PACKAGING

standards are contained in the CGMP section of

the Code of Federal Regulations (1), in the USP-NF
(15), and in the FDAs Guidelines for Submitting
Documentation for Packaging for Human Drugs
and Biologics (16)

means of providing presentation,

protection, identification/information,
containment, convenience and

compliance for a product during

storage, carriage, display and use until
such time as the product is used or

administered

PACKAGING MATERIALS

PRIMARY PACKAGE
SYSTEM
(IMMEDIATE CONTAINER)
is composed of those package components that actually come in
direct contact with the product at all times or which have a direct effect
on the product shelf-life

SECONDARY
PACKAGE SYSTEM
packaging external to
the primary pack which
provides
additional
physical
protection
necessary to ensure the
safe warehousing and
delivery of the product.
includes other outer
packaging forms such
as cartons, corrugated
shippers, pallets

CONTAINER
is a device that holds a drug and is, or may be in direct
contact with the drug.

TYPES OF CONTAINERS

ACCORDING TO PROTECTION
ABILITY FROM EXTERNAL CONDITIONS
1.

Well-closed container

2.

Tight container

3.

Hermetic container

4.

Light resistant container

WELL-CLOSED
CONTAINER
protects against extraneous solids and loss of drug under
ordinary conditions of handling, shipment, storage and
distribution

TIGHT CONTAINER
protects the contents from contamination by
extraneous solids, liquids or vapors, from loss of
drug and from efflorescence, deliquescence or
evaporation and loss of drug under ordinary
conditions of handling, shipment, storage and
distribution
it is capable of reclosure to its original
capability after being well-opened.

HERMETIC
CONTAINER
impervious to air or any
other gas under ordinary
conditions of handling,
shipment, storage and
distribution.
it is sterile and is
generally used to hold
pharmaceutical
preparations intended for
injection or parenteral
administration

SINGLE UNIT
CONTAINER
holds a quantity of drug intended as a single dose and when
opened, cannot be resealed with assurance that sterility has
been maintained

MULTIPLE DOSE
CONTAINER
contains more than a single unit or dose of the medication
permits withdrawal of successive portions of the contents without
changing the strength of quality or purity of the remaining portion

LIGHT RESISTANT
CONTAINER
protects
the
contents
from
photochemical
deterioration
USP should provide
protection against 290-450
nm
amber
opaque total protection
blue for antacid
manufactured
by
adding
Ferrous oxide or Manganese
dioxide to the glass melt
during manufacturing

Coextruded two-layer high-density polyethylene bottle

- inner layer (black polyethylene

coextruded)
- outer layer (white polyethylene)

provides light resistance and

moisture protection
packaging of tablets and capsules

PHARMACEUTICAL PREPARATIONS

CONTAINER/S

Aerosols

Well closed container

Capsules

Well closed container

Cataplasms

Tight container

Creams

Tight container

Elixirs

Tight container

Emulsions

Tight container

Fluid extracts

Tight container

Gels

Tight container

Granules

Hermetic container/Tight container

Inhalation

Hermetic container/Tight container

Implants

Tight container/Pressure-resistant
container

Injections

Tight container

Irrigations

Hermetic container

Lotion

Tight container

Medicated chewing gums

Well closed container

Nasal preparation

Tight container

PHARMACEUTICAL PREPARATIONS

CONTAINER/S

Ointments

Tight container

Ophthalmic ointments

Tight container

Ophthalmic solutions

Tight container

Pastes

Well closed container

Otic solution

Tight container

Pills

Well closed container/Tight container

Plasters

Well closed container/Tight container

Powder

Tight container

Suppositories

Well closed container

Suspension

Tight container

Syrup

Well closed container

Tablet

Well closed container

Tinctures

Tight container

Transdermals

Tight container

Troches

Well closed container

FACTORS IN CHOOSING A
PACKAGE
1.

physical and chemical characteristics of the product

2.

protective needs

3.

marketing requirements

QUALITIES OF AN IDEAL
PACKAGING MATERIAL
1.
2.
3.
4.
5.
6.
7.
8.

must protect the product from environmental

conditions
must not be reactive with the product
must not impart tastes and/or odors
must be nontoxic
must be BFAD approved
must meet tamper-resistant requirements
must be adaptable to high-speed packaging
equipment.
must have promotional and marketing value

PACKAGING
MATERIALS

MATERIALS USED FOR

PACKAGING:
1.

GLASS

2.

PLASTIC

3.

METAL

4.

RUBBER

5.

PAPER AND BOARD

GLASS - ADVANTAGES
it possesses superior protective properties

containers are readily available in various shapes and sizes

chemically inert
impermeable

provides excellent barrier system against other elements except

light
it does not deteriorate with age, with proper closure system

ADVANTAGES
(CONTINUATION)
transparency
economical
strong rigidity and stackability

effective closuring and reclosuring

easy cleaning

DISADVANTAGES
fragility
heavy weight
some glass impart alkalinity (can be overcome by the choice
of glass tube for a given application)

GLASS (OFFICIAL GLASS

TYPES)

Type

General Description

Uses

Test

Highly resistant
borosilicate glass

For buffered and non-buffered

aqueous solutions; suitable for all
products

Powdered
Glass Test
Water Attack
Test

II

Treated Soda-Lime
Glass

Buffered aqueous solutions with pH

below 7; dry powders or substances
and oily or oleaginous solutions

Water Attack
Test

III

Regular Soda-Lime
Glass

For anhydrous liquids or dry

substances; dry powders or
substances and oily or oleaginous
solutions

Powdered
Glass Test
Water Attack
Test

NP

General Purpose
Soda-Lime

Oral solid and liquid dosage forms

and external preparations

Powdered
Glass Test
Water Attack

Type I. Borosilicate Glass

made up of either boron and/or aluminum

and zinc
Type II. Treated Sodalime Glass

treated or has been de-alkalinized

(sulphur treatment)
to remove surface
alkali and prevents weathering of empty
bottles
Type III. Regular Sodalime Glass

made of commercial sodalime glass

USP TESTS ON GLASS

*Powdered Glass Test performed on
powdered glass; challenges the leaching
potential of the interior structure of the
glass.
*Water Attack Test performed on the
whole container; challenges only the intact
surface of the container.
determined the amount of alkali released
from the glass under specified conditions

PLASTIC ADVANTAGES
lightness in weight
flexibility (freedom of design and mouldability)
durable (resistance to breakage during distribution)
consumer preference

ADVANTAGES

(CONTINUATION)
economical

odorless and inert to some chemicals

unbreakable

leakproof
have a unique suck-back feature which prevents product
ooze

DISADVANTAGES
permeation of vapors and other molecules in either direction
through the wall of the plastic container
leaching of constituents from plastic into the product
sorption (absorption and/or adsorption) of drug molecules or
ions on the plastic material

DISADVANTAGES
(CONT.)
unclear (inspection is impeded)
soften or melt in thermal sterilization of some products

transmission of light through the container

alteration of the container upon storage

PLASTIC MATERIALS
Thermosets
manufactured by compression moulded
firm, rigid and with thermal stability

Examples:
Melamine Formaldehyde
Phenol Formaldehyde

Urea Formaldehyde

Melamine
Formaldehyde
good to excellent
dimensional stability, high
torque strength and good
impact as closures, good
resistance to oils, grease,
and many organic
solvents

Urea Formaldehyde

Phenol Formaldehyde
provides good scratchresistant parts.
very low shrinkage
low water absorption
properties
relatively brittle plastic

good dimensional
stability
good strength properties
highly rigid
good resistance to
alcohols, oils, grease,
and some of the weaker
acids.
injection-molded heads
for collapsible tubes.

PLASTIC
Thermoplastics
flexible
Polyolefins:
PE (Polyethylene)
PET (Polyethylene Terephthalate)
PP (Polypropylene)
PVC (Polyvinylchloride)

THERMOPLASTICS
Polyvinyl chloride (PVC)
resistant to oils; less prone to
stress and cracking than
polyethylene
blister packaging of tablets
and capsules due to its glasslike clarity and inexpensive.
blood bags, examination
gloves, IV solution
containers, and pump tubing

THERMOPLASTICS
Polyethylene (PE)
High density PE (linear) heat resistant, stiffer, better moisture-barrier
property, better tensile strength
bottles of solid dosage forms, jars, films and closures

Low density PE (branched) flexible

bottles of spray and drops, drum liners for bulk solid drugs, jars,
collapsible tubes, films, closures.

THERMOPLASTICS
Polyethylene
Terephthalate (PET)
high strength, excellent
clarity, low transmission rate
to gas and water vapor, and
sterilizability by all major
modes.
foods and beverages
liquid oral dosage forms

THERMOPLASTICS
Polypropylene (PP)
lighter than PE, much stiffer, more heat resistant
sterilizable with steam (autoclavable) and
ethylene oxide
chemically resistant (cannot be heat-bonded or
solvent bonded)
used for jars, bottles, rigid tubes, closures, and
thermoformed components.

METAL
Tin (Sn) and/or Aluminum
(Al)
Aluminum vial caps
Tin ointment tubes
Uses:
closures
caps
metal ring on vials
needles of syringe

RUBBER
closure for parenteral products
Natural composition depends on the source
Synthetic preferred in pharmaceuticals because of a
definite composition

PAPER AND BOARD

blister packs, labels,
strips and pouches

CLOSURES
Basic Designs of
Closures
screw-, threaded
crimp-on or crown
press-on or snap
roll-on

SAFETY PACKAGING
Child-Resistant (CR)
Tamper-Resistant or Tamper-Evident

CHILD-RESISTANT
(CR)
one that is difficult for most children under 5 years
of age to open or gain access to the contents or
obtain a harmful amount of the contents
based on the principle that a young child is
unlikely to coordinate two or more separate
actions to achieve a successful opening.

CHILD-RESISTANT

CRREO Packaging
Wise cap

TAMPER-RESISTANT/
TAMPER-EVIDENT
uses an indicator or barrier to entry that is
distinctive by design, or must employ an
identifying characteristic which, if breached
or missing can reasonably be expected to
provide visible evidence to consumers that
tampering has occurred.

EXAMPLES OF
TAMPER-RESISTANT
PACKAGING
film wrappers
blister/strip packs
bubble packs
shrink seals/bands
foil, paper, or plastic pouches
bottle seals
tape seals
breakable caps
sealed tubes
sealed cartons
aerosol containers
can

FILM WRAPPERS
film wrapped and sealed around product and/or product
containers; the film must be cut or torn to remove the
product.

BLISTER/STRIP PACKS
individually sealed dosage units;
removal requires tearing or breaking
individual component

BUBBLE PACKS
product and container
sealed
in
plastic,
usually mounted on/in
display card; plastic
must be cut or broken
to remove the product

SHRINK SEALS/BANDS
bands or wrappers which are
shrunk by heat or drying to
conform
to
cap
and
containers; torn to open

FOIL, PAPER, OR PLASTIC

POUCHES
sealed individual
packages; must be
torn to reach
product

BOTTLE SEALS
paper or foil sealed
to mouth of a
container under
cap; must be torn or
broken to reach
product

TAPE SEALS
paper or foil sealed
over carton flap or
bottle cap; must be
torn to reach
product.

BREAKABLE CAPS
plastic
or
metal
tearaway
caps
over
container;
must be broken to
remove cap

SEALED CARTONS
Carton flaps are
sealed;
carton
cannot be opened
without damage

AEROSOL CONTAINERS
tamper-resistant by
design; the only true
tamper
resistant
container

CAN