There are many factors affecting microbial spoilage of pharmaceutical products.
These include:
- Nutritional Factors
- Water
- Storage Temperature
- pH
- Package Design
Nutritional Factors
Microorganisms utilize many formulation components as substrates for biosynthesis & growth.
Water
It is the most important cause of the survival and growth of micro-organisms.
Storage Temperature
Spoilage of pharmaceuticals could occur potentially over the range of about 20°C to 60°C, although it is much less likely at the extremes.
pH
Micro-organisms grow at neutral pH, therefore acidic or alkaline formulations are less susceptible to spoilage.
Packaging Design
It can have a major influence on microbial stability of some formulations in controlling the access of contaminants during both storage and use.
Other Factors
Other factors affecting microbial spoilage of pharmaceutical products include:
- Relative Humidity
- Oxygen Availability
- Osmotic Pressure
- Oxidation-Reduction Balance
- Surface Tension
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