The pharmaceutical product shall not be contaminated by anyway. Contamination may have an adverse impact on product quality.
Contaminants can originate from the environment, other product or microbial or maybe personnel.
Contamination by Environment:
-Particles, micro-organisms, dust containing another product example of environmental contamination.
Product contamination:
-The pharmaceutical product may be contaminant other than the product other than the product manufactured (e.g. products resulting from air pollution).
-Foreign products, such as metal parts from equipment, paint chips, etc.
-Particulate matter, especially dangerous in injectables.
Microbial contamination
Micro-organisms - a particular problem for sterile products.
Endotoxins: Even if killed by thermal treatment, micro-organisms are degraded to endotoxins and can cause damage.
Other contamination:
Contaminants are in fact the presence of anything in the manufactured product which should not be in manufacturing facility. Equipment residues of other products, oil, particles, rust, gaskets, meta) and can be brought into the product by air movements.
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