This document discusses container closure systems for drug packaging and outlines some of the key issues. It begins by defining containers and closures, describing common types of containers including well-closed, single and multi-dose, light-resistant, airtight, and aerosol containers. It also classifies and discusses materials used for containers and closures. The document then outlines several issues facing modern drug packaging, including globalization, regulations, economics, new product costs, speed to market pressures, informed consumers, and serialization requirements. It concludes by noting the document will discuss advantages and disadvantages of container closure systems.

1. Container Closure System, Issues
facing modern drug packaging,
different Guidelines, Advantages
and Disadvantages
By- Sarda Prathamesh Pradeep
PGDRA

2. Contents
• Introduction
• Containers
• Types of containers
• Material used for manufacture of containers
• Closures
• Purpose of closure
• Classification of closure
• Material used for manufacture of closures
• Issues facing modern drug packaging
• Advantages and disadvantages

3. Introduction
• Containers can be defined as an object that can be used to
hold or transport something.
• Pharmaceutical containers is a device that can hold a
pharmaceutical product and it may or may not be in direct
contact with it.

4. Containers
• A device in which drug is enclosed and in
direct contact with the drug.

5. Types of containers
1) Well closed containers- protect the contents
from loss during transport, storage
2) Single dose containers- used to supply only
one of the medicaments
3) Multi dose containers- allow the withdrawal
of dose at various intervals
4) Light resistant containers- protect the
medicaments from harmful effect of light

6. 5) Air tight containers (hermetic container)- they
have air tight sealing or closing
6) Aerosol container- they have adequate
mechanical strength in order to bear pressure

7. Material used for manufacture of
containers
• Mainly four types of material used in
manufacture of containers
1) Glass
2) Plastic
3) Metal
4) Rubber

8. Closures

9. Purpose of closures
• Retains the content
• Provides a barrier to dirt, oxygen, moisture,
etc
• Keeps the product secure from undesired and
premature opening
• Assists in dispensing and using of product
• Provides a totally hermetic seal

10. Classification of closures

11. Material used for manufacturing of
closures
• Metal- aluminum, aluminum alloy
• Rubber- natural and synthetic
• Plastic- thermosetting and thermoplastic
• Glass

12. Issues facing modern drug
packaging
• Globalization
• Regulations
• Economics
• New-product cost
• Speed-to-market
• Informed consumers
• Serialization and usability

13. • 1) Globalization. The push to globalize, to
capitalize on huge marketplaces in rapidly
developing nations with this comes pressure
to adhere to complex standards.
• 2) Regulations. Developing and implementing
superior processes related to rapidly evolving
labels and new regulatory regimens for
information and anti-counterfeiting.

14. • 3) Economics. Downward price pressure due
to broad governmental and economic factors
is an ongoing challenge for the pharma
packaging industry.
• 4) New-product cost. A shrinking new-product
pipeline, with fewer blockbuster drugs and
increasing new-product cost.

15. • 5) Speed-to-market. The need for speed-to-market
and agility to capitalize on short windows of
exclusivity.
• 6) Informed consumers. Consumers are paying far
more attention to the health, nutritional, and fitness
benefits of the brands they buy, using information
they find on the internet, through social media, and
on a growing selection of “clean label” products to
guide their choices.

16. • 7) Serialization and usability. The requirement
for a clear serialization strategy driven by the
Falsified Medicines Directive — not only do
patients need the correct medication without
the risk of counterfeit products, they need to
know how to use the packaging and have a
clear understanding of how it works.

17. Advantages and disadvantages.

21. Thank you