Intro to Temperature Mapping

Speaker: Yan, Moderator; Nathan Roman, Director of Validation at Genesis; Adam Hartman from Yupri.

Welcome and Session Overview

• Moderator: Yan
  • Welcomed attendees and introduced the session.
  • The session titled "Intro to Temperature Mapping: How to Determine Sensor Location & Amount".
  • Webinar goals:
    • Understand what temperature mapping is and its importance.
    • Learn how to determine the number of sensors needed.
  • Q&A session with guest speaker Adam from Yupri.
  • Session recorded; links provided later.
  • Interaction encouraged via chat and Q&A features.
  • Certificates of attendance offered.

Speaker Introduction – Nathan Roman

• Title: Director of Validation at Genesis
  • Over 22 years of experience in temperature mapping and validation services.
  • Goal: Help ensure compliance with regulations through practical tools and expertise.
  • Journey: Started as a computer-aided draftsman, moved into pharmaceutical validation.
  • Focus: Temperature mapping studies, placing sensors, equipment qualification.

Agenda

1. About Nathan Roman: Background and qualification experience.
2. About Attendees: Understanding their current knowledge and needs.
3. Keys to Effective Temperature Mapping: Key elements for success.
4. Guide to Mapping Protocols: Steps and components of a protocol.
5. Determining Sensor Locations: How to determine and place sensors.
6. Q&A Session: With Adam from Yupri.

Key Points on Temperature Mapping

• Importance: Ensuring and proving temperature-controlled spaces are suitable for their intended purpose.
  • Essential for product stability, effectiveness, and regulatory compliance.
  • Important for various industries: Pharma, Biotech, Med device, Food & Beverage.
• Definitions:
  • Temperature Mapping: Collecting and analyzing temperature data from various locations.
  • Qualification: Documented evidence that a system meets required specifications.

Regulatory Guidance and Considerations (FDA, USP, CDC, EU, MHRA, WHO)

• FDA: Ensuring storage and transportation conditions for drug products.
• USP: Guidance for mapping and storage.
• CDC: SOPs for storage and handling; appointing responsible person.
• EU and MHRA: Seasonal mapping and maintaining control.
• WHO: Extensive guidelines for temperature control.

Why Temperature Mapping?

1. Ensuring Product Stability & Effectiveness: Identifying temperature excursions that can compromise product integrity.
2. Validating Temperature Control Systems: Ensuring equipment is functioning as expected and can maintain necessary conditions.
3. Meeting Regulatory Requirements: Ensuring compliance with international regulatory standards.
4. Identifying Infrastructure Issues: Recognizing system and design flaws that affect temperature regulation.

Effective Temperature Mapping (5-Step Process)

1. About the temperature mapping process.
2. Review of regulatory guidelines.
3. Determining necessary equipment.
4. Setting up mapping protocols.
5. Placing sensors accurately.

Types of Controlled Temperature Units (CTUs) & Equipment Needed

• Examples: Cryogenic storage, freezers, refrigerators, incubators, ovens, walk-in cold rooms, stability chambers, warehouses.
• Equipment for mapping: Minimum 10 sensors (one in each of the eight corners, one in the geometric center, one adjacent to the control probe).

Conducting Qualification (IQ, OQ, PQ)

• Steps Include:
  1. Developing detailed test plans (protocols) with acceptance criteria.
  2. Installation Qualification (IQ): Ensuring correct installation.
  3. Operational Qualification (OQ): Ensuring equipment functions as expected.
  4. Performance Qualification (PQ): Ensuring consistent performance under real conditions.
  5. Review and approval process to confirm the equipment meets qualification criteria.

Determining Sensor Locations & Number of Sensors

• Factors to consider: Size of the chamber, product volume, temperature zones, precision level, airflow patterns, product location, temperature gradients, potential interference.
• Placement of sensors: Strategically to achieve comprehensive coverage and reliable data.
• Example: Minimum of 10 sensors for typical CTUs (one in each corner, one in the geometric center, one near the control probe).

Step-by-Step Guide for Sensor Placement

1. Define scope and objectives.
2. Identify critical temperature zones.
3. Determine number and placement.
4. Install sensors properly.
5. Test and calibrate sensors.
6. Collect and analyze data.

Practical Tips for Good Temperature Mapping Experience

1. Know and understand equipment requirements.
2. Verify calibration prior to execution.
3. Document placement of each sensor at the time of placement.
4. Ensure correct sampling intervals.
5. Allow sensors to reach temperature equilibrium.
6. Label each sensor for identification.
7. Keep sensors away from walls.
8. Ensure sensors measure in open air, not buffers.

Q&A Session Highlights (Moderated by Adam Hartman)

• Troubleshooting Common Issues: Managing equipment failures, calibration lapses, and data accuracy.
• Post-Calibration: Required for thermocouples, not always needed for RTD/thermistor sensors.
• Warehouse Mapping: Addressing challenges in mapping large spaces, managing loaded vs. empty tests.
• Ongoing Monitoring: Deciding monitoring points post-mapping to ensure ongoing compliance and temperature stability.

Conclusion

• Temperature mapping is crucial for ensuring product stability, compliance, and operational efficiency.
• Following industry standards and engaging in effective mappings such as those taught in this webinar can greatly benefit product storage and transportation.
• Reminder: Webinar recording and certificates will be emailed to participants.
• Encouragement to join future webinars and engage in continued learning on this topic.

Next Steps & Resources

• Polls and Feedback: Audience encouraged to provide feedback on additional topics of interest for future webinars.
• Contact Information: Provided for further questions and consultation.

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Note: For further details and updates, participants can reach out via LinkedIn or check upcoming webinar schedules.