Mastering Commissioning & Qualification: A Complete Guide for Temperature-Controlled Units

Welcome To Our Latest Edition of "Temperature Matters"

In this issue, we’re diving deep into the critical process of Commissioning & Qualification (C&Q) for temperature-controlled units. Whether you're ensuring compliance for pharmaceutical storage, biotech materials, or any temperature-sensitive products, mastering C&Q is key to maintaining product safety and integrity. We’ll walk you through a step-by-step guide on how to ensure your storage units are performing optimally, including expert insights on user requirement specifications, temperature mapping, sensor placement, and ongoing maintenance.

Let’s get started!

First, a heartfelt thank you to our incredible sponsors, whose support allows us to share this knowledge on LinkedIn at no cost. Your dedication to our community is deeply appreciated.

Today's issue is brought to you by:

Qualistery is a leading knowledge platform dedicated to the pharmaceutical industry, offering professionals access to the latest in cGMP standards and regulatory insights. They help pharmaceutical decision-makers, quality professionals, and industry leaders stay informed and connected.

Through expert-led webinars, virtual events, and diverse educational content, Qualistery empowers professionals to make informed decisions, drive innovation, and ensure compliance with the latest industry standards.

Reach out to Yan Kugel to Learn More

Lifecycle Labs , a leader in tailored environment monitoring services for the healthcare and life science sectors. With a commitment to scientific excellence, regulatory compliance, and environmental stewardship, we strive to be your trusted partner in ensuring the safety, quality, and sustainability of your operations.

Reach out to Irina Belyakova ?? to Learn More

Comprehensive Commissioning & Qualification for Temperature-Controlled Units

By Nathan Roman

In the world of pharmaceuticals, biotech, and other regulated industries, temperature control is a critical aspect of maintaining product safety and integrity. Whether you're storing vaccines, sensitive biological materials, or temperature-sensitive drug products, ensuring that your temperature-controlled units (CTUs) are compliant and reliable is essential.

But how can you be sure that your storage units are up to the task? The answer lies in a well-planned Commissioning & Qualification (C&Q) process. In this article, we’ll walk through a complete, step-by-step guide to the lifecycle of a C&Q project for CTUs, from initial planning to ongoing maintenance. Let’s dive in!

1. Start with Your User Requirement Specification (URS)

Before you do anything else, it’s essential to define what you need from your temperature-controlled unit. This is where the User Requirement Specification (URS) comes in. The URS acts as your blueprint, outlining all the critical features your unit must have, from temperature ranges and load capacity to alarm systems and backup power.

Your URS should reflect the unique needs of your products and regulatory requirements, ensuring that your equipment meets both operational and compliance standards. This document will guide every step of your C&Q project, from vendor selection to qualification testing.

2. Validate the Design with Design Qualification (DQ)

Once you’ve established the URS, the next step is to ensure that the design of the CTU aligns with these requirements. This process, known as Design Qualification (DQ), involves reviewing the technical specifications and ensuring that everything is in place to deliver the desired performance.

Ask yourself: Does this design support my operational needs? Is the unit built to withstand real-world conditions in my facility? Design Qualification gives you the confidence to move forward, knowing that your equipment is capable of performing as required.

3. Test Before You Install: FAT and SAT

Before your temperature-controlled unit even reaches your facility, it undergoes Factory Acceptance Testing (FAT). This step verifies that the unit functions as expected at the manufacturer’s site, ensuring it meets all the technical and operational criteria in your URS. Think of it as a preemptive check that saves you time and hassle later on.

Once the unit arrives, Site Acceptance Testing (SAT) is your next line of defense. This process confirms that the equipment is ready to operate under your specific conditions, verifying installation, calibration, and initial performance. If any issues arise, you can resolve them before moving into the formal qualification stages.

4. Installation Qualification (IQ): Laying the Foundation

Now it’s time to get the unit installed and verified. During Installation Qualification (IQ), you’ll ensure that every component is set up correctly—right down to the temperature sensors and control systems. IQ also confirms that everything is connected to the right utilities, like power supplies and backup systems, and verifies that critical instruments are calibrated and ready to go.

By the end of this stage, your CTU will be fully installed, documented, and prepared for operational testing.

5. Operational Qualification (OQ): Proving It Works

With the unit installed, it’s time to put it to the test. Operational Qualification (OQ) is the phase where you validate that the unit operates within the defined parameters of the URS. This involves empty-chamber temperature mapping, setpoint verification, and alarm testing under different operational conditions. For example, if there’s a power outage, will your unit hold temperature until backup systems kick in?

These tests ensure that the unit operates as expected in an empty state, giving you confidence that it’s ready for real-world use.

6. Performance Qualification (PQ): Testing Under Real Conditions

The final qualification stage is Performance Qualification (PQ), which confirms that your unit performs consistently under actual, loaded conditions. This is where you simulate real-world usage by loading the unit with products and conducting temperature mapping to ensure that it maintains temperature uniformity throughout.

Loaded chamber testing is essential to prove that your unit can handle the everyday demands of your facility, ensuring product safety and regulatory compliance.

7. Temperature Mapping: Precision in Sensor Placement

Accurate temperature mapping is critical for understanding how your unit handles temperature control across different zones. But how do you know where to place your sensors?

A risk-based approach to sensor placement helps prioritize areas where temperature excursions pose the highest risks. Here’s a quick guide:

• For small chambers (up to 2 cubic meters): Use 10 sensors placed throughout the usable space and one near the control probe for correlation.
• For larger chambers (up to 20 cubic meters): Increase the number of sensors to 16, distributed evenly across all zones, with one sensor dedicated to the monitoring/control probe.
• For large facilities: Arrange sensors in a grid pattern, spaced every 5 to 10 meters, and add vertical layers to monitor temperature stratification.

By taking a strategic approach to sensor placement, you ensure that your temperature mapping results reflect the true performance of your unit.

8. Calibration and Ongoing Maintenance: Ensuring Long-Term Reliability

Qualification doesn’t stop once your unit is operational. To ensure continued compliance, you’ll need a plan for ongoing calibration and maintenance. A risk-based calibration schedule ensures that critical components, like temperature sensors, are recalibrated regularly based on their impact on product quality.

Routine maintenance checks, requalification after repairs, and periodic recalibration are all essential to keeping your unit in top form, ensuring it continues to perform reliably over time.

9. Embrace Digital Monitoring Tools

In today’s fast-paced world, manual checks just aren’t enough. That’s why digital monitoring tools are becoming increasingly popular in regulated industries. These systems provide real-time data logging, alarm notifications, and automated reporting, helping you catch deviations before they become costly problems.

With digital tools in place, you can optimize your monitoring processes, improve efficiency, and ensure that your equipment stays compliant with regulatory standards.

Final Thoughts: The Key to Reliable C&Q

Commissioning & Qualification for temperature-controlled units doesn’t have to be overwhelming. By following this comprehensive, step-by-step approach, you’ll ensure that your units are not only compliant but also reliable and capable of supporting your operational needs long-term.

Temperature control is vital to the success of your products, and the right C&Q process will give you the peace of mind that your equipment is up to the task.

If you want to stay ahead of the curve in temperature control, make sure to keep refining your C&Q processes with best practices from industry leaders like ISPE, USP, and WHO. Remember, well-qualified equipment is the foundation of a well-qualified operation!

Stay tuned for more insights and guidance on temperature mapping and C&Q processes in our next issue of Temperature Matters. 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.

Feel free to share your thoughts and experiences with us—your feedback is always welcome! Thank you for being a part of this community.

Ready to Elevate Your Temperature Mapping Expertise?

Whenever you're ready, there are 3 ways we can assist you in mastering temperature mapping studies:

?? Explore Expert Insights: Subscribe and discover actionable tips, industry trends, and expert knowledge to enhance your skills.

?? Join the Pharma Temp Mapping LinkedIn Group: Gain access to in-depth content, practical workshops, and a community of fellow temperature mapping enthusiasts. Join here: Pharma Temp Mapping

?? Book a Call with Me: Schedule a personalized 30-minute call designed to help you take the next step in your temperature mapping journey. Receive tailored advice and insights to overcome specific challenges and enhance your expertise. Book A Call

Choose your path to temperature mapping excellence, and let's embark on this journey together. We're committed to your success in temperature mapping and look forward to journeying together.

I hope you're able to find value in this article. If you did, please subscribe to this newsletter and follow me on LinkedIn.

Warm regards,

Nathan Roman ??

P.S. Promote Yourself!

?? Get Featured: Put your brand in front of our engaged audience of industry experts and decision-makers. Secure your spot in our newsletter, and connect with 16,000+ followers who value expertise and innovation. Send me a Direct Message.

#TemperatureMapping #Validation