Temper proof packaging

packaging is the art and science of preparing articles for transport ,storage, display and use This is the process by which
pharmaceuticals are suitably placed so that they should retain their therapeutic effectiveness from time of their packaging till they are consumed A pharmaceutical pack contains , protect and deliver a safe ,efficacious drug product

2. What is packaging :
What is packaging It is the art and science of preparing articles for
transport ,storage, display and use This is the process by which
pharmaceuticals are suitably placed so that they should retain their
therapeutic effectiveness from time of their packaging till they are
consumed A pharmaceutical pack contains , protect and deliver a safe
,efficacious drug product

Objective of packaging :
Objective of packaging Presentation Protection: light ,temperature,
moisture, compression, vibration ,microorganism Identification
,information Convenience and compliance

Types of packaging :
Types of packaging 1.Primary packaging: Packaging component that is
or may be in direct contact with the dosage form 2.Secondary packaging
: Packaging component that is not direct in contact with the dosage form

Containers :
Well-closed containers :Must protect the contents from extraneous
matter or from loss of the substance under normal conditions of
handling, shipment or storage
Tightly closed containers: Must protect the contents from extraneous
matter, from loss of the substance, and from efflorescence deliquescence
or evaporation under normal conditions of handling, shipment or
storage. If the container is intended to be opened on several occasions, it
must be designed to be airtight after reclosure.
Hermetically closed containers: Must protect the contents from
extraneous matter and from loss of the substance, and be impervious to
air or any other gas under normal conditions of handling, shipment or
storage.
Light-resistant containers: For drug which undergo photolytic
degradation
Multi-dose container : A container that holds a quantity of the
preparation suitable for two or more doses. Single-dose container .

3. A container that holds a quantity of the preparation intended for total or
partial use as a single administration. Sealed container . A container
closed by fusion of the material of the container.

Tamper resistance: Difficult to compromise the content of package
Tamper evidence: If the component are compromised it is evident to
customer that tampering has occurred prior to use(absence of damage )
Tamper proof:It is considered as 100% guarantee and therefore
technically not feasible and there for not realistic

Tamper Resistant packaging:
1. Tamper Resistant packaging 1982- OTC drugs – malicious
adulteration of Tylenol capsules laced with cyanide lead death of
seven people
2. 5 th November 1982 FDA regulation –federal register
3. In 1994 changes all its terminology from ‘tamper resistant’ to
‘tamper evidence’
4. FDR regulation 21 part 211,314,700 which cover the tamper-
resistant packaging of OTC drug

Definition: According to FDA
“ A tamper resistant package is one having an indicator or barrier to
entry which ,if breached or missing ,can be reasonably be expected to
provide visible evidence to consumer that tampering has occurred”

Tamper resistance packaging may involve immediate container or
closure systems or secondary container or carton system or any
combination thereof intended to provide a visual indication of package
integrity when handled in a reasonable manner during manufacturing
,distribution and retail display

Types of tamper-resistant packaging:
1. Film wrappers
2. Blister package
3. Strip package
4. Bubble package

4. 5. Shrink seals and bands
6. foil,paper,or plastic pouches
7. Bottle seals
8. Tape seals
9. Breakable caps
10.Sealed tubes
11. Aerosal container
12. Sealed Cartons

1. Film wrapper :
Film wrapping has been used extensively over the years for product
requiring package integrity or environmental protection It can be
accomplished by various ways and varies in configuration from
packaging equipment to packaging equipment .
Types of film wrapper
a) End- folded wrapper
b) fin seal wrapper
c)Shrink wrapper

End-folded wrapper
The end-folded wrapper is formed by pushing the product into a sheet of
overwrapping film,which forms the film around the product and fold the
film in gift-wrap fashion .The folded area are sealed by pressing against
a heated bar
Material used:
 Cellophane: coated with either polyvinylidene chloride or
nitrocellulose to impart heat sealing characteristics .
 Polypropylene (acrylic coated) -lower cost

Fin seal wrapper:
The seal are formed by crimping the film together and sealing together
the two inside surface of film ,producing a fin seal Since the seals are
formed by compressing the material between two heater bars rather than
sealing against the package ,much greater and more consistence sealing

5. pressure can be applied and consequently ,better sealing integrity can be
accomplished Material used commonly are polyethylene

2. Shrink wrapper:
The shrink wrapper concept involves the packaging of a product in
thermoplastic film that has been stretched and oriented during its
manufacture and that have the property of reverting back to its
unstretched dimension once the molecular structure is unfrozen by
the application of heat.
Commonly used materials are heat shrinkable grade of
polypropylene, polyethylene and polyvinyl chloride

3. BLISTER PACKAGE:
The blister package is formed by heat-softening a sheet of
thermoplastic resin and the vacuum drawing the softened sheet of a
plastic into contoured mold.
After cooling ,the seat is released from the mold and proceeds to
the feeling station of the packaging machine .The semi-rigid blister
previously formed is filled with product and lidded with a heat-
sealable backing material.
The backing material or lidding can be of either a push through or
peelable type For the push through type of blister ,the backing
material is usually heat-seal-coated aluminum foil Peelable
backing material are used to make child resistant packaging and
should me puncture resistace.
Blister package Material commonly used for thermolabile blister
are
 polyvinyl chloride (PVC),
 polystyrene and polypropylene
 For moisture protection polyvinylidene chloride(saran) or
polychlorotrifluoroethylene ( Aclar )may be laminated to
PVC For prolonged and extremely humid condition PVC/
Aclar is preferred.

6. 4. STRIP PACKAGE :
It is most commonly used for tablets and capsules A strip package
is 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 form
the final set of seals A continuous strip of packet is formed which
is cut into desired number of packets in the length.

The seals can be in the simple rectangular or picture frame format
or can be countered to the shape of product A number of different
packaging materials are used for strip packaging .For high barrier
application a paper /polyethylene/foil /polyethylene lamination is

7. commonly used When product visibility is important, a heat-
sealable cellophane or heat-sealable polyester is used

5. BUBBLE PACK :
 The bubble pack can be made in several ways but is usually
formed by sandwiching the product between a thermolabile,
extensible, or heat shrinkable plastic film and a rigid
packaging material.
 This is generally accomplished by heat-softening the plastic
film and vacuum drawing a pocket into a film in a manner
similar to the formation of blister in blister package.
 The product is dropped into the pocket, Which is then sealed
to a rigid material such as heat-sealed-coated paperboard.
 If the heat shrinkable material is used, the package is passed
through heated tunnels, which shrink the film into bubble or
skin over the product, firmly attaching to the backing card.


6. SHRINK BANDING :
This concept makes use of the heat-shrinking characteristic of stretch-
oriented polymer, usually PVC. The heat shrinkable polymer is
manufactured as an extruded, oriented tube in diameter slightly larger
than the cap and neck ring of the bottle to be sealed.
The proper length of PVC tubing is slid over the capped bottle far
enough to engage both the cap and neck ring of the bottle. The bottle
is then moved through a heat tunnel, which shrink the tubing tightly
around the cap and bottle preventing the disengagement of cap
without destroyed the shrink band

8. 7. BOTTLE SEALS:A bottle may be made tamper resistant by
banding an inner seal to the rim of the bottle in such a way that
access to the product can only be attained by irreversibly
destroying the seal

8. TAPE SEALS:Tape sealing involves the application of a 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.The paper used most often is a high density light weight
paper with poor tear strength

9. BREAKABLE CAPS : The cap blank is held on the bottle under
pressure while rollers crimp and contour the bottle tread into cap
blank .The bottom portion of cap is rolled around and under the
locking ring on bottle neck finish .The lower portion of cap blank
is usually perforated so that it break away when the cap is
unscrewed ,which serve as visible sign of prior opening

10.SEALED TUBE :Collapsible tubes used for packaging are
constructed of metal , plastic,paper or lamination foil Metal tubes
are still used for those products that require high degree of barrier
protection afforded by metal Puncture inserts ,which are usually
made of of aluminum 3 to 5 mil thick are used to seal the tube

9. opening for tamper resistance For high barrier packaging metal or
laminated tube are used
11.AEROSAL CONTAINER : Usually made of alumina A
hydrocarbon propellant( propane,butane,isobutane ) in its cooled
liquid phase is added to the container along with the product ,and
spray nozzle contained in a gasketed metal ferrule is crimped over
the opening of the aerosal The dip tube is attached to the inside of
the spray nozzle and dips into the product ,drawing product into
the spray nozzle when the sprayer is activated The spray nozzle are
usually metered to allow a specific dose to be dispensed with each
spray