Primary And Second Packaging

it describes the packaging materials used for drug packaging.Different types of packaging .Evalutation of packaging materials

1. PRIMARY AND SECONDARY
PACKAGING

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2. 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
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3. OBJECTIVES OF PACKAGING
Physical protection
Barrier protection
Containment or agglomeration
Security
Convenience
Portion control
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4. PACKAGING TYPES
Primary packaging is the material that first envelops the
product and holds it. This usually is the smallest unit of
distribution or use and is the package which is in direct
contact with the contents.
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5. Secondary packaging is outside the primary packaging –
perhaps used to group primary packages together
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6. Tertiary packaging is used for bulk handling ,
warehouse storage and transport shipping. The most
common form is a palletized unit load that packs tightly
into containers.
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7. Different types of primary packaging
Ampoules
Vials
Containers
Dosing dropper
Closures (plastic, metal)
Syringe
Strip package
Blister packaging
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8. DIFFERENT TYPES OF SECONDARY
PACKAGING
•Paper and boards
•Cartons
•Corrugated fibers
•Box manufacture


 
 
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9. PRIMARY PACKAGING MATERIALS
GLASS :
Glass has been widely used as a drug
packaging material.

Advantages of glass:
It allows easy inspection of the containers contents.
It is available in variously shaped containers.

Disadvantages of Glass: -
It is fragile
It is expensive when compared to the price of plastic.

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10. TYPE I GLASS
It is widely used as glass ampoules and vials to package
fluids for injection.

AMPOULES
One point cut ampoules.
Flat Based and Constricted Neck ampoules
Flame cut ampoules.
Closed ampoules
Ampoules with colour break band and identification bands
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11. 11
TUBULAR VIALS

12. TYPES OF GLASS CONTAINERS
BOTTLES:-
Used in the dispensary as either amber metric medical
bottles or ribbed(fluted )oval bottles.
Available in sizes from 50ml to 500ml.

Amber metric medical bottles are used for packaging a wide
range of oral medicines. .
Ribbed oval bottles attached are used to package various
product that should not be taken orally.
This includes liniments, lotions, inhalations and antiseptic
solutions.
 
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13. 13

14. DROPPER BOTTLES :-

Eye drop and dropper bottles for ear and nasal use are
hexagonal-shaped amber glass container fluted on three
sides.
They are fitted with a cap, rubber teat and dropper as the
closure. The bottles are used at a capacity of 10ml or
20ml.
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15. JARS
o Powders and semi-solid preparations are generally
packed in wide-mouthed cylindrical jars made of clear or
amber glass.
o Jars varies from 15ml to 500ml.
oJars are used for packing prepared ointments and pastes.
PLASTICS
Used as container for the product and as secondary
packaging
Two classes of plastics are used and these are known as
thermosets and thermoplastics.
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16. ADVANTAGES OF PLASTICS :-
oFlexible and not easily broken.
oLow density and light in weight.
oAre cheap
DISADVANTAGES OF PLASTICS :-
They are not as chemically inert as Type -I glass.
They are not as impermeable to gas and vapour as glass.
They may possess an electrostatic charge which will
attract particles.
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17. Used for many types of pack including rigid bottles for
tablets and capsules, squeezable bottles for eye drops and
nasal sprays, jars, flexible tubes and strip and blister
packs.

POLY ETHYLENE:
This is used as high and low density polyethylene
Low density polyethylene (LDPE) is preferred plastic for
squeeze bottles.
High density poly ethylene (HDPE) 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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18. POLYVINYLCHLORIDE (PVC):-
Used as rigid packaging material and main component of
intravenous bags.
POLY PROPYLENE:-
It has good resistance to cracking when flexed. Suitable for
use in closures , tablet containers and intravenous bottles.
POLYSTYRENE:-
. It is also used for jars for ointments and creams with low
water content.
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19. PLASTIC CONTAINERS
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20. METALS
Metals used such as tin-plated steel, mild steel, stainless
steel, tin-free steel, and aluminum and its various alloys.
Metal is strong, opaque, and impermeable to moisture,
gases, odors, light, bacteria, etc. It is resistant to high and
low temperatures
TIN:-
Tin 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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21. TINPLATE:-
Tinplate 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:-
 Aluminium lighter in weight and can be easier to
shape.
The thick rigid closures are used mainly for cans or
aerosol containers, while the thin flexible material is used
primarily for the closure of ,bottles or thermoforms
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22. Blister packs use a hard temper (so that the tablet can be
pushed through the material).
Tubes can be supplied internally by
 Lacquered
 Wax coated
 Latex line
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23. PLASTIC TUBES
Flexible plastic tubes in a range of sizes dia. 19 mm,
to 50 mm dia. and volume up to 300 ml.
Orifice 2 mm to 8 mm ( 3 mm Standard ) Tube wall
thickness with 400 - 500 micron.

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24. LAMINATED TUBES
Multilayer tubes with Aluminum foil / nylon /
polyester act as barrier against oxygen, moisture, aroma
loss and provide a glossy surface enhancing printing
quality.

Transparent stretch polypropylene and PET tubes with
dispenser caps are designed
 Different caps such as conical, flip-top, can be custom
designed for an aesthetic look.
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25. BULK CONTAINERS
For bulk drug and active pharmaceutical ingredient
packaging, bags and drum liners manufactured in a cGMP-
compliant environment. LDPE and foil laminate bags and
drum liners are custom-produced in a wide range of sizes
and constructions .

 cGMP-compliant with respect to quality systems, complete
traceability, change control, SOPs and pharmaceutical grade
housekeeping, and are registered in Drug Master File .

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26. BULK CONTAINER
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27. BLISTER PACK:-
Blister packs are commonly used as unit dose
packaging for pharmaceutical tablets, capsules or lozenges
Blister packs consist of two principal components : 1) a
formed base web creating the cavity inside which the
product fits and 2) the lidding foil for dispensing the
product out of the pack.
 There are two types of forming the cavity into a base web
sheet: thermoforming and cold forming
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28. Thermoforming
In the case of thermoforming, a plastic film or sheet is
unwound from the reel and guided though a pre-heating
station on the blister line
The temperature of the pre-heating plates (upper and lower
plates) is such that the plastic will soften and become
moldable.
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29. COLD FORMING
In the case of cold forming, an aluminum-based laminate
film is simply pressed into a mold by means of a stamp.
 The aluminum will be elongated and maintain the formed
shape.
Advantage of cold form foil blisters is that the use of
aluminum is offering a near complete barrier for water
and oxygen, allowing an extended product expiry date.
 The 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
size of the blister card
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30. Example for cold forming method
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31. Aluminium Foils for Blister Packing
Aluminium Foil suitable for blister packing of
Pharmaceutical Products such as Tablet, Capsules, etc.
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32. STRIP PACKAGE:-
It is commonly used for the packaging of tablets and
capsules. A strip package is formed by feeding two webs of
a heat sealable flexible film through a heated crimping
roller .The product is dropped into the pocket formed
before forming the final set of seals. A continuous strip of
packets is formed which is cut to the desired number of
packets in length.
The materials used for strip package are cellophane,
polyester, polyethylene, polypropylene, polyvinylchloride.

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33. Example for strip package
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34. CLOSURES :-
 Closures 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 volatilization.
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 , oxygen or carbon
dioxide.
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35. MATERIALS USED FOR MAKING OF CLOSURES
The closures for containers meant for storage of
pharmaceutical products are generally made from the
following basic materials.
Cork
Glass
Plastic
Metal
Rubber
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36. SECONDARY PACKAGING MATERIALS
PAPER:-
This can be used as a flexible wrap for products, or
as a closure material for jars. Most paper materials are
used with a liner applied either as a laminate or as a
coating.
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37. PHARMACEUTICAL CORRUGATED FIBERBOARD

 Corrugated fiberboard is a paper-based construction
material consisting of a fluted corrugated sheet and one or
two flat linerboards. It is widely used in the manufacture
of corrugated boxes
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38. CARTON
A carton is a type of suitable for food,
pharmaceuticals, hardware, and many other types of
products. Folding cartons are usually combined into a tube
at the manufacturer and shipped flat (knocked down) to
the packager.
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39. SYMBOLS USED ON PACKAGES AND LABELS
Many types of symbols for package labelling are
nationally and internationally standardized. For product
certifications, trademarks, proof of purchase, etc.
identification code .

Fragile This way up Keep way from sunlight
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40. Keep away from water Do not use hand hooks
Do not clamp as indicated
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41. TRENDS IN PHARMACEUTICAL
PACKAGING
Packaging of oral medicines generally conforms to
requirements for easy dispensing, child resistance but
senior-friendliness, but packs must also be
identifiable, functional and very often hermetically
sealed to cut the number of accidental poisonings
Gentle handling is also essential and packs should be
hermetically sealed for higher product safety. A
solution to achieve hermetically sealed packs for
blister, blow-fill-seal pouches, vials and other
products is to overwrap them into a horizontal flow
wrap.
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42. . New packaging lines will have to offer high flexibility
while maintaining production levels.
To meet validation requirements, pharmaceutical companies
increasingly demand that machinery is modularized and
standardized. This includes a standardized operating
interface and control systems for all components. Such
systems also have monitoring systems for maximum
production safety
Sstandardisation that is sufficient to produce high
efficiencies. The entire packaging process needs to be
harmonised and there is a huge optimisation potential in this
area.
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43. EVALUATION OF PRIMARY PACKAGING
MATERIAL:-
Leakage test
Hydrolytic resistance
Collapsibility
Residue on Ignition
Buffering Capacity
Light Transmission
Water Vapour Permeation
Heavy Metals & Non Volatile Residue
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44. EVALUATION OF SECONDARY
PACKAGING MATERIAL

Testingofpaperandboard

Airpermeability
: - Permeability is the mean air flow
through unit area under unit pressure difference in
unit time, under specific conditions, expressed in
Pa
-1
s
-1
.
 : -
Tensilestrength
both wet and dry. The maximum
tensile force per unit width that a paper or board will
withstand before breaking
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45. COBB TEST: -
This measures the mass of water absorbed by 1cm
2
of the test piece in a specified time under a head of 1 cm
of water. It is determined by weighing before and after
exposure to the water, and usually quoted in g/m
2
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46. SPECIFIC TESTS FOR CARTONS
Compression: - Assessment of the strength of the
erected package, thereby estimating the degree of
protection that it confers on the contents.
Crease stiffness: - Also called the crease recovery test.
This involves testing a carton board piece and folding it
through 90
0
. It will then try to recover its former position
when the bending force is removed. The increase and
decrease in the inherent board stiffness after folding is
measured.

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47. FUTURE CHALLENGES
Moisture sensitive drugs increasing barrier requirements
Novel delivery systems
Emphasis on speed to market
Control of R&D Expenditure/resource - number of stability
studies
Global - Regional - Local packs
Anti-counterfeiting, illegal cross border trading
Multiple studies for different packs vs. Year-on-Year
manufacturing costs

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48. REFERENCES :-
Dean DA, Evans ER, Hall H. Pharmaceutical packaging
technology ,1
st
ed,Pg:210-65.
 Remington.The Science and Practice of Pharmacy,
21
st
ed,Vol-1;Pg:1047-10 .
Indian Pharmacopiea,2007,Vol-1;Pg:599-25
 Leon Lachman, Liberman AH, Kanig JL.The Theory
and Practice of Industrial pharmacy,4
th
ed,Pg:711-22.
Hanlon J. Handbook of Packaging
Engineering.4
th
ed;Pg:412-49
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49. THANK YOU
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