Name : Parth M.
Sem. : 2nd sem
Roll no : 12
Date : 24/2/2014
What is Packaging?
Selection criteria for Packaging material
Characteristics of Packaging material
Uses of Packaging
Types of Packaging
Types of Packaging material
6.Films,Foils & Laminates
Packaging is the science, art, and technology of
enclosing or protecting products for distribution,
storage, sale, and use.
Packaging also refers to the process of design,
evaluation, and production of packages.
Packaging may also be defined as the collection of
different components (e.g. bottle, vial, closure, cap,
ampoule, blister) which surround the pharmaceutical
product from the time of production until its use.
SELECTION CRITERIA FOR
There are many factors which need to consider when
selecting a suitable type of pack for the product:
•The product or pack contents
•The application of the product
•Content stability, and the need of protection from any
•Content reactivity ( with relevant to the packaging
•Acceptibilty of the pack to the consumer or user
The packaging process
•Regulatory, legal and quality issues
The material selected must have the following
•Must meet tamper-resistance requirements
•Must be FDA approved
•Must be non-toxic
•Must not impart odor/taste to the product
•Must not reactive with the product
•They must protect the preparation from environmental
USES OF PACKAGING:
•Physical protection: It protects from, among other things, mechanical
shock, vibration, electrostatic discharge, compression, temperature, etc.
•Information transmission: Packages and labels communicate how to use,
transport, recycle, or dispose of the package or product. With
pharmaceuticals, food, medical, and chemical products, some types of
information are required by governments.
•Marketing: The packaging and labels can be used by marketers to
encourage potential buyers to purchase the product.
•Convenience: Packages can have features that add convenience in
distribution, handling, display, sale, opening, re-closing, use, reuse,
recycling, and ease of disposal.
•Security: Packaging can play an important role in reducing the security
risks of shipment. Packages can be made with improved tamper
resistance to deter tampering and also can have tamper-evident features to
help indicate tampering. Packages can be engineered to help reduce the
risks of package pilferage.
TYPES OF PACKAGING
Primary packaging is the material that first envelops the
product and holds it. This usually is the smallest unit of
distribution or use and is the package which is in direct
contact with the contents.
Examples: Ampoules,Vials ,Containers ,Dosing dropper
,Closures (plastic, metal) ,Syringe ,Strip package, Blister
Secondary packaging is outside the primary packaging –
perhaps used to group primary packages together.
Example: Paper and boards, Cartons ,Corrugated fibers ,Box
Tertiary packaging is used for bulk handling , warehouse
storage and transport shipping. The most common form is a
palletized unit load that packs tightly into containers.
TYPES OF PACKAGING MATERIAL
V) Fibrous material
VI) Films, Foils and laminates
Glass has been widely used as a drug packaging
Glass is composed of sand, soda ash, limestone,&
Si, Al, Na, K, Ca, Mg, Zn & Ba are generally used
into preparation of glass
• They are hygienic and suitable for sterilization
• They are relatively non reactive ( depending on the
• It can accept a variety of closures
• They can be used on high speed packaging lines
• They are transparent.
• They have good protection power.
• They can be easily labeled.
• It is relatively heavy
• Glass is fragile so easily broken.
• Release alkali to aqueous preparation
Metal containers are used solely for medicinal products
for non-parenteral administration.
Metal is strong, opaque, impermeable to moisture, gases,
odors, light, bacteria, and shatterproof, it is the ideal
packaging material for pressurized containers.
It is resistant to high and low temperatures
They include tubes, packs made from foil or blisters,
cans, and aerosol and gas cylinders.
Aluminium and stainless steel are the metals of choice for
both primary and secondary packaging for medicinal
Form an excellent tamper evident containers.
• Thickest aluminium is used for rigid containers such as
aerosol cans and tubes for effervescent tablets.
• Intermediate thickness are when mechanical integrity is still
important but the pack should be capable of being reformed
under a reasonable force.
e.g. Collapsible tubes for semi solid preparations or roll on
• Thinnest aluminium is used in flexible foil that are usually a
component of laminated packaging material.
• Excellent material for forming seals, used to form closures
such as bungs for vials or in similar applications such as
gaskets in aerosol cans.
Categories of Rubbers:
1) Natural rubbers;
• Suitable for multiple use closures for injectable products as
rubber reseals after multiple insertion of needle.
• Disadvantages are;
i. It doesn't well tolerate multiple autoclaving becoming
brittle and leads to relative degree of extractable
material in presence of additives.
ii. Risk of product absorbing on or in to a rubber.
iii. It has certain degree of moisture & gas permeation.
2) Synthetic rubber:
• Have fewer additives and thus fewer extractable and
tends to experience less sorption of product
• Are less suitable for repeated insertions of needle
because they tend to fragment or core pushing small
particles of the rubber in to the product.
• E.g. Silicone, butyl, bromobutyl, chlorobutyl etc.
• Silicone is least reactive but it does experience
permeability to moisture and gas.
Softer rubbers experience less coring and reseal better,
harder rubbers are easier to process on high speed
Classes of plastics:
There are two classes of plastics, reflecting the behavior
with respect to individual or repeated exposure to heating and
Capable of being shaped after initial heating and
solidifying by cooling.
Resistant to breakage and cheap to produce and providing the
right plastics are chosen will provide the necessary protection
of the product in an attractive containers.
E.g. Polystyrene, polyethylene and polyvinyl chloride.
They need heat for processing into a permanent
shape. During heating such materials form permanent
crosslinks between the linear chains, resulting in solidification
and loss of plastic flow.
E.g. Phenolic, urea and melamine are representative of
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
• Least expensive than glasses
• Ease of transportation
• No risk of breakage
• Light in weight
• They are not as chemically inert .
• They are not as impermeable to gas and vapour as
• They may possess an electrostatic charge which will
The fibrous materials are the important part of
Fibrous materials include: Papers, Labels, Cartons,
Bags, Outers, Trays For Shrink Wraps, Layer Boards
On Pallets, etc.
Corrugated Fiber board
The Applications as well as Advantages of Cartons
Increases display area
Provides better stacking for display of stock items
Provides physical protection especially to items like
metal collapsible tubes.
Fiberboard outers either as solid or corrugated board
also find substantial application for bulk shipments.
Regenerated cellulose film, trade names Cellophane &
Rayophane, is used for either individual cartons or to
assemble a no. of cartons.
FOILS,FILMS & LAMINATES
The most important metal for pharmaceutical
application is aluminium.
Cellophane is an attractive transparent film which
can be colored and printed upon so it useful as
Laminates are used to combine the properties of
individual foil and films and strictly are made by
bonding the layer with adhesive.
• Uses of films, foils, laminations:
Diaphragm seals for bottles
Liners for boxes either attached or loose bag-in-box
systems & bags.
• Foil blisters:
When sealed with a metal foil-cover, the blister can
provide a hermetic pack i.e. an isolated system, which
excludes any exchange of gases between the product &
Blister packs are commonly used as unit dose packaging
for pharmaceutical tablets, capsules.
Blister packs consist of two principal components :
1) a formed base web creating the cavity inside which
the product fits and
2) the lidding foil for dispensing the product out of the
There are two types of forming the cavity into a base
web sheet: thermoforming and cold forming
In the case of thermoforming, a plastic film or
sheet is unwound from the reel and guided though
a pre-heating station on the blister line
The temperature of the pre-heating plates (upper
and lower plates) is such that the plastic will soften
and become moldable.
• Cold forming
• In the case of cold forming, an aluminum-based
laminate film is simply pressed into a mold by
means of a stamp.
• The aluminum will be elongated and maintain the
• Advantage of cold form foil blisters is that the use
of aluminum is offering a near complete barrier for
water and oxygen, allowing an extended product
• The disadvantages of cold form foil blisters are the
slower speed of production compared to
thermoforming and the lack of transparency of the
package and the larger size of the blister card
Aluminium Foils for Blister Packing
Aluminium Foil suitable for blister packing of
Pharmaceutical Products such as Tablet, Capsules, etc.
It 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 before forming the final set of seals. A
continuous strip of packets is formed which is cut to the
desired number of packets in length.
The materials used for strip package are cellophane,
polyester, polyethylene, polypropylene,
SYMBOLS USED ON PACKAGES
Many types of symbols for package labeling are nationally and
internationally standardized. For product certifications,
trademarks, proof of purchase, etc. identification code .
Fragile This way up Keep away from sunlight Keep away from water
Mehta R.M., “Pharmaceutics- 1”Published by vallabh
prakashan, delhi, 2nd edition.
Lachman leon, Lieberman Herbert A., Kanig Joseph L.,
“The theory & practice of industrial pharmacy”
published by Varghese publishing house, bombay, 3rd