How well do you really know your cleanroom setup? How would you explain the failure of critical experiments due to fluctuations in environmental conditions to your stakeholders? Are you ready to face the financial and reputational damage from non-compliance? What if you failed an audit? Are you confident in your cleaning procedures? How are you addressing external factors that may compromise your quality standards?

Cleanrooms

How We Do It

At XiltriX, our number one priority is quality. We understand that data integrity and unparalleled risk mitigation are crucial for advancing your pipeline. We go beyond monitoring your facility – we ensure that the highest standards of quality and compliance for your cleanrooms are consistently met. Our fully managed service is designed to streamline the quality reporting processes. We provide a comprehensive timeline of events for any incident and help you prevent future ones.

With XiltriX, you can access all necessary data through a single, integrated system, making it easier to pass audits with ease. We're here to support you before, during, and after the building process and also during audits to ensure you're always prepared.

Navigating the complexities of working with multiple vendors and managing various relationships can be overwhelming. We simplify this by collaborating with your vendors to ensure all requirements are seamlessly met. Our validated system along with 24/7 live agent monitoring & support offers peace of mind, allowing you to focus on what you do best. You should not be burdened with the complexities of cleanroom monitoring—our team is here to navigate those challenges for you.

Facility

Door Contacts

Monitoring door openings in validated environments provides important data for root-cause analysis of incidents. Combining door sensor data with differential pressure information allows for the creation of valuable SOPs and insights into optimal entry and exit times.

Backup Power

Backup generators and uninterruptible power supplies (UPS) monitor the stability and availability of the power supply to ensure operational continuity, preventing disruptions that could compromise sample storage conditions.

Local/Visual Alarms

Local and visual alarms, such as LED indicators and flashing lights are essential for immediate notification of any deviations in cleanroom conditions. These alarms provide instant feedback to personnel, allowing for quick corrective actions.

Light Intensity

Light can affect various processes. It can alter the stability and efficacy of light-sensitive drugs and biological samples, leading to potential product failures. Monitoring light intensity ensures compliance standards are met, which is essential for certification and operational approval.

Environment

Air Quality

Air quality in cleanrooms must be constantly tested for temperature, humidity, differential pressure, vocs, and airborne particles. Imbalances in these parameters can cause quality issues during manufacturing processes.

- Differential Pressure: In a cleanroom, measuring and monitoring proper air pressure (positive or negative) is essential to maintain a contamination-free environment and ensure product efficacy. A digital setup that tracks and maintains records is crucial. An analog system provides no historical data or value, and won’t be useful if you’re away from your facility. The era of paper charts is long gone.
- Volatile Organic Compounds (VOCs): VOC sensors detect the presence and volume of VOC particles in the air. Integrating VOC sensors with a 24/7 real-time monitoring solution allows for prompt detection and alerts to address air quality issues before they become catastrophic.
- Relative Humidity & Temperature: High humidity levels and variable temperatures can cause many cleanroom problems, such as bacterial growth, product damage, and static electricity. Equipment can start reporting inaccurate measurements if the temperature or humidity varies, and a lack of real-time monitoring can quickly destroy precision measuring equipment and sensitive compounds, products, or ingredients. To detect spikes and prevent disasters, it’s important to continuously monitor the relative humidity and temperature within your cleanrooms.
- Particle Counting: Particle counting is a crucial feature of air quality monitoring in the cleanroom due to the numerous products and processes sensitive to environmental contamination. Continuous particle counting is recommended rather than portable ones as they provide full insight and assurance of real-time alerts.

Vibration

Monitoring vibration levels in cleanrooms is essential to protect sensitive equipment and processes. Excessive vibrations can affect accuracy, reliability, and can also cause particle matter to become airborne or be dislodged from the HEPA filter, leading to contamination. By monitoring vibrations, cleanrooms can ensure a stable environment and maintain air quality.

Dry Contacts

This type of alarm does two things: it detects if a condition has gone out of parameters, and it triggers an alarm in response. Dry contacts typically don’t supply data on the cause of an alarm; they just alert you when a condition breaches set limits. Speak with your monitoring provider to ensure you get remote dry contact alerts for your critical equipment, systems, and infrastructure.

XiltriX Sensors & Integrations

  
    Differential Pressure
    Vibration
  
    Door Contacts
    VOCs
  
    rH&T
    Particle Counting
  
    Backup Power
    Light Intensity
  
    Local/Visual Alarms
    Dry Contacts

+ Many More

Don’t see what you’re looking for? Contact our team to speak with an expert.

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