Tamper resistant packaging
( TRP)
Dr. Sana Inam
Assistant professor
FPS, GCUF
1
Definition
According to FDA
“A tamper resistance package is one having an indicator and
barrier to entry which, if breached or missing, can be reasonably
be expected to provide visible evidence to consumer that
tampering has occurred”
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Features of tamper resistant materials
Not readily available
e.g. aerosol system
Carry a distinctive design
or logo
Cannot be readily
reproduce
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TYPES OF
PACKAGING
MEETING THE
REQUIREMENT OF
TRP
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Film Wrapper
Blister Packaging
Strip Package
Bubble Pack
Shrink seal and
bands
Foil, Paper and
plastic Packaging
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Bottle seals
Tape seals
Breakable caps Sealed Tubes
Aerosol
Containers
Sealed cartons
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1.Film wrapper
Film wrapper has been used extensively over the
years for products requiring package integrity or
environmental protection
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Types of film wrapping
End folded wrapper
Fin seal wrapper
Shrink wrapper
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a)End folded wrapper
Formed by passing the product into a sheet
of over wrapping film, which forms the film
around the product and fold the edges in a gift
wrap fashion as shown in Figure;
Film must be heat sealable on both surfaces
The material commonly used for this purpose
1-cellophane (coated with PVDC/nitrocellulose)
2-polypropylene (dominates the market)
PVDC --- durable moisture barrier so PVDC coated cellophane ---- used for
moisture sensitive products
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a) END FOLDED WRAPER
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a)End folded wrapper
To be Tamper-resistant overwrap must be
sealed and must be printed or uniquely
decorated
Printed surface of the carton may also be
coated with a heat sensitive varnish, that
causes the overwrap to permanently bond to
the paperboard carton during the sealing
The removal of the overwrap would deface
the carton , making it unsuitable for reuse
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b)Fin seal wrapper
Formed by crimping the film together and sealing
together the two inside surface of the film,
producing a “Fin” seal
superior than end folded wrapper with good seal
integrity
The over wrap can removed or opened by tearing
the wrapper.
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Fin seal wrapping machine
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c)Shrink wrapper
Packaging of the product in a thermoplastic film
that has been stretched and oriented during its
manufacture
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An L-shaped sealer seals the overwrap
The major advantages of this type of wrapper
are the flexibility and low cost of packaging
equipment
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2.Blister package
Formed by heat softening sheet of thermoplastic resin
and vacuum drawing machine
After cooling, sheet is released from mold and
proceeded to packaging machine
The semi rigid tray previously formed is filling with
tablets/capsule and lidded with a heat sealable backing
material
The backing/lidding material is usually heat seal
coated aluminum foil
Excellent environmental protection, esthetic
appearance, user convenience, child resistance (peelable
baking material) 16
2.Blister package
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2.Blister package
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2.Blister package
•Materials for thermoformable blister
Consists of PVC, polyethylene combination,
polystyrene, polyprpylene
•Moisture protection
Consists of polyvinylidene cholride
(PVDC)Saran or polychloro trifluoroethylene/Aclar
films may be laminated to PVC
Aclar/PVC superior to Saran/PVC
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3.Strip package
Form of unit dose packaging
Commonly used for the packaging of tablets/capsules.
Formed by feeding two webs of a heat sealable flexible
film through either a heated crimping roller or a heated
reciprocating platen
The product is dropped into the pocket formed prior to
forming the final set of seals
Cut to desired number of packets in length
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3.Strip package
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Strip packaging system
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•High barrier materials such as foil laminations or
saran coated films commonly used (moisture sensitive
products)
•Heat sealable cellophane or a polyester ----when
visibility is important
•Front and back may use dissimilar materials---
depends on product and equipment requirement
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4.Bubble pack
Formed by sandwiching the product between a
thermoplastic film and a rigid backing material
Accomplished in a manner similar to blister pack
Product dropped into the pocket and sealed to a rigid
material
The backing material cannot be readily separated
from the bubble or easily replaced without leaving
evidence of tampering
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5.Shrink banding
Manufactured as a tube in a diameter slightly larger
than the cap and neck ring of the bottle to be sealed
Heat shrinkable polymer----usually PVC
Placed over the bottle cap and moved through a
heated tunnel, which shrinks the tubing tightly around
the cap
Prevent disengagement of the cap without destroying
the shrink band
For opening ---provides with tear perforations
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6.Paper, film and plastic pouches
provide high degree of environmental protection
Flexible pouch usually formed during the product
filling operation by either vertical or horizontal
forming, filling and sealing (f/f/s) equipment
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6.Paper, film and plastic pouches
Vertical f/f/s machines
are gravity-fed and
primarily used for liquid
powder & granular
products
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6.Paper, film and plastic pouches
Used for products of smaller volume--- amenable to
flatter format
Three sided perimeter seal
Fin sealer ---a type of horizontal f/f/s packaging
system
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6.Paper, film and plastic pouches
Most commonly used film are
1. Paper
2. Polyester, nylon and cellophane (transparency,
puncture resistance or gloss is desired)
3. Foil (made of aluminum) ---moisture and oxygen-
sensitive products
4. Metallized polyester ---replacing foil owing to
reduced cost, flexural endurance and excellent
appearance
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7.Bottle seals
Made tamper resistant by bonding an inner seal to the
rim of the bottle
To meet the tamper resistant criteria, the inner seal
must be printed or decorated with unique design
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inner seal Composition
Glassine and foil laminations
Glue mounted
Pressure sensitive adhesives
Heat sensitive adhesive (Al foil)
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8.Tape seals
Glued or pressure sensitive
tape or label around or over the
closure of the package, which
must be destroyed to gain access
to the packaged product
Paper used is high density
light-weight paper with poor
tearing strength
Paper or foil with a distinctive
design is sealed over all carton
flaps or a bottle cap 35
9.Breakable caps
A ratchet- style plastic cap is commonly used
The bottom portion of the closure has a tear-away strip
To remove the closure, the bottom portion of the closure
must be torn away to disengage the ratchet and allow the
removal of cap
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10.Sealed tubes
Collapsible tubes used for packaging
are constructed of metal, plastic, or a
lamination of foil, paper and plastic
Metal tubes ---for products that
require high degree of barrier
protection
Puncture inserts, made of aluminium
3 to 5 mil thick are used to seal the tube
opening for tamper resistance
Inserts have to be punctured to gain
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access to the product
Laminted tubes
11.Aerosol containers
Usually made up of drawn Al &
inside of container may be coated
Pressurized aerosol containers are
inherently tamper resistant because
of their particular design
Direct printing of the label on the
container is preferred to using a
paper label which could be removed
and substituted
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12.Sealed Cartons
Type of packaging for pharmaceuticals, and many
other types of products
Usually used as a secondary package
Can be made from many materials e.g paper board,
white kraft, recycled and many more various plastics
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12.Sealed Cartons
Fold by “Tuck end ” design with augmented TRP such
as film wrapping, Tape sealing and glue sealing
Specifically designed to ensure that in order to obtain
the product, the carton seal must be cut or must be
non-resealable
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Significance of tamper resistant
packaging
• Extra strong and secure packaging
• Regulation ---- some pharmaceuticals require it
• Packages can not be resealed
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Thank you
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