行业：食品医药

Overall solution for gas safety monitoring in the food and pharmaceutical industry

行业痛点

食品医药行业是"高洁净度 + 多气种 + 严合规"复合场景：① **食品加工**：CO2（碳酸饮料 / 啤酒发酵 / 速冻库）+ NH3（冷库制冷剂，泄漏低浓度毒性 + 高浓度爆炸 LEL 16-25%）+ CH4（厌氧发酵）+ 卫生级别要求接触食品的探头不可有重金属 + 抗 CIP 清洁循环；② **乳业 / 酒业**：发酵罐 CO2 监测（员工进入受限空间事故频发，发酵罐 CO2 80%+ 极易缺氧）；③ **医药制剂**：洁净厂房 ISO 5-7 级（每立方 ≤ 100 个 0.5μm 颗粒）+ AMC 监测 + EO 环氧乙烷灭菌（强致癌物 PC-TWA 1 ppm）+ 注射剂车间 N2 + 制氢车间 H2；④ **疫苗 / 生物制品**：BSL-3 P3 实验室 + 冻干工艺 + 严格压差控制；⑤ **GMP 合规**：每个监测点必须经过 IQ / OQ / PQ 三级验证 + 21 CFR Part 11 电子记录可追溯 + FDA / NMPA 认证。一次合规缺陷可触发 GMP 证书撤销 → 全厂停产 → 数十亿损失（如某药企 2023 年因数据完整性问题被 FDA 警告信）。

方案概述

优锐安食品医药版方案严格符合 GMP / 21 CFR Part 11 / GB 50457 + 食品级卫生：① **冷库 + 制冷机房**：NH3 量程 0-1000 ppm + 缺氧 O2 + LEL（NH3 爆炸下限 16%），自动联动应急排风 + 切断 NH3 主供管 + 启动洒水稀释；② **食品发酵 / 酒类酿造**：CO2 0-100% + 受限空间作业便携 4 合一，进入发酵罐前强制检测；③ **医药洁净厂房**：颗粒物（0.3μm / 0.5μm 多档）+ 温湿度 + 压差 + AMC 集成监测，符合 GB 50457 + ISO 14644；④ **EO 环氧乙烷灭菌室**：EO 专用电化学探头（量程 0-50 ppm，PC-TWA 1 ppm）+ 灭菌后残留分析；⑤ **制氢站 / 注射剂车间**：H2 / N2 监测 + 防爆 Ex d IIC T1；⑥ **BSL-3 实验室**：负压联锁 + HEPA 过滤效率 + 室内气体异常报警；⑦ **数据 21 CFR Part 11 合规**：电子签名 + 审计追踪 + 数据不可篡改 + 周期性回溯审查。

## Key Monitoring Nodes

### Food Cold Chain / Refrigeration
– **Ammonia refrigeration room**: NH3 (range 0-1000 ppm, PC-TWA 20 mg/m³) + O2 + LEL
– **Inside the cold storage**: CO2 (rapid freezing CO2 process) + oxygen deficiency (O2)
– **Emergency linkage**: When NH3 concentration exceeds 30 ppm, initiate exhaust ventilation, shut down the compressor, and activate water spray dilution (NH3 is easily soluble in water)

### Food Fermentation / Wine Industry
– **Fermentation tank / Wine storage tank**: CO2 0-100% + Portable for confined space operations 4-in-1 (O2 + LEL + CO2 + H2S)
– **Baijiu / Yellow Wine Brewing**: Ethanol LEL + Explosion-proof Ex d IIB T3
– **Beer / Carbonated Drinks**: CO2 + Food-Grade Sanitary Certification (Contact Surface 316L Stainless Steel + Food-Grade Seal Ring)

### Pharmaceutical Cleanrooms (GMP Grade A/B/C/D)
– **Particulate Matter**: Real-time counting of multiple ranges including 0.3μm, 0.5μm, and 1.0μm
– **AMC**: Silicon / Boron / Sodium / Sulfur / Chlorine (affecting OLED / semiconductor-grade raw materials)
– **Temperature and Humidity**: ± 1℃ / ± 5%RH
– **Pressure difference**: adjacent rooms ≥ 10Pa (decreasing from Level A to Level B to Level C)
– **Ethylene Oxide Sterilization**: dedicated electrochemical sensor for EO (range 0-50 ppm, PC-TWA 1 ppm, PC-STEL 5 ppm)
– **Hydrogen generation station**: H2 measuring range 0-100% LEL, explosion-proof IIC T1

### BSL-3 / P3 Laboratory (Vaccine + Pathogenic Microorganisms)
– Real-time monitoring of negative pressure ranging from -25Pa to -40Pa
– HEPA filtration efficiency (verified through annual on-site scanning)
– Indoor O2 / CO2 + emergency SCBA backup

## Data Compliance (GMP Core)

1. **21 CFR Part 11 / GB 50457 / NMPA**: Electronic records + Electronic signatures + Audit trail + Data integrity
2. **IQ / OQ / PQ Verification Documentation**: Level 3 verification reports (Installation Qualification / Operational Qualification / Performance Qualification) for each monitoring point, which are mandatory for FDA inspections
3. **Change Control**: Any parameter modification must be accompanied by a change control sheet, impact assessment, approval, and revalidation
4. **Periodic Review**: Automatically generate a data integrity review report annually

## Key Technical Specifications

– Sanitary grade: 316L stainless steel probe housing + EHEDG food-grade certification (for food contact applications)
– Explosion-proof: Ex d IIB T3 (ethanol) / IIC T1 (hydrogen)
– Protection: IP69K (CIP online cleaning cycle withstands high-pressure hot water)
– Measurement Range: Dedicated measurement ranges for NH3, CO2, EO, and oxygen
– Communication: Modbus + EtherNet/IP, interfacing with BMS / EMS / SCADA

## Applicable Customers

Food groups (Master Kong / Mengniu / Yili / Nestle China / Nongfu Spring / Haitian); liquor industry (Moutai / Wuliangye / Tsingtao Beer / China Resources Snowflake); pharmaceutical CDMO + active pharmaceutical ingredient (WuXi AppTec / Chemex / Huahai / Prolo / Hisun); vaccine + biological products (Zhifei / Wantai / Watson / Sanye / Sinopharm); in vitro diagnostics (Mindray / Wondfo / Antu); hospital pharmacy + medical device production base.