As winter settles in and temperatures drop, it’s the perfect time to plan your winter temperature mapping exercises for areas where pharmaceutical products are stored. As per MHRA guidance, seasonal temperature mapping is critical for ensuring compliance and maintaining the integrity of temperature-sensitive products.  

Let’s look at what temperature mapping involves, why it’s important, and how to execute it effectively this winter.

What is Temperature Mapping?

In essence, temperature mapping is the process of qualifying a storage environment to thoroughly understand the temperature variations experienced across the area. This is typically done by deploying temperature data loggers in a grid like pattern throughout the facility.

• Duration: Data is typically collected over 7 to 14 days to account for fluctuations during working hours, nights and weekends.
• Documentation: A detailed protocol and floor plan are developed before the exercise. These include the project scope and the exact placement of loggers.
• Outcome: After data collection, a comprehensive report is created to:

• Highlight facility performance.
• Identify temperature excursions or deviations.
• Recommend probe placement for permanent monitoring systems (a regulatory requirement).

Why is This Important?

• Regulatory Compliance: Temperature mapping ensures adherence to regulatory requirements and guidance such as the MHRA, EU GDP, WHO.
• Facility Performance Assurance: Confirms storage areas are performing as expected, avoiding risks of temperature abuse.
• Product Safety: Protects temperature-sensitive products from degradation due to poor storage conditions.

How Often Should You Perform Temperature Mapping?

Seasonal Mapping

To meet regulatory standards and address environmental variations, mapping must be performed during both seasonal extremes:

• Winter Mapping: Typically conducted between late November and early February. If your mapping exercise is due, now is the time to act!
• Summer Mapping :  Typically conducted between July and August

Requalification Intervals

The frequency of temperature mapping depends on a risk-based approach, but here are some general guidelines:

• Mapping for ambient areas is commonly repeated every three years with a regular Risk Assessment process
• The Risk Assessment process should highlight any significant changes to the facility that may have an impact on performance, and could justify a requalification sooner than the 3 year period

How Can Biomap Help?

At Biomap, we specialize in temperature compliance services tailored to your needs:

• Full Mapping Services: With expert engineers managing the entire project.
• DIY Options: Hire calibrated loggers to complete the exercise independently.
• Consulting Services: Guidance on regulatory requirements and optimization of storage conditions.
• Permanent Monitoring Systems: Design and implementation to ensure ongoing compliance.

Get Ready for Your Winter Mapping Exercise.

Don’t wait for the chill to pass—plan your winter temperature mapping now to ensure your facilities remain compliant and your products are safe.

Contact Biomap today for a no-obligation consultation or to schedule a site survey.