challenge

The protein produced by a biopharmaceutical manufacturer for sustaining life can significantly reduce the side effects of chemotherapy, but it faces challenges in terms of cleanliness validation. The company's production facilities have stable performance, reliable operation, and advanced technology, ensuring that the production process is smooth, safe, and cost-effective. For example, the company did not use the highly limited HPLC method to analyze routine wiping samples for cleaning validation and product conversion, but instead adopted a non exclusive total organic carbon (TOC) analysis method, which saved a lot of expenses.

They are still conducting TOC validation on the challenging compounds in the Z-adverse conditions of the four regions on the protein purification column in their process flow. The four week pilot validation study shows that the company's clean validation (routine validation and product conversion) program conducted in the laboratory is expected to increase its clean validation costs by $54000. If the company continues to operate in its current state, its cleaning validation costs will exceed $500000.

Analyzing water-based cleaning samples in the laboratory is not tedious, but it requires a lot of manpower and time, and cannot produce the expected results. However, clean validation is not just about laboratory technicians going to the production workshop to extract samples and then bringing them back to the laboratory. Assuming the testing equipment is ready, the staff still need to load the samples and wait for the processing to end. After obtaining the results, the staff even need to spend more time recording the results in the experimental notes and equipment notes, and filling out the report.

Solution

After evaluating multiple alternative options, the company ultimately decided to adopt the sideline at line TOC analysis method, which is on-site analysis. Similar to online sampling, staff collect samples near the process flow (rather than within the process flow) and use portable analyzers for on-site analysis. As shown on the right side of Figure 1, this method fundamentally eliminates the expensive non value added steps in the previous TOC sampling process. The test results can be generated in just 30 minutes, and the staff only need to enter the results into the production records.

result

After completing the necessary change control assessment and documentation, the company realized that adopting the 900 portable analyzer could immediately save a significant amount of costs. Due to its lightweight design, the manufacturing team is able to conduct sample analysis in multiple production workshops. Including the supply costs of containers, cotton swabs, and standard samples, as well as equipment validation costs, the annual cost of using this analyzer is only $40000, far lower than the estimated $500000 required for laboratory testing.

The company compared the cost data of the laboratory TOC method with the cost data of the sideline TOC analysis method collected so far. They expect that if they leave the laboratory and directly implement the TOC method in the production workshop, the annual sampling cost for cleaning validation and product conversion will be significantly reduced by 92%. In addition, the QC department and production team can also utilize their time more effectively. There will be no endless procrastination during the analysis process; On the contrary, the staff can record the analysis results in real time and quickly sign off on the verification plan and product conversion records with certainty.

More content can be found in the attached materials!