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Pharmaceutical Compliance Made Simple with Dry Well Validations
Source: | Author:Y | Published time: 2025-06-27 | 1 Views | Share:

Regulatory Requirements
FDA 21 CFR Part 11 demands traceable calibration for autoclaves and freeze dryers.

Dry Well Solutions

  • Probe Traceability: Kaye systems log data for each of 48 probes, linking to reference standards2.

  • Audit-Ready Reports: Fluke 744 calibrators generate PDF reports via 9930 software4.

Validation Protocol

Perform pre/post-calibration checks at 121°C (sterilization temperature) with a stability tolerance of ±0.1°C2.