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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.
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
PHARMACEUTICAL PREPARATIONS
CONTAINER/S
Aerosols
Capsules
Cataplasms
Tight container
Creams
Tight container
Elixirs
Tight container
Emulsions
Tight container
Fluid extracts
Tight container
Gels
Tight container
Granules
Inhalation
Implants
Tight container/Pressure-resistant
container
Injections
Tight container
Irrigations
Hermetic container
Lotion
Tight container
Nasal preparation
Tight container
PHARMACEUTICAL PREPARATIONS
CONTAINER/S
Ointments
Tight container
Ophthalmic ointments
Tight container
Ophthalmic solutions
Tight container
Pastes
Otic solution
Tight container
Pills
Plasters
Powder
Tight container
Suppositories
Suspension
Tight container
Syrup
Tablet
Tinctures
Tight container
Transdermals
Tight container
Troches
FACTORS IN CHOOSING A
PACKAGE
1.
2.
protective needs
3.
marketing requirements
QUALITIES OF AN IDEAL
PACKAGING MATERIAL
1.
2.
3.
4.
5.
6.
7.
8.
PACKAGING
MATERIALS
GLASS
2.
PLASTIC
3.
METAL
4.
RUBBER
5.
GLASS - ADVANTAGES
it possesses superior protective properties
ADVANTAGES
(CONTINUATION)
transparency
economical
strong rigidity and stackability
DISADVANTAGES
fragility
heavy weight
some glass impart alkalinity (can be overcome by the choice
of glass tube for a given application)
Type
General Description
Uses
Test
Highly resistant
borosilicate glass
Powdered
Glass Test
Water Attack
Test
II
Treated Soda-Lime
Glass
Water Attack
Test
III
Regular Soda-Lime
Glass
Powdered
Glass Test
Water Attack
Test
NP
General Purpose
Soda-Lime
Powdered
Glass Test
Water Attack
PLASTIC ADVANTAGES
lightness in weight
flexibility (freedom of design and mouldability)
durable (resistance to breakage during distribution)
consumer preference
ADVANTAGES
(CONTINUATION)
economical
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
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
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
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
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