plastics like low density polyethylene
• Material for cap is of high density polyethylene,
polypropylene and pvc.
• Adv. Of metal collapsible tube
- risk of contamination of portion remaining in the tube is
minimum because inner material is not suck back
13

14. Collapsibility test for Injectable and Non-Injectable preparation( IP
1996)
-This test is applicable for those containers, which have to be squeezed for the
withdrawal of product.
A container by squeezing yields at least 90% of its nominal contents at require
flow rate at ambient temperature.
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15. Aerosol spray :
Container: To withstand pressure 140-180 psig
1) Tin plate container- it is sheet of steel plates electroplated
on both side with tin
2) Aluminum container- it has seamless nature and greater
resistance to corrosion
(corroded by pure water and pure ethanol)
3)Stainless steel container –used inhalation aerosol
- No coating required
-extremely strong and resistant to most matter
4)Glass container – type I glass is used
Valve
1) Mounting cup / ferrule –tin plate steel, Aluminum, Brass
- it is used to attach the valve proper to container
2) Valve body/Housing – it is opening at the point of attachment of the dip tube.
-- Nylon or delrin
15

16. Dip tube –allows the liquid to enter the valve
- Polyethylene and polypropylene
Gasket - it is seal between the valve cup and
aerosol can .
-Buna N and Neoprene rubber
Stem -Nylon and Delrin or metal like Brass ,
stainless steel
Spring -Hold gasket in place
Actuator – is used to delivered the product
types of actuator
1) Spray – orifice is 0.016 – 0.040 inch in dia.
2) foam – orifice is 0.070- 0.125 inch in dia.
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17. Test of aerosol
Valve acceptance : The test procedure of metered valve having the
following value:
54µL or less, the limits are +/- 15%
55 to 200µL, the limits are +/- 10%
1) Of the 50 individual deliveries, if four or more are outside the limits, the valves
are rejected.
2) If three or two deliveries are outside the limits, another 25 valves are sampled
and test is repeated. The lot is accepted if not more than one delivery is outside
the specifications
Weight checking: :
This is usually accomplished by periodically adding to the empty
aerosol containers, which after being filled with concentrate, are removed and
accurately weighed to check the accuracy of filling operation.
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18. Leak testing :
The testing of efficiency of the valve closure is accomplished by passing
the filled containers through the water bath. Periodic checks are made of the
temperature of the water bath and the results are recorded
Spray testing: :
This method is based on the impingement of the spray on the paper that
has been treated with a dye-talc mixture. The particles that strike the paper cause
dye to go into solution and to be absorbed onto the paper. This gives the record
of spray.
18

19.  Glass Ampoules :
• Type I (borosilicate glass is used)
• Packaging is 100% tamper proof.
• One point or colour break ring offers consistent
breaking force.
• Up to 3 colour can be placed for identification purpose.
• PVC mono films used for 20 packaging.
MINIMUM
TYPE OF FORMULATION QUALITY OF
PACKAGE TYPE
CAN BE PACKED GLASS THAT
CAN BE USED
Aqueous Injectables Of Any
Type I
pH
Aqueous Injectables Of pH
Ampoule Type II
Less Than 7
Non-Aqueous Injectables Type III 19

20. Sealing of ampoule:
1) Tip sealing - seal is made by melting sufficient glass at the tip of the ampoule
neck
to form bead of the glass and close the opening.
2) Pull seals - seals are made by heating the neck of rotating ampoule below the
tip,
then pulling the tip away to form small, twisted capillary prior to being
melted closed
• Now a days, plastic ampoules for “water for injection” are available in the
market.
20

21. Vial With Stopper :
• Vials are mainly used for multiple dose
parenteral preparation and are provided with
the closure followed by aluminum seal to
ensure the perfect air tight packing
Aqueous Injectable Of Any pH Type I
Aqueous Injectables Of pH Less
Vial Type II
Than 7
Non-Aqueous Injectables Type III
Closure:
• Made from Butyl rubber ,Nitrile rubbers ,Neoprene, Silicon
rubbers.
• It has compression recovery, coring resistance, solvant
resistance, heat resistant , radiation resistance with very low 21
water absorption and permeability properties.

22. Test of closure
1) Fragmentation test :
Place a volume of water corresponding to nominal volume minus 4 ml in each of
12 clean vials.
Close the vial with closure and secure caps for 16 hours.
Pierce the closures with 21 SWG hypodermic needle (bevel angle of 10 to 14) and
inject 1 ml water and remove 1 ml air.
Repeat the above operation 4 times for each closure (use new needle for each
closure).
Count the number of the fragments visible to the naked eye.
Total numbers of the fragments should not be more than 10 except butyl rubber
where the fragments should not exceed 15.
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23. 2) Self sealability test for rubber closure applicable to multidose containers
only.
Fill 10 vials with water with nominal volume and close the vials with closure, secure
the cap.
Pierce the caps 10 times at different sites with 21 SWG hypodermic needle.
Immerse the vials in 0.1% w/v methylene blue solution under reduced external
pressure (27K Pa) for 10 mins.
Restore the normal pressure and keep the container immersed for 30 mins.
Wash the vials. None of the vials should contain trace of colored solution
3) Closure efficiency
Putting liquid in pack, inverting and applying a vacuum. A poor seal is detected by
liquid seeping.
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24. - Pre-Filled Syringe:
• It is used for small volume parenteral
preparation.
• Reduction of medication errors like drug
overfill.
• It gives Increased assurance of sterility
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25. Blow-fill-seal Technology :
• The basic concept of blow fill seal (BFS) is that a container is
formed, filled, and sealed in a continuous process without human
intervention, in a sterile enclosed area inside a machine.
• Plastic containers are made up of polyethylene and polypropylene.
• Polypropylene is more commonly used for containers because it
has greater thermo stability which is further sterilized by
autoclaving.
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26. A ) Thermoplastic resin is extruded into a tubular shape called a parison
.
B) When the parison reaches the proper length, the mold is closed and the parison
is cut
C)The blow-fill nozzle is lowered into the parison and by blowing sterile filtered
compressed
air into the parison and expanding it against the walls and the sterile product
is metered into the container through the fill nozzle.
D) Mold comes close at the top and hermetically seal the container.
E)The mold opens, and the formed, filled and sealed container
is conveyed out of the machine
26

27. Sterile plastic devices :
Irrigation solution container :
• It is made of LDPE , Polyolefin , polypropylenes
• Avoid hanging breakable glass
• It is light in weight, transparent, impermeable to
water
• Material have high boiling point so that it is
sterilizable .
27

28. I.V. Infusion :
• It is made of acrylonitrile butadiene styrene
• Spike is made of nylon
• tube is made of polyvinyl chloride
• Niddle adapter is made of polymethacrilate
Catheter:
• Catheter is inserted into a body cavity, duct, vessels.
• It is made of Silicone because it is inert and unreactive
to body fluids and a range of medical fluids with which
it might come into contact.
28

29. Disposable syringe :
• material used are polycarbonate, polyethylene,
polypropylene.
• Material used for piston are natural rubbers, butyl rubbers for sliding well
• Silicone and floroelastomer is more long lived than butyl rubbers..
• They have property of abrasion resistance, radiation resistance, excellent self-
life properties.
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30. Tests on the plastic containers
1 ) Leakage test for Injectable & Non-Injectable(IP 1996)
Fill the 10 containers with water and fit the closure.
Keep them inverted at RT for 24 hours.
No sign of leakage from any container.
2) Water vapor permeability test for injectable preparation(IP 1996)
Fill the 5 containers with nominal volume of water and seal.
Weigh the each container.
Allow to stand for 14 days at RH of 60 + 5% at 20 c to 25 c.
Reweigh the container.
Loss of the weight in each container should not be more than 0.2%.
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31. Test Toxicity Evaluation:
1) Implanting small pieces of plastic material intramuscularly in rabbits
2) Injecting the eluates using the sodium chloride injection with or without
alcohol intravenously in the mice and injecting the eluates using the
polyethylene glycol 400 and oil intraperetonially in mice
3) Injecting all four eluates subcutaneously in rabbits
The reaction from the test sample must not be significantly grater than non
reactive control sample.
31

32. 1) Plastic bottles:
• Material used for plastic bottle is
low density polyethylene, HDPE
• Consumers often get too little with each squeeze
• LDPE used in ophthalmics usually
contains minimal additives
• for caps are harder plastic materials
such as LLDPE, HighdensityP.E. ,
or Polypropelene is used.
2) Collapsible Tube
3) blow-Fill-Seal Plastic Bottle 32

33. • Backing Films
-To protect the active layer and safeguard the stability of the system
The most common materials used
- polypropylene, polyethylene (both high and low density), saran, polyesters,
PVC,and nylon.
• Semi-Permeable Membranes - act as a rate-limiting membrane
Material used are Ethylene Vinyl Acetate Membranes (EVA): Polyethylene
Membranes
33
- The permeability depends on the percentage of the EVA - the higher the

34. Pouching Materials
There are three main layers in the composite materials
used for pouches:
1) Internal plastic heat sealable layer, -
material used -polyethylene, surlyn
2) Aluminium foil layer –
Its important role in protecting the product
from light and oxygen.
3) External printable layer. It is used to achieve a
better 'finishing' and printing quality
material- Paper or polyester film is used
34

35. Tests of T.D.D.S. :
1) Thickness :
The thickness of transdermal film is determined by traveling
microscope, dial gauge, screw gauge, micrometer at different
points of the film.
2) Uniformity of weight :
Weight variation is studied by individually weighing -10 randomly
selected
patches and calculating the average weight. The individual weight
should
not deviate significantly from the average weight
3) Moisture Uptake: Weighed films are kept in a desiccator at room
temperature for 24 h. These are then taken out and exposed to 84%
relative humidity using saturated solution of Potassium chloride in a
desiccator .
% moisture uptake is calculated as-
35
% moisture uptake = Final weight – Initial weight X 100

36. Kurve technology :
• By this it is possible to deliver drug to
the entire nasal cavity as well as
olfactory region and paranasal sinuses
• It increases nasal residence time and
reduses the deposition of compound in
lungs and stomach
36

37. Opti-nose device :
• In this , air is blown out of the container and
sealing nozzle is used its direct flow of air in
nose
• It gives bi-directional flow so that it prevents
deposition of drug in lungs.
37

38. Direct-haler device :
for moisture protection
Transparenc
y of divice for
drug visibility
for turbulent
dispersion of dose
38

39.  Packaging materials are varies as the dosage form is
changes.
.
 By using different packaging device we can target drug
to specific site.
 We can protect the drug from external environment with
help of packaging material.
39

40.  Lachman, Libarman; “The theory and practice of
industrial pharmacy”, third edition, varghese publishing
house
 Jain U.K., Nayak S.; “Pharmaceutical packaging
technology”
PharmaMed Press
 Dean D.A., Hall I.H.; “Pharmaceutical packaging
technology”
Taylor and Francis
 Hanlon F. J., “Handbook of package engineering”, 40

41.  
All
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42.  
?
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