Stainless Steel System Derouging & Maintenance Service

A renowned domestic pharmaceutical company, founded in 2000, specializes in producing small-volume injectable, tablets, lyophilized powder injections, etc. It operates a modern GMP-compliant production base. The core production system utilizes 316L stainless steel, with the Water for Injection (WFI) storage and distribution system serving as critical infrastructure that directly impacts product quality and production continuity.

AUSTAR Solution

• Comprehensive Technical Assessment: Used borescope inspection to locate concentrated rust areas (e.g., pump cavities, welds) and assess microbial contamination. Quantified tank corrosion levels using a surface roughness tester. • Customized Process Design – Segmented Chemical Cleaning: Applied CIP100 alkaline cleaner (STERIS USA, 5%, 70°C) in circulation to strip biofilm matrices. Utilized CIP200 acidic cleaner (STERIS USA, primarily phosphoric & citric acid, concentration gradient control) to target-dissolve iron oxide deposits and restore the passivation layer. • Precision Resource Allocation: Assembled an expert team (cleaning engineers, lab specialists, etc.) for around-the-clock shift rotation. • Optimized cleaning processes and on-site connection plans to minimize assembly time. Employed Critical Path Method (CPM) for task scheduling, enabling parallel operations across multiple systems.

AUSTAR Value & Client Benefits

• Efficiency Breakthrough: Completed treatment of 3 sets of WFI storage & distribution systems in just 4 days, reducing the standard cycle time by 20%. • Quality Compliance: Achieved zero visual rouging residue, passed all passivation layer tests, and restored water quality to meet production standards. • Added Value: Provided the client with a stainless-steel derouging management lifecycle model and assisted in establishing a preventative maintenance mechanism.

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