Podcast Summary: Let's Combinate - Drugs + Devices
Episode 106: Temperature Mapping, Validation, Data Loggers, Cold Chain, Monitoring and Commissioning with Nathan Roman
Release Date: October 11, 2023

Introduction: Meet Nathan Roman

In Episode 106 of "Let's Combinate - Drugs + Devices," host Subhi Saadeh welcomes Nathan Roman, a seasoned expert in validation and temperature control. Nathan brings over two decades of experience in the field, transitioning from a CAD draftsman to a specialist in validation and temperature mapping.

Notable Quote:
[00:49] Subhi Saadeh: "Nathan Roman is a validation and temp control expert and he branched off on his own in his field about 20ish years ago."

Nathan’s Journey: From Draftsman to Validation Specialist

Nathan shares his unconventional career path, moving from designing steel structures for quarry plants in Pennsylvania to validation work at Raytheon, thanks to an opportunity presented by his uncle. Starting with rudimentary tasks like reading P&IDs and equipment walkthroughs, Nathan gradually immersed himself in validation protocols, documenting practices, and risk management.

Notable Quote:
[02:36] Nathan Roman: "I was able to help him out. So I went all the way over and helped him."

Evolution of Temperature Mapping and Validation

Nathan discusses significant advancements in temperature mapping over the past two decades. Previously, large, cumbersome data loggers and extensive wiring with thermocouples were standard. Today, wireless data loggers simplify the process, making temperature mapping more efficient and less labor-intensive.

Notable Quote:
[06:53] Nathan Roman: "In the past, we used these big chunky data loggers... now we just place a simple data logger on the shelf wireless thing."

Subhi adds that the digitization of processes has streamlined documentation and execution, with platforms now enabling paperless approvals and protocol executions.

Notable Quote:
[08:05] Subhi Saadeh: "With systems like paperless, systems like NEAT and other things you can do all that generation review and approval and execution all in one platform."

The Critical Role of Temperature Mapping

Temperature mapping is highlighted as a crucial component in maintaining the integrity of drug products, reagents, and samples. Nathan emphasizes that inadequate temperature control can lead to product degradation, rendering drugs ineffective—a particularly vital concern for vaccines.

Notable Quote:
[08:12] Nathan Roman: "Temperature mapping is important because it's a critical aspect to drug product, to samples, to reagents, to food. It's critical."

Subhi seeks to understand the emphasis on temperature mapping over other factors like humidity, to which Nathan explains that while both are important, temperature often requires more granular monitoring.

Temperature vs. Humidity Mapping

While temperature is paramount, humidity also plays a significant role, especially in environments like stability chambers and clean rooms. Nathan notes that humidity changes less drastically than temperature, reducing the need for numerous sensors.

Notable Quote:
[10:31] Nathan Roman: "Humidity will cover a larger amount of space and it doesn't change as drastically as temperature... so we don't need to utilize as many humidity sensors."

Regulatory Guidelines and Acceptance Criteria

Nathan outlines that temperature and humidity controls are governed by broad regulatory guidelines, which vary based on specific product requirements. For instance, clean rooms have defined humidity ranges based on their classification, and storage requirements depend on product labels.

Notable Quote:
[11:03] Nathan Roman: "There are guidelines, there are acceptance criterias that are specified... it really depends on your activity, your product, and your design."

Integration of Temperature Mapping in Validation Processes

Subhi inquires whether temperature mapping is a standalone validation or part of a broader validation framework. Nathan clarifies that it can function both independently and as a component of comprehensive equipment qualifications.

Notable Quote:
[20:11] Nathan Roman: "Temperature mapping has been its own thing, its own standalone item... but it can also stand as its own as well."

Commissioning, Qualification, and Validation (CQV) Explained

Nathan delves into the distinctions and overlaps between Commissioning, Qualification, and Validation (CQV). He explains that traditionally, these were separate phases involving redundant testing. Modern practices have integrated these steps to enhance efficiency, with quality assurance involved from the outset.

Notable Quote:
[24:15] Nathan Roman: "Today’s standard of CQV is they've combined the commissioning and the qualification aspect of things together to alleviate all that redundant testing."

Subhi notes the differences between Medtech and Biotech in handling validation, observing that in Pharma, validation tends to be more closely integrated within quality departments.

Temperature Ranges and Associated Challenges

The discussion shifts to various temperature ranges used in drug storage and their unique challenges:

• Standard Refrigerators (2°C to 8°C): Ensure basic storage conditions.
• Ultra-Cold Freezers (-20°C to -80°C): Require specialized equipment and handling, such as LN2 (liquid nitrogen) tanks for cryogenic storage.
• Ambient Conditions (15°C to 30°C): Governed by USP guidelines but tailored based on specific product needs.

Nathan Roman explains:
[26:23] Nathan Roman: "USP says that [ambient temperature] is 15 to 30 degrees is the acceptable range... it's based upon your need and your product's requirements."

He highlights the importance of selecting appropriate equipment capable of handling extreme temperatures and ensuring safety measures are in place.

Notable Quote:
[27:50] Nathan Roman: "You need to protect, be safe. Protection... not all equipment can be used for these extreme temperatures."

Shipping Validation and Data Loggers

Nathan elaborates on the role of data loggers in maintaining temperature integrity during shipping. These devices can either be single-use or reusable, depending on the requirements and budget. Real-time monitors provide live feedback to ensure conditions remain within specified ranges throughout transit.

Notable Quote:
[29:04] Nathan Roman: "Shipping validation... verify your packaging can maintain that temperature requirement."

He explains that data loggers used in shipping can vary in complexity and reusability, emphasizing the importance of accuracy in monitoring.

Notable Quote:
[30:35] Nathan Roman: "There are multiple use sensors where you can use them multiple times... but the accuracy and things like that is what matters for us."

Conclusion: Connecting with Nathan Roman

As the episode wraps up, Nathan shares how listeners can connect with him for further insights and professional collaboration. He is active on LinkedIn and participates in industry events, making him accessible for networking and knowledge sharing.

Notable Quote:
[31:57] Nathan Roman: "People can find me online LinkedIn... at ISPE events, you can find me at our typical industry networking events."

Final Thoughts

This episode offers an in-depth exploration of temperature mapping and its critical role in the pharmaceutical and medical device industries. Nathan Roman’s expertise provides valuable insights into the evolution of validation processes, the significance of accurate temperature and humidity monitoring, and the integration of modern technologies to streamline operations. For professionals navigating the complexities of drugs and devices, this discussion underscores the importance of meticulous temperature control in safeguarding product efficacy and compliance.

Key Takeaways:

• Temperature Mapping is Essential: Ensures the integrity and efficacy of temperature-sensitive products.
• Technological Advancements: Wireless data loggers and paperless documentation have revolutionized validation processes.
• Regulatory Compliance: Adhering to guidelines for temperature and humidity is crucial, tailored to specific product requirements.
• Integrated Validation Processes: Modern CQV combines commissioning and qualification to enhance efficiency and reduce redundancy.
• Shipping Validation: Critical for maintaining product conditions during transit, leveraging various types of data loggers.

For those interested in deepening their understanding of validation and temperature mapping, connecting with experts like Nathan Roman can provide practical knowledge and industry best practices.