Medical device packaging science

1. Pharmaceutical
packaging
Presenter
Ravichandra Nadagouda
NH0120008
Pharmaceutical Quality Assurance
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2. CONTENTS
• INTRODUCTION
• Types of packaging
• Different types of packaging material
• Medical device packing
• Reference
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3. What is packaging?
Packaging can be defined as an art, science and
technology to ensure the safer delivery of the
product throughout its journey from marketing to
that end use.
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4. Functions of packaging
Protection Preservation Presentation Promotion
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5. Ideal qualities of a
pharmaceutical packaging
• It should have sufficient mechanical strength so as
to withstand handling filling closing and
transportation
• It should not react with the contents stored in it
• It should of such shape that can be elegant also
the contents can be easily drawn from it
• It should not leach alkali in the contents
• The container should not support mold growth
• The container must withstand the heat when it is
to be sterilized
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6. Ideal qualities of a
pharmaceutical packaging
• The contents of the container should not be
absorbed by the container
• The material used for making the container should
be neutral or inert
• Any part of the container or closure should not
react with each other
• Closure should of non toxic nature and chemically
stable with container contents
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7. Types of packaging
• Primary packaging
• Secondary packaging
• Tertiary packaging
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8. Primary packaging
• Primary packaging are those package which are in
direct contact with the pharmaceutical formulation
• The main aim of primary package is to protect the
formulation from environmental, chemical
mechanical and other hazards.
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9. Secondary packaging
• The package external to primary package is known
as secondary packaging
• This package provide additional protection during
warehousing and also provide information about
drug product for e.g. leaflets.
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10. Tertiary packaging
• It is outer package of secondary packaging and
prevents damage to the products
• It is used for bulk handling and shipping
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11. Types of packaging material
Metal
• Tin
• Aluminum
• Lead
Glass
• Type 1
• Type 2
• Type 3
• Type 4
Plastic
• Polyethylene
• Polyvinyl
chloride
• Nylon
• Polycarbonate
• Polyethylene
terephthalate
Rubber
• Butyl rubber
• Nitrile rubber
• Chloroprene
rubber
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12. Medical device packaging
What is a Medical Device?
An instrument, apparatus, implement, machine, contrivance,
implant, in vitro reagent, or other similar or related article,
including a component part, or accessory which is:
1. Recognized in the Formulary, or the Pharmacopoeia,
2. Intended for use in the diagnosis of disease or other conditions,
or in the cure, mitigation, treatment, or prevention of disease, in
man or other animals, or
3. Intended to affect the structure or any function of the body of
man or other animals
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14. Medical device packing
• Selection of packaging style can impact package integrity.
• The type of package is largely driven by the
characteristics of the device being packaged. These include
size, shape, profile, irregularities, density, weight, and
configuration.
• Parameters for selection of packaging material :
1. Critical product characteristics
2. Type of protection required(physical , UV , light, Oxygen
water vapor transmission, etc.)
3. Type of sterilization process
4. Where and how the product is going to be dispensed( OTC,
surgery , etc.)
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15. • Early packaging forms for medical devices included bags,
cartons, and wraps; the primary material was paper.
• Glass and metal containers were used to lesser extent.
• The coming of Thermoformable materials in 1950s and
1960s made tray and blister packaging possible, but the
lack of good lidding materials limited their expansion.
• Boxes , cartons , and paper bags were not easy to use ,
inconvenient to dispense and difficult to provide sterile
delivery .
• The introduction of new thermoplastic polymers and
peelable materials, along with improved film lamination has
led to the packaging forms most commonly used today
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16. Package types used in medical
device packing
• Thermoform trays
• Flexible formed pouches
• Flexible non-formed pouches
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17. Thermoform Trays (Semirigid)
Thermoformed trays are commonly used for surgical
procedure kits and are ideal for high-profile, irregularly shaped
devices.
There are two types of thermoformed trays: semirigid and
flexible.
The most important difference is that semirigid trays are
structurally self supporting.
They can provide good physical protection and are suitable for
multicomponent applications.
Formed flexible packaging is more suitable for low-cost
devices and for simple tray configurations, but do not offer the
same degree of structural protection as the semirigid trays.
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18. Thermoform trays
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19. Advantages of thermoform trays
• Ease of forming
• Heat resistance
• Sterilization compatibility
• Sealant compatibility
• Cost-effective
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20. Flexible Non formed Pouches
• This type of pouch is commonly used for single-use
disposable items such as gloves, catheters, tubing,
adhesive bandages, dressings, syringes, and so on.
• Flexible packages tend to provide less physical
protection than the rigid ones (10) and are a
preferred choice for high-volume, low-cost devices.
• It is a packaging form that provides: a sterile
barrier, the ability to withstand sterilization, and, if
properly designed, easy opening features for
dispensing.
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21. Flexible non formed pouches
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22. Characteristic
• Relatively low cost,
suitable to high-volume,
low-cost devices
• May be made to be heat
sealable
• Ease of forming
• Available for form-fill-seal
operations
• Suited to relatively simple
tray configurations
• Can conform to product
• Good visibility of product
• Cannot be preformed
• Offer little structural
protection
• Limited variety of
materials available
• Relatively lower heat
resistance
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23. Flexible Formed Pouches
• Flexible material is drawn by the thermoform
process into a flexible “tray.” Packages are
generally not self-supporting
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24. Characteristics
• Relatively low cost,
suitable to high-volume,
low-cost devices
• May be made to be heat
sealable
• Ease of forming
• Available for form-fill-seal
operations
• Suited to relatively simple
tray configurations
• Can conform to product
• Good visibility of product
• Cannot be preformed
• Offer little structural
protection
• Limited variety of
materials available
• Relatively lower heat
resistance
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25. Primary materials
1. Tyvek
Tyvek is a spun-bonded olefin, is used in almost every
major form of sterile package composed entirely of
extremely fine, continuous strands of high-density
polyethylene.
Tyvek is used most often with ethylene oxide (ETO)
sterilization
Other attributes
• Water repellency.
• Chemical resistance.
• Radiation stability.
• temperature stability.
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26. 2. Films and Laminates
• Many films are used in medical device packaging
applications. Both flexible formed and non-formed
pouches, as well as bags . Available in mono films, and
laminations.
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27. 3.Paper
For many years, paper was the only
choice for package types until the
introduction of Tyvek
However, paper still plays a significant
role in the medical device industry.
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28. 4. Foils
Foil laminate materials are used in applications where
high moisture, gas, and light barriers are essential.
It is used for
• Lidding of thermoform tray packages
• Wet devices such as dressings, solutions, sponges,
swabs
• For solutions
Foil laminations with high-density polyethylene or
polypropylene are common constructions for these
package types.
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29. .
5. Thermoformable Plastics
The most widely used package materials
Provides aesthetic appeal, medical device applications,
and versatility for customized designs to fit
A. Polyethylene Terephthalate (PET) is probably the most
widely used material for medical packaging
applications
B. Polycarbonate (PC). Polycarbonate is used for high-
performance package applications where high strength
and toughness are required.
C. Polyvinyl Chloride (PVC) and Polyvinylidene Chloride
(PVDC).
D. Polystyrene (PS) is one of the most versatile, easily
fabricated, and cost effective plastic used in the
packaging industry
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30. Secondary Materials
1.Paperboard Cartons
2.Corrugated Fiberboard Boxes
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31. Refence
• Medical device packaging by Laura bix
• Textbook theory and practice of industrial
pharmacy
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32. THANKYOU
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