Refrigeration Reality Check: Unveiling Critical Vulnerabilities in Culinary Operations

realtime monitoring pharma

Food for thought...

During a recent hospitality and restaurant facility tour, I conducted an assessment of the culinary operations within the establishment. As per local hygiene regulations, the temperature of refrigeration units is subject to meticulous monitoring in adherence to the Hazard Analysis and Critical Control Points (HACCP) protocol. This entails twice-daily verification and logging of temperature parameters.

temperature monitoring sheet

Further scrutiny of the regulatory framework

(Source: Ministère de l’agriculture et de la souverainité Almentaire:

reveals that prolonged deviations from the prescribed temperature range should trigger an alarm, prompting corrective measures. In addition, records of temperature readings must be retained for at least five years.

Despite ostensibly compliant practices, my expertise as a monitoring specialist uncovers several critical vulnerabilities:

  1. The temperature readings are predicated on the fridge's set point rather than the actual internal temperature, rendering deviations undetectable until the onset of mechanical malfunction.
  2. A twice-daily sampling regimen is insufficient to guarantee the integrity of the cold chain, particularly given the permissible duration of temperature excursions.
  3. Documentation lapses, indicative of human error, are evident in the incomplete data entries.

In response to these observations, I went back to a local installation of an RMS-TCD-S-001 within Rotronic AG’s canteen refrigerator. The next week's temperature recordings revealed significant fluctuations caused by the inherent operational dynamics of refrigeration systems:

temperature monitoring sheet

Why is the temperature always fluctuating? See the interesting video “This is how a fridge works” (Source: Into The Ordinary)

Closer analysis of the data from the previous 24 hours unveils the following useful insights:

alarm threshold 24h

While alarm thresholds have yet to be configured for real-time monitoring, a retrospective examination reveals deviations that are worth noting. The minimum recorded temperature dipped to -1.24°C, surpassing the permissible threshold of 0°C for sustained intervals mandated by regulations. If an alarm had been set with a 60-minute delay, this could have pre-emptively alerted personnel to the deviation, lasting between 9 and 11 minutes, based on the recorded frequency of sub-zero measurements.

alarm threshold 24h

Conversely, the maximum recorded temperature peaked at 7.76°C, exceeding the prescribed limit of 6°C for durations over 60 minutes. Analysis shows that the refrigerator breached this threshold for 26 measurements, translating to deviations ranging between 28 and 26 minutes.

alarm threshold 24h

It is recommended that refrigerators maintain temperatures within the range of 0–4°C. Despite an average temperature reading of 3.68°C over the past 24 hours – marginally lower than the optimum – this remains within the recommended bounds. Notably, the standard deviation from the mean stands at 2.07°C, indicating periodic oscillations between 1.61°C and 5.75°C.

Furthermore, the Mean Kinetic Temperature (MKT), an aggregate metric encapsulating the cumulative impact of temperature fluctuations, stands at 3.94°C. Widely employed in the pharmaceutical sector, MKT offers a holistic assessment of temperature-induced degradation over time.

More details about MKT can be found in in this document (Source: USP-NF)

The data analytics capabilities of the RMS platform allow for comprehensive data extraction in diverse formats, facilitating audit compliance. The built-in audit trail enhances data integrity, ensuring accountability and traceability of all actions undertaken.

It is vital to acknowledge the unique operational context of Rotronic AG’s canteen fridge, characterized by reduced frequency of door openings compared to professional kitchen environments. Imagine the potential deviations when the fridge door is always open…

In conclusion, the meticulous scrutiny of refrigeration practices within culinary establishments underscores the importance of following stringent regulatory standards. While, on the surface, monitoring protocols may be observed, a deeper analysis often reveals subtle, yet significant, deficiencies in operational procedures. The integration of advanced monitoring technologies, exemplified by the RMS-TCD-S-001 digital probe, represents a proactive step towards enhancing food safety protocols.

The elucidation of temperature dynamics, informed by statistical analyses and regulatory benchmarks, serves as a foundation for targeted corrective actions and continuous improvement initiatives. Furthermore, the robust data analytics capabilities offered by platforms such as RMS facilitate comprehensive documentation and audit trail maintenance, ensuring transparency and accountability in efforts to manage regulatory compliance.

Moving forward, stakeholders must remain vigilant in addressing identified weaknesses, leveraging technological advancements and best practices to strengthen the integrity of the cold chain.

By prioritizing precision, diligence, and innovation in refrigeration management, culinary establishments can safeguard consumer welfare and uphold the highest food safety and hygiene standards.

At PST, we understand the complexities of HACCP processes and real-time monitoring requirements. Reach out to us for expert guidance and support in optimizing food safety protocols. Together, we can ensure the highest level of compliance and mitigate risks effectively.

Related Content

Ministère de l'Agriculture et de la Souveraineté alimentaire
United States Pharmacopeia–National Formulary (USP–NF)
Hazard Analysis Critical Control Point (HACCP)
GMP temperature control for contract pharmaceutical manufacturers
Temperature and quality: the critical connection for pharmaceutical production
Rotronic Monitoring System - Overview

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