How to Calibrate Your CTC Temperature Monitoring Probe: 1-Point vs. Multi-Point Calibration

Welcome To Our Latest Edition of "Temperature Matters"

In this issue, we’re excited to feature an article by Steve Lauver , diving into the critical topic of calibrating Controlled Temperature Chamber (CTC) monitoring probes. Steven addresses the common question of whether a 1-point or multi-point calibration is necessary, providing practical insights to help you make informed decisions about your calibration processes. Whether you're aiming for compliance or operational efficiency, this article offers clear guidance on navigating calibration challenges.

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Do I Need to Calibrate My CTC Temperature Monitoring Probe at One Point or Multiple Points?

By Steven Lauver

Balancing Compliance with Practical Calibration Processes

Many companies struggle to determine how many calibration points are necessary for their Controlled Temperature Chamber (CTC) monitoring probes. The decision often stems from balancing regulatory compliance with calibration requirements for temperature-controlled environments. Choosing between a 1-point or multi-point calibration can seem daunting, especially when trying to minimize downtime and avoid unnecessary complexity.

When Is 1-Point Calibration Sufficient?

For Controlled Temperature Chambers (CTCs) operating at a single setpoint, such as Cryo units, Freezers, Refrigerators, or Incubators, a 1-point in-situ calibration for temperature monitoring probes is generally effective.

Calibration is typically done during CTC validation and ongoing requalification for CTCs, focusing on that critical operating setpoint. Since this is the most important point in your system’s performance, many companies find single-point calibration for CTC monitoring probes to be both reasonable and justified.

However, there are situations where multi-point calibration (often 3 points) is recommended. For instance, companies may choose multi-point calibration to confirm system performance across a range of temperatures. This often requires removing the probe from the CTC and placing it in an external bath for more extensive testing.

Identifying the Right Calibration Approach

The choice between a 1-point and multi-point calibration ultimately depends on the risk to product integrity, patient safety, and regulatory compliance for temperature-controlled environments. If your system operates at a single static temperature, a well-documented CTC calibration process that follows your SOPs—like “Equipment operating at a single static temperature will be calibrated at the operating point unless otherwise specified”—may be enough to justify 1-point calibration for temperature monitoring probes.

On the other hand, if your unit’s temperature fluctuates or you anticipate regulatory scrutiny, a 3-point calibration might be necessary. This is particularly relevant for equipment like incubators that run at various temperatures based on product needs.

Important Considerations

Avoiding Common Pitfalls

When performing multi-point calibration for CTC monitoring probes, remember that the probe must be removed from the chamber. This introduces additional challenges, such as removing product or adding temporary temperature monitoring for CTC calibration to maintain compliance during calibration.

Additionally, some companies use glycerin-stabilized fluid to dampen CTC probe response times and mimic product reaction to temperature changes. While this can be effective, it’s essential to avoid placing the controlling probe in stabilizing fluid for accurate temperature monitoring.

Dealing with Auditor Requests

Even with a well-designed CTC temperature monitoring calibration program, auditors may sometimes question your methods and push for changes, often based on their personal experiences or best practices they’ve encountered elsewhere.

In some cases, companies have compromised by adding 3-point simulated calibration (that tests only the electronics but not the probe) alongside their standard 1-point checks—though this doesn’t always improve process robustness. The key is to maintain a solid, documented CTC calibration process and stand firm when justified.

Where Should the Calibration Probe Be Placed?

Best practice is to position the standard calibration probe as close as possible to the CTC monitoring probe. Some companies prefer placing it at the geometric center of the CTC. Both methods are acceptable, but the goal is to ensure that your monitoring probe is calibrated accurately, which makes proximity the most practical choice.

Closing Thoughts

Staying Agile in a Dynamic Environment

Ultimately, each company must decide what calibration approach for CTC monitoring systems works best based on their unique risk profile. While industry best practices for CTC calibration guide decisions, it’s crucial to maintain a documented, consistent, and well-trained approach to calibration for temperature-controlled chambers—and react swiftly to any deviations.

A big THANK YOU to Steve Lauver for this detailed exploration of CTC calibration strategies. If you’re navigating calibration decisions or want to optimize your program, Steve has a Calibration Program Setup and Management guide out that I'd love to share with you.

If you would like a FREE PDF copy of Steve's handbook, please reach out to me directly, and I will be happy to forward it to you. Don't miss this opportunity to enhance your calibration management skills with expert guidance.

Stay Tuned:

Stay tuned for more insights and reflections in our upcoming editions. As we continue to navigate the complexities and advancements in our field, we'll share experiences, challenges, and successes that connect us all. Your engagement and feedback are not just welcomed; they are essential in shaping our journey together. So, let's keep the conversation going, learning from each other and striving towards excellence in everything we do. Thank you for being a part of this community.

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