1. Presented by Shifa A. Sheikh
M. Pharm 1st Year, Quality Assurance
Institute of Pharmaceutical Education and Research, Borgaon
(Meghe) Wardha
2. The packaging can be defined as the economical
means of providing presentation, protection,
identification, information, containment,
convenience, compliance, integrity and stability
for a product during storage, transportation
display and until it is consumed or throughout its
shelf life.
Pharmaceutical 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.
3. They must protect the preparation from
environmental conditions.
They must not be reactive with the product.
They must not impart to the product tastes or
odors.
They must be nontoxic.
They must be FDA approved.
They must meet applicable tamper-resistance
requirements.
4. MATERIALS TYPES EXAMPLE OF USE
Glass Primary Metric medical bottle,
ampoule, vial
Plastic Primary Metric medical bottle,
ampoule, vial
Cardboard Secondary Box to contain
primary pack
Paper Secondary Labels, patient
information leaflet
5. Primary Packaging:-
It 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), Syring , Strip
package, Blister packaging.
6. Secondary Packaging :-
Secondary packaging is outside the primary
packaging – perhaps used to group primary
packages together.
Example: Paper and boards, Cartons,
Corrugated fibers, Box
7. Tertiary Packaging :-
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.
8. Packaging of an enteral product in cans and
glass bottles uses the same techniques and
process as other consumer products in the same
packages. The package must be able to withstand
the sterilization or processing of product and also
must be able to protect all of the food components
from degradation over an extended period of time.
9. Packaging, processing, and the product itself are
inextricably linked in providing enteral nutrition to
critically ill patients.
Medical nutritional products come in two forms,
powders or liquids. The type packaging used for
medical nutritional products include metal cans,
glass bottles, plastic bottles,
plastic films, pouches, and
laminated multilayer plastic
structures.
10. Aseptic packaging is the filling of a commercially
sterile product into sterile containers under sterile
conditions and sealing the containers so that re-
infection is prevented.
11.
12. Medical device packaging design is an integral part
of delivering your device to market safely and
securely, with the sterile barrier intact.
Most single-use sterile medical devices can be
opened with a high degree of confidence that the
product has maintained sterility throughout the
product lifecycle, yet getting to this point can
prove troublesome.
13. Blister packs are commonly used as unit dose
packaging for pharmaceutical tablets, capsules or
lozenges
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.
14. 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.
Materials used :- cellophane,
polyester, polyethylene,
polypropylene,
polyvinylchloride
15. Container is defined as a object that can be used to
hold or transport something.
Pharmaceutical container is a device that hold the
pharmaceutical product and it may or may not be
in direct contact with it.
The ideal container or package should Protect the
contents from the following environmental hazards
:
1. Light 4. Atmospheric gases
2. Temperature 5. Particles
3. Moisture 6.Microorganism
16. Protects the content from the following mechanical
hazards :
1. Vibration 4. Puncture
2. Compression 5. Abrasion
3. Shock
Types of Container :-
Well closed container Light resistant
container
18. A closure is the part of the package which prevent
the contents from escaping and allow no substance
to enter the container.
Closures are available in five basic designs:
1. Screw on, threaded or lug :-
A screw closure is a mechanical device which is
screwed on and off of a threaded "finish" on a
container.
19. 2. Crimp on(crowns) :-
This style cap is commonly used as a crimped closure
for beverage bottles.
3. Press on(snap) :-
Some closures snap on. For opening, the top is
designed to pray off or, break off, or have a built
in dispenser.
20. 4. Child Resistant :-
Child-resistant packaging has special
closures designed to reduce the risk of
children ingesting dangerous items.
5. Tamper Evident :-
A tamper-evident band or security
ring serves as a temper resistant or
tamper evident function to screw
cap or closure. It can be integral
with the cap or can be a separate
package component.
