Microbiological & Physico-Chemical Quality of Production Water

As the single most used raw material for the manufacturing industry, water is often used as an ingredient of the final product, as well as for cleaning purposes. Because quality of the production water has a direct impact on the quality of the finished product, production water facilities must be designed, commissioned, qualified and maintained in order to guarantee the quality of water from its generation to distribution to each point of use. We also pay special attention to results interpretation, management and troubleshooting.

Choose Eurofins Medical Device Testing to help you:

• Ensure the quality of water is adequate throughout the entire product development process of your product.
• Identify the best analysis method for the production water of your sterile or non-sterile product, following ISO 17025 and cGMP guidelines.
• Provide suitable containers and transport conditions.

Testing Available

Eurofins Medical Device Testing network of laboratories provides comprehensive testing for monitoring water quality according to international guidelines, including:

• Microbiological Control (total aerobic count and tests for specific microorganisms)
• Genotypic and Phenotypic Identification of Bacteria and Fungi by Molecular Typing, Sequencing and MALDI-TOF Technologies
• Endotoxin Testing (Limulus Amoebocyte Lysate Test)
• Total Organic Carbon (TOC)
• Conductivity
• Physico-Chemical Parameters (Nitrate, Sulphate, Chloride, Heavy Metals, Oxidizing Substances etc.)

What is water sterility?

Water sterility for production water is an important aspect of the quality and safety of pharmaceutical products. Water sterility refers to the absence of viable microorganisms in water that is used for the manufacture of active substances, finished products, or as a cleaning agent for rinsing vessels, equipment, primary packaging materials, etc.