Automatic Xenon Test Chamber for R&D FDA 21 CFR Part 11 Compliance Audit Trail and Data Security

Automatic Xenon Test Chamber for R&D FDA 21 CFR Part 11 Compliance Audit Trail and Data Security

638005.0 INR/Unit

Product Details:

  • Automation Grade Fully automatic
  • Port Size 1.5 Inch
  • Application Weathering, light fastness, R&D, FDA 21 CFR Part 11 compliance testing
  • Interface Type Ethernet, USB, RS232
  • Response Time 1 s
  • Specimen Size 50 mm 150 mm
  • Features FDA 21 CFR Part 11 audit trail, data security, programmable cycles
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Automatic Xenon Test Chamber for R&D FDA 21 CFR Part 11 Compliance Audit Trail and Data Security Price And Quantity

  • 638005.0 INR/Unit
  • 1 Unit
  • Programmable with real-time clock
  • 545 C, <75% RH
  • up to 1.0 MPa
  • 128 GB internal memory
  • 60 dB(A)
  • Ergonomic, non-corrosive clamps
  • Full Spectrum Xenon Arc Lamp, 2.2 kW
  • Integrated Temp/Humidity/Light
  • FDA 21 CFR Part 11, CE
  • Encrypted data storage, audit log
  • 304 Stainless steel
  • Over-temperature, lamp fault alarms, emergency shutdown
  • Closed loop water-cooling
  • Automatic internal calibration option
  • Plug-and-play, comes with installation kit
  • Web interface for monitoring/control
  • up to 2000 h
  • Static, dynamic, cycling

Automatic Xenon Test Chamber for R&D FDA 21 CFR Part 11 Compliance Audit Trail and Data Security Product Specifications

  • 220/230 V AC
  • Industrial grade steel
  • UV/Xenon testing for R&D, compliance labs
  • 230V 10%, 50 Hz
  • 18C60C control
  • 05000 h
  • 380 L
  • up to 5000 h exposure
  • 0.512 m/min
  • 1%
  • 150 mm
  • Floor standing
  • 1580 mm
  • 50 Hz
  • 01 MPa adjustable
  • 0.1 h
  • Touchscreen PLC, Software enabled
  • 7-Inch LCD digital touchscreen display
  • Automatic Xenon Test Chamber
  • up to 500 mm
  • up to 36 samples
  • 280 Kg
  • 30%98% RH
  • 50 mm 150 mm
  • FDA 21 CFR Part 11 audit trail, data security, programmable cycles
  • Ethernet, USB, RS232
  • 1 s
  • Weathering, light fastness, R&D, FDA 21 CFR Part 11 compliance testing
  • Fully automatic
  • 1.5 Inch
  • Programmable with real-time clock
  • 545 C, <75% RH
  • up to 1.0 MPa
  • 128 GB internal memory
  • 60 dB(A)
  • Ergonomic, non-corrosive clamps
  • Full Spectrum Xenon Arc Lamp, 2.2 kW
  • Integrated Temp/Humidity/Light
  • FDA 21 CFR Part 11, CE
  • Encrypted data storage, audit log
  • 304 Stainless steel
  • Over-temperature, lamp fault alarms, emergency shutdown
  • Closed loop water-cooling
  • Automatic internal calibration option
  • Plug-and-play, comes with installation kit
  • Web interface for monitoring/control
  • up to 2000 h
  • Static, dynamic, cycling

Automatic Xenon Test Chamber for R&D FDA 21 CFR Part 11 Compliance Audit Trail and Data Security Trade Information

  • Cash in Advance (CID)
  • 100 Unit Per Month
  • 10 Days
  • All India

Product Description

Standard Features

Model

DR-H301

Internal dimension (WxDxH)

500*600*500mm

External dimension (WxDxH)

1000*1000*1750mm

Temperature range

RT+10~ 60 (suggest to use 402)

Temperature Fluctuation

1

Ozone concentration

50~1000 pphm, adjustable

Ozone concentration deviation

10%

Sample holder

SUS#304 stainless steel

Temperature controller

Programmable touch screen controller

Ozone concentration analysis

Concentration analysis meter

Ozone generator

High pressure silence discharge type

Protection system

Leakage, short circuit, over temperature, over heat

Test criteria

ASTM D1149, ISO 1431, JIS K6259...


The Automatic Xenon Test Chamber is a cutting-edge solution engineered to meet the rigorous demands of R&D laboratories and industrial research teams. By replicating solar radiation, temperature fluctuations, and humidity cycles, this chamber enables precise accelerated weathering studies, empowering innovators to validate material performance, predict product longevity, and comply with global testing standards. Below is a detailed technical overview, optimized for search engines while maintaining originality and user-centric value.


Technical Specifications & Key Features

1. Precision Environmental Simulation

  • Light Spectrum:

    • Xenon Arc Lamps: Air-cooled lamps with spectral output spanning 290800 nm, closely matching natural sunlight (ISO 4892-2, ASTM G155).

    • Adjustable Irradiance: 0.31.5 W/m at 340 nm, calibrated to simulate global solar conditions (equatorial, desert, or temperate climates).

  • Temperature Control:

    • Black Panel Temperature (BPT): 30C to 100C (0.5C accuracy).

    • Chamber Air Temperature: 10C to 70C (1C uniformity).

  • Humidity Management:

    • Relative Humidity: 10%95% RH (2% stability), with programmable dew/condensation cycles (ASTM D4587).

2. Automation & Smart Controls

  • Pre-Set Test Profiles: One-touch operation for standards like ISO 4892-2SAE J2527, and AATCC TM16.

  • Self-Diagnostic System: Automatically calibrates irradiance, detects lamp degradation, and alerts for maintenance.

  • IoT Integration: Remote monitoring via cloud platforms (e.g., AWS, Microsoft Azure) and compatibility with LIMS (Laboratory Information Management Systems).

3. Advanced Data Management

  • Touchscreen HMI: User-friendly interface with real-time graphs for temperature, humidity, and irradiance.

  • Data Export: Generate compliance-ready reports in CSV, PDF, or Excel formats, including metadata (test duration, cycle counts).

  • Encrypted Storage: Secure local and cloud-based data retention for audit trails.

4. Chamber Design & Safety

  • Compact Benchtop Models: 50L150L capacity, optimized for lab spaces.

  • Corrosion-Resistant Construction: 316L stainless steel interior, quartz viewing windows, and double-sealed doors.

  • Safety Protocols: Over-temperature shutdown, water leakage sensors, and emergency stop function.


Applications Across Industries

  1. Automotive R&D:

    • Test UV resistance of paints, dashboards, and exterior plastics under simulated sunlight.

    • Validate EV battery casing materials for thermal and humidity resilience.

  2. Consumer Electronics:

    • Evaluate display coatings, polymer casings, and adhesives for outdoor durability.

  3. Textile Innovation:

    • Assess colorfastness and fiber integrity in fabrics exposed to prolonged UV/heat.

  4. Sustainable Materials:

    • Accelerate aging studies for biodegradable plastics and recyclable composites.

  5. Pharmaceutical Packaging:

    • Test blister packs and labels for stability under ICH Q1B photostability guidelines.



Advanced Data Security and Compliance

Meeting FDA 21 CFR Part 11 and CE requirements, this chamber's software ensures encrypted data storage, audit logging, and secure access. Laboratory managers can confidently use automated audit trails for regulatory compliance, making it ideal for pharmaceutical, cosmetic, and material science R&D.


Optimized Performance and Testing Flexibility

This chamber supports static, dynamic, and cycling test modes, offering precise control over environmental conditions-temperature (18C-60C), humidity (30%-98% RH), and vapor pressure (up to 1.0 MPa). Program complex exposure cycles with ease and ensure testing accuracy within 1%.


Intuitive Operation and Ergonomic Design

The plug-and-play system comes with an installation kit for rapid setup. With a floor-standing design, industrial-grade steel construction, ergonomic sample holders, and 7-inch touchscreen PLC control, users enjoy effortless specimen loading, testing, and monitoring-even remotely via web interface.

FAQ's of Automatic Xenon Test Chamber for R&D FDA 21 CFR Part 11 Compliance Audit Trail and Data Security:


Q: How does the Automatic Xenon Test Chamber ensure FDA 21 CFR Part 11 compliance?

A: The chamber provides secure, encrypted data storage, complete audit trails, and user authentication features via its compliant software. All data recording and retrieval actions are logged for traceability, fulfilling 21 CFR Part 11 requirements for data integrity in regulated labs.

Q: What types of samples and applications is this test chamber most suitable for?

A: This chamber is engineered for weathering and light fastness tests of various materials, supporting R&D in pharmaceuticals, cosmetics, polymers, and coatings. It accommodates up to 36 specimens sized 50 150 mm, with tailored mounting for non-corrosive testing environments.

Q: When is it necessary to calibrate the xenon test chamber, and how is calibration managed?

A: The chamber features automatic internal calibration, minimizing manual intervention. Calibration can be scheduled through the programmable menu, ensuring consistent accuracy and reliability for each test cycle.

Q: Where can I access and monitor test results remotely?

A: All results and test statuses are accessible through a secure web interface. With Ethernet, USB, and RS232 connectivity, authorized users can monitor and control experiments remotely from any networked location.

Q: What is the process for setting up test parameters and starting a new test cycle?

A: Users configure test modes (static, dynamic, cycling), environmental conditions, and timer functions via the intuitive 7-inch LCD touchscreen PLC. Test cycles can be programmed with real-time clocks for automatic start and stop, ensuring repeatable, precise exposures.

Q: How does the chamber enhance operator safety during prolonged operation?

A: Safety features include over-temperature protection, lamp fault alarms, and an emergency shutdown system. These ensure that any anomaly is promptly addressed, safeguarding operators and specimens throughout long-duration tests.

Q: What are the primary benefits of using this chamber in compliance and R&D labs?

A: Key benefits include robust compliance with data integrity standards, versatile test modes, advanced programmable control, ergonomic specimen handling, reliable remote access, and durable construction. These factors enable efficient, repeatable testing crucial for product development and regulatory submissions.

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