Page 7 - Cleaning and sanitation in GMP
P. 7
GMP Training – Cleaning and Sanitation in GMP Areas by www.gmpsop.com
The origins of biological contamination are varied, but
include the environment, personnel, raw materials,
contaminated water, and poorly cleaned or wet
equipment.
While cleaning reduces biological contamination,
sanitizing agents play an important role in killing
micro-organisms.
GOOD TO KNOW - VISUAL EVIDENCE OF CONTAMINANTS
Visual inspection of products is easy and inexpensive, but it is often labor-
intensive and unreliable. Although obvious contaminants can be seen, there
may be microscopic contaminants in the product, such as microbial,
particulate, and product chemical residues, which are all difficult and
expensive to detect once they are inside product.
The aim in good cleaning and sanitation practices is to prevent contamination
arising in the first place, rather than try to detect it once it is present.
These two ampoules are actually
contaminated. However, you cannot see this
with the naked eye. It's important to know that
not all contamination in medicinal products
can be seen, and in many cases, cannot be
detected in laboratory testing.
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