Topic: Cleaning Validation
Cleaning Validation should be conducted at appropriate intervals to ensure that the equipment used in the manufacture of pharmaceutical and biopharmaceutical products is properly cleaned and free from contamination. The Experts at MEDVACON can assist you and your company in establishing the correct intervals. The frequency of cleaning validation will depend on the specific equipment, product, and process, but generally, it should be conducted:
- Before initial use: Cleaning validation should be conducted before equipment is used for the first time to ensure that it is properly cleaned and free from any contaminants.
- After any changes to the process or equipment: Cleaning validation should be conducted after any changes to the process or equipment to ensure that the changes do not affect the cleaning process and that the equipment is still properly cleaned and free from contamination.
- After any maintenance or repair: Cleaning validation should be conducted after any maintenance or repair to ensure that the equipment is properly cleaned and free from contamination.
- Periodically: Cleaning validation should be conducted periodically, such as annually, to ensure that the equipment remains properly cleaned and free from contamination over time.
- When a change of product occurs: Cleaning validation should be conducted when a change of product occurs to ensure that there is no cross-contamination between products.
It’s important to have a cleaning validation protocol in place that outlines the procedures, acceptance criteria, and frequency for conducting cleaning validation. The protocol should also include a plan for addressing any deviations or nonconformities that are identified during the validation process. The cleaning validation protocol should be reviewed and updated as needed to ensure its continued effectiveness.
