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PACKAGINGstandards are contained in the CGMP section of
the Code of Federal Regu lations (1), in the USP-NF
(15), and in the FDA’s Guidelines for Subm it t ing
Documentat ion for Packaging for Human Drugs
and B iolog ics (16)
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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
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PACKAGING MATERIALS
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PRIMARY PACKAGE
SYSTEM
(IMMEDIATE CONTAINER)
is composed of those package components that actually come indirect contact with the product at all times or which have a direct effecton the product shelf-life
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SECONDARY
PACKAGE SYSTEM
packaging external tothe primary pack whichprovides additionalphysical protectionnecessary to ensure thesafe warehousing anddelivery of the product.
includes other outerpackaging forms suchas cartons, corrugatedshippers, pallets
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CONTAINER
is a device that holds a drug and is, or may be in direct
contact with the drug.
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TYPES OF CONTAINERS
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ACCORDING TO PROTECTION
ABILITY FROM EXTERNAL CONDITIONS
1. Well-closed container
2. Tight container
3. Hermetic container
4. Light resistant container
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WELL-CLOSED
CONTAINER
protects against extraneous solids and loss of drug under
ordinary conditions of handling, shipment, storage and
distribution
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TIGHT CONTAINERprotects the contents from contamination byextraneous solids, liquids or vapors, from loss ofdrug and from efflorescence, deliquescence orevaporation and loss of drug under ordinaryconditions of handling, shipment, storage and
distribution
it is capable of reclosure to its original
capability after being well-opened.
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HERMETIC
CONTAINERimpervious 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 forinjection or parenteral
administration
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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
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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
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LIGHT RESISTANT
CONTAINERprotects the contentsfrom photochemicaldeterioration
USP – should provide
protection against 290-450nm
• amber• opaque – total protection
• blue – for antacid
manufactured by addingFerrous oxide or Manganesedioxide to the glass meltduring manufacturing
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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
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PHARMACEUTICAL PREPARATIONS CONTAINER/S
Aerosols Well closed container
Capsules Well closed container
Cataplasms Tight containerCreams 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
containerInjections Tight container
Irrigations Hermetic container
Lotion Tight container
Medicated chewing gums Well closed container
Nasal preparation Tight container
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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 containerPowder 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
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FACTORS IN CHOOSING A
PACKAGE
1. physical and chemical characteristics of the product
2. protective needs
3. marketing requirements
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PACKAGING
MATERIALS
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MATERIALS USED FOR
PACKAGING:
1. GLASS
2. PLASTIC
3. METAL
4. RUBBER
5. PAPER AND BOARD
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GLASS - ADVANTAGESit possesses superior protective properties
containers are readily available in various shapes and sizes
chemically inert
impermeable
provides excellent barrier system against other elements exceptlight
it does not deteriorate with age, with proper closure system
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ADVANTAGES
(CONTINUATION)
transparency
economical
strong rigidity and stackability
effective closuring and reclosuring
easy cleaning
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DISADVANTAGES
fragility
heavy weight
some glass impart alkalinity (can be overcome by the choice
of glass tube for a given application)
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TYPES)
Type General Description Uses Test
I Highly resistantborosilicate glass
For buffered and non-bufferedaqueous solutions; suitable for allproducts
PowderedGlass Test
Water AttackTest
II Treated Soda-LimeGlass
Buffered aqueous solutions with pHbelow 7; dry powders or substancesand oily or oleaginous solutions
Water AttackTest
III Regular Soda-LimeGlass
For anhydrous liquids or drysubstances; dry powders or
substances and oily or oleaginoussolutions
PowderedGlass Test
Water AttackTest
NP General PurposeSoda-Lime
Oral solid and liquid dosage formsand external preparations
PowderedGlass Test
Water Attack
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Type I. Borosilicate Glass
made up of either boron and/or aluminum
and zincType 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
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USP TESTS ON GLASS
*Powdered Glass Test – performed on
powdered glass; challenges the leaching
potential of the interior structure of theglass.
*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
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PLASTIC -
ADVANTAGES
lightness in weight
flexibility (freedom of design and mouldability)
durable (resistance to breakage during distribution)
consumer preference
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ADVANTAGES
(CONTINUATION)economicalodorless and inert to some chemicals
unbreakable
leakproof
have a unique “suck-back” feature which prevents product
ooze
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DISADVANTAGES
permeation of vapors and other molecules in either directionthrough 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
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PLASTIC MATERIALS
Thermosets
manufactured by compression moulded
firm, rigid and with thermal stability
Examples:Melamine Formaldehyde
Phenol Formaldehyde
Urea Formaldehyde
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Melamine
Formaldehyde• good to excellent
dimensional stability, high
torque strength and good
impact as closures, goodresistance to oils, grease,
and many organic
solvents
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Phenol Formaldehyde
• provides good scratch-
resistant parts.
• very low shrinkage
• low water absorption
properties
• relatively brittle plastic
Urea Formaldehyde
• good dimensionalstability
• good strength properties• highly rigid
• good resistance toalcohols, oils, grease,
and some of the weakeracids.
• injection-molded headsfor collapsible tubes.
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PLASTIC
Thermoplastics
flexible
Polyolefins:
• PE (Polyethylene)
• PET (Polyethylene Terephthalate)
• PP (Polypropylene)
• PVC (Polyvinylchloride)
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THERMOPLASTICS
Polyvinyl chloride (PVC)
resistant to oils; less prone to
stress and cracking than
polyethylene
• blister packaging of tablets
and capsules due to its glass-
like clarity and inexpensive.
•
blood bags, examinationgloves, IV solution
containers, and pump tubing
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THERMOPLASTICSPolyethylene (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.
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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
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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.
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METAL
Tin (Sn) and/or Aluminum
(Al)
Aluminum – vial capsTin – ointment tubes
Uses:
•closures
• caps
• metal ring on vials
• needles of syringe
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RUBBER
closure for parenteral products
Natural – composition depends on the source
Synthetic – preferred in pharmaceuticals because of a
definite composition
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PAPER AND BOARD
blister packs, labels,
strips and pouches
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CLOSURESBasic Designs of
Closures
• screw-, threaded
• crimp-on or crown• press-on or snap
• roll-on
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SAFETY PACKAGING
Child-Resistant (CR)
Tamper-Resistant or Tamper-Evident
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CHILD-RESISTANT
(CR)
one that is difficult for most children under 5 yearsof age to open or gain access to the contents orobtain a harmful amount of the contents
based on the principle that a young child isunlikely to coordinate two or more separateactions to achieve a successful opening.
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CHILD-RESISTANT
CRREO Packaging
Wise cap
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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 toprovide visible evidence to consumers that
tampering has occurred.
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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
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FILM WRAPPERS
film wrapped and sealed around product and/or product
containers; the film must be cut or torn to remove the
product.
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BLISTER/STRIP PACKS
individually sealed dosage units;
removal requires tearing or breaking
individual component
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BUBBLE PACKS
product and containersealed in plastic,usually mounted on/in
display card; plasticmust be cut or brokento remove the product
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SHRINK SEALS/BANDS
bands or wrappers which are
shrunk by heat or drying to
conform to cap and
containers; torn to open
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FOIL, PAPER, OR PLASTIC
POUCHES
sealed individual
packages; must be
torn to reach
product
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BOTTLE SEALS
paper or foil sealed
to mouth of a
container under
cap; must be torn or
broken to reach
product
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TAPE SEALS
paper or foil sealed
over carton flap or
bottle cap; must be
torn to reach
product.
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BREAKABLE CAPS
plastic or metal
“tearaway” caps
over container;
must be broken to
remove cap
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SEALED CARTONS
Carton flaps are
sealed; carton
cannot be opened
without damage
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AEROSOL CONTAINERS
tamper-resistant by
design; the only true
tamper resistant
container
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CAN