Areas must be regularly cleaned and, where necessary, disinfected.

A high level of cleansing and hygiene should be practiced in every aspect of the manufacture of drug product.

Suitable Grade

Suitable grade of cleaning agents should be used to minimize health risks.

Contact time, application, temperature, mechanical action and the chemistry of the cleaning agents should all be considered during the design of the cleaning process.

No Direct Contact

Materials used for cleaning should not come in direct contact with the product.

Validation of cleaning practices must be carried out to provide evidence that the process is effective in controlling microbial contamination.