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Waseem Ahmed

Pharmaceutical Packaging Professional


aqwaseem@hotmail.com
https://www.linkedin.com/in/aqwaseem/
CONTENTS:
 What is PACKAGING
 Characteristic of PACKAGING
 The Role of PACKAGING
 Levels of PACKAGING
 Types of PACKAGING
 Types of Material for PACKAGING

Waseem Ahmed
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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.

Waseem Ahmed
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Keeping the contents clean, fresh, sterile and safe for the
intended shelf life is a primary function.

Among other things, mechanical shock, vibration, electrostatic discharge,


Physical protection
compression, temperature

Barrier protection Barrier from oxygen, water vapor, dust, etc.


Containment or Small objects are typically grouped together in one package for reasons of
agglomeration efficiency.
Communicate how to use, transport, recycle, or dispose of the package or
Information transmission
product
Can be used by marketers to encourage potential buyers to purchase the
Marketing
product
Security Can play an important role in reducing the security risks against counterfeit
Physical protection
Barrier protection Can have features that add convenience in distribution, handling, stacking,
Containment or agglomeration Convenience
Information transmission display, sale, opening, reclosing, use, dispensing, and reuse
Marketing
Security
Convenience Portion control Precise amount of contents to control usage
Portion control

Waseem Ahmed
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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

Waseem Ahmed
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Primary Tertiary
Packaging Packaging

Secondary
Packaging

The material that first Used for bulk


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

Waseem Ahmed
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Multidose /
Bulk
Re-closeables
Unit
Dose/Non-re-
closeables

Bottles Bottles
Aerosol packs Drums/Kegs
Tubes Sacks/Bags

Ampoules, Blister packs


Prefilled syringes, Vials
Sachets
Form/Blow-Fill-Seal (FFS, BFS) - Various pack formats

Waseem Ahmed
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Glass Metal Plastic Rubber

Jars, Tubes, Tubes, Closures


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

Waseem Ahmed
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Glass

 Glass widely used as a drug packaging material for many


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

Waseem Ahmed
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Glass

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.

Waseem Ahmed
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Glass

Advantages of Glass

 They are transparent and allows easy


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

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Glass
Types of Glass  Except for type I glass containers, glass containers for pharmaceutical
preparation are not to be re-used.
Type I Glass   Containers
It is highly resistant glass. for human blood and blood components
 Laboratory must not be re-used.
glass apparatus.
Borosilicate glass / Neutral glass  It has high melting point.  Can be used to contain strong acids and alkalis.
(contains 80% silica, 10% boric oxide,  It is more chemically inert than the soda lime glass.  Suitable for parenteral or non-parenteral.
small amount of sodium oxide and  Reduce leaching action.
aluminium oxide)

Type II Glass  This is a modified type of Type III glass container with a high  They are suitable for most acidic and neutral
Soda-lime-silica glass/ treated soda-lime hydrolytic resistance resulting from suitable treatment of the aqueous preparations whether parenteral or non-
glass/ De alkalized soda lime glass inner surface of a type III glass with sulphur. parenteral.
 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.
Type III Glass  This is an untreated soda lime glass with average chemical  They are used as packaging material for parenteral
Regular soda lime glass resistance. products or powders for parenteral use ONLY WHERE
 It contains 75% silica, 15% sodium oxide, 10% calcium oxide, there is suitable stability test data indicating that Type
small amounts of aluminium oxide, magnesium oxide, and III glass is satisfactory.
potassium oxide.  They used in packaging non-aqueous preparations and
 Aluminium oxide impacts chemical durability while powders for parenteral use with the exception of
magnesium oxide reduces the temperature required during freeze-dried preparations
moulding.  It is also used in packaging non-parenteral
preparations.
Type IV Glass  This type of glass container has low hydrolytic resistance.  It is used to store topical products and oral dosage
Type NP glass/General-purpose soda  This type of glass containers are not used for products that forms
lime glass need to be autoclaved as it will increase erosion reaction rate
of the glass container.

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Glass

Process of Forming Glass Containers

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.

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Glass
Examples - Glass 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

For filling syrups, oral liquid

For filling vitamins and nutritional


supplements that come in a form of a
pill, a tablet or a capsule.
Flint and amber glass ampoules.
Straight-stem, funnel-type and closed Glass Dropper Bottles are suitable for
ampoules. Various brake systems such as The Dropper Bottles are a smoked packing tinctures, oils and oral liquid
OPC (One Point Cut), CBR (Color Break glass bottle with a black bulb and preparations as well as other
Ring) and Score Ring. cap, containing a clear pipette. pharmaceutical liquids.

Waseem Ahmed
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Plastic

 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.

Waseem Ahmed
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Plastic
Properties of Glass Disadvantages of Glass

 Low in cost  Poor physical stability (interaction,


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

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Plastic
Chemical Structure Orientation

 Linear polymer chain  The alignment of crystalline structure in


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

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Plastic
Drug Plastic Considerations

 A packaging system must protect the


drug without altering the composition of
the product until the last dose is
removed.
Important problems
 Drug plastic consideration have been
divided into five categories.  Sorption
 Desorption (Leaching)
 Permeation
 Photo degradation
 Polymer Modification

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Plastic
Important problems
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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Plastic

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

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Plastic

Types of Plastic

Thermosets (Thermosetting plastics consist of those plastics


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

Waseem Ahmed
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Plastic
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)

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Plastic

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

 For thin-wall blow moulded containers


 Injection moulding of closures
Waseem Ahmed
 Industrial and consumer bags and thermoformed trays
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Plastic

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

 Used in squeezable bottles and tubes.


 Injection moulding of closures
 Industrial and consumer bags and thermoformed trays
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Plastic

Polypropylene (PP)
Characteristics:

 It has good resistance to cracking when Advantages: Disadvantage:


flexed.
 Lighter, much stiffer and more heat resistant  Low cost  Low impact strength
than HDPE  Light weight
 Same chemical resistance properties to oil  Less shrinkage
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.
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.
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Plastic

Polyvinyl Chloride (PVC)


Characteristics:

 Used as rigid packaging material. Advantages: Disadvantage:


 PVC is naturally clear, have extremely good
resistance to oils, and have very low oxygen  Inexpensive  Change colour to yellow
transmission.  Rigid or tough when exposed to heat or
 Plasticized PVC reduces chemical resistant  Transparent UV light
and increases gas and moisture permeation  Scratches are visible
 Polyvinyl chloride (PVC) - Factors to consider  Corrosive when
when PVC is uses for pharmaceutical overheated
- Stabilizers – Plasticizer - Monomer residue -
Modifiers – Lubricants - Catalytic residue
Applications:

 Used as rigid packaging material and main component of intravenous bags.


 Blister packaging for pharmaceuticals

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Plastic

Poly vinylidene chloride (PVdC)


Characteristics:

 Trade name “Saran” Advantages: Disadvantage:


 Copolymer of vinyl chloride or vinyl acetate
and vinylidene chloride  Inexpensive  Change colour to yellow
 Excellent resistance to permeation by  Rigid or tough when exposed to heat or
moisture UV light, aroma, inorganic acids,  Transparent UV light
alkalis, aqueous salt solutions, organic water-  Scratches are visible
soluble acids, aliphatic hydrocarbons, esters  Corrosive when
of long chain fatty acids, and gas. overheated
 Good thermoforming.
 Medical grade and non-toxic.
 High level of transparency which improves the
aesthetic of the product.
Applications:

 Most widely used as a coating of Rigid PVC barrier films

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Plastic

Polystyrene (PS)
Characteristics:

 PS has relative low heat resistance and is attacked Advantages: Disadvantage:


by several chemical agents.
 Conventional grade – clear crystal grade, lack of  Clear and light weight  May shrink, change colour
impact strength.  Economical in sunlight.
 Impact-modified graded – copolymerized with  Easily molded into any  Craze and become cloudy
acrylonitrile and butadiene, poor optical shape, metallized and
properties. hot-stamping.
 Easily molded into any shape.
Applications:

 It is used for jars ointments and cream with low water content.
 Also used to manufacture syringes.

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Plastic

Polycarbonates
Characteristics:

 PC are formed by condensation of polyphenols Advantages: Disadvantage:


such as bisphenol-A with phosgene.
 PC are transparent thermoplastics with high  Excellent clarity and high  Expensive
strength and high temperatures resistance. softening temperature.  High permeation of
 Good clarity, impact strength, ductility and low  Dimensionally stable moisture and gases
controllable mold shrinkage. and processable  Sensitive to Oxygen and
 Sterilizable and tolerates gamma radiation.  Odorless and non- CO2
 Expensive, their use is limited to specialty staining
application.
Applications:

 Used in the preparation of surgical instruments.

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Plastic

Ionomer
Characteristics:

 Ionomer are sodium or zinc salts of ethylene/ Advantages: Disadvantage:


Manufacturers methacrylic acid copolymers.
Dow  excellent adhesion to  Expensive
SK Global Chemical  Ionomer are used as an inner ply in laminates,
aluminium and other polar
Ineos offering god heat sealing (even when the seal area
ExxonMobil is contaminated by liquid or powder) over a wide substrates
Entec temperature range.
Lyondellbasell  Clear , semiflexible, tough materials with good
abrasion resistance.
Applications:

 Valued in sachet and pouch packs.

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Plastic

Polymonochlorotrifluoroethylene (PCTFE)
Characteristics:

 Extremely low transmission of moisture. Advantages: Disadvantage:


 Transparent, and can be heat sealed, laminated,
printed, thermoformed, metallized.  Excellent water repulsion  Expensive
 Because it is the most expensive plastic used in and chemical stability
the pharmaceutical industry, it is employed only
where the most demanding barrier properties are
required.
 Heat resistance is up to 175 °C
Applications:

 Laminated PCTFE (Aclar)/PVC sheet is used widely in thermoformed blister pack for
moisture-sensitive solid dosage form.

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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.

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Rubber

 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.

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Rubber

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

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Metal

 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.

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Metal

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

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Metal

Metal used for Pharmaceutical


Products are

 Aluminum
 Lead
 Tin

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Metal

Aluminum
Characteristics:

 Aluminium is a very light metal with a specific Advantages: Disadvantage:


weight of 2.7 g/cm3, about a third that of steel.
 Aluminum naturally generates a protective oxide  Impermeable and lets  Expensive
coating and is highly corrasion resistant. Different neither light or aroma nor
types of surface treatment such as anodizing, taste substance out.
painting or lacquering can further improve this  Metal is non-toxic and
property. releases no aroma or taste
 Aluminum is a good reflector of light as well as substance which makes it
heat, and that together with its low weight, makes ideal for packaging
it an ideal material for reflector in. sensitive products.
 100% recyclable with no
downgrading of its
qualities.
 Excellent barrier.
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.

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Metal
Examples - Aluminum

Tubes

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.

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Metal

Lead
Characteristics:

 It is a heavy metal that is denser than most Advantages: Disadvantage:


common materials.
 Lead is soft and malleable and has a relatively low  Lowest cost of all the  Economical
melting point. When freshly cut, lead is silvery metals used in  When taken internally
with a hint of blue. pharmaceutical. there is risk of lead
 It tarnishes to a dull gray colour when exposed to  Soft poisoning. So lead
air. 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.

Waseem Ahmed
aqwaseem@hotmail.com
https://www.linkedin.com/in/aqwaseem/
Metal

Tin
Characteristics:

 Tin-free steel and tinplate are commonly used in Advantages: Disadvantage:


the packaging industry.
 Tinplate is a black plate coated with tin. It is  Highly polished  Expensive
produced by tin coating, might or might not be  Used as protective coat.
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.
Applications:

 Tin-free steel are generally used for screw & lug caps, tops, snap & press on closures and
shallow drawn food cans.

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

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