Drainage System Components in Biopharmaceutical Cleanroom Engineering

Critical Elements of Pharmaceutical Grade Drainage Systems

The drainage system in biopharmaceutical cleanroom engineering is a critical component that ensures compliance with GMP (Good Manufacturing Practice) requirements. The system must meet stringent hygiene standards, contamination control specifications, and fluid management regulations.

1. Aesthetic Welding of Drainage Risers

Drainage riser welds must meet the following requirements:

· Automatic welding processes to ensure uniform and smooth welds (per ASME BPE-2019 standard)

· Weld surface roughness Ra≤0.5μm (ISO 1302 standard)

· 100% endoscopic inspection (ASTM E1417 standard compliant)

2. Installation of Drain Pipe Traps

Trap installations must comply with:

Item	Requirement	Standard Reference
Water Seal Depth	≥50mm	GB 50015-2019
Material	316L Stainless Steel	ASME BPE-2019
Cleaning Method	CIP/SIP Compatible	ISPE Baseline Guide

3. Rational and Aesthetic Layout of Process Equipment Drainage

Equipment drainage layout principles:

· Gravity drainage design with ≥1% slope (FDA cGMP compliant)

· Drain point-to-equipment distance ≤1.5m (ISPE recommended value)

· Sanitary clamp connections (3A Sanitary Standard)

4. Equipment Wiring Conduits

Wiring conduit installation requirements:

· IP68 protection rating (IEC 60529 standard)

· 316 stainless steel material (ASTM A276 standard)

· 5° anti-pooling tilt design (PIC/S PI 007 recommendation)

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