Different types packaging and technologies

1. Pharmaceutical Packaging
Technology
Sonia Barua PhD
Assistant professor
Department of Pharmacy
USTC, Chittagong

2. What is Pharmaceutical Packaging?
According to WHO packaging:
‘The Collection of different components which surrounds the
pharmaceutical product from the time of production until its use’.

3. Purpose of packaging?
The primary purpose of packaging is to protect the drugs and drug products from any
damage that could happen during transport, handling and storage. Packaging
retains the product intact throughout its logistics chain from manufacturer to the
users. It protects the products from humidity, light, heat and other external
factors such breakage and spoilage hence increasing the safety and
sustainability of the products.

4. Functions of Packaging:
1. Product Identification: Packaging greatly helps in identification of products.
2. Product Protection: Packaging protects the contents of a product from
spoilage, breakage, leakage, etc.
3. Facilitating the use of product: Packaging should be convenience to open,
handle and use for the consumers
4. Product Promotion: An well controlled Packaging could be used in product
promotion and attract the consumer attention while purchasing.

5. 6 Convenience: Packages should have features that ease the distribution,
handling, stacking, display, sale, opening, re-closing, use, dispensing, reuse,
recycling, and ease of disposal of the products.
7 Barrier protection: Some packaging also contain silica to protect the product
from moisture and oxidation.
8 Reduces Risk: Packaging play an important role
in reducing the risks during shipment. Hence all
pharmaceutical packages should be made with
temper resistance or tamper evident features.
Functions of Packaging:

6. ➢Mechanical Properties
➢Physical Properties
➢Chemical Properties
Drug products are designed to provide effective and safe treatment to a medical
condition. Safe treatment includes maintaining the effectiveness of a product over
its stated shelf life. This means the product and package must maintain both the
integrity and effectiveness of a drug from the time of manufacture and packaging to
the point where the product is consumed.
Properties of Pharmaceutical packaging as follows:
Properties of Pharmaceutical Packaging

7. ➢Mechanical Properties
I. Packaging material must have sufficient mechanical strength to withstand heat, moisture and
humidity during manufacturing, transporting and storage and lastly supply from the retailer to the
patients.
II. Tensile strength comes under the mechanical properties of the packaging in which packages have
ability to endure the maximum stress that is before breakage and pressure apply during stacking.
III. Tear resistance is a measurement of packaging material withstand the effect of tearing.
IV. Puncture resistance while handling operation.
V. Protect the content from vibration during transportation

8. ➢Physical Properties
I. The material should be impervious to any possible contaminants. (e.g., solid,
liquid, gases, vapors or microorganisms)
II. The material must able to withstand heat while processing includes sterilization.
Examples glass containers, rubber closures
III. The container surface must be capable of clear labeling which is often difficult.
(e.g., plastic bottles ).
IV. The materials must be protected from light such as UV light. For example:
Amber colored bottle or ampoules.
V. The material must be thermo resistance in case of thermo sensitive APIs and
should continue this properties unless use.

9. VI Must be easy to label and thus to identify the product.
VII Protect the content from particulate contamination.
VIII Protect the content from abrasion this may create electrostatic effect.
VIX Must be unleachable.
X Protect the content to loss of volatile materials.
XII Protects the content from both loss and gain of water.
XIII Must be FDA approved.
➢Physical Properties

10. ➢Chemical Properties
I. A bulk package used during manufacture must not interact with a drug during
manufacture, and final or individual dose packaging must be proven to not have
any interaction.
II. The package also must not interact in a significant way with the product during
distribution and storage throughout its stated shelf life
III. The API should not react with container or closure, as might happen in case of
alkaline substances in aluminum container and certain reactions with plastic
containers.

11. ➢ Chemical Properties
IV Packaging must be chemically inert and non toxic.
V The container or the closure must not produce any substances to the products.
That means changes of APIs to a different isoform. For examples- plastic
containers.
VI Must produce antipermeable effect from gas vapor or liquids (oxygen and
water). For example, materials such as nylon produce poor barrier to water
vapors while some hydrophobic materials as polyethylene provide much better
barriers.

12. Factors Influencing Packaging
Following factors are important to consider in pharmaceutical
packaging
1. The type of dosage form
2. The route or mode of administration or use
3. The type of pack
4. The mode of sale/marketing area
5. The mode of dispensing via a combined device/pack
6. Administration by a device separate to the pack.

13. 1. The type of dosage form
• The type of dosage form is primarily related to the physical state, e.g.
solid, liquid or gas, and whether it is sterile, nonsterile, unit dose or
multi-dose.
• Solids may be regular, irregular, free-flowing, cohesive, i.e. powders,
tablets, capsules, suppositories, etc.
• Liquid or semi-liquid products may be based on water, alcohol,
solvents, oils, gels, etc., i.e. emulsions, suspensions, Creams,
ointments, solutions, etc.
• Gases may be liquefied, pressurised, volatile, inert, i.e. vapours,
inhalations, aerosols.

14. 2. The route of administration
• The route of administration may make certain packaging features
desirable or necessary. Possible routes include the following.
• Oral dispensing, dosing, with absorption/mode of action occurring
between mouth and colon.
• Local topical applications to the skin, hair.
• Parenteral (large and small volume) sterile products administered
intravenously, intramuscularly, intrathecally, subcutaneously, etc., in
single or multi-dose packs.
• Orifice introduction ear, nose, eye, rectal, vaginal, etc.
• Inhalation via mouth or nose using a face mask, breathing tube or
direct inhalation into mouth or lungs

15. 3. Type of packaging material
• Type of pack can refer to either the basic materials employed, i.e.
glass, plastic, metal, etc. or
• The pack style/type, e.g. bottle, tube, sachet, blister. Packs may
provide single (non-reclosable) use, or multi-use (reclosable).
• Both groups have influences on the product and have to be considered
in terms of the material characteristics and the total packaging concept
involving such factors as product compatibility, functional and
aesthetic design, production performance, material costs, production
costs and user convenience

16. 4. Mode of sales or market area
• Ethical products are normally available only through or via the
profession, i.e. pharmacist, doctor, dentist, nurse, veterinarian, etc.
They may be supplied either as a bulk pack which is then broken down
into a smaller quantity at the patient-dispenser interface or as an
original pack whereby a course of treatment is supplied in the pack as
produced by the pharmaceutical manufacturer (also called patient pack
or unit of use pack).
• OTC or proprietary products, as their name suggests, are products
designed for direct sale to the general public. How the sale occurs, i.e.
through pharmacies, drug stores, etc., largely depends on legal
requirements of the country concerned, and how the drug is classified
in terms of the prevailing poison enactments, food and drugs
legislation, etc

17. OTC products Ethical products

18. 5. Administration
• The mode of dispensing and the use of packs which act as a device are both related to how a
product is administered, and the route or mode of administration. To help the administration, the
pack may be required to act as a dispensing aid or a device, e.g. an aerosol, or have accessories
which can either be made part of the pack or used as a separate unit, e.g. a dropper assembly
• Finally, the pack may either become part of a device, e.g. a cartridge tube which may be used with
a reusable or disposable syringe, or have a separate device which administers the product once
removed from the pack, e.g. a hand- or power-operated nebuliser.

19. • From this broad introduction it should be recognised that the main
objective of most pharmaceutical products is to deliver, introduce or
apply a drug of proven stability and safety to a specific site where the
most effective activity can be achieved.

20. Types of package:
1. Primary packaging:
Direct contact with the formulations
Protect from environmental, chemical and mechanical
2. Secondary packaging:
Secondary packaging material:
Provide information about the product
Protection from tough handling during transportation
3. Tertiary packaging:
Outer package of secondary packaging
Bulk handling and shipping

22. Glass
• Silica, soda ash and limestone are the main constituents of the glass. In
addition, following compounds are added in trace amounts:
• Alumina (Al2 O3) increases the hardness, durability and clarity of the
glass
• Selenium or cobalt oxides improve clarity
• Lead oxide gives clarity and sparkle (but makes glass soft)
• Boron compounds give low thermal expansion and high heat-shock
resistance
• Arsenic trioxide and sodium sulphate are added to reduce blisters in
the glass.
Types of packaging materials

23. Types of Glass Main constituents Properties Uses
Type I
Borosilicate glass
e.g Pyrex Borosil
• SiO2-80%
• B2O3-12%
• Al2O3-2%
• Na20+Cao-6%
• Has high melting point so can
withstand heat
• Chemical resistant
• Reduced leaching action
• Laboratory glass apparatus
• For injections
• For water for injections
Type II
Treated soda lime
glass
• Made of soda lime
glass
• Dealkalized the
surface with SO2 at
500 0c and moisture
• Water resistant
• Surfur treatment neutralizes the
alkaline oxides on the surface
thereby rendering the glass more
chemically resistant
• Used for alkali sensitive products
• Infusion fluid blood and plasma
• Large volume container
Type III
Regular soda lime
glass
• Sio2
• Na2o
• Cao
• It contains high concentration of
alkaline oxides and imparts
alkalinity to aqueous substances
• Flake separate easily
• May crake due to sudden change
of temperature
• For all solid dosage forms (tablets,
powder)
• For oily injections
• Not to be used for aqueous
injections
• Not to be used for alkaline
sensitive substances
NP-Non
parenteral glass
• For oral and topical use
• Not for injections
Colored glass • Glass and iron oxide • Produce amber color glass
• Can resist from radiation 290 400
and 450 nm
• For photosensitive products

24. Advantages
• They are hygienic and suitable for sterilization
• They are relatively non reactive ( depending on the grade chosen)
• It can accept a variety of closures
• They can be used on high speed packaging lines
• They are transparent.
• They have good protection power.
• They can be easily labeled.

25. Disadvantages
• It is relatively heavy
• Glass is fragile so easily broken.
• Release alkali to aqueous preparation

26. Plastics
• Properties of Plastics:
• Plastics are synthetic polymers of high molecular weight.
• They are sensitive to heat and may melt or soften below at 100oc.
• They are light and can be clear or opaque (opacity to protect the
contained medicine).
• Plastics are easily shaped and sealed, which gives great versatility in
the design and allows the inclusion of administration aids, such as a
squeezable dropper.

27. Types of Plastics
• Thermoplastics
• In general, thermoplastics have linear and branched polymer chains.
At high temperature, thermoplastic polymers melt and become liquid,
therefore materials can be moulded into a variety of shapes, such as
bottles, tubes and films.
• They can be Softening and re-shaping by the application of heat and
mechanical force can be performed multiple times. Examples of
thermoplastics include: polyvinyl chloride, polyethylene, polystyrene,
polypropylene, nylon, polyester, polycarbonate

28. • Thermoset polymer: these are polymers cross-linked polymers
• They can only be shaped once following the polymer formation, due to
the act that the cross-linked polymer chains cannot flow. Further
heating would lead to breakage of the bonds in the polymer causes
polymer degradation. Examples of thermoset polymers are: urea
formaldehyde, epoxides, urethanes, unsaturated polyesters and
rubbers.
• Mainly use n manufacturing of closures, as metal coatings, and
adhesives in the pharmaceutical packaging industry

29. • Table books: (refer:Alton)
Advantages:
• Plastic containers are not breakable.
• They are light in weight and resistant to leakage.
• They are cheap to manufacture.
• They can be easily moulded or remoulded multiple times with , high
quality and with various design.
• Plastic containers are chemically inert and resistant to corrosion. They
are collapsible

30. • Disadvantage
• Plastics are less resistant to heat and long-term light exposure than
glass and metal.
• Plastics are also liable to undergo stress cracking, where the presence
of solvents, such as alcohols, acids or oils, cause a plastic pack to
become brittle, crack and eventually fail over time.
• Certain components of the plastic packaging material can
contaminated the product by leaching out the packaging materials.
• They are permeable to moisture

31. • METALS :
• Metal is widely used to package food, beverages, etc. Aluminium and tinplate (a sheet of steel that
is coated with a thin deposit of tin) are the metals used in the packaging of pharmaceuticals. They
are used in the form of cans (e.g. pressurized metered dose inhaler (pMDI) containers), tubes ( or
creams, ointments, gels), pouches ( or powders, granules, liquids, suppositories), blister packs and
in closures.
• Advantages:
• It is mechanically strong and can withstand the high internal pressure in pMDI containers, it is
shatterproo lightweight compared to glass container.
• Labels can printed directly on to their surface.
• Disadvantages:
• They are expensive.
• They react with certain chemicals

32. Rubbers and elastomers
• These are extensively used as stoppers (closures on parenteral containers). When
used as a closure they allow a hypodermic needle to enter the container, and reseal
when the needle is removed.
• They are soft enough to mould and conform to the opening of the container and
allow a tight seal.
• Like other plastics, rubbers are not totally inert. They are permeable to some
extent; they may also absorb components of the packaged product and may leach
residues and low molecular weight components into the packaged contents

33. Rubbers and elastomers
• Elastomers are polymers that can be stretched (to equal to or more than twice their
original length) and which return to their original length once the force is
removed.
• Common pharmaceutical examples include butyl, chlorobutyl, natural and silicone
elastomers. Butyl and chlorobutyl elastomers are least permeable to oxygen and
water vapour. These materials are not used alone, however. For example, natural
rubber is mixed with chlorobutyl to help resist coring in closures which must
withstand multiple penetrations by a needle

34. Closures
• A closure is a device – e.g. stopper, lid, top or cap which is used to close a
container, and is an integral part o the pack. The closure must be inert, compatible
with the contents, and protect the latter against environmental hazards, such as
oxygen, light, moisture, etc.
Properties of Closures:
• The closure has to be user- friendly, allow easy opening to consumers and be easy
to reclose ( or multi-unit packs)
• child-resistant, tamper resistant and tamper-evident

35. • Closures may also include dispensing devices, e.g. a pump on bottles
containing creams. The outer surface of the closure may also be ribbed
to allow good grip when opening by twisting.
• Pharmaceutical closures are mostly made of plastic (thermosets and
thermoplastics), although metal is also used, e.g. on parenteral vials

36. Tamper resistant packaging
Film wrapper
• There are mainly three types of film wrapper as follows:
• End folded: it is formed by pushing the wrapper into a sheet of over
wrapping film which forms the film around the product and fold the edges
in a gift wrap fashion. It must be heat sealable and tamper resistant. eg
cellophane (regenerated cellulose) and polypolpylene.
• Fin wrapper: the seals are formed by crimping the film together and
sealing together the two inside surfaces of the film producing a fin seal.
Polyethyelene and surlayn are used.
• Shrink Wrap: It is used in wrap from with the center folded in the direction
of winding. As the film unwind in overwrapping machine, a packet is
formed in which the product is inserted. Remaining overwrap is sealed by L
shaped slealer and trims off the excess film. Heat shrinkable polyethyelene,
polypropylene and polyvinyl chloride.

37. End
folded
Fin
wrapper

38. Shrink
wrap

39. • Advantages of Film Wrapper
• Its durable
• Provide high quality features and its hard to damage
• Facilitate long distance transport

40. Blister packaging
• Blister pack or bubble pack is widely used in variety of products such in
small consumer goods, foods, and in pharmaceuticals.
• Blistering: Blistering is the process of making Blisters or enclosing the
tablets & capsules.
• Blister packaging is composed of semi rigid blister or transfarent blister
which is filled with product and lidded with a heat sealable backing
material. Backing material can be either push through or peelable type.
Push through is coated with heat sealable aluminium foil.
• Blister packaging must be tamper resistant and child resistant
• Must have sufficient tensile strength
Tamper resistant packaging

41. Blister
packaging

42. Advantages of Blister packaging
• They provide barrier protection to the product from moisture, gas,
light & temperature
• They also provide a degree of tamper resistance
• The patient could handle the blister package more easily and could
store it more conveniently than conventional packages.
• Reduced costs and provide higher packaging speeds relative to other
packaging materials.
• lot number, and expiration date of the dosage form can be labelled.

43. • Strip package
• It is a unit dose packaging and commonly used for tablets and capsules
A strip package is formed by feeding two webs of a heat sealable
flexible film through a heat crimping roller or heated reciprocating
platen.
• The product is dropped into the pocket form prior to forming final set
of seals.
Tamper resistant packaging

44. Strip packaging

45. • Bubble pack is made by sandwiching the product between a
thermoformable, extensible or heat shrinkable plastic film and rigid
backing material. Product are dropped into the pocket then sealed by
a rigid material such as heat seal coated paper board.
• Shrink banding Heat shrinakble polymer such as PVC is used in this
type of packaging. Its diameter must be slightly larger then the cap and
neck of the bottle to be sealed. Tear performtions are supplied to easy
opening of shrink band
Tamper resistant packaging

46. •Tape seals and breakable caps
These are application of a glued or pressure sensitive tape or label around or
over the closure package which must be destroyed to gain access to the
packaged product. Poor tear strength with light weight paper is used for
labelling.
Breakable caps are comes with variety of types such as roll on cap and a
ratchet style plastic cap.
Tamper resistant packaging

47. • Aerosols containers
• It consists of a drawn aluminum.
• A hydrocarbon propellant along with the product is added into the
container
• A spray nozzle holding with a gasketed metal ferrule is crimped over
the opening of the container.
• A polyethylene tube or dipped tube is attached to the inside of the
spray nozzle dipped into the product. Its draw the product into the
nozzles when sprayer is activated.
• Spray nozzle are usually metered to allow a specific dose to be
dispensed with each spray.

49. • Sealed tubes or collapsible tubes
• These usually consist of metal, plastics or laminations of foil, plastics and paper.
• Metal tubes are used which require the high degree of barrier protection. This are
made of aluminum and usually coated. Puncture inserts consist of 3 to 5 mm
aluminum to provide tamper resistant.
• This must be punctured to pried out or move to gain access to the product.
.
Tamper resistant packaging

50. • Extruded plastics tube are widely used for the product which are compatible with
the limited barrier characteristics of the plastics.
• Laminators tube is employ for the high barrier protected materials. They are
consist of foil paper and plastics with multilayer lamination.
• This tube made of laminated body with head injection molded onto the tube. Since
the head is injection-molded any number of design that must be cut or broken to
gain access to the product

51. Laminates
• A laminate is made by bonding together two or more plies (layers) of
different materials, such as paper, plastic and metal. The aim is to combine
the desirable properties of the different plies into a single packaging
structure. eg laminated tube.
• Laminates are used to produce pharmaceutical packs such as sachets, blister
packs, tubes, pouches, etc.
• An example is a structure consisting of paper/ metal oil/polythene plies,
used for sachet packaging. The paper provides strength, printability and the
ability to easily tear the package, the oil provides an excellent barrier to
light, moisture and gases and the polythene enables heat sealability.
• It is cost effective.
Tamper resistant packaging

52. • Pharmaceutical packaging testing:
• Deformation vs compressive forces:
• This test measures the compressive strength of the packaging such
boxes, drums and cans.
• Packing includes shipping containers made of corrugated fiberboard,
wooden boxes and crates

53. • Distribution simulation test:
• This test includes stability of packaging materials during shipping from
manufacture to the sterilization facility, distribution center, health
care facility, etc.
• A medical package falling from a fork lift, swaying around a truck
during transit, or being stacked on top of other packages / containers
in a storage warehouse are all examples of distribution occurrences.

54. • Packaging integrity test:
• Dye test- seal integrity test. Dye solution is used to inspect any defects
in sterile closure seal.
• Visual inspection
• Bubble test
• Leak test

55. • Packaging strength test:
• Packaging material integrity test. It is to ensure that packaging
materials are not going to deform or separate when special forces are
applied. Seal peal or burst testing method is used.
• Vibration strength test:
• This test confirms the durability of packaging during distribution.
• Hydraulic table replicate test.
• Forklift test to ensure the packages integrity exposure to shock.
Rotational edge drop and flat drop test are includes.

56. • Water attack test:
• This test is to determine the leaches alkalhi from the surface of the
container. Examples; glasses
• Hydrolytic resistance test or withstand to heat during autoclave.
• Arsenic test for glass containers intended purpose for parenteral
dosage forms
• Thermal shock test: breaks and cracks of the containers during
thermal shock.
• Leakage test. Presence of cracks or breakage.

57. • Fragmentation test for rubber closure: detect the number of
fragments visible on the rubber.
• Self sealabity test for closures intend to be used for parenteral
solution for multiple use.
• Light absorption test:
• Water vapor permeability test.

58. Different types of packaging machines
Blister packaging:
• The pharmacy blister packing machine is a unit dosing packaging
machine for the pharmaceutical industry.
• This machine uses blister materials like polyvinyl chloride,
polystyrene, and polypropylene, among others
• Tablet, capsules and other products such as syringe, bottles, ampoules
and vials.
• Their functios include handle auto-counting, horizontal perforation,
waster side cutting, printing batch numbers, and auto punching

59. Blister packaging

60. • Strip packing machine:
• It provide high speed rate for packing various products like tablets,
capsules, etc.
• The machine has a very high packing speed of up to 2400 units per
minute
• the machine is suitable for most heat-sealable foils such as aluminum
poly, glassine, and paper poly

61. Strip packaging machine

62. • Functions include
• Used to package uncoated and coated tablets
• It is also used to package hard gelatin, soft gelatin, and capsules.
• Confectionary products such as lozenges and medicinal chewing gums
• It is also used in the production line for automatic production in the
big industries

63. •Effervescent Tablets packing machine is designed to pack
effervescent tablets into tubes.
•This machine accurately packs large numbers of tablets in the
elongated tubes.
•This makes it suitable for packaging fragile products like the
effervescent tablets within a short time
Effervescent tablets machine

64. • Syrup powder filler:
• The primary function of the syrup powder filler machine is to fill the
syrup powder into the ampoules bottles. It is mostly used in the
pharmaceutical industry because it ensures strict parameter of
cleanliness, thus avoiding contamination.
• The filler machine is also used in sealing of the filled ampoule bottles
with the help of SS conveyor belt.
• Its is used as a washing machine.
• It also helps in the mixing of the syrup, and labeling of the already
filled bottles.

65. Syrup powder filler

66. Cartoning Machine in Pharmaceutical Industry
• A cartoning machine is used for packaging
pharmaceutical products into cartons.

67. • Liquid Filling Packaging Machine
• Liquid filling machine is specifically designed to fill liquids into various
containers.
• Following packaging materials are used for filling liquid dosage forms:
• Bottles
• Vials
• Ampoules
• IV bags
• Functions
• Ensure accurate filling with no wastages
• The filling process must be accuarte
• Help to achieve consistent and reliable fills
• Filling must be free of contamination

68. Liquid filling packaging machine

69. • Packaging line
• In an industrial process, the final phase is the packaging line. In the
pharmaceutical sector, the function of this line is to convey the
products to be packaged. Generally, it can be operated by an operator
and/or controlled from a computer station
• For dry pharmaceutical product.
• Inhalers, tablets, gelatin capsules or powder filled sachet or injection
containers. Additional machines include coating machines for tablets,
fillers and blister packaging machines

70. Packaging line for pharmaceutical products

71. • Filling machines for liquid products
• Either single machines or complete line for liquid pharmaceutical
products where the bottle, ampoule or needle is washed, sterilized,
filled, sealed and marked.
• The line can be built in an isolator and include inspection machines,
sterilization and aggregation

72. Filling machine for liquid products

73. • Stick-pack and sachet machines are produced for powder, gel and
fluid products. The output for these lines are 50-600 units/min
depending on the machine model
Stick-pack and sachet machine

74. Labeling
• The pharmaceutical industry has stringent labeling requirements
• The US, for example, has the Fair Packaging and Labeling Act, which
guides how this labeling must be done.
• For example, the label must include product identity, contents,
manufacturer and supplier address, net quantity, and prescription
information.