Module 3 Presentations

07/05/2024

Effects of environmental conditions

External influences

● climatic influences – air temperature – air humidity – light ● biological influences – e.g. insects, bacteria, viruses, fungi ● chemical influences – e.g. oxygen, ozone

The Organisation for Professionals in Regulatory Affairs

13

Effects of environmental conditions

Climatic influences

● air temperature – affects the maximum possible amount of water vapor that can be absorbed in the air – as the temperature rises, the air's ability to absorb moisture increases, which increased the availability of water vapor which is needed for reactions – the temperature also influences the possible loss of ingredients of the drug product (e.g. by vaporization of solvents) – affects the rate of reactions – according to van’t-Hoff’s Rule reactions double their reaction rate if the temperature is increased by 10 K – increases the ionization of water which promotes acid/base-catalysed reactions – may lead to modification of a molecule – denaturation (structural modification) of biomolecules, e.g. caused by break down of bonds due to temperature-related molecular vibrations

The Organisation for Professionals in Regulatory Affairs

14