Not only because it is the law, Code of Federal Regulations (CFR) requirement, but it also makes good business sense. Pharmaceutical product and active pharmaceutical ingredients (APIs) can be contaminated by other pharmaceutical products or APIs, by cleaning agents, by microorganisms or by other materials in the air such as particles, from dust, from lubricants, and other raw components used in the process.
The main purpose for cleaning is performed to remove product and non-product contaminating material from product contact surfaces whether this occurs directly or indirectly. Ineffective cleaning can lead to adulterated product, which may be from previous product batches, cleaning agent, other raw material introduced by the process or lastly, in cases where the same equipment may be used in a manufacturing process of a different product.
To avoid contamination source or facility configuration there is a need to ensure that your cleaning procedure must strictly follow carefully established and validated method of execution. The cleaning procedure must have a validated wash, rinse and final rinse times established. It is recommended, that coupon studies be performed for preliminary solubility studies and effectiveness studies. Followed by cleaning cycle time evaluations to determine best wash, rinse and final rinse times that meet pre-established acceptance limits. Once those parameters have been established, a cleaning validation process needs to be performed to demonstrate that your process is robust and reproducible, therefore more then a single trial is necessary and be documented.