Hygiene monitoring
(WFI/purified water).
For GMP-compliant monitoring of water quality in pharmaceutical production.
Would you like to ensure that your WFI (Water for Injection) or purified water is free from microbial, organic, and physical contaminants? Water quality is a key component of every GMP-regulated manufacturing process. Even the smallest deviations can have an impact on product safety—and thus on your eligibility for approval.
To continuously ensure the safety and purity of your processes, we test the water used according to the relevant methods of the Ph. Eur. (2.6.14 and 2.2.44). We combine microbiological, organic, and physical analyses for comprehensive hygiene monitoring that meets internationally recognized standards.
Our testing methods at a glance:
- Microbiological testing: We analyze the water for microbial contamination. This ensures that there are no harmful microorganisms that could endanger the product or the patient.
- TOC analysis: We measure total organic carbon (TOC) to quantify the organic load in the water. A low TOC value confirms high purity and minimization of possible contamination.
- Particle testing: We check the water for visible and invisible particles. This allows us to ensure physical purity and identify potential sources of contamination in your manufacturing process at an early stage.
In addition, we document all results in an audit-compliant and traceable manner. Our expertise ensures that you are on the safe side during inspections by authorities such as the FDA or EMA.
In this way, we create the basis for GMP-compliant, safe, and reliable production processes—and give you the certainty that your water meets the highest pharmaceutical requirements.
CUSTOMER voices
We have been growing together with CUP Contract Labs for two decades and have enjoyed a fruitful partnership. They have proven to be a competent partner for the development and validation of our methods. Their reliable support in the release of our products makes them an indispensable part of our success.
