Stability aspects of packaging materials (4).pptx

B pharm stability of packaging materials unit 5

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

3. Aim of the stability testing

4. Stability Test Protocols The 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 . International 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.

5. Tests

6. Compression Strength Testing Packages behave differently when exposed to compressive forces. It uses testing capabilities to apply compressive forces to packages and products.

7. Distribution Simulation Testing Packages experience many different forces during the shipping and distribution process . It is the product manufacturer’s responsibility to evaluate and document the ability of the package to withstand the distribution and storage environments

8. 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

9. Package Integrity Testing It uses established tests to test the integrity of a pharmaceutical package . Such tests include dye leak, visual inspection, vacuum leak and bubble leak testing to inspect the package's integrity capabilities