Course Code: ELM-705-03

Factors Affecting Microbial Spoilage of Pharmaceutical Products

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

Author

Joginder Mittal

Manager - Quality Compliance Glatt Pharma Engineering