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Category: Facility and Process Validation

Nelson Laboratories, Inc. performs environmental studies, which include water system validations, cleanroom validations, disinfectant studies and environmental monitoring.

Tests available for Facility and Process Validation

Environmental water & monitoring

Environments such as clean rooms and other work areas often require air quality analysis.

USP/EP Water Tests USP

The current USP and EP both have multiple categories and requirements for different types of water. These include (most commonly) Purified Water, Sterile Purified Water, Water for Injection, and Sterile Water for Injection. Contact the Sales Department at sales@nelsonlabs.com for an abbreviated test set or specific water category quote.

Residual Manufacturing Materials (RMM)

With the increased awareness of the potential dangers of residual manufacturing materials on medical devices, the Food and Drug Administration (FDA) commonly requests documentation of a thorough validation of the cleaning processes used to remove these materials from newly manufactured devices.  Nelson Laboratories, Inc. (NLI) provides several choices for these validations, including Total Organic Carbon (TOC) analysis, soap/detergent residual analysis by Ultraviolet/Visible (UV/VIS) Spectroscopy, and gravimetric analysis.