pharmaceutical packaging by harshal chaudhari r. c. patel institute of pharmaceutical education and research shirpur

1. PHARMACEUTICAL
PACKAGING
Presented By
Harshal P. Chaudhari
M. Pharm – I ( Quality Assurance)
RCPIPER, Shirpur 425405
2014-15

2. Contents
• What is Packaging ?
• Role of Packaging in Pharmaceutical
• Type of packaging
• Classification of the Packaging materials
• Primary Packaging
• Secondary Packaging
• Labeling
• References
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3. What is Packaging ?
Definition:
Packaging can be defined as an art, science and technology to ensure
the safer delivery of the product throughout its journey from
manufacturing to the end use.
Functions of Packaging:
• Protection
• Preservation
• Presentation
This is widely known as 3P concept. The latest inclusion of the 4th P is
Promotion of the product
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4. Role of Packaging in Pharmaceutical
 Protecting the product from the environment and vice versa.
 Providing all necessary information.
 Enabling accurate dosing and compliance.
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5. Significance of Pharma packaging
 Product protection up to shelf life
 Legal compliance
 Customer convenience
 Route of administration
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6. 6
Types of Packaging
 Solid Product
 Semi Solid Product
 Liquid Product
 Unit Pack
 Child Resistance Packaging
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 Solid Product
 Solid dosage form such as tablet and capsule are far the most
commonly use today.
 Traditionally they have been packed in bottles, originally made from
lass but laterally from various plastic.
 The wall of the container are usually umber or completely opaque to
minimize the possibility of photo degradation
 Powder or granules have a variety of role when used as final dosage
form
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 Semi Solid Product
 Semi solid product include creams, emulsions, ointments or gels
 Flexible tube are frequently use to contain semi solid
 This can be made from aluminum or plastic such as polyethylene
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9. 9
 Liquid Product
Traditionally glass has been the material choice for the
packaging of liquid but a variety of plastics is now widely use
providing they have little or no permeability to the liquid.
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10. 10
 Unit Pack
Unit pack in which individual dosage are separated from each other
are popular for many type of dosage form.
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 Child Resistance Packaging
Child resistance container works on one of two principle-
 Certain degree of strength will be needed to open the product
 High degree of manual coordination is required
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12. Classification of the Packaging materials
•Primary Packaging
Direct contact with product, also known as critical packaging
component. Tendency to have influence on the finished product
quality.
Eg: Containers, closures, blisters strips, desiccant etc.
•Secondary Packaging
This encloses one or more primary packs, also known as non‐critical
Packaging component
Eg: Cartons, e‐flute boxes, e‐fluted trays, etc.
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13.  Primary Packaging
 Containers:
• Plastic
High Density Polyethylene (HDPE) Containers
Mostly used for tablets, capsules, dry powders and sometimes for liquids, suspensions
Properties:
1.Good moisture barrier
2.Easily moldable
3.Protection from Light
4.Good strength
• Polyethylene Terephthalate (PET) Containers
Mostly used for liquid solutions
Properties:
i. Light weight
ii. Gas Barrier properties
iii.Chemically inert
iv.Unbreakable
v. Wide range of designs
vi.Good strength
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14. Advantages
• Lighter than glass or metal
• Can be used in thinner section
• Less prone to breakage and in case breakage occurs, fragments are less
hazardous
Disadvantages
• Low chemical inertness compared to glass
• More permeable than glass
• Low resistance to high temperature compared to glass
• For topical ointments, vaccines and transfusion bottles, flexible plastic
called polyolefin's are used.
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15. • Glass
.Mostly used for the liquid solutions, Injections, PFOs
Types of Glass
According to pharmacopoeia (USP, EP, BP):
1. Type I – Borosilicate Glass
2. Type II – Treated Soda-Lime Glass
3. Type III – Regular Soda-Lime Glass
4. Type NP – General Purpose Soda-Lime Glass
Advantages:
 Readily available material
 Inert i.e. provides excellent product-pack compatibility
 Provides good product presentation
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16. Properties:
1. Complete barrier to moisture and gas
2. Inert material
3. Excellent Chemically resistant
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17. Metal
Advantages
 Strong material
 Opaque
 Impermeable to liquids, gases, odors and bacteria
 Resistant to both low and high temperature
Types of metal materials
- Aluminum
- Tin
- Steel
- Tinplate
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18. Disadvantages
 Chemical reaction with drug products i.e. not inert
 Corrosion might occur from inside or outside. To overcome corrosion metal
substances are coated e.g. Tinplate, made by coating low carbon steel sheet
electronically with pure tin
 Most commonly used metal packaging material is Aluminum because:
- It can be used uncoated
- It is light weight
- It is ductible
- It is non-toxic
- Resistant to corrosion
- Sterilizable
- Can be shaped into rigid, semi rigid or collapsible containers
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19. •Closures:
Most effective closure for glass ampoules is sealing by fusion
because product is in contact with only one material.
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20. Types of Closures:
• Child Resistant Closures
• Screw Closures
• Tamper Evident Screw Closures
• ROPP
• Rubber stoppers
A good closures ,
 Preserves freshness
 Authenticates product integrity
 Prevents leakage
 Ensures Consumer Confidence
 Prevents product contamination throughout supply chain
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21.  SECONDARY PACKAGING COMPONENTS
 Are not intended to make contact with the dosage form (eg. outer
cartons)
 Provide additional protection from excessive moisture and reactive gases
 Provide additional protection against light
 Provide additional protection against microbial and dirt contamination
 May protect the product from rough handling
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22.  A label is an information tag, wrapper, seal, or imprinted
message attached to a product.
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23. Labeling Requirements
oCountry specific requirements
oBarcode
oPharmacode
oNDC No.
oBlister pocket to have barcode, lot no. & expiry
oBraille script on carton
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25. 1. Theory and Practice of Industrial Pharmacy, L. Lachman, H. A.
Liberman, J. L. Kanig. 4th edition, (1991), Varghese publication
house, Bombay, p. no. 711-732
2. Pharmaceutical Quality Assurance, M. Potdar, 2nd edition(2007),
Nirali Prakashan, Pune, p. .no.5.5
3. Introduction to Pharmaceutics, A. Pawar, 2nd edition(2012), Career
Publication, Nashik, p.no.103
4. www.mypharmaguide.com
5. Plastic Packaging, Remington, The Science and Practice of
Pharmacy, 19th edition, Volume II, p. no. 1487.
References:
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6. Modern pharmaceutics , GS Banker and TR Christopher, 4th edition,
Revised and expanded, Informa healthcare pub. 121:595- 596.
7. Pharmaeutics-1, R. M. Mehta, 2nd edition , vallabh prakashan,
Delhi, p. no. 73-93
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