Packaging 2016.pdf

8/17/2019 Packaging 2016.pdf

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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

Documents

Packaging 2016.pdf