ISPE Glossary of Pharmaceutical and Biotechnology Terminology

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Unstable (Reactive) Material

A material other than an explosive, which in the pure state or as commercially produced will vigorously polymerize, decompose, condense or become self-reactive and undergo other violent chemical changes, including explosion, when exposed to heat, friction or shock, or in the absence of an inhibitor or in the presence of contaminants or in contact with noncompatible materials. Unstable, reactive materials are subdivided as follows:

1. Class 4 – Materials that in themselves are readily capable of detonation or of explosive decomposition or explosive reaction at normal temperatures and pressures. This class includes materials that are sensitive to mechanical or localized thermal shock at normal temperatures and pressures.

2. Class 3 – Materials that in themselves, are capable of detonation or of explosive decomposition or explosive reaction but which require a strong initiating source or which must be heated under confinement before initiation. This class includes materials that are sensitive to thermal or mechanical shock at elevated temperatures and pressures.

3. Class 2 – Materials that in themselves are normally unstable and readily undergo violent chemical change but do not detonate. This class includes materials which can undergo chemical change with rapid release of energy at normal temperatures and pressures and which can undergo violent chemical change at elevated temperatures and pressures.

4. Class 1 – Materials that in themselves are normally stable but which can become unstable at elevated temperatures and pressures.

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