The document discusses stability testing of packaging materials. Stability testing aims to determine how the quality of packaging varies over time under different environmental conditions, establish shelf-life, and determine suitable storage conditions. It also ensures the packaging can withstand forces involved in compression, distribution simulation, and maintains integrity. The document outlines protocols for stability testing according to ICH guidelines and different tests conducted including compression strength, distribution simulation, package strength, and package integrity testing.

1. STABILITY ASPECTS OF
PACKAGING MATERIALS
UNIT FIVE

2. PURPOSE OF STABILITY TESTING
• To provide evidence on how the quality of a packaging material
varies with time under the influence of a variety of environmental
conditions
• To establish a shelf-life for the pharmaceutical packaging
• To determine the storage conditions
• The in-use stability should be conducted on the dosage form
packaged in the container closure system proposed for marketing
• Ultimate proof of suitability of the container closure system

4. Aim of the stability testing

5. STABILITY TEST PROTOCOLS
oThe protocol for stability testing is a pre-requisite for starting
stability testing and is necessarily a written document that describes
the key components of a regulated and well-controlled stability
study.
oInternational Council for Harmonization of Technical Requirements
for Pharmaceuticals for Human Use (ICH) is an organization in which
several countries have made uniform guidelines on various aspects of
quality control tests.

6. TESTS

7. COMPRESSION STRENGTH
TESTING
oPackages behave differently when exposed to compressive forces.
oIt uses testing capabilities to apply compressive forces to packages
and products.

8. DISTRIBUTION SIMULATION
TESTING
oPackages experience many different forces during the shipping and
distribution process.
oIt is the product manufacturer’s responsibility to evaluate and
document the ability of the package to withstand the distribution and
storage environments

9. PACKAGE STRENGTH TESTING
Package strength testing is conducted to measure and ensure that the
components of the package will not separate when specific forces are
applied.
The testing of flexible components such as pouches, seal peel or
burst testing are methods used to prove the packages strength

10. PACKAGE INTEGRITY TESTING
oIt uses established tests to test the integrity of a pharmaceutical
package.
oSuch tests include dye leak, visual inspection, vacuum leak and
bubble leak testing to inspect the package's integrity capabilities