Pharmaceutical Engineering

Applicable Scenarios: Drug synthesis reactions, aseptic preparation production, drug purification and separation, pharmaceutical excipient storage, and aseptic solution preparation.

Material Selection: 316L stainless steel for drug synthesis; 316L electropolished stainless steel for aseptic preparation; special corrosion-resistant stainless steel for halogen-containing media to prevent drug contamination or degradation.

Core Requirements: Strictly adhere to GMP, FDA 21 CFR, ICH Q9, and other standards; container inner surface roughness Ra≤0.4μm, no dead corners, no blind tubes, and no dents; possess a complete aseptic barrier system; seals are made of food-grade PTFE or EPDM materials, conforming to USP Class VI standards; withstand high pressure (0.6-10MPa), high temperature (50-200℃), and acid/alkali corrosion during the reaction process; equipped with online monitoring and recording devices for pressure, temperature, and liquid level, with traceable and tamper-proof data; equipment must pass installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) verification.

Typical equipment includes: pharmaceutical high-pressure reactors, sterile dispensing tanks, drug distillation towers, pharmaceutical excipient storage tanks, and crystallization kettles.