Purified Water Storage and Distribution System
Purified Water Storage and Distribution System in Pharmaceuticals
Purified water is a critical utility in pharmaceutical manufacturing, widely used in formulations, cleaning, rinsing, and as a raw material. A robust storage and distribution system ensures that water of required quality is consistently delivered up to the point of use without microbial proliferation or contamination.
Key Aspects:
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Storage Tank Design: Usually stainless steel 316L, with sloped bottoms, spray ball for CIP/SIP, vent filters, and controlled temperature (25–30°C or hot loop at 70–80°C).
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Distribution Loop: Designed as a continuous loop with recirculation to prevent stagnation. Maintains turbulent flow to minimize biofilm formation.
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Sanitization: Can be thermal (hot water/steam) or chemical (ozone, hydrogen peroxide). Regular sanitization prevents microbial growth.
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Monitoring: Online monitoring of TOC, conductivity, temperature, and microbial limits ensures compliance with pharmacopeial requirements (USP, EP, IP).
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Validation: System undergoes Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) to ensure reliability.
Benefits:
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Ensures compliance with GMP.
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Maintains sterility and microbiological safety.
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Reduces risk of OOS results and contamination in manufacturing.
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