PACKAGING

PACKAGIN
G
 Packaging is the science, art, and technology of
enclosing or protecting products distribution,
for
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 PACKAGING
MATERIAL
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 environmental factors
•Content reactivity ( with relevant to the
packaging material)
•Acceptibilty of the pack to the consumer or user
The packaging process
•Regulatory, legal and quality issues
 CHARACTERISTICS OF
PACKAGING
MATERIAL:
The material selected must have the
following characteristics:

•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 conditions
 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 have features that add convenience in

distribution,
can handling, sale, opening, re-closing, use,
recycling,
display, and ease of disposal. reuse,
•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
packaging.
Secondary packaging is outside the primary packaging
– perhaps used to group primary packages together.
Example: Paper and boards, Cartons ,Corrugated fibers ,Box
manufacture)
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

I) Glass

II) Metals

III) Rubbers

IV) Plastics

V) Fibrous material

VI) Films, Foils and laminates

 GLASS:
 Glass has been widely used as a drug packaging
material.
 Glass is composed of sand, soda ash, limestone,&
cullet.
 Si, Al, Na, K, Ca, Mg, Zn & Ba are generally used
into preparation of glass
Advantag
es
• They are hygienic and suitable for sterilization
• They are relatively non reactive ( depending on
the
grade chosen)
• 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.
DISADVANTAGES

• It is relatively heavy
• Glass is fragile so easily broken.
• Release alkali to aqueous preparation
 METAL
S
 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
products.
 Form an excellent tamper evident containers.
 For e.g.
ALUMINIUM

• 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
screw caps.
• Thinnest aluminium is used in flexible foil that are usually a
component of laminated packaging material.
 RUBBERS (Elastomers):
• 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
ingredients.
• 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
packaging lines.
 PLASTICS
Classes of plastics:
There are two classes of plastics, reflecting the behavior
with respect to individual or repeated exposure to heating and
cooling.
1. Thermoplastics
2. Thermosets

 Thermoplastics
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.
 Thermosets
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
thermosets.
Uses

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.
Advantages

• Least expensive than glasses

• Ease of transportation
• No risk of breakage
• Flexible
• Light in weight

Disadvantages

• They are not as chemically inert .

• They are not as impermeable to gas and vapour as
glass.
• They may possess an electrostatic charge which will
attract particles.
FIBROUS MATERIALS
 The fibrous materials are the important part of
pharmaceutical packaging.
 Fibrous materials include: Papers, Labels, Cartons,
Bags, Outers, Trays For Shrink Wraps, Layer Boards
On Pallets, etc.

Paper
Corrugated Fiber board
 Cont…..

 The Applications as well as Advantages of

Cartons include:
 Increases display area
 Provides better stacking for display of stock items
 Assembles leaflets
 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
FOILS:
The most important metal for pharmaceutical
application is aluminium.
FILMS
Cellophane is an attractive transparent film which
can be colored and printed upon so it useful as
outer wrap.

LAMINATES

Laminates are used to combine the properties of

individual foil and films and strictly are made by
bonding the layer with adhesive.
23
• Uses of films, foils, laminations:
 Strip packs
 Blister packs
 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 &
surrounding atmosphere.
BLISTER PACK
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
pack.

 There are two types of forming the cavity into a base

web sheet: thermoforming and cold forming
Thermoforming
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 formed shape.
• 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
expiry date.
• 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.
STRIP PACKING
 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, polyvinylchloride.
 SYMBOLS USED ON PACKAGES
AND LABELS
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
 Materials handling is
the art and science of moving,
packing and storing of
substances in any form.
 Function of production control
 Concerned with scheduling of production control
 Material Handling adds value to product cost
 Material Handling increases effectiveness of
in plant layout by reducing the cost
 To Lowers unit materials handling cost
 To reduce manufacturing cycle time
 To provide better control of the flow of materials
 To provide better working conditions
 To provide Contribution for better quality
by avoiding damages to products
 To Increase storage capacity
 To provide higher at lower
productivity manufacturing costs
 Material should be moved as little as possible
 Reduction in time by using shortest routers and
mechanical material handling equipment
 The material movement should be in lots rather
than in individual units
 Design of material handling equipment should
be such that it can increase the effectiveness
 Gravity should be used
 Rehandling and back tracking of materials
should be avoided
 Periodically Repairing ,Maintaince & Checkup
of existing material handling equipments
 Factors affecting the
Selection of Materials
Handling Equipment

Capabilities of the
Production Human element handling
problem involved equipment
available
 Volume of
Production to be
maintained

Production Layout of plant &

Problem building
facilities

Class of materials
to be handled
 Adaptability
Flexibility
Speed

Load
capacity

Space
Equipments requirements

Factors
Power

Supervision
required

Ease of
Maintaince
Cost Environment
 Human Factors

Capabilities of Safety of Personnel

manpower
1. Equipments oriented systems :-
a) Convey or Systems
b) Tractor transfer system
c) Fork lift truck
d) Industrial truck system
e) Underground system
2. Material Oriented Systems
a) Unit handling system
b) Bulk handling system
c) Liquid handling system
3. Methods oriented system
a) Manual systems
b) Automated systems
c) Job shop handling system
d) Mass production system
4. Function oriented system
a) Transportation systems
b) Conveying systems
c) Transferring systems
d) Elevating systems
1. Conveyers
2. Cranes, Elevators and
Hoists
3. Industrial Trucks
4. Auxiliary Equipments
 1. Conveyors-
 Gravity or powered devices
 Used for moving loads from one point to point over
fixed paths.
These are overhead devices used for moving
varying loads intermittently between points
within an area.