Cleaning Validation
Валидация процесса очистки



Книги и презентации


Development of cleaning programs in general is a rigorous, time consuming and often frustrating experience. The objective of cleaning validation is to ensure that a specific cleaning process will consistently clean to predetermined limits so as to prevent contaminants (product or cleaning process related) from leaving residues that will adulterate and adversely affect the safety and quality of the next product manufactured. Cleaning validation is documented proof that one can consistently and effectively cleanse a system or equipment item. Pharmaceutical Services Corporation has extensive experience in developing meaningful acceptance criteria and ensuring the execution is conducted in an orderly manner. Our experienced staff can provide services in Cleaning validation. Our highly skilled individuals can ensure that equipment-cleaning procedures are removing residues to predetermined levels of acceptability. These individuals are trained to:

  • Understand regulatory (FDA) requirements, guidelines and expectations
  • Select and evaluate effective cleaning methods and processes
  • Establish residue limits and calculate sample acceptance criteria
  • Select sampling and analytical methods
  • Simplify the cleaning validation program.


  Title Статья
Using Swabs for Cleaning Validation Использование свабов
Validation (Part 2): Cleaning validation Валидация. Часть 2. Валидация очистки.
Cleaning Validation. Official requirements Офицальные требования к валидации очистки
Validatability of cleaning procedures Валидация процедуры очистки
Cleaning validation master plan Мастер план по валидации очистки
Establishing the scope of validation Определение цели валидации
Acceptance criteria and limit calculation Критерии приемлимости
Sampling procedures Процедура отбора проб
Analytical procedures Аналитическая процедура
Documentation Документация
Maintenance of the validated status Поддержание валидационного статуса
Cleaning validation documentation (example) Примеры валидации очистки
Prevention of cross-contamination Предупреждение перекрестной контаминации

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