Addressing Cleanroom Challenges

Using real-time monitoring data, the XiltriX team helped a cell therapeutics company identify a malfunction in their cleanroom design that was causing issues with maintaining appropriate pressure levels.

Summary

Maintaining the integrity of controlled environments is essential for cleanrooms. The customer selected XiltriX as their environmental monitoring provider to ensure the integrity of their cleanrooms at their new facility.

Initially, everything appeared to be in order with the cleanroom setup. However, the customer encountered multiple issues, including inaccurate pressure readings, delayed gauge responses, and compromised seals. This highlighted the need for a comprehensive evaluation of the cleanroom’s operational integrity. The customer reached out to the XiltriX Team for professional assistance.

differential pressure graph

The differential pressure measurements shown above are breaching both the upper (red) and lower (blue) alarm limits. When the differential pressure breaches the upper limit, it can signal bad filtration. If it’s breaching the lower limit, it can indicate that air is being brought in, which is also problematic.

Solution

The XiltriX Team began its investigation by comparing the cleanroom's pressure readings against those of a manometer, revealing discrepancies induced by kinked tubing installed by a third-party contractor. The reason why the cleanroom was showing incorrect pressure readings was that the tubes were bent at an angle, obstructing airflow and creating a false sense of operational functionality. The XiltriX Team identified the flawed tubing and ensured its replacement with a more flexible variant to prevent future kinking.

The customer was experiencing frequent alarms due to the gauges’ response time calibration, which determines how quickly the system reacts to changes in pressure. The XiltriX Team adjusted this setting to improve the accuracy of the system and provide the customer with clearer, more reliable data, ultimately making their monitoring process smoother and more efficient.

Despite the facility being new, the XiltriX Team discovered another issue that caused fluctuations. They discovered unsealed room penetrations and door sweeps, further compromising the cleanroom's controlled environment. This highlights the importance of thorough inspections and collaboration. The customer's proactive engagement and the XiltriX Team's efforts led to the proper stabilization of the cleanroom environment.

To ensure an optimal cleanroom environment, the XiltriX Team also addressed issues stemming from cleaning procedures. They advised the customer on best practices to prevent sensor ports and lines from becoming overly exposed during cleaning. If liquid enters the sensing lines, it can clog them and cause temporary obstructions that prevent accurate pressure adjustments until the liquid evaporates.

XiltriX Benefits

The resolution of these challenges highlights the value of partnering with a provider that offers professional support. Leaning on subject matter experts who provide comprehensive insights is crucial. In this instance, when issues arose, the problems were immediately escalated. The XiltriX team diagnosed the problems and identified the causes of the pressure discrepancies so the customer could work with the builder to rectify the issues. This case study demonstrates the XiltriX Team’s precision, expertise, and adaptability in managing controlled environments. The XiltriX Team also supplied the third-party vendor responsible for the tubing with the necessary information to prevent future issues. Effective collaboration goes a long way. 

XiltriX's involvement was pivotal in not just resolving an immediate issue but in setting proactive and comprehensive standard for environmental control, ensuring the safety and integrity of the cleanroom before it became operational.

What is SafetyNet?

SafetyNet is a team of monitoring experts who provide 24/7 live support. In addition to being on every alarm escalation protocol, the SafetyNet team will assist you with system configuration and administration, troubleshooting, unlimited training, live phone calls, and they’ll act as an extension of your team.

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