This document discusses various aspects of pharmaceutical packaging including primary, secondary and tertiary packaging. It describes different types of materials used for packaging like glass, plastics, metals, rubber and closures. Glass containers discussed include types I, II, III and NP glass. Common plastics used are polyethylene, polyvinyl chloride, polymethyl methacrylate and polypropylene. Factors to consider for drug-plastic compatibility and different types of closures are also summarized.

2. PACKAGING: It is the science, art and technology of enclosing
or protecting product for distribution, storage, sale, and use. It
also refers to the process of design, evaluation and fabrication
of the packages.
PHARMACEUTICAL PACKAGING: It can be defined as means
for providing protection, presentation, identification,
information, convenience, compliance and compatible unit,
which maintain the integrity and stability of the product

3.  WELL CLOSED CONTAINER: It protects the contents from extraneous solid and from loss
of the article under the ordinary condition of handing, shipment, storage and distribution
.
 TIGHT CONTAINER: It protects contents from the contamination by extraneous liquid,
solid or vapor from loss of the article and from efflorescence, deliquescence or evaporation.
 HERMETIC CONTAINER: It is impervious to air or any other gas under the ordinary
condition of handing, shipment, storage and distribution.
 LIGHT RESISTANT CONTAINER: It protects the contents from the effect of light. A clear
and colorless or translucent container may be made light resistant by means of opaque
covering.
 TAMPER EVIDENT CONTAINER: The container or individual carton of a sterile article
intended for ophthalmic or optic use which cannot be used without destruction of the seal.

6.  Stability
 Compatibility with the contents
 Strength of container and the degree of protection required
 Moisture-proof.
 Resistance to corrosion by Acids or Alkalis
 Resistance to grease
 Protection against salt
 Resistance to microorganisms
 Resistance to insects and rodents
 Resistance to differences in temperature
 Protection against light, fire and pilferage
 Odor retention and transmission.
 Cost
 Machine suitability of packaging and the filling method
 Convenience of the packaging for the physician, pharmacist and finally the
patient (size, weight, method of opening/re-closing, legibility of printing)

7. Primary
packaging
Secondary
packaging
Tertiary
packaging
E.g.
Blister , Strip
Sachets & pouches
Collapsible tube
Heat sealed membranes & closures
O intm e nt tube s
Vials, am po ule s
Pre -fille d syring e s
Ae ro so lco ntaine rs
Pre -fille d inhale rs
E.g.
cartons
Prescribe dispensing box
Corrugated boxes
Paper drums
Shipping containers
Injection trays
E.g.
Intermediate bulk
container
Slip sheet
Edge protector

8. PRIMARY PACKAGING
MATERIALS
GLASS
Vials
Ampoules
Tubular vials
Bottles
Dropper bottle
Aerosol containers
PLASTIC
Plastic jar
Plastic tube
Bottles
Syringes
Bags
Laminates
Pouches
Lids, taps, stems,
METALS
Collapsible tube
Laminated tube
Aerosol containers
PAPER
Labels,
Display units
Pouches
Laminates
Cartons
Boxes
Foil
Gum tapes
Paper drums
RUBBER
Closures
Vial wrappers
Caps
Plungers

10. TYPES OF PACKAGING :
Primary packaging is the material that envelopes the product and holds it.
This usually is the smallest unit of distribution or use and is the package
which is in direct contact with the contents.
Primary packaging :

11. Secondary packaging
Is outside the primary packaging-perhaps used to group primary packages
together.

12. Tertiary packages:
Is used for bulk handling, warehouse storage and transport shipping. The
most common form is a palletized unit load that packs tightly into the
container.

13. MATERIALS USED FOR MAKING OF CONTAINERS:
GLASS-
e.g.bottles,vials,ampules,syringes,i.v containers, aerosol containers.
PLASTIC-
e.g.bottlespouches,tapes,tubes,aerosolcontainers,laminates.

14. RUBBER-
e.g. closures, caps,vialswrapers,plungers.
Metals-
e.g. collapsabletubes,foils,needles,aerosol containers

15. Paper or cardboard-
e.g. secondary packaging
labels,inserts,displayunits,pouches,laminates,cartons,carrogated
boxes,foils,paper drums

16. Composition of glass:
Glass is composed principally of sand, soda ash, lime stone and
cullet.
Sand is almost pure sillica,soda ash is sodium carbonate, lime
stone is calcium carbonate.
Cullet is broken glass that is mixed with the batch and acts as
fusion agent for the entire mixture.
GLASS CONTAINERS:

17. Manufacture of glass:
The four basic processes used in the production of glass are:-
1.Blowing uses compressed air to form the molten glass in the cavity of
metal mold.
2.In drawing, molten glass is pulled through dies or rollers that shape the
soft glass.
3.In pressing mechanical force is used to press the molten glass against the
side of a mold.
4.Casting uses gravity or centrifugal force to cause molten glass to form in
the cavity of mold.

18. TYPES OF GLASSES:
Type I-borosilicate glass
It is highly resistant glass.
It has high melting point so can with stand high temperatures.
It is more chemically inert than the soda lime glass.
It can resist strong acids,alkalies and all types of solvents.
Reduced leaching action.
USES:
Laboratory glass apparatus.
For injection and water for injection.

19. Type II-treated soda lime glass
Type II containers are made of commercial soda lime glass that has been dealkalised or
treated to remove surface alkali.
The de-alkalizing process is know as sulfur treatment.
Sulfur treatment neutralizes the alkaline oxides on the surface, rendering the glass
more chemically resistant.
Uses:
Used for alkali sensitive products.
Infusion fluids, blood and plasma.
Large volume container.

20. Type-III regular soda lime glass
Containers are untreated are made of commercial soda lime glass of
average are better than average chemical resistance.
It contains high concentration of alkaline oxides and imparts alkalinity to
aqueous substances.
Flakes separate easily.
USES:
For all solid dosage forms.
For oily injections.

21. Type NP-general purpose soda lime glass
Containers are made of soda lime glass supplied for non parental products,
intended for oral or topical use.
USES:
FOR ORAL USE.
TOPICAL PURPOSE.

22. GLASS:
Advantage disadvantage
They are strong and rigid. They are brittle and break
easily.
They are transparent which allows visual inspection. They may crack when
subject to sudden changes
in temperatures
They are available in various shapes and sizes. They are heavier in
comparison to plastic
containers
They can withstand with temperature and pressure
during sterilization.
They are economical and readily available.
They can protect the photosensitive medicaments
from light during their storage.

23. PLASTIC CONTAINERS:
Plastics are synthetic polymers of high molecular weight.
Plastics as packaging have proved useful for a number of reasons,
including the ease with which they can be formed, their high quality and the
freedom to design.
Plastic containers are extremely resistant to breakage and offer safety
consumers.

24. PLASTIC ARE OF TWO FROMS:
1.Amorphous plastic.
2.Crystalline plastic.
AMORPHOUS PLASTIC:
They give good transparency.
They are hard but posses little brittleness.
They are more permeable to gases and vapour.
They are of less inert.

25. CRYSTALLINE PLASTICS:
For photo sensitive drugs this type of plastics are selected.
They are opaque.
They are more flexible.
They are less permeable to gases and vapour.
They are more inert.

26. Plastic containers for pharmaceutical products are
primarily made from the following polymers:
 polyethylene
 polypropylene
 poly vinyl chloride
 polystyrene
 polymethyl methacrylate
 amino formaldehyde
 poly amides

27. Thermoplastic type :-
On heating, they are soften to viscous fluid which hardens again on
cooling.
e.g. polyethylene ,PVC ,Polystyrene, polypropylene, Polyamide,
Polycarbonate.
Thermosetting type :-
When heated , they may become flexible but they do not become liquid.
Phenol formaldehyde ,urea formaldehyde, melamine formaldehyde
TYPES OF PLASTICS:

28. 1) Polyethylene:
 Its is flexible, very light but tough plastic.
 It is impermeable to water vapour and does not deteriorate with
age unless it is exposed to sunlight for long time.
 It has permeability to certain oils and preservatives.
 Its melting point being in the range of 1100
to 1500
c
 It has high melting point and can sterilized by autoclaving.
 It is divided into 1. HDPE (HIGH DENSITY POLYETHYLENE )
2. LDPE ( LOW DENSITY POLYETHYLENE )
 HDPE : Inert, low cost, tough in nature.
 LDPE : Inert, great resistant to gases, low cost.

29. POLYVINYL CHLORIDE (PVC ):
It is less flexible , heavier and more permeable to water vapour as
compared with normal polythene.it has high clarity and not effected
by sunlight. It is used for preparing eye ointment tubes.

30. POLYMETYL METOCARYLATE(PMMA):
It is hard , strong but light, transparent plastic.
It softens at about1000
c.
It is used for preparing bottles and tubes.

31. POLYSTYRENE:
It is a hard, rigid , light material.
It can be easily molded into any shape.
So it is used for preparing bottles, tubes , jars , boxes
and syringes.

32. POLYPROPYLENE:
It is similar to high density polythene.
It is very light and heat resistant.
Its melting point is 1700
c
It has high melting point and can sterilized by
autoclaving.
So it is used for preparing squeeze bottles, tubes, and
syringes.

33. POLYCARBONATE:
It is transparent, has high impact strength and very
good heat resistance.
It is used in the preparation of surgical equipment.

34. Advantage Disadvantage
They are light in weight and can be
handled easily.
They are permeable to water
vapour and atmospheric gases
They are transported easily. They are poor conductor to heat.
They are unbreakable. They may absorb chemical
substances, such as preservative
for solutions.
They available in various shapes
and sizes.
They are resistant to inorganic
chemicals.
They are relatively expensive.
PLASTICS:

35. DRUG-PLASTIC CONSIDERATIONS
A packaging system must protect the drug without altering the
composition of the product until the last dose is removed.
Drug-plastic considerations have been divided into five
categories:
1.Permeation
2.Leaching
3.Sorption
4.Chemical reaction
5.Alteration

36. Permeation:
It is the transmission of gases, vapors or liquids through plastic
packaging material.
Permeation of water vapor and oxygen through plastic wall into
the drug is a major problem is the dosage form is sensitive to
hydrolysis and oxidation.
The volatile ingredients might change when stored in plastic
containers and the taste of the medicinal products may change for
the same reason of permeation.

37. Leaching:
Some plastic containers have one or more ingredients added to
stabilize it, these may leach into the drug product.
Problems may arise with plastics when coloring agents are added
in small quantities to the formula.
Particular dyes may migrate into the parental solution and cause a
toxic effect.

38. Sorption:
This process involves the removable of constituents from the drug
product by the packaging material.
The therapeutic efficacy of the product may be reduced due to
sorption.
Sorption may change the chemical structure, Ph., solvent system,
concentration of active ingredients and temperature etc…

39. Chemical reactivity:
Certain ingredients in plastic formulations may react chemically
with one or more components of the drug product.
Even in micro quantities if incompatibility occurs may alter the
appearance of the plastic or the drug product.

40. Modification:
The physical and chemical alteration of the packaging material
by the drug product is called modification.
Some solvent systems found to be considerable changes in the
mechanical properties of the plastics.
For example oils have a softening effect on polyethylene,
hydrocarbons attack polyethylene and PVC.

41. METALS:
Metals are used for construction of containers. The
metals commonly used for this purpose are aluminum
,tin plated steel, stainless steel, tin and lead.

42. ADVANTAGES: DISADVANTAGES:
They are impermeable to light, moisture and
gases.
They are expensive.
They are made into rigid unbreakable containers
by impact extrusion.
They react with certain
chemicals.
They are light in weight compared to glass
containers.
Labels can printed directly on to their surface.
METALS:

43. COLLAPSIBLE TUBES
METAL
•The collapsible metal tube is an attractive container that permits
controlled amounts to be dispensed easily, with good reclosure,and
adequate protection of the product.
•It is light in weight and unbreakable and lends itself to high speed
automatic filling operations.
•Any ductile metal that can be worked cold is suitable for
collapsible tubes, but the most commonly used are tin, aluminium
and lead. Tin is most expensive and lead is cheapest.

44. Tin:
Tin containers are preferred for food, pharmaceuticals and any
product for which purity is considered.
Tin is the most chemically inert of all collapsible metal tubes.

45. Aluminum:
Aluminum tubes offer significant savings in product shipping costs
because of their light weight.
They are attractive in nature.

46. Lead:
Lead has the lowest cost of all tube metals and is widely used for
non food products such as adhesives,inks.paints and lubricants.
Lead should never be used alone for anything taken internally
because of the risk lead poison.
With internal linings, lead tubes are used for products such as
chloride tooth paste.

47. CLOSURE:
A closure is the part of the package which prevent the contents
from escaping and allow no substance to enter the container.
Closures are available in five basic designs
1.Screw on, threaded or lug
2.Crimp on(crowns)
3.Press on(snap)
4.Roll on and
5.Friction

48. Threaded screw cap:
When a screw cap is applied, its threads engaged with the corresponding
threads molded on the neck of the bottle.
The screw cap is commonly made of metal or plastics. The metal is usually
tin plate or aluminum and in plastic is thermoplastic and thermosetting material.

49. Lug cap:
The lug cap is similar to the threaded screw cap and operates on the same
principle.
It is simply an interrupted thread on the glass finish, instead of a
continuous thread.
Unlike the threaded closure, it requires only a quarter turn.
The lug cap is used for both normal atmosphere pressure and vacuum
pressure closing.

50. Crown caps:
This style cap is commonly used as a crimped closure for beverage bottles.

51. Roll-on closures
The aluminum roll on cap can be seal securely, opened easily and
resealed effectively.
Resealable,non resalable and pilfer proof types of roll on closures
are available for use on glass or plastic bottles.

52. Pilfer proof closures
It is similar to roll on closure but has a greater skirt length.
This additional length extends below the threaded portion and fastened to the
basic cap by the series of narrow bridges.
When the closure is removed the extra portion remains in the space on neck
of the container, this indicates that the package has been opened.

53. RUBBER:
Rubber is used mainly for the construction of closure meant for
vials, transfusion fluid bottles, dropping bottles and as washers in
many other types of product.
BUTYL RUBBER:
Advantages:
Permeability to water vapor .
Water absorption is very low.
They are relatively cheaper compared to other synthetic rubbers.
Disadvantages:
Slow decomposition takes place above 1300
C.
Oil and solvent resistance is not very good.

54. NITRILE RUBBER:
Advantages:
Oil resistant due to polar nitrile group.
Heat resistant.
Disadvantages:
Absorption of bactericide and leaching of extractives are
considerable.
CHLOROPRENE
RUBBERS:
Advantages:
Oil resistant.
heat stability is good.

55. SILICON RUBBERS:
Advantages:
Heat resistance.
Extremely low absorption and permeability of water.
Excellent aging characteristic.
Disadvantages:
They are very expensive.

56. FDA approves the following configurations as tamper
resistant packaging:
1.Film wrappers
2.Blister package
3.Strip package
4.Bubble pack
5.Shrink seals and bands
6.Oil, paper, plastic pouches
7.Bottle seals
8.Tape seals
9.Breakable caps
10.Aerosol containers

57. 1. Film wrapper
Film wrapping has been used extensively over the years for
products requiring package integrity or environmental
protection.
It is categorizes into following types:
i. End folded wrapper
ii. Fin seal wrapper
iii. Shrink wrapper

58. End folded wrapper
The end folded wrapper is formed by passing the product into
a sheet of over wrapping film, which forms the film around the
product and folds the edges in a gift wrap fashion.
The folded areas are sealed by pressing against a heated bar.
The materials commonly used for this purpose are cellophane
and polypropylene.

59. Fin seal wrapper
The seals are formed by crimping the film together and
sealing together the two inside surfaces of the film, producing a
fin seal.
Fin sealing is superior than end folded wrapper
With good seal integrity the over wrap can removed or opened
by tearing the wrapper.

60. Shrink wrapper
The shrink wrap concept involves the packaging of the product
in a thermoplastic film that has been stretched and oriented
during its manufacture.
An L shaped sealer seals the over wrap
The major advantage of this type of wrapper are the flexibility
and low cost of packaging equipment.

61. BLISTER PACKAGE:
Blister package provides excellent environmental protection,
esthetically leasing and efficacious appearance.
It also provides user functionality in terms of convenience ,child
resistance and tamper resistance
The blister package is formed by heat softening a sheet of
thermoplastic resin and vacuum drawing the soften sheet of
plastic into a contoured mold.
After cooling the sheet is released from the mold and proceeds
to the filling station of the machine.
It is then lidded with heat sealable backing material

62. Peel able backing material is used to meet the requirements
of child resistance packaging.
The material such as polyester or paper is used as a
component of backing lamination.
Materials commonly used for the thermo formable blister are
PVC, polyethylene combinations , polystyrene and
polypropylene.

63. STRIP PACKAGE
A strip package is a form of unit dose packaging that is
commonly used for the packaging of tablets and capsule.
A strip package is formed by feeding two webs of a heat sealable
flexible through heated crimping roller.
The product is dropped into the pocket formed prior to forming
the final set of seals.
A continuous strip of packets is formed in general.

64. The strip of packets is cut into desired number of packets.
Different packaging materials used are:
paper/polyethylene/foil/PVC.

65. BUBBLE PACK
A bubble can be made usually by sandwiching the product
between a thermo formable, extensible or heat shrinkable plastic
film and a rigid backing material.
The product is dropped into pocket which is then sealed with
heat sealed coated paper board.

66. SHRINK BANDING
The shrink band concept make use of heat shrinking
characteristics of a stretch oriented polymer usually the PVC.
The polymer is manufactured as a extruded oriented tube in a
diameter slightly larger than the cap and neck ring of the bottle to
be sealed.

67. BOTTLE SEALS
A bottle may be made tamper resistant by bonding and inner seal
to the rim of the bottle in such a way that the product can only be
attained by destroying the seal.
For pressure sensitive inner seals pressure sensitive adhesive is
coated on the surface of the inner seal as an encapsulated
adhesive.

68. TAPE SEALS
It involves the application of glued or pressure sensitive tape or
label around or over the closure of the package which is to be
destroyed to obtain the product.
Labels made of self destructing papers are available.
But these cannot survive any attempt at removal once they have
been applied.

69. BREAKABLE CAPS
Breakable closures come in many different designs.
The roll-on cap design of aluminum shell used for carbonated
beverages.
The bottom portion of the cap is rolled around the bottle neck
finish.
The lower portion of the cap
blank is usually perforated so that
it breaks away when the cap is
unscrewed.

70. SEALED TUBES
Collapsible tubes used for packaging are constructed of metal,
plastic or lamination of foil, paper and plastic.
Metal tubes are still used for products that required high
degree of barrier protection.
Most of these are made of aluminum.
Extruded plastic tubes are widely used for products that are
compactable and limited protection of plastic.

71. AEROSOL CONTAINER
The aerosol container used for pharmaceutical products is
usually made of drawn aluminum.
A hydrocarbon propellant in its cooled liquid phase is added to
the container along with the product.
A spray nozzle contained in a gasket metal is crimped over the
opening of the container.
A dip tube is attached inside, draw the product through the spray
nozzle.

72. The spray nozzles are usually metered to allow a specific dose to
be dispensed with each spray.

73. SEALED CARTONS
Folding paperboard cartons have been used as a secondary
package for OTC products.
The popularity is based on both functional and marketing
considerations.

74. EVALUATION OF PACKAGING
MATERIALS
TESTS FOR GLASS CONTAINERS:
1) Powdered glass test
2) Water attack test
Preparation of specimen for powdered glass test:
Rinse 6 or more containers and dry them
Crushed in to fragments
Divide 100gms of coarsely crushed glass in to
three equal parts

75. place 1 portion in a mortar
Crush further by striking 3 or 4 blows with
hammer
Nest the sieves (# 20,40 at least)
Empty the mortar in to sieve 20
Shake the sieves and remove the glass particles
from # 20 and 40
Crush them again and sieve them
Transfer the retained portion on # 50

76. Spread the specimen on a glazed paper
and remove iron particles with the help of magnet
Wash with 6 portions of 30ml acetone
Dry the contents for 20mins at 140o
c
Transfer to weighing bottle and cool in a desiccator
Final specimen should be used in powdered glass
test

77. 1) POWDERED GLASS TEST: (acco rding to USP vo lum e 27 )
Transfer 10gms of prepared specimen in a 250ml
conical flask digested previously with high purity water in a
bath at 90o
c
Add to conical flask containing 50ml high purity water
Cap all the flasks and auto clave
Adjust temperature to 150o
c
Cold the temperature to 121o
c for 30mins
Cool the flasks under running water

78. Wash the residue powdered glass(4 times with 15ml
purity water)
Add the decanted washings to main portion.
add five drops of methyl red solution.
Titrate immediately with 0.02N sulphuric acid.
Record the volume of 0.02N sulphuric acid.
Volume does not exceed i.e. indicated in the USP
as per the type of glass concerned

79. WATER ATTACK TEST:(USP)
rinse 3 or more containers with high purity water
fill each container to 90%of its over flow capacity
cap all the flasks and autoclave for 60mints
empty the contents and cool the contents in 250ml conical
flasks to a volume of 100ml
add 5 drops of methyl red solution
titrate with 0.02N sulphuric acid while warm
record the volume of 0.02Nsulphuric acid consumed
volume should not exceed as indicated in USP as for type of glass

80. Type Types of the test Limits size(ml) Limits(ml of o.o2N)
I Powdered glass test All 1.0
II Water attack test 100 or
less
0.7
III Powdered glass test All 8.5
IV Powdered glass test All 15.0
STANDARDS:

81. 
Hydrolytic Resistance (EP)
•
By titration of the extract solutions obtained under the conditions
described for test A, B and C
•
TEST A : SURFACE TEST (hydrolytic resistance of the inner
surfaces of glass container)
•
TEST B : GLASS GRAINS TEST (hydrolytic resistance of glass
grains)
•
TEST C : ETCHING TEST ( To determine whether the
containers have been surface-treated)
•
Limits for Glass Grains Test
(Test B):

82. 
Light transmission test
•
A spectrometer of suitable sensitivity is used to cut the section of
glass container. The transmittance of the selection is measured
and transmission of light is observed.
•
Maximum % of light transmission at any wavelength between
299nm and 450nm.

Arsenic: Use 35ml of solution prepared by procedure under
water attack at 121ºC and test against std. arsenic. Limit is 0.1ug
per g.

83. TESTS FOR PLASTIC CONTAINERS
1.Leakage test for plastic containers(non injectables
and injectables 1996 IP):
fill 10 plastic containers with water and fit the
closure
keep them inverted at room temperature for 24 hrs
no sign of leakage should be there from any
container

84. 2.WATER PERMEABILITY TEST FOR
PLASTIC CONTAINERS(INJECTABLE
PREPARATIONS IP 1996):
fill 5 containers with nominal volume of water and
sealed
weigh each container
allow to stand for 14 days at relative humidity of
60% at 20-250C
reweigh the container
loss of weight in each container should not be more
than 0.2%

85. 
Compatibility test

Compatibility components will not interact with the dosage form
and may not show leaching. Regular screening is done by liquid
chromatography, mass spectrometry, GC-MS etc.
•
Other changes like PH shift, precipitation, discoloration, which
may cause the degradation of the product should be evaluated.

86. TESTS FOR RUBBER/RUBBER CLOSURES
1.FRAGMENTATION TEST(IP 1996):
place a volume of water corresponding to nominal
volume-4ml in each of 12 clean vials
close vial with closure and secure caps for 16hrs
pierce the closure with number 21 hypodermic
needle(bevel angle of 10 to 140c)and inject 1ml water and
remove 1ml air
repeat the above operation 4 times for each closure
count the number of fragments visible to naked eye
Total number of fragments should not be more than

87. 2.SELF SEALABILITY TEST FOR RUBBER
CLOSURES APPLICABLE TO MULTI DOSE
CONTAINERS ONLY(IP 1996):
fill 10 vials with water to nominal volume and
close the vials with closures
pierce the cap and closures 10 times at different
places with no 21 syringe needle
immerse the vials in 0.1 %W/v solution of
methylene blue under reduced pressure
restore the nominal pressure and keep the
container for 30 min and wash the vials
none of the vial should contain traces of colored
solution

88. 
Leakage testing and package integrity testing

Mainly two types of testing are involved for checking package integrity.
Destructive type testing
Dip the packages in the pot containing the colored water (15-25 c) and place
the pot in the vaccum chamber.
Apply the vaccum of 33K Pa for strip packages and 24K Pa for blister packs
for 30 sec.
Return to the atmospheric pressure and remove the pot from the vaccum
chamber.
Examine the package for ingress of the water in to the package

89. 
Non-destructive type testing
•
This type of testing equipment is based on a dry pressure vaccum
procedure followed by detection of pack distortion (deflection)
or non-distortion, i.e. packs with effective seals become concave
them convex as positive pressure changes to negative pressure,
while leaking packs either do not change or show less or limited
distortion, depending on the scale of the leakage.

Pinholes and package integrity
•
Pinholes are the common features of aluminium foil. It can be
detected by water vapor permeation. High water vapor
permeation indicates the high numbers of the pinholes.

90. •
Testing of paper and board Air permeability: - Permeability
is the mean air flow through unit area under unit pressure
difference in unit time, under specific conditions, expressed in
Pa-1s-1.
•
Tensile strength: - both wet and dry. The maximum tensile
force per unit width that a paper or board will withstand before
breaking.
•
COBB TEST: - This measures the mass of water absorbed by
1cm2 of the test piece in a specified time under a head of 1 cm
of water. It is determined by weighing before and after exposure
to the water, and usually quoted in g/m2

91. •
Carton opening force: Hold the flat carton as
delivered by its crease between thumb first figure and
press. The carton should spring open in to the square
position without the need for unreasonable force.
•
Compression: - Assessment of the strength of the
erected package, thereby estimating the degree of
protection that it confers on the contents.

93. • The following characteristics are common requirements of
most regulatory agencies:
1.Product or preparation related requirements
• Protection of the product
• Protection of the consumer
• Control of doses
1.Label related requirements
• Information to the receiver
• Legal control of the product

94. 3.Environmental aspects:
•Packaging wastage
•Ozone depletion
4.Consumer protection:
•Child resistant closures
•Tamper evident packaging

95. Packaging Concerns forCommon Classes of Drug Products
Degree of Concern Associated with the Route of
administration
PACKAGING COMPONENT-DOSAGE FORM
INTERACTION
HIGH MEDIUM LOW
HIGHEST Inhalation Aerosol and
Solution ;
Injectables
Sterile powder
and powder
of injection
HIGH Ophthalmic solution,
susp.,
Transdermal
Patches, nasal
sprays
LOW Topical solution ,susp.
Aerosol, Oral
sol.,susp.
Topical Powders
Oral Powders
Oral Tablets
and
Capsule

96. • FDA packaging guidelines defines the types of
containers to be used, dividing them into :-
• Parentral containers (glass/plastic)
• Nonparentral containers (glass, plastic & metal)
• Pressurized containers
• Bulk containers of API & drug products

97. • According to FDA guidelines, for submitting documents for
packaging for human drugs and biological, the following are
required.
1.Purpose:
• Package must maintain standards, identity, strength, quality &
purity for intended shelf-life
• Full information needed
• Type of container/closure
• Suitability for intended use
• Submission of packaging information & date.

98. 2. Environmental concerns:
• With increased environmental concerns there has been a
considerable pressure to reduce contamination of environment
with particular concern on amount of packaging & its disposal.
• Ozone depletion is also of concern with the use of pressurized
containers.
• Regarding this aspects, the increase in concerns has led to the
European E Commission packaging waste directive which
requires:
Reduction in quantity of waste
Reduction in harmfulness of waste
Increase in reuse of packaging
Recycling & recovery of packaging waste &
Reduction of the total packaging to be disposed of.

99. • Description
Overall general description of the container closure system and
For each packaging component :
 Name, Product code, Manufacturer, Physical description
 Materials of construction
 Description of any additional treatments or preparation.
• Suitability
Protection : Safety :
 Light exposure  Chemical composition
 Reactive gases  Extractables
 Moisture permeation  Extraction/toxicological
study
 Solvent loss  Other studies as
appropriate
 Microbial contamination
Compatibility : Performance :
 Interaction  Functionality
 Post approval stability studies  Drug delivery

100. Quality Control
For Each Packaging Component Received by the Applicant
 Applicant`s test and acceptance criteria
 Dimensional and performance criteria
 Method to monitor consistency in composition
For Each Packaging Component Provided by the Supplier
 Manufacturer`s acceptance criteria for release
 Brief description of Mfg. Process
Stability
 Container closure system should be monitored for sign of instability.
Applicant should investigate any observed change In the packaging system
used in stability studies.
If corrective action requires a change in an approved container closure
system, a supplemental application should be submitted.

101. Child resistant packaging
Elder friendly
Temper proof packaging

102. • The packaging that excludes the entry of children of
less than 5 years age but not adults to access the
contents of the pack.
• Legally : “ At least 80% of children between the
ages of 20 and 42 months forming a test panel are
unable to open the packaging within 10 minutes of
receiving it.”

103. Some of the "elder-friendly" concepts we expect to see
include the conversion to square- or rectangular-footprint
bottles from cylinders--to facilitate container opening and
to resist rolling off countertops.
Unit-dose packaging itself would be a help.
Other problem with geriatric patient is poor vision in dark
in such cases glow-in-the dark inks can be used in printing
packaging material.
 Missing dose is still a common problem for which a
specially printed strips are designed on which the day &
time is printed at which the drug is to be taken.

104. • Tamper proof containers are those that resist the tampering of
the product before consuming the product.
• Tampering includes three aspects,
Altering,
Pilfering and
Falsifying
• They help in….
Receiving the products by patients “ as manufactured “
Preventing “ product browsing and sampling “

105. Film Wrappers
Blister or Strip Packs
Bubble Packs
Heat Shrink Bands or Wrappers
Foil, Paper, or Plastic Pouches
Bottle Mouth Inner Seals
Tape Seals
Breakable Caps
Sealed Metal Tubes or

106. • Reckitt Benkiser has launched the easily portable
‘handy tube’ version of its popular strepsils.
• The new packaging is not only convenient to carry but
also provides adequate humidity protaction during its
shelf life.

107. • Catalent’s Delpouch starter kit packaging system,
designed for topical treatments.
• Delpouch measures the right amount of topical creams or
ointment to simplify the application process.

108. • Cypack’s advance medication monitoring and report
card systems, can record the time and date that a pill was
taken based on when it is removed from its blister.

109. • Packaging company Amcor flexibles introduced a Child
resistant blister pack, which is compliant to CR / Senior
friendly regulations in the Europe and US.

110. • UK packaging producer, Burgopak’s sliding CR blister pack
can only be opened by applying pressure at two separate points
on the packaging.
• Burgopak Healthcare & technology – won the award for the
‘most innovative child resistant packging design’ at the
Pharmapack Paris exhibition on 16th
feb. 2012.

111. • In august 2011, Keystone folding box company and Legacy
pharmaceutical packaging launched their Ecoslide-RX
sustainable compliance packaging.
• The pack is made from 100% recycled material, using
unbleached paperboard and a clay coated surface , designed to
house blister packaging with a minimum of unsustainable film
and foil.
• It doesn’t require heat sealing in the mfg. process.

113. • A DISKUS® is a dry powder inhaler that holds 60 doses.
• It features a built-in counter, so that you always know
how many doses you have left in it.

114. • Give the importance of pharmaceutical packaging. ( July
2011,Dec 2010)
• Classify packaging materials with examples. (Dec. 2010)
• Discuss factors affecting selection of packaging material. (Dec.
2010)

115. • Write a note on child resistant and temper proof packaging.
(July 2010)
• Define pharmaceutical package. Enlist the criteria for selection
of package type and packaging material. Classify the
packaging materials. (July 2010)
• Discuss the regulatory aspects for packaging materials. ( July
2011,Dec. 2010)

116. • D.A.Dean, E.R.Evans, Pharmaceutical Packaging
Technology,Taylor and Francis, pg no.50-72
• G.S.Banker, Modern Pharmaceutics, fourth edition,
Marcel Dekker,Inc.
• E.J.Bauer, Pharmaceutical packaging Handbook,
Informa Healthcare, pg no. 157-162
• James Swarbrick, Encyclipedia of Pharmaceutical
Technology, volume 1, Third edition, Informa
Healthcare.

117. • www.karishmainternational.com
• www.aclan packaging .com