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Home > products > Cleanroom Air Shower > 21 CFR Part 11 Data Logging Cleanroom Air Shower with IoT Remote Monitoring and H13 HEPA Filtration for Pharmaceutical Air Shower

21 CFR Part 11 Data Logging Cleanroom Air Shower with IoT Remote Monitoring and H13 HEPA Filtration for Pharmaceutical Air Shower

Product Details

Place of Origin: Guangdong, China

Brand Name: YN

Certification: CE, ISO 14644, RoHS

Model Number: YN-ASIOT1400

Payment & Shipping Terms

Minimum Order Quantity: 1 Set

Price: USD 3,200-6,800 / Set

Packaging Details: PE film wrapped, plywood export case with fumigation-free packing

Delivery Time: 15-25 working days after deposit

Payment Terms: T/T,L/C at sight,Western Union,L/C,D/A,D/P

Supply Ability: 3000 Sets per Month

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Product Details
Highlight:

IoT Remote Monitoring Air Shower

,

21 CFR Part 11 Data Logging

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IQ OQ PQ Validation Package

Material:
SUS304 Stainless Steel, 1.2mm Inner Panel
Control System:
Industrial PLC With 10 Inch Touch Screen, Ethernet And RS485
Data Logging:
Event Log With User ID, Timestamp, Shower Cycle And Differential Pressure, Export To CSV
Compliance:
21 CFR Part 11 Audit Trail With Electronic Signature Support
Validation Package:
IQ OQ PQ Protocols, DQ, FAT SAT And Calibration Certificates
Remote Monitoring:
IoT Gateway, MQTT To Cloud Dashboard, Alarm Push To Email And WeChat
Filtration:
H13 HEPA With Differential Pressure Transmitter And Alarm
Air Velocity:
25 M/s At Nozzle, Continuous Monitoring
Interlock:
Electronic Interlock With Door Status Recording
Power Supply:
AC 220V / 380V, 50/60Hz
Material:
SUS304 Stainless Steel, 1.2mm Inner Panel
Control System:
Industrial PLC With 10 Inch Touch Screen, Ethernet And RS485
Data Logging:
Event Log With User ID, Timestamp, Shower Cycle And Differential Pressure, Export To CSV
Compliance:
21 CFR Part 11 Audit Trail With Electronic Signature Support
Validation Package:
IQ OQ PQ Protocols, DQ, FAT SAT And Calibration Certificates
Remote Monitoring:
IoT Gateway, MQTT To Cloud Dashboard, Alarm Push To Email And WeChat
Filtration:
H13 HEPA With Differential Pressure Transmitter And Alarm
Air Velocity:
25 M/s At Nozzle, Continuous Monitoring
Interlock:
Electronic Interlock With Door Status Recording
Power Supply:
AC 220V / 380V, 50/60Hz
Product Description
Smart Cleanroom Air Shower with IoT Monitoring and 21 CFR Part 11 Data Logging

Pharmaceutical and biological manufacturers must prove that every decontamination cycle actually happened. This smart air shower records operator identity, entry time, shower duration, air velocity and HEPA differential pressure, stores the records in a tamper-proof audit trail and pushes live status to a cloud dashboard.

Technical Specifications
Material SUS304 stainless steel 1.2mm
Controller PLC + 10 inch touch screen
Audit trail 21 CFR Part 11 with e-signature
Validation IQ OQ PQ, DQ, FAT SAT documents
Connectivity Ethernet, RS485, MQTT IoT gateway
Filtration H13 HEPA with DP transmitter
Air velocity 25 m/s monitored
Power AC 220V/380V 50/60Hz
Key Features
  • Complete electronic batch record for each air shower cycle with user ID and timestamp
  • 21 CFR Part 11 compliant audit trail, no record can be edited or deleted
  • IQ OQ PQ validation documentation package ready for your QA review
  • HEPA differential pressure transmitter with high alarm and trend logging
  • Remote monitoring dashboard with email and mobile alarm notification
Typical Applications
  • Pharmaceutical sterile workshops
  • Biological laboratories and vaccine plants
  • Medical device manufacturing
  • Compounding pharmacies

Customized sizes, blowing directions and control configurations are available. Send us your cleanroom layout drawing for a tailored solution and quotation.