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In this article, we will learn about contaminants its types, contamination, and cross-contamination
in pharmaceutical manufacturing sites. Let’s begins with the definition, types of contaminants,
contamination, and cross-contamination.
Contaminants: Contaminants are any impurity, Product, or substance other than product
manufacturing. Foreign products, Particulate matter, Microorganisms, Endotoxin (degrade
microorganisms), Cross-contamination is a case of contamination.
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Types of contamination:
Chemical contamination (leftover residue of the previous process)
Microbiological contamination ( microbiological flora)
Particulate contamination ( particles like dust, fibers, oil, or grease from the pieces of
equipment. others like haires, skin fragments.)
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Dust extraction duct should be designed with sufficient transfer velocity to ensure dust is carried
away. Airflow direction should be carefully chosen that the operator does not contaminate the
Product. Use of well-validated HEPA filters in series to provide additional protection. A
sophisticated computer-based data monitoring system may be installed.
Conclusion:
The system or equipment shall be validated to prevent the Product from contamination and
cross-contamination. Cleaning validation of equipment and area with a well-defined procedure
shall be maintained. Using the cleaning validation approach, we can easily identify any
discrepancy or loops in a system.
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cycle. Failure to prevent contamination and cross-contamination can lead to a loss in customer
faith or satisfaction from the investors, loss of market values, loss in money, and direct
consequences from regulatory bodies.
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