As discussed in the previous topics, the CIP or Cleaning in Place is today, a mandatory requirement in any process industry especially in pharmaceutical and biopharmaceutical. The case in Pharma and BioPharma is very severe because of contamination issues and regulatory conformance. CIP must be validated to ensure proper cleaning.
Some of the mandatory requirement of CIP solutions is discussed. CIP ensures safety, prevent toxic contamination of products, and minimize recontamination of the process. To achieve cleaning efficiency and effectiveness, a complex mixture of chemicals is required during CIP.
CIP solution includes normally an acid, alkali and detergent and rinsing with purified / soft water / water for Injection or WFI.
An alkali mixture based on sodium hydroxide (NaOH) and surfactants which remove organic and fatty contamination, emulsions and gels. Sodium hypochlorite is also employed.
An acidic mixture based on nitric, phosphoric or sulphuric acid which remove inorganic sediments in tanks, tubes, fermentation or similar equipment subjected to CIP. Acetic acid and hydrogen peroxide is also used for the acid rinse.
After these steps, it is necessary to remove the chemicals used. So, water at very pure form like purified water or WFI is used. The CIP is actually complete only when the rinsing water is free of conductivity. (This stands true for WFI water which during initial rinses will remove the residual chemicals and finally show the conductivity as the null).