The clean room contaminants can be divided into four major categories:
- Physical Contaminants
- Chemical Contaminants
- Viable/Microbial Viable Contaminants
- Non-Viable Contaminants
A physical contaminant is anything that can be visibly seen and is not part of the product or raw material originally. Examples of physical contaminants include airborne non-viable particulate contaminants and foreign materials such as metals, glass particles and fibers etc.
A chemical contaminant is any unwanted chemical that makes a drug unfit for use. Examples of chemical contaminants include API of different drug product, intermediate excipients, intermediate chemical reagents and cleaning agents.
A viable/microbial contaminant is any infectious material that affects the quality of the drug. Examples of microbiological contaminants include bacteria, yeast, mould, fungi, virus, prions, protozoa or their toxins and by-products.
Examples of where viable contamination can come from include:
- People
- Surfaces
- Equipment
- Air
- And water
Why are these examples considered sources of viable contamination? How is living contamination transferred from one surface to another?
All of the examples listed can harbor viable or living organisms or microbes. They can blow through the air, live in water or on surfaces and equipment. Organisms live on human skin and hair.
Examples of where non-viable contamination can come from include:
- Paper
- Equipment
- Tubing
- Rust
- Dust
- And Disinfectants