Series of 24 Articles: Part 3 – Cost Comparison Between TOC Analyzers and HPLC in Cleaning Validation

Cleaning validation is a critical process in the pharmaceutical industry. Various analytical methods are used to confirm that manufacturing equipment is properly cleaned. Among these methods, Total Organic Carbon (TOC) analyzers and High-Performance Liquid Chromatography (HPLC) are widely used as representative techniques. This article explores the cost comparison between these two methods.

Initial Cost Comparison

First, let’s look at the initial costs. TOC analyzers have a simpler structure compared to HPLC systems, which helps reduce the initial investment. On the other hand, HPLC systems are more complex and thus more expensive. Even at the initial investment stage, TOC analyzers already have a cost advantage.

Maintenance Cost Comparison

Next, consider the maintenance costs. HPLC systems consist of many components and require regular maintenance. The replacement of parts and service costs can accumulate, resulting in high annual maintenance expenses. In contrast, TOC analyzers require relatively simple maintenance and incur lower maintenance costs.

Running Cost Comparison

TOC analyzers also excel in terms of running costs. Annual running costs for TOC analyzers—including consumables, reagents, and labor—are lower than those for HPLC. Particularly in terms of labor, operating and analyzing data from HPLC requires a high level of expertise, while TOC analyzers offer better cost performance due to their ease of use.

Summary and Implementation Consideration

Overall, TOC analyzers are more cost-effective than HPLC in terms of initial, maintenance, and running costs. Furthermore, cost savings from implementing TOC analyzers can be recovered within less than three years, and in some cases, even within the first year depending on the operational method.

In this way, the use of TOC analyzers in cleaning validation offers many economic advantages and is expected to contribute to more efficient operations. In the pharmaceutical industry, considering TOC analyzers can be a worthwhile step toward cost reduction and operational efficiency.

Contact