TOC testing for water, equipment cleaning validation

TOC Testing Services

Water Systems & Equipment Cleaning Validation per USP <643>

Overview Service

Capzer Pharmaceuticals performs Total Organic Carbon (TOC) analysis for purified water (PW), water for injection (WFI), clean steam, and equipment rinse/swab samples in cGMP cleaning validation programs. Our FDA/DEA-registered laboratory uses validated TOC analyzers to detect organic residues ensuring system purity and cross-contamination control.

Water Testing Application

TOC verifies PW (≤500 ppbC) and WFI (≤30 ppbC) per USP <643> via combustion/NDIR or UV-persulfate oxidation with system suitability (SSS ≤10–15% RSD). Routine monitoring trends organic excursions from storage/use points, complementing conductivity (<645>).

Cleaning Validation Application

Post-cleaning swabs/rinses from tablet presses, granulators, and dryers target <10–50 ppm API residues or 0.1–1.0 µg/cm² NVR via swab recovery studies. Non-specific TOC detects surfactants, polymers, and APIs, supporting worst-case protocols for Gabapentin and multi-product lines.

Key Capabilities

Benefits for Partners

Partners achieve compliant CoAs for Empagliflozin scale-up and facility PQ from our ISO 17025 lab, minimizing hold times and enabling rapid batch turnover in oral solid manufacturing.

Other Service

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