Information related to pharmaceutical packaging.

1. Pharmaceutical Packaging
By Mahesh Narkhede
Department Of QA
Rc Patel Institute Of
pharmaceutical Education and
Research Dist.Dhule,Shirpur.
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2.  Introduction Of pharmaceutical packaging
 Type & Characteristics Of Packaging
 Container
 Pharmaceutical packaging Material
 Glass
 Plastic
 Metal
 Pepar And Card Board
 Closure
 Tamper Resistant packaging
Content
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3.  Packaging is the science, art and technology of enclosing
or protecting products for distribution, storage, sale, and
use.
 Pharmaceutical packaging can be defined as the
economical means of providing presentation, protection,
identification , information, convenience ,compliance ,
integrity and stability of the product .
Introduction
 Protective Function
 Storage Function
 Loading and Transport Function
 Identification Of Product
 Mechanical Protection
 Environmental Protection
 Chemical Protection
 Biological protection
 Marketing
Function Of Packaging
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4. Types Of Packaging
 Primary packaging- is the material that first envelops the product
and hold it. This usually is the smallest unit of distribution or use.
Ex. Aerosol spray can, blister packs, bottle
• Secondary packaging -Is outside the primary packaging perhaps used
to group primary package together.
Ex. Boxes,cartons
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5.  Tertiary packaging- is used to bulk handling warehouse
storage and shipping.
Ex. Barrel, container,edge protector
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6. container
 Pharmaceutical container has been defined as a
device which hold the drug and it may or may not be
in direct contact with pharmaceutical preparations.
Charecterestic of container
1. It should withstand during normal handling.
2. It have pharmaceutically elegant appearance.
3. Dose can be drawn from it conveniently.
4. It should protect product from enviormental factor.
5. Material use in production of container should be
non toxic.
6. It should be stable in temperature and pressure
during sterilization in autoclave.
7. It should not interact physically and chemically
with product.
8. Easily labelled.
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7. Types Of Container
1. Single dose container
2. Multi dose container
3. Light resistance container
4. Well closed container
5. Air tight container
6. Tightly closed container
7. Tamper evident container
8. Aerosol container
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8. Pharmaceutical packaging material
 It is use in the production of container by using
following material.
1. Glass
2. Plastic
3. Metal
4. Pepar and board
Ideal Property Of Packaging Material
1. They must protect the preaparation from
enviormental.
2. It should not react with product.
3. It should not change product taste or odour.
4. It shoud be non toxic.
5. It should be FDA approved.
6. It should produce tamper resistance requirement.
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9. Glass
 Glass container commonly used in pharmaceutical
packaging.
Advantage:
1. Transparent
2. Available in various shape and size.
3. Stable in temprature and pressure during sterilisation.
4. Economical and readily available
5. Protect photosensitive medicament by light
6. Impermeable to moisture and atmosperic gases
7. Do not deteriorate with age
Disadvantages:
1. Fragile
2. Heavy in weight
3. Release alkali
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10. Composition of glass
 Sand (silicon dioxide), Soda ash (sodium
carbonate),Limestone (calcium carbonate),Cullet
(broken glass) - aluminium, boron, potassium,
magnesium, zinc, barium.
Type of glass
I. COLOURED GLASS OR AMBER GLASS
II. SULPHURED GLASS
III. BOROSILICATE GLASS
IV. TREATED SODALIME GLASS
V. REGULAR SODALIME GLASS
VI. GENERAL PURPOSE SODALIME GLASS
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11. Amber colour glass:
 Use for photosensitive product.
 Obtained by c,s,fe,and magnesium oxide
Sulphur glass:
 It is obtained by exposing soda lime glass to moist SO2 at
about 500°c to get sulphured glass.
Type I—Highly resistant borosilicate glass.
 Alkalinity is removed by using boric oxide to neutralized
the oxide of potassium and sodium
 It is highly resistant glass.
 It has high melting point so can with stand high
temperatures.
 It is more chemically inert than the soda lime glass
 It can resist strong acids,alkalies and all types of
solvents. Reduced leaching action.
USES:
 Laboratory glass apparatus.
 For injection and water for injection 11

12. Type II-treated soda lime glass:
 Type II containers are made of commercial soda lime
glass that has been dealkalized or treated to remove
surface alkali
 . The de-alkalizing process is know as sulphur
treatment.
 Sulfur treatment neutralizes the alkaline oxides on the
surface, rendering the glass more chemically resistant.
 Uses: Used for alkali sensitive products. Infusion fluids,
blood and plasma. Large volume container.
Type III-Regular soda lime glass:
 It is a soda lime silicate glass with only moderate
hydrolytic resistance.
 Container form this glass is used for non aquas
parenterals preparation.
 Ex powder for parenterals use.
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13. Type IV-non parenterals genral purpose soda lime
glass:
 Container made by this glass use for topical or oral
preparation.
MANUFACTURE OF GLASS:
The four basic processes used in the production of glass
are:
 Blowing uses compressed air form the molten glass in
the cavity of metal mold.
 In drawing , molten glass is pulled through dies or
rollers that shape the soft glass.
 In pressing mechanical force is used to press the
molten glass against the side of a mold.
 Casting uses gravity or centrifugal force to cause
molten glass to form in the cavity of mold.
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14. Plastic
 Plastics may be defined as any group of substances, of
natural or synthetic origins, consisting chiefly of polymers of
high molecular weight that can be moulded into a shape or
form by heat and pressure.
Advantages
 Less weight than glass,
 flexible
 Variety of sizes and shapes
 Extremely resistant to breakage
 Transport easily and have mechanical strength
Disadvantages
 Absorption permeable to moisture
 Poor printing, thermostatic charge.
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15. TYPES OF PLASTICS
Thermosetting type –
When heated they may become flexible but they do not
become liquid
e.g. Urea formaldehyde (UF),Phenol formaldehyde
,Melamine formaldehyde (MF), Epoxy resins (epoxides),
Polyurethanes (PURs)
Thermoplastics type-
On heating they are soften to viscous fluid which harden
again on cooling.
e.g. Polyethylene{HDPE – LDPE},
Polyvinylchloride(PVC),Polystyrene Polypropylene,
Nylon(PA), Polyethylene terepthalate(PET)
,Polyvinylidene chloride(PVdC), Polycarbonate
Acrylonitrile butadiene styrene(ABS)
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16. Metals
Metals are used for construction of containers. The metals
commonly used for this purpose are aluminium ,tin
plated steel, stainless steel, tin and lead
Advantages:
 They are impermeable to light, moisture and gases.
 They are made into rigid unbreakable containers by
impact extrusion.
 They are light in weight compared to glass containers.
 Labels can printed directly on to their surface.
Disadvantages:
 They are expensive.
 They react with certain chemicals
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17. COLLAPSIBLE TUBES METAL
 The collapsible metal tube is an attractive container that
permits controlled amounts to be dispensed easily, with
good reclosure, and adequate protection of the product.
 It is light in weight and unbreakable and lends itself to
high speed automatic filling operations.
 Most commonly used are tin, aluminium and lead.
Paper And Board
•Use in various form of packaging of pharmaceutical
products.
•Use for preaparing outer container
•Ex carton,boxes,envelopes and fiber drums.
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18. Closures
 Closures are device by means of container
can be opened and closed.
Types of closures
1. Plug type
2. Crown type
3. Push fit cap
4. Screw closure
Material for closure making
1. Cork
2. Glass
3. Plastic
4. Metal
5. Rubber
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19. TAMPER RESISTANT PACKAGING:
1. Film wrappers
2. Blister package
3. Strip package
4. Shrink seals
5. Aerosol containers
1.Film wrapper
 Film wrapping has been used extensively over the years
for products requiring package integrity or environmental
protection.
It is categorizes into following types:
1. End folded wrapper
2. Fin seal wrapper
3. Shrink wrapper
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20. 1.End folded wrapper
 The end folded wrapper is formed by passing the
product into a sheet of over wrapping film, which forms
the film around the product and folds the edges in a gift
wrap fashion.
 The folded areas are sealed by pressing against a
heated bar. The materials commonly used for this
purpose are cellophane and polypropylene.
2.Fin seal wrapper
 The seals are formed by crimping the film together and
sealing together the two inside surfaces of the film,
producing a fin seal.
 Fin sealing is superior than end folded wrapper With
good seal integrity the over wrap can removed or opened
by tearing the wrapper.
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21. 3.Shrink wrapper
 The shrink wrap concept involves the packaging of the
product in a thermoplastic film that has been stretched
and oriented during its manufacture.
 An L shaped sealer seals the over wrap
 The major advantage of this type of wrapper are the
flexibility and low cost of packaging equipment .
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22. 2.BLISTER PACKAGE:
 Blister package provides excellent environmental protection, and
efficacious appearance.
 The blister package is formed by heat softening a sheet of
thermoplastic resin and vacuum drawing the soften sheet of plastic
into a contoured mold .
 After cooling the sheet is released from the mold and proceeds to
the filling station of the machine. It is then lidded with heat
sealable backing material.
 Material use for themoformable blister is PVC, polyethylene
combinations , polystyrene and polypropylene.
 Material for back cover is polyster or pepar.
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23. 3.STRIP PACKAGE
 A strip package is a form of unit dose packaging that is
commonly used for the packaging of tablets and capsule .
 A strip package is formed by feeding two webs of a heat
sealable flexible through heated crimping roller.
 The product is dropped into the pocket formed prior to
forming the final set of seals. A continuous strip of packets is
formed.
 The strip of packets is cut into desired number of packets.
 packaging materials used are: polyethylene,foil,PVC
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24. 4.SHRINK SEAL PACKAGE
 Shrink wrap, also shrink film, is a material made up
of polymer plastic film. When heat is applied, it shrinks
tightly over whatever it is covering after passing through
heat tunnel.
 PVC, Polyethylene, Polypropylene .
5.AEROSOL PACKAGING
Aerosol is defined as "An Aerosol is a disperse phase
system, in which very fine solid drug particles or liquid
droplets get dispersed in the propellants (gas), which
acts as continuous phase.
1. Container
2. Valve
3. Actuator
4. Dip tube
Packaging of Aerosol
1. Cold fill process
2. Pressure fill process
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25. Conclusion:
 Packaging is very important to protect the product as well
as it maintain the pharmaceutical products stability.
 If the attractive packaging has been done then it is
beneficial for marketing purpose to improve the sale of
product.
Referance
I. Lachman leon, Lieberman Herbert A., Kanig Joseph L.,
“The theory & practice of industrial pharmacy” published
by Varghese publishing house, bombay, 3rd
edition,1991,pp 711-732.
II. Cooper and Gunn’s, “Tutorial pharmacy”, edited by
S.J.Carter,Publishing by CBS publisher &distributors,
Delhi, 6th edition, 2005,pp 131-141.
III. Mehta R.M., “Pharmaceutics- 1”Published by vallabh
prakashan, delhi, 2nd edition, pp 73-93.
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26. THANK YOU
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