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Cleaning Validation Glossary

Direct Equipment

Equipment that is in direct contact with the product during its normal flow through the unit.

Direct equipment is expected to come into contact with the manufacturing process and as a result will be in a soiled state after the completion of production. Direct equipment must be cleaned to a pre-determine acceptable level and its cleanliness must be assessed through appropriate means. When designing a cleaning process, all direct equipment should be identified and those equipments should be scrutinized for difficult to clean areas and worst-case locations for the collection of process residues.

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