Introduction

Total organic carbon (TOC) and conductivity are key attributes of water quality, but manual detection of these two parameters can take several hours. The time-consuming testing steps include testing samples, recording data, waiting for review, and approving recorded data in written or electronic laboratory data management systems. A global biotechnology company in the United States is actively seeking a platform that can simultaneously detect TOC and conductivity to improve efficiency, streamline processes, and export test results to laboratory data management systems.

Solution

In order to improve efficiency and reduce costs, the company evaluated the Sievers * M9 laboratory analyzer produced by Sievers analyzer, which can simultaneously detect TOC from a single container [Dual Purpose Conductivity and TOC Sample Bottle (DUCT Sample Bottle)] and the Stage 1 conductivity of USP/ChP in the United States Pharmacopeia. The M9 analyzer also has advantages such as shorter sample analysis time, less sample usage, and the ability to integrate laboratory data management systems.

The method used by this global biotechnology company is confirmed through the explanation of USP 1225 "Pharmacopeial Method Validation". The company evaluated three aspects of the testing, the first two of which are the applicability confirmation of TOC and USP Stage 1 conductivity testing methods, which are direct requirements of USP 1225. The third aspect of testing is to verify the suitability of the new Sievers DUCT sampling container and evaluate the sample retention time of the container to support internal program operation. We will not discuss the above-mentioned tests here, as the Sievers analyzer has been tested separately and supports a 5-day sample retention time for TOC and conductivity samples in DUCT sample bottles.

The company transferred the conductivity method using the Sievers M9 laboratory analyzer and clearly demonstrated that the method is accurate, precise, and linear. Please refer to the data in Table 1.

The set of TOC analysis methods has been validated on current TOC analyzers, using considerable analytical techniques. Therefore, the company chose to run the system suitability standard kit from the same batch on the new M9 laboratory analyzer from Sievers, along with the previous 900 TOC analyzer. Due to the change in sample bottle types, the company also implemented a system suitability kit for Sievers DUCT sample bottle preparation to demonstrate the comparability of the containers.

All three system suitability kits meet the 85-115% qualification criteria when using the Sievers M9 laboratory analyzer. The response efficiency percentage indicates the applicability and acceptability of using both Sievers M9 laboratory analyzer and DUCT sample bottle simultaneously. Please refer to the data in Figure 1.

The Sievers M9 laboratory analyzer not only has qualified analytical performance, but is also compatible with laboratory data management systems, and can analyze TOC and conductivity simultaneously. This function of exporting TOC and USP Stage 1 conductivity results in electronic file format eliminates the error of manually copying data and saves analysis time. In this example, the company is able to configure the system to automatically fill in multiple sample results. Once the results are qualified, the laboratory data management system records them for review and approval, making the entire process from sampling to result review paperless. The company estimates that it can save about 4 hours per day.

result

After calculation, the investment return rate, investment payback period, and net present value achieved by the company are: 5-year 400% investment return rate, 7-month investment payback period, and approximately $400000 5-year net present value. The most obvious aspect of the return on investment is that although the integration of Sievers DUCT sample bottles increased the cost of consumables, the reduction in sample quantity greatly saved the company's total cost.

The above investment return rate comes from the integration of the analyzer with the laboratory data management system.

If manual operation is continued instead of a data management system, the investment payback period will increase to 11 months, but still within 1 year.

This example demonstrates that using the Sievers M9 laboratory analyzer to simultaneously detect TOC and USP stage 1 conductivity can save businesses a lot of time and cost. This method reduces the demand for testing samples in the laboratory, greatly reducing costs and enabling enterprises to use the saved resources for other production and innovation areas.