pharmacy wills abbottabad

1. Women Institute of learning and
Rehabilitation science, Abbottabad
Subject: Industrial Pharmacy
Chapter-5
Packing & Packaging
Lecture 1
Dr. Aamna Shah
Pharm.D, M.S, Ph.D. (Pharmaceutics)
Assistant Professor

2. Key Points
Introduction
Components of packing/packaging
Characteristics/ Qualities of Packaging
Material/Components
 Types of packaging
Primary packaging
Secondary packaging
Tertiary packaging
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3. NTRODUCTION
Packing is the process of placing items or objects
inside a box, suitcase, paper bags or container for
shipping. Packing is a verb.
Packaging refer to the covering that
manufacturer used around an objects or items to
make the products more presentable to the
customers
Packaging is the process of wrapping products
with a special materials. It is noun
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4. Pharmaceutical Packaging is the science, art, and
technology of enclosing or protecting products for
distribution, storage, sale, and use.
It means to protect and maintain the products stability,
safety, efficacy, uniformity, integrity and purity
throughout the products’ shelf-life.
Pharmaceutical Packaging may also be defined as the
collection of different components (e.g. bottle, vial,
closure, cap, ampoule, blister) which surround the
pharmaceutical product from the time of production
until it is consumed or throughout its shelf life.

5. What is Pack/ Package/ packaging components?
 All those materials/ components which are used for
packaging of products such as
• Containers/ bottles,
• ampoules and vials
• Closures/ caps
• prefilled syringes,
• stoppers
• cartons and
• labels etc.

6. Characteristics/ Qualities of Packaging
Material/Components
Packaging components should have the following
properties or qualities.
1. They must not be reactive with the product.
2. They must not impart to the product tastes or odors.
3. They must be nontoxic.
4. They must be FDA approved.
5. They must meet applicable tamper-resistance
requirements.
6. They must not be the cause of product degradation.
7. They must be adaptable to commonly employed high
speed packaging equipment.

7. FUNCTIONS OF PACKAGING COMPONENTS
1. Product Identification: the package must give clear
identification of the product at all stage to the user
2. Product Protection: The Package must protects the
contents of a product from spoilage, breakage,
leakage, mechanical stress and external influences
such as light, temperature, humidity, & oxygen, etc.
3. Products Presentations/ Promotion: Good
presentations attracts the consumers during display.
The public can judge the product only by the
appearance of the package and professional
presentation will give confidence to the user.
Packaging is also used for promotion.

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4. Facilitating the use of product: Packaging
should be convenient to open, handle and use for the
consumers.
5.Convenience: Packages should be convenient for
the manufacturer, distribution, handling, display,
sale, opening, re-closing, use, dispensing, reuse,
recycling, and ease of disposal.
6. Economical: Packaging cost should be
economical or minimal to the consumers.
7. Barrier protection: A barrier from oxygen, water
vapor, dust, etc., is often required.

9. Permeation is a critical factor in design. Some packages
contain desiccants or oxygen absorbency to help
extend shelf life. Keeping the contents clean, fresh,
sterile and safe for the intended shelf life is a primary
function.
8. Security: Packaging can play an important role in
reducing the security risks of shipment. Packages can
be made with improved tamper resistance to deter
tampering and also can have tamper-evident features
to help indicate tampering. Packages can be
engineered to help reduce the risks of package
pilferage.

10. TYPES OF PACKAGING
Primary packaging Those components/ material that first
envelops the product and holds it. This package usually is in
direct contact with the contents.
 Examples: Ampoules, Vials, Bottle Containers, Dosing
dropper, Closures, Syringe, Strip package, Blister packaging.

11. Secondary Packaging is defined as the packaging
that lies outside the primary packaging. It is
perhaps used to provide additional protection.
Example: Paper, Cartons,, Box, and labels

12. Tertiary packaging: The components which is used
to facilitate the bulk handling , warehouse storage and
transport shipping. The most common form is a
palletized unit load that packs tightly into containers.
Examples: Barrel, container, crates, shipper, and
ancillary components such as leaflets, Spoons,
droppers etc.

13. Subject: Industrial Pharmacy
Chapter-5
Packing & Packaging
Lecture-2
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14. Key points
Glass containers
Advantages
Disadvantages
Composition
Examples
Manufacturing
Types of glass for drugs
Type-I
Types-II
Types-III
Types-IV
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15. Glass containers
 Glass is most commonly used pharmaceutical
packaging because of the following reasons
(Advantages of glass):
1. It possess superior protective qualities
2. It is economical
3. Available in a variety of size and shape easily
4. Chemically inert
5. Impermeable, strong and rigid
6. Does not deteriorate with age
7. Excellent barrier against every element except light but
amber color gives protection against light too
8. Easy to clean
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16. Disadvantages
1. Fragility
2. Heavy weight
Compositions
Glass is composed of the following components:
Sands (almost pure silica)
Soda ash (sodium carbonate)
Lime stone (calcium carbonate)
Cullet (broken glass or refine glass or refuse
glass)
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17. Compositions: Most common cations found in
pharmaceutical glasswares are
Silicone, aluminum, boron, sodium potassium, lead,
calcium, magnesium, zinc, and barium
The only anions found in glass container is oxygen
Thus the qualities of glass is affected by the types of
elements it contains
Examples
1. Reduce quantities of sodium ions makes the glass
chemically resistant but without sodium or other
alkalis, glass is difficult to melt and become
expensive
2. Similarly, incorporation of boron oxides in glass,
will help melting process at low temperature
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18. 3. Lead in small quantities gives clarity and brilliance/
brightness but produce a relatively soft grade of glass
4. Aluminum oxide is used to increase hardness, durability
and resistance to chemicals
Glass Manufacturing
Four types of processes are used in glass production
1. Blowing: compressed air is used to form the molten
glass in the cavity of metal mold. Commercial glass
and jars are produced by this method.
2. Drawing :Molten glass is pulled into the die or
rollers that gives shape to the soft glass. Rods, tubes,
sheets, ampoule, vials and cartridge are produced by
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19. 3. Pressing: In this method, mechanical force is
used to press the molten glass against the side of
mold. Glass sheet are produced by this method
4. Casting :In this method, centrifugal force or
gravity is used, to initiate the molten glass to form
in the cavity of the mold.
Colored Glass
 Amber color and red color glass are effective in
protecting the content of glass from sunlight by
screening out harmful ultrasonic rays
 According to USP specification for light resistant
glass container; the glass must provide protection
against 2900 - 4500 angstroms of light, so amber
color glass meets this specification. 7/20/2
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20.  To produce amber color glass, iron oxide is added to
glass which could leach out into the product.
 Therefore, if the product contains such ingredients
which is catalyzed by iron for chemical reaction, then,
amber color should not be used.
Types of Glass for Drugs
 USP and NF, describe the various types of glass for
evaluating the chemical resistance of glass.
 Two types of tests are conducted on all types of glasses
i.e.
1. Powder glass test (Glass grain test-BP)
2. Water attack test (Hydrolytic resistance test –BP)
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21. TYPES OF GLASS FOR DRUGS
 These tests are conducted to measure the amount of
alkalinity leached from the glass under controlled
temperature/condition.
 Water attack test is used only for type –II glass
while, powdered glass test is used for other types.
 Four types of Glass Containers are as follows;
1. Type – I:  Highly resistant, borosilicate glass
2. Type – II: Treated soda lime glass
3. Type – III: Soda lime Glass
4. Type – IV or NP:  General purpose soda lime
glass
 NP - means, Non – Parenterals or Not for
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22. 1-Type – I:  Highly resistant, borosilicate glass
 It is highly resistant glass and chemically inert
 It can be used for all strong acid and alkali as well as all
types of solvents
 It has some chemical reaction with water b/c sodium is
loosely combined with silicone and is leached from the
surface of glass by water.
 Distilled water stored for one year in type – III container
pick up 10 – 15 parts per million (ppm) of sodium
hydroxide from the glass container per year.
 Addition of approx. 6% boron to form type – I
borosilicate glass reduce the leaching action, so that only
0.5ppm is dissolved in a year.
 Type – I glass is intended for parenteral preparation.
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23. 2-Type – II: Treated Soda Lime Glass
 Glasswares when stored for several months at
elevated temperature or uncontrolled conditions,
then wetting of the surface by condensation results
the salts being dissolved out of the glass. This
process is called blooming or weathering
 Type – II glass is made of soda lime that has been
de-alkalinized with water or treated with sulfur to
remove surface alkali.
 The de-alkalizing process is known as “sulfur
treatment” which prevent weathering of empty
bottle.
 The glass are exposed to water vapors or sulfur
dioxide at an elevated temperature
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24.  The gas react with the alkali on the glass surface
and forms a “sulfate bloom”/ white powdery mass
which is removed when the container are washed
before filling
 So sulfur treatment neutralized the alkaline oxide
on the glass surface, thereby rendering the glass
more chemically resistant
 This type is most commonly used for acidic, basic
and neutral preparations.
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25. 3-Type – III: Soda lime Glass
 These are untreated and commercial soda lime
glass of average resistant
 Usually not used for parenteral EXCEPT suitable
data indicates that it is satisfactory for parenterals.
 Mostly used for oily injection and dry powder
injection (vials).
4-Type – IV or NP:  General purpose soda
lime glass
 It is used for non-parenteral products, that are
intended for oral and topical uses
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26. Subject: Industrial Pharmacy
Chapter-5
Packing & Packaging
Lecture-03
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27. Key points
Plastic containers
Composition
Additives
Polymers used in plastic containers
Polyethylene (PE)
Polypropylene (PP)
Polyvinyl chloride (PVC)
Polystyrene (PS)
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28.  PLASTIC CONTAINERS
 Plastic containers are also used in pharmaceutical industry
for packaging because of the following reasons (Advantages):
1. It is easy to form and design
2. Extremely resistant to breakage or damage
3. Safety to customers due to reduction of chance of breakage
Compositions
Plastic containers are made up of different polymers such as
 Polyethylene
 Polypropylene
 Polyvinyl chloride,
 Polystyrene
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 Polymethyl methacrylate
 Polyethylene terephthalate
 Polytrifluoroethylene
 Polyamide

29.  These plastic container consist of one or more polymers
together with certain additives but the amount of additive
depend upon the process used to convert plastic into
container
Theses additives are as follows
 Antioxidant (to prevent oxidations)
 Antistatic agents (reduce the static charges build up in
polymers which is generated due to frictional contact with
different materials). Also reduce dust accumulations
 Color
 Lubricant
 Plasticizer: to increase the durability of the plastic
container
 Stabilizer
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30. 1-Polyethylene (PE)
High density PE is widely used in pharmaceutical packaging
BECAUSE
Advantages
 It is good barrier against moisture but poor for oxygen and
other gases
 Most of the solvent don’t attacked and unaffected by strong
acids and bases.
Disadvantages
 Lack of clarity
 High rate of permeation of essential order, flavors and
oxygens
 Despite of these problems it offers best all round protection
to greatest no of product at a lowest cost.
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31. The density is ranges from 0.91 – 0.96 poise. As the
density increase
 Materials becomes more stiffer i.e. increase melting
temperature
 Becomes less permeable to gases and vapors
 But less resistant to stress cracking
These polymers are susceptible to oxidative
degradation during processing and exposure so
antioxidant is used in 100 ppm. E.g. butylated hydroxy
toluene , di-laurly thiodipropionate etc.
Anti static agent are also used to minimized airborne
dust accumulation at surface of bottle during handling ,
filling and storage. E.g. Polyethylene glycol or long
chain fatty amides are used at 0.1 – 0.2% conc. in high
density PE container
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32. 2-Polypropylene (PP)
 It is also very good polymers for packaging pharmaceutical
Advantages
 It does not stress crack under any conditions
 It can be used for almost all chemical such as strong acids,
alkalis and most of organic martials except aromatic and
halogenated solvents which soften it
 It is excellent barrier to gas and vapors i.e. resistant to
permeation
 I has high melting point so suitable for sterilizable product
Disadvantages/ draw back
 Lack of clarity
 Brittleness to low temperature
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33. 3-Polyvinyl Chloride (PVC)
 It is crystal clear rigid, polymer which provide good oxygen
barrier
 It can be soften by plasticizer
 It must not be over heated b/c it starts to degrade at 138◦C
and the degradative product is extremely corrosive
 It becomes yellow when expose to sunlight or UV light
 Stabilizer are used during processing b/c vinyl group
degraded at elevated temperature e.g. dioctyl tin
mercaptoacetate and maleate, sulfur, zinc and calcium salt
 Polyvinyl chloride is an excellent barrier for oil, volatile and
fixed alcohol, petroleum solvent, order, flavor and oxygen
 It does not effect by acids and alkalis
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34. 4-Polystyrene (PS)
It is crystal clear rigid plastic
It is widely used in dispensing pharmacies by
pharmacist for solid dosage form b/c it is relatively
low cost and not useful for liquid product
It has high water vapor and oxygen permeability
Polystyrene container are easily scratched and
cracked when dropped
It has low melting point (88◦C), so can not be used
for hot items or high temperature application
/exposure.
 it is not resistant to strong oxidizing acid, alkalis,
and many other chemical , therefore generally used
for packaging of dry products only
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35. Subject: Industrial Pharmacy
Chapter-5
Packing & Packaging
Lecture-04
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36. Key points
Problems associated with plastic containers
1. Permeation
2. Leaching
3. Sorption
4. Chemical reactivity
5. Modification or alteration
Closure system
Types of closure
Closure liners/Wads
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37. Problems Associated With Plastic Containers
 A packaging system must protect the drug without
changing the composition of product until last dose
is removed.
 There are five types of problems associated with
the plastic containers such as
1. Permeation
2. Leaching
3. Sorption
4. Chemical reactivity
5. Modification or alteration
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38. 1. Permeation
 Permeation means transmission of gases, vapors or
liquid through plastic packaging materials that can
adversely effects the shelf life of drug
 Permeation of water vapors and oxygen through
plastic wall into container causes oxidation and
hydrolysis of drugs
 Temperature and humidity also influences the
permeability of oxygen and water, so increase
temperature increases the permeability of gases
 Polyethylene container gives different permeability
value at various temperature.
 If the formulation contains volatile ingredients and
upon storage in plastic container, one or more
ingredient may passes through the wall of the
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39. 2. Leaching
 Since most of the plastic containers contains additives
such as stabilizer, antioxidant, color, antistatic agents,
and plasticizer which may be leached out into the
products and cause contamination of product.
 Particularly dyes/colors may migrate solutions and
causes toxic effects and change the color of the
products
3. Sorption
 Both adsorption and absorption process are
cumulatively called sorption.
 Adsorption means to adhere to the surface of the
container
 Absorption means to diffuse into the containers
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40.  Sorption means removal of the constituents of the
drug products by the plastic containers via
adsorption and absorption processes.
 E.g. (1) if the drug is in solution form in the
preparation and is highly potent (in small quantity
with high efficacy) then sorption may lead to
serious consequences i.e. loss the therapeutic
efficacy of preparation
 (2). Commonly observed problems is the loss of
preservatives i.e. these agents are very less
quantities and loss of these through sorption may
unprotect the product against microbial growth
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41. 4. Chemical Reactivity or Reaction
 Certain ingredients that are used in plastic container may
reacts with one or more components of a drug products or
ingredients in the formulations may reacts with plastic.
 Even microquantities of chemicals substance may alter the
appearances of plastic or drug products.
 Ultimately they causes degradation of drug or products
5. Modification or alterations
 The physical and chemical alteration of packaging
materials by drug products is called modifications
 Permeation, sorptions and leaching may alters the
plastic containers and causes degradation
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42. Some solvent systems have been found to be
responsible for changes in the properties of plastic
container.
 Examples:
 Oils have softening effects on polyethylene
containers
 Fluorinated hydrocarbons attacks on polyethylene
and PVC and causes softness
 Some content may extract the plasticizer,
antioxidant or stabilizer , thus changing the
flexibility of the packaging
 PVC is excellent barrier for petroleum solvent but
the plasticizer in PVC is extracted out by the
solvent thus the plastic becomes hard and stiff
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43. CLOSURES SYSTEM
 Closure/ Cap is one of the most important and critical
components of container b/c of stability and compatibility
concerned
 An effective closure must prevent the content from escaping and
allows no substance to enter the container.
Types of Closures/Cap:
 Closures are available in different designs and shapes such as
1. Threaded screw cap:
 It is a type of closure which is molded on the neck of the bottle.
The threads of bottle is engage with the cap. E.g. all bottle used
in oral preparations
2. Lug cap:
 It is similar to threaded screw cap. It required only a quarter
turn (1/4th rotating). It is widely used in food industry. E.g.
Jam cap 7/20/2022
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44. 3. Crown Cap or Crimp on Cap:
 It is commonly used as a crimped closure for
beverages bottle /cold drink. It is made up of tin.
4. Press on Cap:
 First press then open by rolling. It is also called snap
fit cap. Cap is pressed to seal and close with a click.
E.g. Mospel liquid bottle cap
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45. 7/20/2022
Faculty of Pharmacy, Hamdard University Karachi
45
5. Roll on Cap:
The aluminum roll on closure can be sealed securely,
opened easily, and resealed effectively
It is widely used in packaging of foods, beverage,
chemical and pharmaceuticals.

46. Roll on cap is further divided into three classes
1. Resealable cap:
 It can open and closed multiple times
2. Non-resealable cap:
 It is once opened then discarded
3. Pilfer proof (PP) cap:
 It has additional length extended below the
threaded portion to form “band/ collar” which is
then fastened by forming “bridges”.
 When PP closure is removed or opened then the
bridges break and the band remains in place on the
neck the bottle / container.
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47.  The user can seal the containers but the detached
band indicates that the package has been opened
6. Rubber Cap:
 Rubber caps are also used in packing/sealing of
vials and as plungers (rubber used in syringes).
 They are used to prevent oxygen, CO2, moisture,
microorganism, escape of volatile liquids and
drugs.
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48. Closure Liners/ Wads
 The materials that is inserted in a cap to make the seal
effective b/w closure and containers
 It is also called wads.
 It is made up of either plastic or rubbers, resins, wax.
 Liners should be chemically inert with the products b/c it is
in direct contact with the products so that no possible
changes in purity and potency occurs
 Sometimes the liner is glued or sealed with an adhesion to
make the sealing more effective like resin, waxes, glue.
 Liners are made up of resilient backing and facing
materials
 The facing part is in contact with the products and
backing part provides cushioning and sealing properties
required 7/20/2022
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49. REFERENCES
 Aulton’s Pharmaceutics:
 Part 6, chapter 47, packaging
 Modern Pharmaceutics:
 Chapter 17 (Packaging of pharmaceutical dosage
forms),
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