Cleaning validation

CEHT (Clean Equipment Hold Time Study)

Why is the CEHT important for the control of a cleaning process? Essentially the reason is that nothing stays clean forever. It should be realized that recontamination of the equipment may be an event-related...

MACO Calculation

Maximum Allowable Carryover (MACO) shall be calculated based upon theses three criteria. Using Health Based Data Based on Therapeutic Daily Dose (TDD) Based on LD50 Acceptance Criteria using Health Based Data CalculateADE (Acceptable Daily Exposure) according to following equation & use the...

Cleaning Validation in Pharmaceutical Industry

“It is documented evidence that an approved cleaning procedure will provide equipment which is suitable for processing or manufacturing of medicinal products” It is based on few principles that are listed below: (B) Selecting worst...

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