What would you do if your lab failed an audit because critical data was missing? Is your data scattered across multiple systems making it nearly impossible to present a clear, cohesive narrative to auditors? What if your equipment failed overnight and no alarms were triggered? Who monitors your lab to prevent catastrophes when the facility is empty?
Failure to pass an audit could lead to fines, penalties, and revocation of licenses and certifications. Was your facility issued an FDA 483 form? Products could also be rejected, and the company could suffer from a loss of trust and decreased investor confidence. That’s just the start of it.
GxP Environments
How We Do It
At XiltriX, we streamline your environmental monitoring by integrating all your data into a single, reliable platform. Our team monitors environmental inconsistencies, provides unparalleled risk mitigation, and supports you throughout audits.
We make audit preparation straightforward and stress-free for your quality team. We act as an extension of your team by monitoring your facility 24/7 and ensuring no alarm goes unnoticed to prevent catastrophic failures.
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Monitoring-as-a-Service for Quality Teams
Equipment
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.
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
Local/Visual Alarms
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.
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.
Environment
HVAC
Heating, ventilation, and air conditioning (HVAC) systems are vital for maintaining air quality in the facility, ensuring a stable environment. Integrating your HVAC system into an environmental monitoring system (EMS) addresses these concerns, helping facility teams maintain a controlled environment.
Key Parameters Include:
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. Monitoring light intensity ensures compliance standards are met, which is essential for certification and operational approval.
XiltriX Sensors & Integrations
| 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
Don’t see what you’re looking for? Contact our team to speak with an expert.