It must be proven whether the cleaning processes used to prevent product contamination and cross-contamination in the production of medical devices, drugs and food are fully valid.

Contamination sources can be active and auxiliary substances, detergents, etc. in drug production.

In the production of medical devices, oil, detergent, chemical substances and microbiological pollution may occur.

In order to ensure product quality, we need to have carried out cleaning validation studies, which can be defined as the whole of processes that show the effectiveness of cleaning processes-processes, and that the amount of residue remaining from the previously produced product is within the determined limits, with physical, chemical and microbiological tests, for products produced using the same method / equipment. .

Cleaning validation studies are a long-term process that varies in its own dynamics. For this reason, the preparatory work should be carried out very sensitively. It is necessary to get professional help in order to save both cost and time and to ensure the accuracy of the work done.

How the pollution will be eliminated should be well defined when creating cleaning procedures. Unnecessary use of chemicals or detergents may lead to another contamination.

Regulatory publications should be followed for cleaning validation.

– PIC's ( Pharmaceutical Inspection Co-operation Scheme)

– ISO, ASTM etc.

– APIC (Active Pharmaceutical Ingredients Committee)
– GMP publications
– Pharmacopies (EU, USP)