PRIMARY AND SECONDARY PACKAGING

PACKAGING
Packaging is the science, art and technology of

enclosing or protecting products for distribution, storage, sale, and use. It refers to the process of design, evaluation, and production of packages Packaging can be described as a coordinated system of preparing goods for transport, warehousing, logistics, sale, and end use

OBJE !I"E# O$ P% &%'I('

Physical protection Barrier protection ontainment or agglomeration #ecurity onvenience Portion control

P% &%'I(' !)PE#
Primary packaging is the material that first envelops the

product and holds it. !his usually is the smallest unit of distribution or use and is the package which is in direct contact with the contents.

Secondary packaging is outside the primary packaging *

perhaps used to group primary packages together

Tertiary packaging is used for bulk handling ,

warehouse storage and transport shipping. !he most common form is a palleti+ed unit load that packs tightly into containers.

Different types of primary packaging

%mpoules "ials ontainers ,osing dropper losures -plastic, metal. #yringe #trip package Blister packaging
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DIFFERENT TYPES OF SECONDARY PACKA IN

Paper and boards artons

orrugated fibers Bo/ manufacture

PRI!ARY PACKA IN
'0%## 1

!ATERIA"S

'lass has been widely used as a drug packaging material. %dvantages of glass1 It allows easy inspection of the containers contents. It is available in variously shaped containers. ,isadvantages of 'lass1 2 It is fragile It is e/pensive when compared to the price of plastic.
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!)PE I '0%## It is widely used as glass ampoules and vials to package

fluids for in3ection. %4PO50E# One point cut ampoules. $lat Based and onstricted (eck ampoules $lame cut ampoules. losed ampoules %mpoules with colour break band and identification bands
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!5B50%6 "I%0#

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TYPES OF

"ASS CONTAINERS

BO!!0E##2 5sed in the dispensary as either amber metric medical bottles or ribbed-fluted .oval bottles. %vailable in si+es from 78ml to 788ml.
%mber metric medical bottles are used for packaging a wide

range of oral medicines. . 6ibbed oval bottles attached are used to package various product that should not be taken orally. !his includes liniments, lotions, inhalations and antiseptic solutions.
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,6OPPE6 BO!!0E#:Eye drop and dropper bottles for ear and nasal use are

he/agonal2shaped amber glass container fluted on three sides. !hey are fitted with a cap, rubber teat and dropper as the closure. !he bottles are used at a capacity of 98ml or :8ml.

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J%6#
o Powders and semi2solid preparations are generally

packed in wide2mouthed cylindrical 3ars made of clear or amber glass. o Jars varies from 97ml to 788ml. o Jars are used for packing prepared ointments and pastes.

P0%#!I #
5sed as container for the product and as secondary

packaging !wo classes of plastics are used and these are known as thermosets and thermoplastics.
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%,"%(!%'E# O$ P0%#!I #12 o $le/ible and not easily broken. o 0ow density and light in weight. o %re cheap ,I#%,"%(!%'E# O$ P0%#!I ##$ !hey are not as chemically inert as !ype 2I glass. !hey are not as impermeable to gas and vapour as glass. !hey may possess an electrostatic charge which will attract particles.
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5sed for many types of pack including rigid bottles for

tablets and capsules, s;uee+able bottles for eye drops and nasal sprays, 3ars, fle/ible tubes and strip and blister packs.

PO0) E!<)0E(E# !his is used as high and low density polyethylene 0ow density polyethylene -0,PE. is preferred plastic for s;uee+e bottles. <igh density poly ethylene -<,PE. is less permeable to gases and more resistant to oils, chemicals and solvents. It is widely used in bottles for solid dosage forms.
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PO0)"I()0 <0O6I,E -P" .12 5sed as rigid packaging material and main component of intravenous bags. PO0) P6OP)0E(E12 It has good resistance to cracking when fle/ed. #uitable for use in closures , tablet containers and intravenous bottles. PO0)#!)6E(E12 . It is also used for 3ars for ointments and creams with low water content.
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PLASTIC CONTAINERS

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4E!%0# 4etals used such as tin2plated steel, mild steel, stainless steel, tin2free steel, and aluminum and its various alloys. 4etal is strong, opa;ue, and impermeable to moisture, gases, odors, light, bacteria, etc. It is resistant to high and low temperatures !I(#$ !in is the most chemically inert of all tube metals. It offers good appearance and compatibility with a wide range of products
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!I(P0%!E12 !inplate is basically a steel structure with a thin layer of tin deposited on either one side or both sides, gives the steel some protection from corrosion . ALUMINIUM: %luminium lighter in weight and can be easier to shape. !he thick rigid closures are used mainly for cans or aerosol containers, while the thin fle/ible material is used primarily for the closure of ,bottles or thermoforms
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Blister packs use a hard temper -so that the tablet can be

pushed through the material.. !ubes can be supplied internally by 0ac;uered =a/ coated 0ate/ line

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P0%#!I !5BE# $le/ible plastic tubes in a range of si+es dia. 9> mm, to 78 mm dia. and volume up to ?88 ml. Orifice : mm to @ mm - ? mm #tandard . !ube wall thickness with A88 2 788 micron.

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0%4I(%!E, !5BE# 4ultilayer tubes with %luminum foil B nylon B polyester act as barrier against o/ygen, moisture, aroma loss and provide a glossy surface enhancing printing ;uality.
!ransparent stretch polypropylene and PE! tubes with

dispenser caps are designed ,ifferent caps such as conical, flip2top, can be custom designed for an aesthetic look.

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B50& O(!%I(E6#
$or bulk drug and active pharmaceutical ingredient

packaging, bags and drum liners manufactured in a c'4P2 compliant environment. 0,PE and foil laminate bags and drum liners are custom2produced in a wide range of si+es and constructions .

c'4P2compliant with respect to ;uality systems, complete

traceability, change control, #OPs and pharmaceutical grade housekeeping, and are registered in ,rug 4aster $ile .

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BULK CONTAINER

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B0I#!E6 P% &12
Blister packs are commonly used as unit dose packaging for pharmaceutical tablets, capsules or lo+enges
Blister packs consist of two principal components 1 9. a

formed base web creating the cavity inside which the product fits and :. the lidding foil for dispensing the product out of the pack.
!here are two types of forming the cavity into a base web

sheet1 thermoforming and cold forming

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Thermoforming In the c !e "# the$%"#"$%&n'( )* !t&c #&*% "$ !heet &!

+n,"+n- #$"% the $ee* n- '+&-e- th"+'h )$e-he t&n' !t t&"n "n the .*&!te$ *&ne The te%)e$ t+$e "# the )$e-he t&n' )* te! /+))e$ n- *",e$ )* te!0 &! !+ch th t the )* !t&c ,&** !"#ten n- .ec"%e %"*- .*e.

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O0, $O64I('
In the case of cold forming, an aluminum2based laminate

film is simply pressed into a mold by means of a stamp. !he aluminum will be elongated and maintain the formed shape. %dvantage of cold form foil blisters is that the use of aluminum is offering a near complete barrier for water and o/ygen, allowing an e/tended product e/piry date. !he disadvantages of cold form foil blisters are the slower speed of production compared to thermoforming and the lack of transparency of the package and the larger si+e of the blister card
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E/ample for cold forming method

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%luminium $oils for Blister Packing %luminium $oil suitable for blister packing of

Pharmaceutical Products such as !ablet, apsules, etc.

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STRIP PACKA E#$

It is commonly used for the packaging of tablets and

capsules. % strip package is formed by feeding two webs of a heat sealable fle/ible film through a heated crimping roller .!he product is dropped into the pocket formed before forming the final set of seals. % continuous strip of packets is formed which is cut to the desired number of packets in length. !he materials used for strip package are cellophane, polyester, polyethylene, polypropylene, polyvinylchloride.
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E/ample for strip package

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0O#56E# 12
losures are the devices by means of which containers can

be opened and closed. Proper closing of the container is necessary because It prevents loss of material by spilling or volatili+ation. It avoids contamination of the product from dirt, microorganisms or insects. It prevents deterioration of the product from the effect of the environment such as moisture , o/ygen or carbon dio/ide.
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1ATERIAL2 U2E3 4OR 1AKIN5 O4 CLO2URE2 !he closures for containers meant for storage of pharmaceutical products are generally made from the following basic materials. ork 'lass Plastic 4etal 6ubber
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#E O(,%6) P% &%'I(' 4%!E6I%0#

PAPER:!his can be used as a fle/ible wrap for products, or as a closure material for 3ars. 4ost paper materials are used with a liner applied either as a laminate or as a coating.

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P<%64% E5!I %0 O665'%!E, $IBE6BO%6,

orrugated fiberboard is a paper2based construction material consisting of a fluted corrugated sheet and one or two flat linerboards. It is widely used in the manufacture of corrugated bo/es

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%6!O(
% carton is a type of suitable for food, pharmaceuticals, hardware, and many other types of products. $olding cartons are usually combined into a tube at the manufacturer and shipped flat -knocked down. to the packager.

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SY!%O"S &SED ON PACKA ES AND "A%E"S

4any types of symbols for package labelling are

nationally and internationally standardi+ed. $or product certifications, trademarks, proof of purchase, etc. identification code .

4$ '&*e

Th&! , 6 +)

Kee) , 6 #$"% !+n*&'ht

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Kee) , 6 #$"% , te$

3" n"t +!e h n- h""7!

3" n"t c* %) ! &n-&c te40

!6E(,# I( P<%64% E5!I %0 P% &%'I('

Packaging of oral medicines generally conforms to

re;uirements for easy dispensing, child resistance but senior2friendliness, but packs must also be identifiable, functional and very often hermetically sealed to cut the number of accidental poisonings 'entle handling is also essential and packs should be hermetically sealed for higher product safety. % solution to achieve hermetically sealed packs for blister, blow2fill2seal pouches, vials and other products is to overwrap them into a hori+ontal flow wrap. 41

. (ew packaging lines will have to offer high fle/ibility

while maintaining production levels. !o meet validation re;uirements, pharmaceutical companies increasingly demand that machinery is modulari+ed and standardi+ed. !his includes a standardi+ed operating interface and control systems for all components. #uch systems also have monitoring systems for ma/imum production safety #standardisation that is sufficient to produce high efficiencies. !he entire packaging process needs to be harmonised and there is a huge optimisation potential in this area.
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E'A"&ATION OF PRI!ARY PACKA IN !ATERIA"#$

0eakage test <ydrolytic resistance ollapsibility 6esidue on Ignition Buffering apacity 0ight !ransmission =ater "apour Permeation <eavy 4etals C (on "olatile 6esidue
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E'A"&ATION OF SECONDARY PACKA IN !ATERIA"

Testingofpaperandboard Airpermeability: - 8e$%e .&*&t6 &! the %e n &$ #*", th$"+'h +n&t $e +n-e$ +n&t )$e!!+$e -&##e$ence &n +n&t t&%e( +n-e$ !)ec&#&c c"n-&t&"n!( e9)$e!!e- &n 8 -1!1 . Tensilestrength:- ."th ,et n- -$6. The % 9&%+% ten!&*e #"$ce )e$ +n&t ,&-th th t ) )e$ "$ ." $- ,&** ,&th!t n- .e#"$e .$e 7&n'

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OBB !E#!1 2

!his measures the mass of water absorbed by 9cm: of the test piece in a specified time under a head of 9 cm of water. It is determined by weighing before and after e/posure to the water, and usually ;uoted in gBm:

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SPECIFIC TESTS FOR CARTONS

Compression# $ %ssessment of the strength of the

erected package, thereby estimating the degree of protection that it confers on the contents. Crease stiffness# $ %lso called the crease recovery test. !his involves testing a carton board piece and folding it through >88. It will then try to recover its former position when the bending force is removed. !he increase and decrease in the inherent board stiffness after folding is measured.
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F&T&RE C(A""EN ES
4oisture sensitive drugs increasing barrier re;uirements (ovel delivery systems Emphasis on speed to market ontrol of 6C, E/penditureBresource 2 number of stability

studies 'lobal 2 6egional 2 0ocal packs %nti2counterfeiting, illegal cross border trading 4ultiple studies for different packs vs. )ear2on2)ear manufacturing costs
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6E$E6E( E# 12
,ean ,%, Evans E6, <all <. Pharmaceutical packaging

technology ,9st ed,Pg1:982D7. 6emington.!he #cience and Practice of Pharmacy, :9st ed,"ol29EPg198AF298 . Indian Pharmacopiea,:88F,"ol29EPg17>>2:7 0eon 0achman, 0iberman %<, &anig J0.!he !heory and Practice of Industrial pharmacy,Athed,Pg1F992::. <anlon J. <andbook of Packaging Engineering.AthedEPg1A9:2A>
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