Pharmaceutical packaging materials

Waseem Ahmed
aqwaseem@hotmail.com
https://www.linkedin.com/in/aqwaseem/
Pharmaceutical Packaging Professional

Waseem Ahmed
CONTENTS:
 What is PACKAGING
 Characteristic of PACKAGING
 The Role of PACKAGING
 Levels of PACKAGING
 Types of PACKAGING
 Types of Material for PACKAGING

Waseem Ahmed
The PACKAGING refers to all those activities related to designing,
evaluating and producing the container for a product. Simply,
PACKAGING is to store and protect product from any physical
damage and at the same time attracting the customer through
its appeal is called as PACKAGIGN.

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Physical protection
Barrier protection
Containment or agglomeration
Information transmission
Marketing
Security
Convenience
Portion control
Keeping the contents clean, fresh, sterile and safe for the
intended shelf life is a primary function.
Physical protection
Among other things, mechanical shock, vibration, electrostatic discharge,
compression, temperature
Barrier protection Barrier from oxygen, water vapor, dust, etc.
Containment or
agglomeration
Small objects are typically grouped together in one package for reasons of
efficiency.
Information transmission
Communicate how to use, transport, recycle, or dispose of the package or
product
Marketing
Can be used by marketers to encourage potential buyers to purchase the
product
Security Can play an important role in reducing the security risks against counterfeit
Convenience
Can have features that add convenience in distribution, handling, stacking,
display, sale, opening, reclosing, use, dispensing, and reuse
Portion control Precise amount of contents to control usage

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Packaging is an integral part of pharmaceutical product
 Protection
 Against light
 Against reactive gases
 Against moisture
 Against microbes
 Against physical damage
 Against pilferage and adulteration
 Presentation
 Identification
 Information
 Compatible
 Convenience

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Primary
Packaging
Secondary
Packaging
Tertiary
Packaging
The material that first
envelops the product and
holds it. This is the smallest
unit of distribution or use
and is the package which is
in direct contact with the
contents.
Outside the primary
packaging used to group
primary packages
together.
Used for bulk
handling, warehouse
storage and transport
shipping.
Primary Packaging
Secondary Packaging
Tertiary Packaging

Waseem Ahmed
Multidose /
Re-closeables
Unit
Dose/Non-re-
closeables
Bulk
Bottles
Aerosol packs
Tubes
Ampoules, Blister packs
Prefilled syringes, Vials
Sachets
Form/Blow-Fill-Seal (FFS, BFS) - Various pack formats
Bottles
Drums/Kegs
Sacks/Bags

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Glass Metal Plastic Rubber
Jars,
Syringe,
Stoppers,
Ampoules,
Bottles,
Vials,
Cartridges,
Dropper,
Aerosol container,
Tubes
Tubes,
Blister & strip packs,
Sachets
Tubes,
Blister & strip packs,
Sachets,
Bottles,
Stopper,
Caps & Covers,
Pumps, Childproof
Closures
Closures
Seals

Waseem Ahmed
 Glass widely used as a drug packaging material for many
pharmaceuticals' products including medicinal products for oral
and local administration.
 Glass containers are usually the ﬁrst choice (e.g. bottles for
tablets, injection syringes for unit- or multi-dose administration).
 Different types of glass may be necessary, depending on the
characteristics and the intended use of the medicinal products.
What is glass composition?
Glass is a hard material normally fragile and transparent common in
our daily life. It is composed mainly of sand (silicates, SiO2) and an
alkali.
Glass
GLASS Composition
 Silica (SiO2) 59-75 %
 Calcium oxide (CaO) 5-12 %
 Sodium oxide (Na2O) 12-17 %
 Alumina (Al2O3) 0.5-3.0 %
 Other oxide :
1) Barium oxide (BaO)
2) Boric oxide (B2O2)
3) Potassium oxdie (K2O)
4) Magnesium oxide (MgO)

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Properties of Glass
 Solid and hard material
 Disordered and amorphous structure
 Fragile and easily breakable into sharp pieces
 Transparent to visible light
 Inert and biologically inactive material
 Glass is 100% recyclable
 0ne of the safest packaging materials due to its composition and
properties
 Glass does not deteriorate, corrode, stain or fade and therefore is
one of the safest packaging materials.
 These properties can be modified and changed by adding other
compounds or heat treatment.
Glass

Waseem Ahmed
Advantages of Glass
 They are transparent and allows easy
inspection of the contents inside.
 They have good protection power.
 They can be easily labeled.
 They are available in different shapes
and sizes.
Disadvantages of Glass
 Glass is fragile so easily broken.
 Release alkali to aqueous
preparation.
 Glass is expensive when compared to
plastic packing material.
Glass

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Type I Glass
Borosilicate glass / Neutral glass
(contains 80% silica, 10% boric oxide,
small amount of sodium oxide and
aluminium oxide)
 It is highly resistant glass.
 It has high melting point.
 It is more chemically inert than the soda lime glass.
 Reduce leaching action.
 Laboratory glass apparatus.
 Can be used to contain strong acids and alkalis.
 Suitable for parenteral or non-parenteral.
Type II Glass
Soda-lime-silica glass/ treated soda-lime
glass/ De alkalized soda lime glass
 This is a modified type of Type III glass container with a high
hydrolytic resistance resulting from suitable treatment of the
inner surface of a type III glass with sulphur.
 This is done to remove leachable oxides and thus prevents
blooming/weathering from bottles.
 Type II glass has lower melting point when compared to Type
I glass and so easier to mould.
 They are suitable for most acidic and neutral
aqueous preparations whether parenteral or non-
parenteral.
Type III Glass
Regular soda lime glass
 This is an untreated soda lime glass with average chemical
resistance.
 It contains 75% silica, 15% sodium oxide, 10% calcium oxide,
small amounts of aluminium oxide, magnesium oxide, and
potassium oxide.
 Aluminium oxide impacts chemical durability while
magnesium oxide reduces the temperature required during
moulding.
 They are used as packaging material for parenteral
products or powders for parenteral use ONLY WHERE
there is suitable stability test data indicating that Type
III glass is satisfactory.
 They used in packaging non-aqueous preparations and
powders for parenteral use with the exception of
freeze-dried preparations
 It is also used in packaging non-parenteral
preparations.
Type IV Glass
Type NP glass/General-purpose soda
lime glass
 This type of glass container has low hydrolytic resistance.
 This type of glass containers are not used for products that
need to be autoclaved as it will increase erosion reaction rate
of the glass container.
 It is used to store topical products and oral dosage
forms
Types of Glass  Except for type I glass containers, glass containers for pharmaceutical
preparation are not to be re-used.
 Containers for human blood and blood components must not be re-used.
Glass

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Glass containers are formed through the following methods
Blowing – this involves the use of compressed air to form the
molten glass in the cavity of a mold.
Drawing – this involves the pulling of molten glass through dies
that shape the soft glass into ampoules, vials etc.
Pressing – The glass is formed by the use of mechanical force which
presses or forces the molten glass against the ride of a mold.
Casting –the force of gravity or centrifugal force is used to initiate
the formation of molten glass in the cavity.
Process of Forming Glass Containers
Glass

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Pharmaceutical vials
Injection vials
Lyophilization vials
Tablet vials
Large OD vials
Diagnostic vials Special vials
Screw thread vials
Screw thread tubes
Chromatography vials
Special vials
Two-compartment vials
Sampler vials
Flint and amber glass ampoules.
Straight-stem, funnel-type and closed
ampoules. Various brake systems such as
OPC (One Point Cut), CBR (Color Break
Ring) and Score Ring.
Examples - Glass
For filling syrups, oral liquid
For filling vitamins and nutritional
supplements that come in a form of a
pill, a tablet or a capsule.
Glass Dropper Bottles are suitable for
packing tinctures, oils and oral liquid
preparations as well as other
pharmaceutical liquids.
The Dropper Bottles are a smoked
glass bottle with a black bulb and
cap, containing a clear pipette.
Glass

Waseem Ahmed
 A plastic is a material that contains an essential ingredient one or more polymeric organic substances of
large molecular weight.
 Plastic containers for pharmaceutical products are primarily made from the following polymers:
polyethylene, polypropylene, polyvinyl chloride, polystyrene, and to a lesser extent, polymethyl
methacrylate, polyethylene terephthalate, polytrifluoroethylene, the amino formaldehydes, and
polyamides.
 Plastic containers consist of one or more polymers together with certain additives.
 The amount and nature of the additives are determined by the nature of the polymer, the process used to
convert the plastic into the containers, and the service expected from the container.
 For plastic containers in general, additives may consist of antioxidants, antistatic agents, colours, impact
modifiers, lubricants, plasticizers, and stabilizers.
Plastic

Waseem Ahmed
Factors responsible for plastics properties
 Chemical structure
 Molecular weight
 Crystallinity and orientation
 Cross-linking
 Addition of other agents
Properties of Glass
 Low in cost
 Light in weight
 Durable
 Pleasant to touch
 Flexible facilitating product dispensing
 Odourless and inert to most chemicals
 Unbreakable
 Leak proof
 Able to retain their shape throughout their
use.
 They have a unique 'suck-back' feature,
which prevents product doze.
Disadvantages of Glass
 Poor physical stability (interaction,
adsorption, absorption lightness)
 Permeable to some degree to moisture,
oxygen, carbon dioxide etc.
 electrostatic attraction
 Stress cracking
 Panelling or cavitation
 Crazing
 Poor impact resistance
Plastic

Waseem Ahmed
Orientation
 The alignment of crystalline structure in
polymeric materials to produce a highly
aligned molecular structure.
 Materials are stretched just below or above
their softening point.
 Depending on the degree of orientation,
significant changes can occur in both the
physical & chemical properties.
1) Improving clarity
2) Reducing to moisture & gas permeation
3) Improving chemical resistant
ChemicalStructure
 Linear polymer chain
 Branched polymer chain
CrystallinityandorientationCrystallinity
 Orderly compact structure of the molecular chain
 Polymer chain may twist, and tangled formation
given an amorphous type polymer
Plastic

Waseem Ahmed
Importantproblems
 Sorption
 Desorption (Leaching)
 Permeation
 Photo degradation
 Polymer Modification
DrugPlasticConsiderations
 A packaging system must protect the
drug without altering the composition of
the product until the last dose is
removed.
 Drug plastic consideration have been
divided into five categories.
Plastic

Waseem Ahmed
Plastic
Importantproblems
Sorption
This process involves the removable of constituents from the drug product by the
packaging material. This may effect on the therapeutic efficacy of the drug. Sorption may
change the chemical
Desorption (leaching)
Problems with the colouring agents used in plastic, these may leach into
the drug.
Permeation
Transmission of gases, vapours or liquids through packaging material to the drug that cause
oxidation or hydrolysis of the drug. This condition may worst with increase in temperature and
humidity.
Photo Degradation
Some ingredients of plastic may react chemically with the drug or vice versa and
change the appearance of the drug.
Polymer Modification
The physical or chemical alteration of the packaging material by the drug is called
modification.

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Forms of Plastic
Amorphous Plastic Crystalline Plastic
 They give good transparency.
 Hard but posses little brittleness.
 More permeable to gases and vapour.
 Less inert.
 They are opaque in nature.
 They are more flexible.
 They are less permeable to gases and vapour.
 More Inert.
Plastic

Waseem Ahmed
Types of Plastic
Thermosets (Thermosetting plastics consist of those plastics
plastics that, when subjected to heat, normally will
become infusible or insoluble, and as such cannot be re-
melted. These plastics are used when good dimensional
and temperature stability are required. The formaldehyde
plastics have been found the most used in the
pharmaceutical industry as closures for glass and /or
plastics containers.
Thermoplastics consist of those
those plastics that normally
are rigid at operating
temperatures but can be re-
melted and reprocessed.
Plastic

Waseem Ahmed
Plastic used for Pharmaceutical Products are primarily made form
the following polymers
 Polyethylene
 Polypropylene
 Poly Vinyl Chloride
 Poly vinylidene chloride (PVdC)
 Polystyrene
 Polymethyl Methacrylate
 Amino Formaldehyde
 Poly Carbonate
 Ionomer
 Polymonochlorotrifluoroethylene
(PCTFE)
Plastic

Waseem Ahmed
Polyethylene
1. Low density polyethylene (LDPE) – branched
chain
2. High density polyethylene (HDPE) – linear
chain
High density
polyethylene
(HDPE)
Characteristics:
 Low cost
 Moderately flexible
 Stiffer and has better barrier properties
 Chemical resistant
 Poor clarity
 Translucent in natural start and can be tinted
with any opaque colour
 Odourless and tasteless
Advantages:
 Low cost
 Good moisture barrier
 Not attack by most
solvent
Disadvantage:
 Poor barrier for oxygen
and other gases
 Orders and flavours are
sometime lost
 Perfume or flavouring oil
can transpire rapidly
 Stress-crack in the
presence of some
products
Applications:
 For thin-wall blow moulded containers
 Injection moulding of closures
 Industrial and consumer bags and thermoformed trays
Plastic

Waseem Ahmed
Polyethylene
1. Low density polyethylene (LDPE) – branched
chain
2. High density polyethylene (HDPE) – linear
chain
Low density
polyethylene
(LDPE)
Characteristics:
 Odourless and tasteless
 Easily blended with copolymers.
 Highly resistant to most solvents
 Poor barrier for gases
 Softening temperature is around 110 – 150 oC
 Easily pigmented
 Good Transparency
 Translucent
Advantages:
 Low cost
 Flexible
 Light weight
 Moisture barrier
 Tough
 Chemical resistant
 Heat sealable
Disadvantage:
 Prone to stress cracking in
the presence of
surfactants, vegetable or
mineral oils.
 May have problem with
flavour or odors.

Applications:
 Used in squeezable bottles and tubes.
 Injection moulding of closures
 Industrial and consumer bags and thermoformed trays
Plastic

Waseem Ahmed
Polypropylene(PP)
Characteristics:
 It has good resistance to cracking when
flexed.
 Lighter, much stiffer and more heat resistant
than HDPE
 Same chemical resistance properties to oil
and gases as HDPE
 Can be sterilized with steam and ethylene
oxide, but not radiation, unless modified PP
are used.
 Biaxial orientation PP (BOPP) will improve its
clarity.
 High melting point 170 oC.
Advantages:
 Low cost
 Light weight
 Less shrinkage
Disadvantage:
 Low impact strength
Applications:
 Suitable for use in closures, tablet containers and intravenous bottles
 Used wildly for solid dosage products.
 Also used for squeeze bottles, tubes and syringes.
 Widely used for ophthalmic preparation.
Plastic

Waseem Ahmed
PolyvinylChloride(PVC)
Characteristics:
 Used as rigid packaging material.
 PVC is naturally clear, have extremely good
resistance to oils, and have very low oxygen
transmission.
 Plasticized PVC reduces chemical resistant
and increases gas and moisture permeation
 Polyvinyl chloride (PVC) - Factors to consider
when PVC is uses for pharmaceutical
- Stabilizers – Plasticizer - Monomer residue -
Modifiers – Lubricants - Catalytic residue
Advantages:
 Inexpensive
 Rigid or tough
 Transparent
Disadvantage:
 Change colour to yellow
when exposed to heat or
UV light
 Scratches are visible
 Corrosive when
overheated
Applications:
 Used as rigid packaging material and main component of intravenous bags.
 Blister packaging for pharmaceuticals
Plastic

Waseem Ahmed
Polyvinylidenechloride(PVdC)
Characteristics:
 Trade name “Saran”
 Copolymer of vinyl chloride or vinyl acetate
and vinylidene chloride
 Excellent resistance to permeation by
moisture UV light, aroma, inorganic acids,
alkalis, aqueous salt solutions, organic water-
soluble acids, aliphatic hydrocarbons, esters
of long chain fatty acids, and gas.
 Good thermoforming.
 Medical grade and non-toxic.
 High level of transparency which improves the
aesthetic of the product.
Advantages:
 Inexpensive
 Rigid or tough
 Transparent
Disadvantage:
 Change colour to yellow
when exposed to heat or
UV light
 Scratches are visible
 Corrosive when
overheated
Applications:
 Most widely used as a coating of Rigid PVC barrier films
Plastic

Waseem Ahmed
Polystyrene(PS)
Characteristics:
 PS has relative low heat resistance and is attacked
by several chemical agents.
 Conventional grade – clear crystal grade, lack of
impact strength.
 Impact-modified graded – copolymerized with
acrylonitrile and butadiene, poor optical
properties.
 Easily molded into any shape.
Advantages:
 Clear and light weight
 Economical
 Easily molded into any
shape, metallized and
hot-stamping.
Disadvantage:
 May shrink, change colour
in sunlight.
 Craze and become cloudy
Applications:
 It is used for jars ointments and cream with low water content.
 Also used to manufacture syringes.
Plastic

Waseem Ahmed
Polycarbonates
Characteristics:
 PC are formed by condensation of polyphenols
such as bisphenol-A with phosgene.
 PC are transparent thermoplastics with high
strength and high temperatures resistance.
 Good clarity, impact strength, ductility and low
controllable mold shrinkage.
 Sterilizable and tolerates gamma radiation.
 Expensive, their use is limited to specialty
application.
Advantages:
 Excellent clarity and high
softening temperature.
 Dimensionally stable
and processable
 Odorless and non-
staining
Disadvantage:
 Expensive
 High permeation of
moisture and gases
 Sensitive to Oxygen and
CO2
Applications:
 Used in the preparation of surgical instruments.
Plastic

Waseem Ahmed
Ionomer
Characteristics:
 Ionomer are sodium or zinc salts of ethylene/
methacrylic acid copolymers.
 Ionomer are used as an inner ply in laminates,
offering god heat sealing (even when the seal area
is contaminated by liquid or powder) over a wide
temperature range.
 Clear , semiflexible, tough materials with good
abrasion resistance.
Manufacturers
Dow
SKGlobalChemical
Ineos
ExxonMobil
Entec
Lyondellbasell
Advantages:
 excellent adhesion to
aluminium and other polar
substrates
Disadvantage:
 Expensive
Applications:
 Valued in sachet and pouch packs.
Plastic

Waseem Ahmed
Polymonochlorotrifluoroethylene(PCTFE)
Characteristics:
 Extremely low transmission of moisture.
 Transparent, and can be heat sealed, laminated,
printed, thermoformed, metallized.
 Because it is the most expensive plastic used in
the pharmaceutical industry, it is employed only
where the most demanding barrier properties are
required.
 Heat resistance is up to 175 °C
Advantages:
 Excellent water repulsion
and chemical stability
Disadvantage:
 Expensive
Applications:
 Laminated PCTFE (Aclar)/PVC sheet is used widely in thermoformed blister pack for
moisture-sensitive solid dosage form.
Plastic

Waseem Ahmed
Plastic
Advantages of Plastic
 Flexible and not easily broken or durable.
 Low density and light weight
 Economical
 Pleasant in touch.
 Flexible facilitating product dispensing.
 Odorless and inert to most of the chemicals
Disadvantages of Plastic
 They are not as impermeable to gas and vapor as glass
 They may posses an electrostatic charge which will
attract particles
 Used for many types of pack including rigid bottles for
tablets and capsules, squeezable bottles for eye drops
and nasal sprays, jars, flexible tubes and strip and
blister packs.

Waseem Ahmed
 Rubber is used mainly to manufacture closures for vials, transfusion fluid bottles, dropping
bottles and washer in many other types of products.
 Categories of rubber are NATURAL and SYNTHETIC rubbers.
 NATURAL Rubber – suitable for closures for injectable products as rubber reseal after multiple
insertion of needle.
 SYNTHETIC Rubber – have fever additives and thus fewer extractable and tends to experience
less sorption of product ingredients. Not suitable for repeated insertion of needle because it
fragment or pushing small particles of the rubber into the product.
Rubber

Waseem Ahmed
Butyl Nitrile Neoprene Silicone
These are copolymers of
isobutylene with 1-3% of
isoprene or butadiene
These are polymers of 1:4
chloprene
Advantages  Resistant to aging and
chemical attack
 Very low permeability
to water vapours and
air
 Low water absorption
 Cheaper compared to
other synthetic
rubbers.
 Oil resistant due to
polar nitrile group
 Heat resistant
 Resistant to oxidation
hence these rubbers
age well
 Oil resistant
 Heat stability is up to
150 oC
 Less water absorption
and permeable than
natural rubbers
 Heat resistant up to
250 oC
 Extremely low
absorption and
permeability of water
 Excellent aging
Disadvantages  Decomposition takes
place above 130 oC
 Oil and solvent
resistance is not very
good
 Absorption of
bactericide and
leaching of extractives
are considerable
 Poor tensile strength
 Expensive
Rubber
TypesofRubber

Waseem Ahmed
 Metals have been the base of packaging industry since a long time. Different type and varieties of
metals are used in the packaging.
 In packaging the metals used in general are Aluminium, Tin, Lead and Stainless steel.
 Metals have the highest temperature tolerance, highest physical strength, most durability, excellent
light, gas and moisture barrier, and stiffness. Some forms of metal packaging also have significant
operational advantages. For example, metal cans can be produced and filled at higher speeds than
glass or plastic bottles.
Metal

Waseem Ahmed
Advantages of Metal
 They are sturdy
 They are impermeable to light, moisture and
gases
 They can be made into rigid unbreakable
containers by impact extrusion
 They are light in weight as compared to glass and
plastic
 Labels can print directly on the surface
Disadvantages of Metal
 Metals are expensive
 They react with certain chemicals/drugs and may
shed metal particles into the drug
Metal

Waseem Ahmed
Metal used for Pharmaceutical
Products are
 Aluminum
 Lead
 Tin
Metal

Waseem Ahmed
Aluminum
Characteristics:
 Aluminium is a very light metal with a specific
weight of 2.7 g/cm3, about a third that of steel.
 Aluminum naturally generates a protective oxide
coating and is highly corrasion resistant. Different
types of surface treatment such as anodizing,
painting or lacquering can further improve this
property.
 Aluminum is a good reflector of light as well as
heat, and that together with its low weight, makes
it an ideal material for reflector in.
Advantages:
 Impermeable and lets
neither light or aroma nor
taste substance out.
 Metal is non-toxic and
releases no aroma or taste
substance which makes it
ideal for packaging
sensitive products.
 100% recyclable with no
downgrading of its
qualities.
 Excellent barrier.
Disadvantage:
 Expensive
Applications:
 Aluminum is used in several products in the packaging industry, such as tubes & foils, aluminum
containers, bottles & cans, caps & closures, lidding materials, casseroles, etc.
Metal

Waseem Ahmed
Tubes
Examples - Aluminum
Foils: Nylon/Foil Laminates - Paper/Foil Laminates - Polyester/Foil Laminates -
LDPE foils - PVC-coated Paper - Aluminum foil laminates – Tube laminates -
Sachet/pouch laminates - Blister lidding - Cold formed laminate etc.
Metal

Waseem Ahmed
Lead
Characteristics:
 It is a heavy metal that is denser than most
common materials.
 Lead is soft and malleable and has a relatively low
melting point. When freshly cut, lead is silvery
with a hint of blue.
 It tarnishes to a dull gray colour when exposed to
air.
Advantages:
 Lowest cost of all the
metals used in
pharmaceutical.
 Soft
Disadvantage:
 Economical
 When taken internally
there is risk of lead
poisoning. So lead
container and tubes
should have internal lining
of inert metal or polymer.
Applications:
 With lining lead tubes are used for such product as fluoride toothpaste.
Metal

Waseem Ahmed
Tin
Characteristics:
 Tin-free steel and tinplate are commonly used in
the packaging industry.
 Tinplate is a black plate coated with tin. It is
produced by tin coating, might or might not be
equally on both sides.
 Tin containers are preferred for food,
pharmaceuticals and any product for which purity
is considered.
 Tin is the most chemically inert of collapsible
metal tubes.
Advantages:
 Highly polished
 Used as protective coat.
Disadvantage:
 Expensive
Applications:
 Tin-free steel are generally used for screw & lug caps, tops, snap & press on closures and
shallow drawn food cans.
Metal

Waseem Ahmed
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