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Key Parameters Measured and Controlled in an Isolator

Precise monitoring and control of critical environmental parameters inside isolators are essential to ensure process integrity, product safety, and regulatory compliance. Below are the main parameters typically measured and controlled using Dwyer and Omega sensors and transmitters supplied by Trias Automation.

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1. Pressure / Differential Pressure

  • Purpose: Maintains correct airflow direction and containment integrity.

  • Measured Parameters:

    • Internal chamber pressure (positive for aseptic isolators, negative for containment isolators)

    • Differential pressure between isolator and surrounding area

  • Typical Range:

    • +10 to +30 Pa for aseptic isolators

    • −10 to −30 Pa for containment isolators

  • Instruments: Pressure transmitters, differential pressure gauges, and Magnehelic indicators.

 

2. Temperature

  • Purpose: Essential for temperature-sensitive processes such as sterilization, incubation, or product filling.

  • Measured Parameters: Chamber air and product or surface temperature.

  • Instruments: RTD sensors, thermocouples, and temperature transmitters.

 

3. Relative Humidity (RH)

  • Purpose: Controls microbial growth, product stability, and static buildup.

  • Measured Parameter: Chamber humidity levels.

  • Instruments: RH sensors and humidity transmitters.

 

4. Particle Count / Air Cleanliness

  • Purpose: Ensures compliance with cleanroom classifications (ISO Class 5 or better).

  • Measured Parameter: Airborne non-viable particle counts (≥0.5 μm and ≥5 μm).

  • Instruments: Particle counters with sampling ports.

 

5. Microbial Contamination (Viable Monitoring)

  • Purpose: Validates aseptic conditions inside the isolator.

  • Methods: Settle plates, active air samplers, and surface contact plates.

 

6. Air Flow Velocity / Volume

  • Purpose: Maintains laminar airflow and prevents turbulence.

  • Measured Parameter: Air velocity at HEPA outlets.

  • Instruments: Hot-wire anemometers and airflow sensors.

 

7. Filter Integrity

  • Purpose: Ensures HEPA filters remain leak-free to preserve sterility.

  • Measured Parameter: Pressure drop and DOP/PAO leak test results.

 

8. Leak Rate / Pressure Decay

  • Purpose: Validates isolator tightness and system integrity.

  • Measured Parameter: Pressure decay over a defined period.

  • Instruments: Pressure decay testers.

 

9. VHP (Vaporized Hydrogen Peroxide) Concentration

  • Purpose: Ensures correct Hâ‚‚Oâ‚‚ concentration during decontamination.

  • Measured Parameter: Hâ‚‚Oâ‚‚ levels in ppm during sterilization and aeration phases.

  • Instruments: Hydrogen peroxide analyzers.

 

10. Glove Integrity

  • Purpose: Prevents contamination through glove breaches.

  • Measured Parameter: Pressure decay or automated glove test results.

 

11. Door/Port Interlocks and Access Logs

  • Purpose: Maintains pressure and prevents cross-contamination during transfers.

  • Measured Parameter: Door status and interlock condition.

 

12. Oxygen Level (for Specific Applications)

  • Purpose: Required for lyophilization or inert atmosphere isolators.

  • Measured Parameter: Oâ‚‚ concentration (% or ppm).

  • Instruments: Oxygen analyzers.

 

At Trias Automation

We provide a wide range of sensors and transmitters from Dwyer and Omega that accurately measure and control these parameters — helping industries achieve optimal isolator performance, compliance, and reliability.

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