Case Study — Pharmaceutical
cGMP-Compliant Washdown System for an FDA-Registered Drug Manufacturer
An FDA-registered pharmaceutical manufacturer needed validated washdown stations with documented temperature control to satisfy cGMP requirements and FDA audit scrutiny.
The Challenge
The facility manufactured oral solid dosage forms under FDA 21 CFR Part 211 cGMP regulations. An FDA pre-approval inspection had cited the washdown system as a potential contamination risk — the existing hot water mixing stations lacked documented temperature validation and had no formal qualification records.
cGMP regulations require that equipment used in drug manufacturing be qualified (IQ/OQ/PQ) and that critical process parameters — including washdown water temperature — be validated and documented. The facility needed to replace their washdown stations with equipment that could be formally qualified and integrated into their validation master plan.
The facility also needed steam-capable stations for high-temperature sterilization of certain equipment surfaces, requiring a mixing station that could blend steam and cold water to precise temperatures between 160°F and 180°F.
The Solution
Northeast Controls specified the SuperKlean DuraMix 8000GM-S — a stainless steel steam and cold water mixing station — for all 16 wash points. The 8000GM-S features a globe valve design that provides precise flow control and a stainless steel body that meets pharmaceutical-grade material requirements.
Northeast Controls provided a complete IQ/OQ documentation package for each station, including installation qualification checklists, operational qualification temperature mapping data, and calibration certificates for the thermostatic elements. All documentation was formatted to meet FDA 21 CFR Part 211 requirements.
Temperature setpoints were validated at 165°F for standard equipment washdown and 180°F for sterilization applications. Each station was tested across its full operating range and the results documented in the facility's validation master plan.
The Results
The 8000GM-S stations gave us the validated temperature control we needed to close the FDA observation. The IQ/OQ documentation package from Northeast Controls was exactly what our validation team needed — it saved us weeks of work.
— Validation Manager, FDA-Registered Pharmaceutical Manufacturer