Cleaning validation is an integral component to cGMP manufacturing in the pharmaceutical industry to ensure safety and purity of products. Total organic carbon (TOC) and conductivity are important quality metrics used in cleaning validation to understand and control the cleanliness of equipment, and advances in technology now allow monitoring to be faster and more reliable than ever. With process analytical technology (PAT) and automation, users have the opportunity to build quality and efficiency into their cleaning programs and decrease human interaction, out-of-specification (OOS) investigations, and equipment downtime.
The three common deployments of TOC technology are laboratory, at-line, and online analysis. When choosing which deployment will best support the overall validation strategy and sampling methods, consider the following to ensure you get the most out of the technology.
Laboratory Analysis (TOC testing performed offline, typically in the QC laboratory):
Benchtop TOC analyzers and software are available that allow you to stack protocols, run system protocols, run large volumes of samples at a time, manage data, and electronically sign and export data. With laboratory analysis, it is inevitable that grab samples must be taken from equipment or purified water points of use.
At-line Analysis (TOC testing performed on the manufacturing floor next to equipment being cleaned):
At-line deployment uses a portable TOC analyzer located directly next to the process to be monitored, reducing downtime. It can provide efficiency gains for the right application in comparison to laboratory analysis. At-line monitoring avoids QC workflow and generates data within minutes following sample collection. This can significantly reduce the amount of time that manufacturing equipment sits idle.
Online Analysis (TOC testing performed from final rise of cleaning cycle):
Online TOC and conductivity testing allows you to go from days to minutes for equipment release time. Online cleaning validation with Sievers TOC Analyzers can provide real-time, validated data with the highest degree of data integrity, process understanding, and process control. Together with efficiency gains and seamless reporting, you get a comprehensive assessment of cleanliness with fewer risks of error. Online analysis allows you to assess the real-time rinse down profile of your process, and leverage 3 key quality metrics for process understanding - inorganic carbon, TOC, and conductivity.
Whether deploying laboratory, at-line, or online TOC analysis for cleaning validation or water testing, consider your goals around efficiency, analytical performance, and data integrity. Analytical instruments that can provide high accuracy, precision, and data integrity while offering opportunities to save you time will be the most valuable to your monitoring programs. Contact a Sievers expert to learn more about what method of analysis is right for you.