Industry: Food and Pharmaceutical

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

Industry Pain Points

The food and pharmaceutical industry operates within a complex scenario characterized by "high cleanliness, multiple gas types, and strict compliance": ① **Food processing**: CO2 (carbonated beverages/beer fermentation/quick-freezing warehouses) + NH3 (refrigerant for cold storage, low-concentration toxicity in case of leakage + high-concentration explosion hazard LEL 16-25%) + CH4 (anaerobic fermentation) + hygiene requirements stipulate that probes in contact with food must be free of heavy metals and resistant to CIP cleaning cycles; ② **Dairy/wine industry**: CO2 monitoring in fermentation tanks (frequent accidents occur when employees enter confined spaces, and CO2 levels in fermentation tanks are often over 80%, making them prone to oxygen deficiency); ③ **Pharmaceutical preparations**: cleanrooms with ISO 5-7 levels (≤ 100 particles per cubic meter of 0.5μm size) + AMC monitoring + EO (ethylene oxide) sterilization (a strong carcinogen with PC-TWA 1 ppm) + N2 in injection workshops + H2 in hydrogen production workshops; ④ **Vaccines/biological products**: BSL-3 P3 laboratories + lyophilization process + strict pressure difference control; ⑤ **GMP compliance**: each monitoring point must undergo IQ/OQ/PQ validation + 21 CFR Part 11 electronic record traceability + FDA/NMPA certification. A single compliance defect can trigger the revocation of the GMP certificate → factory shutdown → billions in losses (for example, a pharmaceutical company received a warning letter from the FDA in 2023 due to data integrity issues).

Solution Overview

The URION food and pharmaceutical solution strictly complies with GMP / 21 CFR Part 11 / GB 50457 + food-grade hygiene: ① **Cold storage + refrigeration room**: NH3 range 0-1000 ppm + oxygen deficiency O2 + LEL (NH3 explosion lower limit 16%), automatic linkage emergency exhaust + shutoff of main NH3 supply pipe + initiation of water spray dilution; ② **Food fermentation / alcohol brewing**: CO2 0-100% + portable 4-in-1 for confined space operations, mandatory detection before entering the fermentation tank; ③ **Pharmaceutical clean workshop**: particulate matter (0.3μm / 0.5μm multi-range) + temperature and humidity + pressure difference + AMC integrated monitoring, compliant with GB 50457 + ISO 14644; ④ **EO ethylene oxide sterilization room**: dedicated EO electrochemical probe (range 0-50 ppm, PC-TWA 1 ppm) + post-sterilization residual analysis; ⑤ **Hydrogen production station / injection workshop**: H2 / N2 monitoring + explosion-proof Ex d IIC T1; ⑥ **BSL-3 laboratory**: negative pressure interlock + HEPA filtration efficiency + indoor gas anomaly alarm; ⑦ **Data 21 CFR Part 11 compliance**: electronic signature + audit trail + data tamper-proof + periodic retrospective review.

## 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.

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