Knoxville, Tennessee in America, 33 units across 7 types, 4-day inspection

"A comprehensive inspection report has been submitted, reflecting the inspector’s sincere engagement, likely inspired by the manufacturer’s excellent preparation."

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Main Function of a Pure Steam Generator

The primary function is to generate clean, high-quality steam using purified water (PW or WFI – Water for Injection) for applications that require sterility and cleanliness.

KEA Inspection at a manufacturer in America

✅ Key Functions & Features

1. Production of Pure Steam

   • Converts pre-treated feedwater (WFI/PW) into dry, saturated steam that meets pharmaceutical-grade standards (e.g., EN285, USP, ISPE).

   • Used for sterilization of equipment, piping, autoclaves, vessels, and cleanroom environments.

     
     

2. Separation of Impurities

   • Employs gravity separation, demisters, or centrifugal separators to remove water droplets and carryover of contaminants.

     
     

3. Compliance with Regulatory Standards

   • Ensures the generated steam meets GMP (Good Manufacturing Practice) and pharmacopoeia requirements.

     
     

4. Continuous Operation & Sanitation

   • Designed for continuous and sanitary operation, with minimal dead legs, and materials like 316L stainless steel.

     
     

📦 Typical Applications

• Sterilization-in-place (SIP) of piping, tanks, and bioreactors

• Autoclaves / Steam sterilizers

• Cleanroom humidification

• Validation of sterile systems

• Medical device manufacturing