Live Agent Environmental Monitoring System for GxP Regulated Environments

24/7 Eyes on Maintaining GxP Compliance

Maintain audit-ready lab conditions, manage critical emergencies, and protect your facility’s GxP compliance and reputation with XiltriX, a 24/7 live agent monitoring solution. XiltriX integrates the environmental data you need into a single, reliable platform. Our team monitors any inconsistencies and supports you throughout the entire audit process.

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When Audits Arise. We Rise to the Occasion.

How does your compliance team manage audits? Struggling with integrating disparate systems to maintain the compliance data you need? XiltriX has you covered. XiltriX adapts to the unique needs of your GxP facility, whether that means integrating environmental data, monitoring inconsistencies, or managing risk. It delivers a reliable EMS through purpose-built hardware, intuitive software, and support from the SafetyNet team.

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The Only GxP Monitoring System with Problem-Solvers Included

With the XiltriX monitoring system, you always have an extra pair of eyes watching over your GxP environment. Our SafetyNet Team is on every alarm escalation protocol, and they can diagnose, evaluate, and address any immediate problem, while also ensuring your lab remains compliant.

Sensors and Integrations for GxP Environments

  
    Bioreactors
    Autoclaves
  
    rH&T
    Particle Counting
  
    Differential Pressure (DP)
    Door Contacts
  
    Light Intensity
    HVAC
  
    VOCs
    Local/Visual Alarms
  
    Digital Alarm Outputs/Dry Contacts

+ Many More

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Equipment Monitored by XiltriX for GxP Compliance

Bioreactors

While some bioreactors integrate directly with your EMS by providing data on parameters within, most do not offer that integration. For these bioreactors, dry contacts are necessary to remotely alert you of any alarms while you’re outside the cleanroom. XiltriX can help you decide which monitoring system is best for your GxP needs.

Autoclaves

An autoclave is a sterilization device that uses pressurized steam to eliminate microbial contamination from clinical instruments and materials. Operating at around 121°C and 15 psi, it ensures that all microorganisms, including spores, are completely destroyed, which is crucial for maintaining sterile conditions essential for meeting regulatory requirements. XiltriX can integrate with these devices to verify that sterilization processes are successfully performed.

Facility Parameters Monitored by XiltriX for GxP Compliance

Local/Visual Alarms

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

Door Contacts

Monitoring door openings in validated environments provides important data for root-cause analysis of incidents. XiltriX can help you combine door sensor data with differential pressure information, allowing you to create valuable SOPs and gain insights into optimal entry and exit times.

Environmental Parameters Monitored by XiltrX for GxP Compliance

HVAC

Heating, ventilation, and air conditioning (HVAC) systems are vital for maintaining air quality in the facility, ensuring a stable environment. XiltriX can integrate with your HVAC system, helping your facility teams maintain a controlled and compliant environment.

- Particle Counting: Particle counting is a crucial feature of air quality monitoring 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.
- Differential Pressure (DP): Differential pressure sensors monitor pressure differences across filters and other components to help maintain system integrity.
- 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 (rH&T): High humidity levels and variable temperatures can lead to bacteria growth, product damage, and static electricity. Continuous monitoring of rH&T is crucial to prevent disasters and ensure the integrity of precision measuring equipment and sensitive compounds.

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. XiltriX monitors light intensity to ensure compliance standards are met, which is essential for certification and operational approval.