PACKAGING

Introduction Defn :- Art & science of enclosing

protecting products for distn, storage, sale & use.

Package label- Written, electronic or graphic on packaging or separate but associated label

Recognition of product

Packaging drug regulations

Objectives Physical protection eg. Shock, vibration

Barrier protection eg. O2, light

Containment eg. 10*10 packs

Information trasmission eg. Direction

Marketing potential

Security eg. Antithept seal,

Convenience eg. Distribution, handling, sale

Portion control eg. Single dosage pack

Primary Packaging Packaging material that is in intimate

contact with product

First envelopes & holds product

Smallest unit of distribution

eg. Aerosol can, wrappers, bottle, envelope

It should be inert (no leaching, absorption or

adsorption, etc.)

Should withstand mfg. condition eg. Freezing

Secondary Packaging

Packaging material outside the primary

packaging

Perhaps used to group primary packaging

eg. Boxes, cartons, shrink-wrap, etc.

Should protect from excessive moisture,

light, reactive gases, microbes, etc.

Protection to flexible container

Ease in handling

Tertiary Packaging

Used for bulk handling and shipping eg.

Barrel, crate, Slip sheet, etc.

Components of Packaging

Container: refers to storage media in which

product is placed or enclosed. Glass, Plastic

Closure: tightly packs container to exclude

O2, CO2, moisture and micro-organisms &

prevent loss of water and volatile

substances from product. Rubber, aluminum

Components of Packaging

Carton: Outer covering which gives sec.

protection against mech. &

environmental hazards also display

written information Cardboard, molded wood pulp,

expanded polystyrene

Box: Prim. defence against ext. hazards

provide containment, absorbs shocks. Cardboard, wood

Components of Packaging

Container Closure Carton

Closures Prevents contents from escaping and allow

no substance to enter the container Resiliency of liner, flatness of sealing

surface & tightness of seal Closure designs:

Threaded screw cap- Engage threads in corresponding threads molded on neck of bottle

Crimp on (crown)- Used for beverage bottles Press on(snap)- Cap pressed to seal Roll on- Seals securely, opened easily, specific,

available as reselable, nonresealable & pliferproof

Friction design

Closure liner Material inserted

in a cap to effect a seal between closure &container usually made of resilient backing & facing material (soft & elastic)

TypesHomogenousHeterogeneous

Selection factorsCompatibilityAppearanceGas Transmission Heat resistanceShelf lifeEconomic

USP Terminology Well closed Container:

Protects from extraneous solids & loss of article under ordinary or customary conditions of handling, shipment, storage & distribution

Tight Container:Protects from contamination by

extraneous material, prevents loss of by vaporization, efflorescence, deliquescence under ordinary or customary conditions of handling, shipment, storage & distribution and capable of tight re-closure.

USP Terminology Hermetic Container:

Impervious to air or any other gas under ordinary…

Light Resistant Containers…

Tamper Resistant Packaging Package having indicator or barrier to

entry which if breached or missing provides evidence of tampering.

It may involve immediate container/closure system or Sec. container/carton system

It was introduced to avoid adulteration of product

Eg. Film wrappers, Blister packages, Strip Package, Bubble packs, Shrink Seal, Aerosol container

Tamper Resistant Packaging Wrapper Strip

Aerosol Blister

Tamper Resistant Packaging Film Wrapper

End folded wrapper-Cellophane,PVDC, nitrocellulose

Fin seal- CrimpingShrink Seal- PE, PP, PVC

Blister PackageHeat softened sheet of thermoplastic resin

& vacuum drawing of sheet in contoured moulds- PVC, PVC/PE, PP, polystyrene,

Push through backing- Heat seal coated Al-foil

Peelable backing-polyester or paper

Tamper Resistant Packaging Strip Package

Formed by feeding 2 webs of heat sealable flexible film thr’ heated crimping roller & product is dropped into pocket formed prior to forming final seal.

Cellophane, PE, PVC, etc. Shrink Banding

Heat shrinkable polymer slightly larger in diameter than cap and neck ring of bottle

Bottle is moved thr’ a heat tunnel which shrinks tubing material tightly to engage cap & neck

Tamper Resistant Packaging Aerosol

HC propellant in its cooled liquid phase added to drawn Al-container along with product and spray nozzle contained in gasketted metal ferrule crimmped over opening of container

Other Temper Resistant PackagingsBubble packBreakable capsSealed TubesSealed Cartons

Pilferproof Packaging Pilferproof packaging has a closure with

greater skirt length which extends below threaded portion to form a bank.

It has several narrow metal “bridges” When pilferproof closure is removed

bridges break and bank remains in place on the neck of container

User can reseal closure but detached band indicates package has been opened

Torque required to break bridge is nominal

Pilferproof Packaging

Child Resistant Package To avoid cases of poisoning Reduce risk of accidental

ingestion medication Safety cap provided for

prescription drug, OTC medicine, pesticide, etc.

Selection of Packaging Material

Glass Material Supercooled liquid of viscosity greater

than 1013 poise which is composed of SiO2 (65-75%) tetrahedron modified with oxides of metal cations

Monovalent cations- M.P. of glass but also reduce strength eg. Na, K, B

Divalent Cations- gives mech. strength and chem. resistance eg. CaO, MgO

Trivalent Cations- chem. durability & mech. Strength eg. B2O3, Al2O3

Selection of Glass Material Advantages

Impermeable InertTransparent InexpensiveWithstand high

temp-pressureEasy to cleanNo absorption of

active

DisadvantagesLeachingFragilityFlakingHeavy wt.Light trasmission

Selection of Glass Material Glass

Flint glass- Colorless glass Amber colored glass/Nonactinic- Iron & MnO2

Siliconized glass- avoids sticking of oily formulation

Type Description Use

I Highly resistant borosilicate (neutral glass)

For aqueous solution

II Surface treated soda lime glass

For Aq. Soln, dry powders, oily solutions

III Sodalime glass (Regular)

For dry powders, oily solutions

IV Nonparenteral glass (NP)

NP use

Evaluation of Glass Powdered Glass Test (Crushed Glass

Test) Digest borosilicate flask 121ْC for 60 min Crush 6 Containers 10gm

powder + 50ml high Decant & titrate purity watersolution with 0.02N H2SO4

Indicator Methyl red

Similarly blank Limits:

Type I = 1.0ml, Type III = 8.5ml, NP= 15.0ml

Sieving40/50#

121 ْ C30 min

Evaluation of Glass Water Attack Test for Type II glass 3 containers filled 90% of overflow

capacity

Autoclaving at 121 ْC for 30 min

100 ml of combined extract titrated with 0.02N H2SO4

Capacity 100ml or less = 0.7 ml H2SO4

Capacity over 100ml = 0.2 ml H2SO4

High Purity Water

Plastic Material Plastics are made of polymer and

additives like plasticizer, antioxidant, antistat agent, fillers, lubricant, etc.

Additives are not chemically bound hence can migrate into product

Material Use

PE, PP IV infusion container

HDPE, PP, PS Disposible syringes

Polypropylene IPP) Dialysis fluid & irrigation solution container

Selection of Plastic Material Advantages

Light Weight, Inexpensive, Nonbreakable Disadvantages

Leaching of plastic additivesSorption of APIPermeation of water vapours or gasLoss of volatile componentsSoftening of plastic material during

autoclavingChemical reactivity

Evaluation of Plastic (USP) Physicochemical Tests

Aq. Extract tested for nonvoalatile residue, residue on ignition, heavy metals, buffering capacity

Biological Reactivity Tests In vitro Test- Extract placed in contact with

mammalian cells to check to toxicity In Vivo Test-

Systemic Injection Test- Mice Intracutaneous Inj. Test- Rabbit Implantation Test & Eye Irritaion Test- Rabbit

Rubber Material

Rubber is generally used as elastomeric

closure for vial infusion bottles &

cartridges

Soft & elastic nature permits needle

insertion

Resilient- Seal integrity maintained

Autoclavable

Rubber Material Composed of

Polymer (elastomer)-Vulcanising Agent- cross linking eg.sulphurAccelerator- reduce sulphur requirement &

time for vulcanization eg. MBTActivator- Activity of acceleratorFiller- carbon black, talcAntioxidant- Prevents oxidatn of elastomerLubricant- Mould release eg.TalcSoftner- Plasticity eg. Mineral oil

Selection of Rubber Material

Types of Rubber

Natural- Haevea brazilensis high

preservative uptake

Grey butyl-Polyisobutyl-Low permeability &

low preservative uptake

Nitrile- Butadiene acrylonitrile Oil resistant

Silicone Rubber- Heat resistant & high

uptake

Selection of Rubber Material Advantages

Softness allows needle insertion

Resilence maintains sterility

Elasticity allows perfect fit

DisadvantagesPermeationLeachingSorptionLoss of volatile

component

Evaluation of Rubber Physico Chemical Testing

Extract of Rubber is prepared and tested for total extractable, heavy metals, pH change, turbidity, reducing agents

Biological Testing In Vitro Test: on mammalian cells direect

contact test In Vivo Test: Systemic Injection Test- Mice Intracutaneous Inj. Test- Rabbits

Evaluation of Rubber Apperance

Closures must be free from dust, fibres, pigments, oily pathces, etc.

TackinessClosures washed several times with

detergent and autoclaved at 121ْC in dist. Water for 30 min. It should not become tacky

Evaluation of Rubber Penetrability

Closure fixed to vial and force required to penetrate it measured. It should not exceed in house limits.

Self SealabilityHalf filled vial with methylene blue, then

25 needle punctures made in 5mm circle diameter

Vials then inverted in water there should not be leakage of coloured solution

Evaluation of Rubber Fragmentation

20 closures selected randomly, 5 times needle penetrated in specific area

Needle washed with water to collect fragments

Fragments NMT 3 per closure Permeability to water vapours

Anhydrous CaCl2 placed in vial, kept it in high humidity conditions, measure wt. gain

Metals Metals used as packaging material for

creams, aerosols, beverages, etc. Metals can be moulded as collapsible

tubes, beverage cans, aerosol containers, etc.

The mechanical strength provided by metal containers is advantageous.

Leaching of metals into products may cause catalytic oxidation of product

Its chemical reactivity may form pharmacologically inert, less active or toxic cpmpounds

Metals Material UseTin Foods, pharmaceuticals,

AerosolAluminium

Collapsible tubes, foil packing, Aerosol

Lead Non food products like inks paints, lubricants

Stainless steel

Aerosol containers

Metals Gen. Properties

Strong(Nonbrekabl)

OpaqueMouldable to any

shape Withstand high

temp-pressure Impermeable to

moisture, microbes, gases, light, etc.

DisadvantagesLeaching (Attcked

by acids & alkalis)SorptionCorrosion

Applications of Metal Cans, pails, boxes. Closures Aluminium foil, laminate, labels Barrels, kegs, drums Crates Metal bandings

Paper and Board Cellulose from gettable fibres (Pulp) Lignin, cerin removed by chemical

process Fillers, coloring agents, etc. added

PropertiesLow cost, nontoxic, renewableStrength depends on moisture contentReadily printablePoor transperancy & gloss comparative to

plasticCan’t be sealed unless coated

Thank You…