In the pharmaceutical industry, QC testing is integral to ensuring the optimum performance and safety of medicinal products. Water plays a pivotal role in lab work analysis. However, the very properties that make it so useful, such as its ability to dissolve a range of compounds and gases, mean that it can be easily contaminated. This, in turn, can have a detrimental impact on testing outcomes, distorting data as well as damaging sensitive lab equipment.
Some QC applications are more sensitive to impurities than others, and laboratories must ensure that the appropriate grade of water is used to minimise contamination and avoid regulatory non-compliance. For example, ultrapure water (Type I+ water) is used for highly sensitive endotoxin analysis, liquid chromatography and cell cultures, while apyrogenic water (Type II or Type II+ water) is typically used for general chemistry and microbiological analysis.
The science of compliance
There are stringent regulations for pharmaceutical companies to ensure that water used in the testing, analysis and production of pharmaceutical products meets required purity standards.
USP 643 Total Organic Carbon and USP 645 Water Conductivity are United States Pharmacopoeia (USP) chemical limit tests that determine the appropriate control and reduction of chemicals in a water purification system. USP 643 is designed to reduce organic contaminants by measuring total organic content, and USP 645 measures ionic impurities in water by assessing its electrical conductivity.
Similarly, FDA 21 CFR Part 11 is a regulation governing electronic systems used in the pharma industry for monitoring water quality. Organisations and laboratories using these systems must ensure they are validated and secure, as well as maintain an audit trail to provide evidence of the accuracy and integrity of water purity data.
Some water purification systems focus on removing specific contaminants, whilst others have a broader spectrum of targets, so identifying the correct purification technology for the task is important.
PURELAB®: ensuring water purity and compliance in QC labs
PURELAB® water purification systems are specifically designed to provide a constant, reliable supply of high-quality water for QC applications. Engineered for simple and efficient operation and maintenance, the PURELAB® range offers three levels of regulatory compliance:
➡️ Low-level compliance: PURELAB® Chorus 1 Life Science or Analytical Research. For labs that require low or non-regulatory control and quality water only. Key features include:
- Up to 2.0 l/min dispense flow rate
- Modular design to optimise valuable lab space
- Real-time TOC monitoring
- In-built auto-recirculation to manage biofilm, delivering reliable water quality and optimal readings
➡️ Mid-level compliance: PURELAB® Chorus 1 Life Science or Analytical Research + VSM (Validation Support Manual). For labs that require some level of documentation, along with a validated system and basic data tracking (such as resistivity, TOC, temperature, etc). Key features: as outlined above.
➡️ High-level compliance: PURELAB® Pharma Compliance. For labs that require detailed documentation, validation to USP 643 and 645, and data tracking to comply with Part 11. Key features include:
- Provision of up to 120 l/day of ultrapure water
- Up to 2.0 l/min dispense flow rate
- Digital record keeping
- Compliance with TOC verification
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Delivering a complete purification solution for pharmaceutical QC
Choosing the wrong purification technologies can result in interruptions to workflow, costing time and money in the cleaning and replacement of parts, as well as reagent wastage and project downtime. In contrast, the right water purification system will improve the productivity, efficiency and accuracy of your lab’s outputs.
The PURELAB® systems (PURELAB® Chorus 1 and PURELAB® flex range) offer real-time TOC monitoring. This facility continuously measures resistivity, calculating the TOC value of water produced before it is dispensed, and displaying the value in real time. It enables units to read all water running through the system, rather than just a sample.
In addition, the PURELAB® Chorus 1 features PureSure® technology, a double purification pack and monitoring system, which uses an enhanced deionised (DI) process that relies on ion exchange (IX) resins to guarantee water quality.
This technology provides a warning when the first DI pack has been fully exhausted, whereupon the second pack kicks in to ensure that water continues to meet the required specification. This allows laboratories to replace the DI pack at a convenient time, without interrupting workflow. The second DI pack can then be moved to the position of the first pack to maximise its use, avoiding wasting valuable resources through premature pack exchange.
Future-proofing with scalable and sustainable purification solutions
Selecting a modular system that allows for expansion without increasing the environmental footprint of your operations is key. Look for efficient designs that minimise water and energy consumption, reduce plastic use and chemical waste, and ensure compliance with environmental standards.
Veolia’s range of water purification systems offers bespoke, efficient, modular solutions for all types of water purity, laboratory applications, budget and production demands.
Our subsidiary company, ELGA, has been working with scientists for over 80 years, providing pure water for laboratories and navigating the challenges that can arise during the development, installation and servicing of purification systems.
Take action today
Pharmaceutical regulations are tightening. Ensure your QC laboratory stays compliant with our expert Quality Control Buyer's Guide. This essential resource includes validation protocols, compliance checklists, and system recommendations from water purification specialists with 80+ years of pharmaceutical experience.
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