This document discusses various types of tamper resistant packaging for pharmaceutical products. It describes film wrappers like end folded, fin seal, and shrink wrappers. It also covers blister packages, strip packages, bubble packs, bottle seals, tape seals, shrink packaging, and foil/plastic pouches. The goal of these packaging types is to provide evidence if the packaging has been tampered with to protect product integrity.

1. Tamper Resistant Packaging
Presented By :-
Jitendra K. Sonawane
M.Pharm (QA)

2. Contents :-
 Introduction
 Film Wrapper.
1. End folded wrapper.
2. Fin seal wrapper.
3. Shrink wrapper.
 Blister Package.
 Strip Packaging.
 Bubble Pack.
 Bottle Seals.
 Tape Seals.
 Shrink Packaging.
 Foil/Plastic Pouches.

3. INTRODUCTION
 The requirement for temper resistant packaging is now one of
the major considerations in the development of packaging for
pharmaceutical products.
 Temper resistant package is one having an indicator to entry in
which, if missing, can seasonally be expected to provide visible
evidence to consumers that tempering has occurred.
 FDA approves the following configurations: film wrappers,
blister package, strip package, bubble pack, shrink seals, and
bands oil, paper, plastic pouches, bottle seals, tape seals,
breakable caps, aerosol containers.

4. I. Film Wrapper
Film wrapping has been used extensively over the years for
products requiring package integrity or environmental protection.
• It has categorizes into following types :
1. End folded wrapper.
2. Fin seal wrapper.
3. Shrink wrapper.

5. 1. 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.

6. 2. Fin seal wrapper:-
 The seals are formed by crimping the film together and
sealing together the two inside surfaces of the film seal.
 Fin sealing is superior than end folded wrapper with good seal
integrity the over wrap can removed or opened by tearing the
wrapper.

7. 3. Shrink wrapper:-
 The 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.

8. Film Wrapper Systems:-

9. II. Blister Package-
 The blister package is formed by heat softening sheet of
thermoplastic and vacuum drawing the softened sheet is
released from the mould and proceeds to the filling station of
the packaging machine.
 The semi rigid tray is previously formed is filling with
tablets/capsules and lidded with a heat sealable backing
material. The backing material is usually heat seal coated
aluminium foil.

10. The plastic material used includes PVC, polyethylene
combination. For added moisture protection polyvinyledene
fluoride or poly chloro trifluoroethylene films may be laminated
to PVC.
o Advantages-
 Unit dosage.
 Convenience.
 Child resistant.
 Pleasing appearance.
 Tamper resistant.

11. III. Strip Packaging-
 Strip package is a form of unit dose packaging that is
commonly used for the packaging of tablets and capsules. A
strip package is formed by feeding two webs of a heat sealable
flexible film through a heated crimping roller.
 The product is dropped into the pocket formed prior to forming
the final set of seals. A number different packaging. For high
barrier applications a proper polyethylene foil/polyethylene
laminations commonly used.

12. IV. Bubble Pack-
The bubble pack can be made in several ways but is usually formed
by sandwiching the product between a thermoplastic film and a rigid
packing material similar to a sin blister.

13. V. Shrink Packaging-
 The shrink pack concept makes use of the heat shrinking
characters of a stretch oriented polymer usually PVC.
 The heat shrinkable polymer-PVC is manufactured as a tube in a
diameter slightly larger then the cap and neck ring of the bottle
to be sealed.
 This is the placed over the bottle cap and the package through a
heated tunnel, which shrinks the plastic cover around the cap,
preventing the disengagement of the cap without destroying the
shrink band.

14. VI. Foil/Plastic Pouches
When a product requires multi-layered packaging, manufacturers
normally use foil pouches. They are used as the innermost layers of
packaging. It’s very important for foil pouches to be of top quality
and extremely hygienic since they are in direct contact with the
packaged product.
Generally, foil pouches are made out of aluminum and protect the
product from extreme temperatures. Additionally, foil pouches
maintain a low rate of moisture vapor transmission.

15. VII.Bottle Seals-
 A bottle may be made temper 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.
 Typically glassine liners are two ply laminations use in two
sheet of glassine paper bounded together with wax or adhesive.
 For pressure sensitive inner seals pressure sensitive adhesive is
coated on the surface of the inner seal as an encapsulated
adhesive.

16. VIII.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.
 The paper used must often is a high density light weight paper
with poor tear strength.

17. IX. Breakable Seals-
These seals are used for Security purpose.

18. X. 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 those are made of aluminum.
 Extruded plastic tubes are widely used for products that are
compactable and limited protection of plastic.

19. Reference:-
i. Leon Lachman, H. A. Lieberman the theory and practice of
industrial pharmacy, Special Indian Edition 2009, page no- 720-
731.
ii. https://www.google.com/search?biw=1360&bih=657&tbm=isch
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