Veolia Water Technologies & Solutions

4 Ways to get the most out of your pharmaceutical water quality analyzers and maximize your return on investment (ROI)

Pharmaceutical manufacturing line


It’s likely you could get more out of your water quality analyzers by understanding a few key areas that impact your return on investment (ROI). With various technologies available for total organic carbon (TOC) and conductivity analysis – each with different levels of accuracy, precision, speed, and price points – it’s important to consider factors such as efficiency, risk mitigation, and sampling processes in your overall cost-benefit analysis. Beyond analyzer technology selection, ROI depends on components such as:

  • How quickly you get your system up and running
  • Your ability to minimize retests and mitigate risk of excursions
  • Choosing vials and sampling processes that maximize efficiency

Water quality monitoring is crucial in pharmaceutical production. Whether used as raw material or for formulation, processing, reagents, intermediates, or cleaning, water plays a fundamental role in GMP processes and must be monitored accordingly. Two critical quality attributes that require monitoring according to the US Pharmacopeia in USP <1231> Water for Pharmaceutical Purposes are TOC and conductivity. These measurements are used to demonstrate compliance to regulations and control processes.

Here are 4 ways to get the most out of your water quality analyzers.

1. Installation and Validation

To maximize the return on investment in new equipment, businesses should focus on validating the system and optimizing its use as quickly as possible. The first steps involve installation and validation, which can be simple or complex depending on the location of the analyzer. Partnering with a qualified service organization that provides the validation test procedure in advance can expedite the process and minimize resource demand.

In pharmaceutical production, equipment and method validation are critical requirements to ensure functionality of the equipment and suitability for a given application. Rather than spending weeks or months on these processes (which include development of validation test procedures, obtaining approval from Quality or Compliance, and execution of testing and reports), many Sievers Instruments customers find it advantageous to rely on our validation services to get them up and running quickly and reliably.

2. Robust Sampling and Monitoring Processes

Once the equipment is validated and put into use, robust sampling or online monitoring processes are essential to maximize the benefits of the analyzer. Here are some considerations when it comes to vials and sampling that contribute to efficiency and minimizing costs:

  • Certified low TOC vials are effective for point of use (POU) sampling, ensuring clean and efficient collection of samples and minimizing external contaminants. This means the TOC results you obtain will be a good representation of the water source or cleaning process in question. With confidence in your measurements, you can minimize costs associated with unnecessary retests.
  • Specialty vials can reduce manual or redundant processes, saving time and costs:
    • Pre-Treated Vials – Adding an acid or a base to samples containing biologics or proteins can improve TOC recovery, avoiding false low recoveries. This is important in applications like cleaning validation where a false low recovery (or a false sense of cleanliness) ultimately increases risks and costs. Sievers offers certified low TOC vials pre-treated with acid or base to eliminate the need to manually add chemicals to each sample collected and ensure consistency in the sampling and analysis process.
    • Simultaneous measurement of TOC and conductivity from a single sample can enhance efficiency and complement a "lean lab" initiative. Sievers Dual Use Conductivity and TOC (DUCT) vials ensure accuracy of both TOC and conductivity measurements and greatly increase sample integrity and time savings over traditional meter and probe analysis.

3. Regular Verification of Monitoring Equipment

To mitigate the risk of defects or excursions, regular verification of monitoring equipment is necessary. The frequency of verification depends on factors such as the cost of undetected defects, potential scrap, production downtime, and the complexity of the verification process. Using certified and accredited reference standards that comply with international traceability and characterization requirements provides confidence that reference materials of appropriate quality are used and process excursions will be detected.

Some companies choose to bracket their TOC or conductivity samples daily or weekly with known reference standards to establish a defined number of samples or time period that could be subject to intervention actions in the event of monitoring system drift.

Sievers reference standards used to verify equipment accuracy and precision are certified and accredited to ISO 17034, General Requirements for the Competence of Reference Material Producers. This accreditation demonstrates the reference standards are produced in a facility with a strong quality management system that is routinely audited by an accrediting body, and the reference materials comply with international requirements.

4. Minimizing Costs of Investigation and Corrective Actions

Equipment failures in water quality monitoring systems can lead to extensive investigations and corrective actions, causing significant costs in time and money. Out-of-specification (OOS) events require resources to investigate and can result in delays in production or release of product until resolved. Frequent equipment verification and a thorough understanding of the process equipment can minimize these costs. Robust traceability across all components involved in the investigation (such as the analyzer measurements, reference standards used for equipment verification, and sampling vials) can accelerate the resolution of root causes, saving valuable resources.

Our Sievers Instruments team partners with companies to aid in the efficient closure of OOS investigations, allowing customers to maximize uptime and manage resources effectively.

Maximize ROI with End-to-End Process Consideration

High-quality analyzers are valuable for water processes that require compendial compliance and process optimization. By simplifying instrument implementation, maximizing product output, reducing OOS events, and providing accurate, critical data, manufacturers can offset upfront investment in tools for water quality monitoring and cleaning validation. Equipment validation, routine performance verification, robust sampling procedures, and high-quality consumables are essential for maximizing the return on analyzer investment. Pharmaceutical companies that consider the end-to-end process of water quality monitoring will be better positioned to achieve cost savings, optimize resource deployment and focus on top business initiatives.

Author: Susan Garcia

Susan Garcia is the Senior Product Manager at Veolia Water Technologies & Solutions for Sievers Analytical Instruments’ consumables and services. She previously served as the Quality Engineer for Sievers consumables and as the Manufacturing Engineering Manager responsible for leading a team of engineers and technicians to support production of Sievers instruments. Susan has led significant quality improvement and product development projects during her tenure, including reference material accreditation to ISO 17025 and ISO 17034 and new consumable product launches associated with TOC and conductivity analyzers.

Susan holds a B.S. from Rice University in Chemical Engineering and has over nineteen years of experience across engineering, quality, manufacturing, and product management roles in healthcare and the life sciences. She joined GE Healthcare in 2005 and transitioned in 2010 to GE Analytical Instruments where she began her tenure with the Sievers product line.

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