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Scope of TOC cleaning verification
Date: 2024-10-23Read: 2
In order to minimize the risks of contamination and cross contamination during drug production, it is necessary to develop a cleaning and certification plan for co production equipment in traditional Chinese medicine extraction workshops, traditional Chinese medicine preparation workshops, and co production equipment for multiple varieties, in accordance with the requirements of GMP (2010 edition). This shows the importance of cleaning validation.
For equipment that is easy to wipe and has a smooth surface, use cotton swab wiping method; For equipment and pipelines that are not easy to wipe and sample, use the rinsing method. Based on the specific situation of the equipment, determine the operable cleaning method, and determine the limit of residual pollutants by measuring the microbial limit and total organic carbon according to different cleaning methods.
For equipment cleaning verification using wiping method, corresponding residue inspection shall be carried out. Cotton swab wiping method shall be used to collect and inspect samples, and total organic carbon shall be measured by dissolving and diluting with water for total organic carbon inspection; If the equipment cleaning is validated using the rinsing method, the corresponding residue inspection is carried out, and the rinsing solution is collected as the inspection sample to determine the total organic carbon.
By verifying the system applicability, linearity, accuracy, and repeatability of the analysis method, it is confirmed that the method is suitable for the detection requirements of equipment cleaning validation, and the sampling recovery rate is used to verify the effectiveness of the sampling method.
Verification purpose
Through the verification of TOC method, it is ensured that the method can accurately and reliably detect residual pollutants after cleaning of co linear production equipment, and meet the expected limit standards. This is something that every colleague in the pharmaceutical industry needs to pay attention to.
Verification scope
The validation of the TOC determination method for collecting samples after cleaning equipment related to co production in traditional Chinese medicine extraction workshops, traditional Chinese medicine preparation workshops, etc.
So, how should the TOC method be defined for clean validation in the pharmaceutical and biopharmaceutical industries?
➤ Simplify the verification method based on the cleaning process rather than the product;
➤ Quickly evaluate the cleaning ability of the cleaning process;
➤ Optimize key cleaning parameters (TACT, i.e. temperature, action, concentration, and time) through wiping and rinsing sampling methods;
➤ Estimate the worst-case scenario and complex compounds, such as cleaning agents;
➤ Accelerate product replacement speed and better produce according to plan.
