Cleaning validation primarily focuses on the methods used to determine the effectiveness of a cleaning process. While different approaches to cleaning validation exist, a key aspect involves the types of sampling methods employed.
According to industry standards, there are two main types of sampling methods used in cleaning validation:
- Direct Sampling: This involves directly sampling the equipment surface after cleaning. This can be achieved through methods like swabbing where a physical swab is used to wipe a defined area of the equipment.
- Indirect Sampling: Also known as rinse sampling, this method involves collecting rinse samples after the cleaning process is complete. The rinse water is then analyzed to determine the levels of residues present.
These sampling methods help determine if cleaning procedures effectively remove residues from manufacturing equipment.
