Process Water Testing

Water is a key component in the manufacturing process of most medical devices. Many device manufacturers have installed water purification systems to improve and control the quality of the water that is used in their manufacturing processes. Water purification systems should be validated to insure that the specified quality of water is consistently produced. SGS Life Science Services in North America is the leading provider of laboratory testing services for water system validation projects. Microbiological testing will be started the same day samples are received. Bacterial endotoxin and chemistry testing are often completed within three working days. Please contact us or submit our Request for Quotation Form to discuss your water system validation requirements.

All water purification systems must be monitored regularly to verify the quality of the water produced. Because water purification systems remove chlorine from the municipal feed water, they can potentially harbor high levels of bacteria. This could cause high bioburden levels and/or excessive levels of pyrogens in the finished product. We can supply sterile and nonpyrogenic containers for collecting water samples. Please contact us to request supplies.

Purified Water System Validation Projects
Chemical and Physical Tests

• Purified Water Monograph – USP
  • Includes conductivity and total organic carbon (TOC).
• Total Organic Carbon (TOC)
• Particulate Matter (2 to 100 microns) – Light Obscuration Method
• LAL – Bacterial Endotoxins Test – Kinetic chromogenic or Turbidimetric

Microbiological Analyses – Water

• Total Heterotrophic Count – Plate Count
• Total Heterotrophic Count – Membrane Filtration
• Total Coliform – Membrane Filtration
• Total Coliform – MPN
• Fecal Coliform – MPN (includes total coliform)
• Pseudomonas aeruginosa – Membrane Filtration

Water Sampling Supplies

• Polycarbonate Bottle, 1 Liter
  • For each purified water monograph, fill one bottle to capacity.
• Glass Bottle with Teflon Lined Cap, 1 Liter (reusable)
  • For each purified water monograph, fill one bottle to capacity.
• Specimen Cups, Sterile, 120 mL
  • For each microbiological analysis, fill one cup to capacity.
• TOC Sample Vials, 40 mL
  • For each TOC test, fill 2 vials to capacity.
• Test Tubes, Sterile, Non-pyrogenic, 15 mL
  • For each LAL test, fill one tube to capacity.