When conducting cleaning validation, calculations are used to determine the effectiveness of cleaning procedures and to ensure that equipment is properly cleaned and free from contamination. The Experts at MEDVACON can assist you and your company in establishing the correct calculations. Some of the key calculations used in cleaning validation include:
- Acceptance Limits (AL): The acceptance limit is the maximum level of residue that is considered acceptable for a given product. This limit is based on the limits established by regulatory agencies such as the FDA and is usually expressed as a percentage of the daily dose of the product.
- Limit of Detection (LOD): The limit of detection is the lowest level of residue that can be detected by the analytical method used. It is important to ensure that the analytical method used has a LOD that is lower than the AL, so that any residue present can be detected.
- Limit of Quantification (LOQ): The limit of quantification is the lowest level of residue that can be accurately quantitated by the analytical method used. It is important to ensure that the analytical method used has a LOQ that is lower than the AL, so that any residue present can be accurately quantitated.
- Recovery: Recovery is the percentage of the residue that is recovered from the equipment after cleaning. It is calculated by comparing the amount of residue present before cleaning to the amount present after cleaning. A recovery rate of 100% indicates that all of the residue has been removed.
- Cleaning Efficiency: Cleaning efficiency is the percentage of the residue that is removed from the equipment during cleaning. It is calculated by comparing the amount of residue present before cleaning to the amount present after cleaning. A cleaning efficiency of 100% indicates that all of the residue has been removed.
- Statistical analysis: statistical methods such as statistical process control (SPC) and design of experiments (DOE) can be used to evaluate the cleaning validation results. This can help identify trends and patterns in the data, which can be used to improve the cleaning process and reduce the risk of contamination.
It’s important to note that these calculations are based on the sampling, testing and analysis of the equipment and process, and the data obtained is used to make decisions on the cleaning validation process. These calculations are also part of the documentation and record-keeping that are required in cleaning validation.
