Temperature Monitoring: Enhancing Quality and Safety in Biotech and Pharmaceuticals

How critical is temperature monitoring to the pharmaceutical and biotech industries?

The rollout of the first COVID-19 vaccines in the United States in 2020 was almost derailed because of it.

Or, to be more exact, because of a spat over how the temperatures of the potentially life-saving vaccines would be monitored once delivered. 

The vaccine manufacturer, according to a report by STAT, “planned to disconnect temperature-monitoring sensors on the containers once they were delivered to health care providers — though many of the providers needed to use the boxes to store the vials for up to 30 days. 

Without the monitoring systems, providers would have no way of knowing if the vials had thawed prematurely, rendering the vaccine unusable.”

In the end, STAT reported, the U.S. government’s WARP Speed project stepped in and got a deal done to ensure temperature monitoring would continue post-delivery.

The saga underlines the critical importance of temperature monitoring in industries where spoilage and deterioration can be a matter of life and death.

The precise control and monitoring of temperature conditions throughout the manufacturing, storage, and distribution processes are essential to preserving product integrity and preventing costly losses – both in monetary and reputational terms. 

The biotech and pharmaceutical industries are tasked with developing, manufacturing, and distributing life-saving medications, vaccines, and biologics. Yet they rely on a dynamic supply chain and countless individuals maintaining strict temperature controls for their drugs to maintain viability.

Scores of county health departments and hospital networks rely on Sonicu to monitor their Vaccine for Children cold storage devices. These systems take advantage of Sonicu’s vast experience and reliability in delivering simple and affordable temperature monitoring systems. 

Case studies from Great Lakes Bay Health Centers, as well as SUNY Downstate and Hamilton County Health Department, highlight a handful of the hundreds of clients who rely on Sonicu to monitor their temperature-sensitive vaccines and other medical or life science assets. 

Temperature monitoring plays a pivotal role in ensuring the efficacy, safety, and quality of their products.

It enables the precise control and surveillance of temperature conditions throughout the entire supply chain.

“Pharmaceutical giants continue to develop new products, including many, such as biologics developed from living organisms, which rely on cold storage throughout their supply chains,” according to the American Journal of Transportation, citing a 2019 IQVIA Institute study. 

“Experts say the biopharmaceuticals industry loses $35 billion a year due to failures in temperature-controlled logistics and that temperature excursions account for 80 percent  of these supply-chain problems.”

That’s to say nothing of what happens to these materials once they arrive at healthcare facilities and pharmacies, which then become responsible for storing them safely until they are ultimately administered to patients.

“If you look at the pipeline of new drugs that are being developed, approximately 20 percent are gene- and cell-based therapies, and there’s a high probability that they will require close temperature control,” said Eric Tichy, PharmD, the vice chair of pharmacy formulary for the Mayo Clinic Health System, in an article in Specialty Pharmacy Continuum. 

“We are moving into a therapeutic era where the cold chain and ultra-cold chain will become increasingly important.”

In an informal ASHP (American Society of Health-System Pharmacists) survey of hospitals with more than 300 beds, more than 90 percent of respondents indicated that they had to acquire additional cold space storage (refrigerators/freezers), with an "average of four additional devices purchased,” the article noted. 

“More than 75 percent reported they had to quarantine drug products related to a cold chain issue, such as a known or suspected temperature excursion, and more than 50 percent  of those experienced a product loss.”

Maintaining specific temperature ranges is crucial for preserving the efficacy and stability of biologics, vaccines, and other temperature-sensitive products.

Temperature variations may:

• Degrade active ingredients
• Alter chemical compounds
• Compromise product efficacy

Maintaining strict temperature controls within specified ranges, as prescribed by the U.S. Food and Drug Administration (FDA), is essential to prevent product degradation and ensure consistent therapeutic outcomes.

Not only can Sonicu deliver alerts via text, email, push notification, and even phone calls to ensure your team is immediately aware of a potential temperature excursion, but our intuitive software automates the creation of reports that satisfy nearly every regulatory agency that audits healthcare and life science organizations. 

Far too many organizations turn to a wireless remote temperature monitoring provider after they suffer asset loss from a temperature excursion or are cited by a regulatory agency. 

Yet more are investing preemptively to stave off the threats posed by a faulty freezer and manual logging errors, and oversights. 

The Perils of Not Monitoring

Here are some of the reasons why temperature monitoring is so important to these industries, and some of the adverse outcomes that can result from a failure to properly monitor sensitive biological and pharmaceutical materials:

1. Preservation of Product Efficacy and Stability:
   

• Temperature plays a pivotal role in determining the efficacy and stability of pharmaceutical products, particularly biologics and vaccines.
• Temperature fluctuations can compromise their molecular structure and therapeutic effectiveness.
• Maintaining strict temperature controls within specified ranges, as mandated by the FDA’s Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP), is essential to prevent product degradation and ensure consistent therapeutic outcomes.

2. Compliance with Regulatory Standards:

• Regulatory agencies such as the FDA and Joint Commission impose stringent requirements on temperature management throughout the pharmaceutical supply chain.
• Both agencies’ guidelines emphasize the need for comprehensive temperature monitoring, documentation, and reporting to ensure the safety and efficacy of pharmaceutical products during storage and transportation.
• Failure to comply with regulatory standards can result in severe consequences, including product recalls, regulatory sanctions, and damage to corporate reputation.

3. Mitigation of Financial and Reputational Risks:

• Temperature excursions, if left unchecked, can lead to product spoilage, rendering pharmaceuticals ineffective or unsafe for patient use.
• Real-world incidents, such as the case of a temperature-sensitive vaccine shipment being compromised due to inadequate monitoring, highlight the financial and reputational risks associated with temperature-related failures.
• Implementing robust temperature monitoring systems enables early detection of deviations, allowing for prompt corrective actions to mitigate risks and minimize financial losses.

4. Ensuring Patient Safety and Public Health:

• Patient safety is paramount in the pharmaceutical industry, and temperature monitoring plays a critical role in safeguarding public health.
• Vaccines, in particular, require stringent temperature control to maintain their potency and efficacy. Deviations from recommended storage temperatures can render vaccines ineffective, compromising immunization efforts and public health initiatives.
• By ensuring the integrity of pharmaceutical products through rigorous temperature monitoring, the industry contributes to the prevention of medication errors, adverse drug reactions, and public health emergencies.

5. Optimization of Supply Chain Efficiency and Reliability:

• Temperature monitoring not only safeguards product quality but also optimizes supply chain efficiency and reliability.
• Real-time monitoring and data analytics enable proactive decision-making, allowing stakeholders to identify potential issues before they escalate into critical failures.
• By minimizing temperature excursions and streamlining logistics operations, temperature monitoring enhances supply chain resilience, reduces waste, and improves overall operational efficiency.

6. Facilitation of Research and Development Efforts:

• In addition to ensuring the quality of commercial pharmaceutical products, temperature monitoring is integral to research and development (R&D) activities in the biotech and pharmaceutical sectors.
• Biotech companies rely on precise temperature control to maintain the stability of biological samples, cell cultures, and experimental reagents during laboratory experiments and clinical trials.
• Accurate temperature monitoring not only enhances the reproducibility and reliability of scientific findings but also accelerates the pace of drug discovery and development.

Stay Safe with Sonicu

Sonicu’s temperature monitoring solutions offer a comprehensive suite of tools designed to address the unique temperature monitoring needs of the biotech and pharmaceutical industries.

Here's how Sonicu's technology can help:

1. Precise Temperature Monitoring:

• Sonicu's advanced sensors provide accurate and real-time temperature monitoring throughout the entire pharmaceutical supply chain, including manufacturing facilities, warehouses, and vehicles.
• The high precision of Sonicu's sensors ensures that temperature deviations are detected promptly, allowing for timely corrective actions to be taken to prevent product spoilage or degradation.

2. Continuous Monitoring and Alerts:

• Sonicu's platform offers continuous monitoring capabilities, allowing stakeholders to track temperature conditions 24/7.
• Automated alerts sent via text, email, push notifications, and even phone calls are triggered when temperature excursions occur, enabling rapid response and intervention to mitigate risks and maintain product integrity.
• Users can respond to alerts via the SoniCloud mobile app, making it simple to stay connected and log responses from virtually anywhere.

3. Remote Monitoring and Accessibility:

• Sonicu's cloud-based platform enables remote monitoring from any internet-connected device, providing stakeholders with real-time access to temperature data and alerts.
• This remote accessibility allows for proactive management of temperature-sensitive products, even when personnel are off-site or working remotely.
• The multi-site dashboard and user and group configuration make it easy for senior leaders to keep an eye on an entire enterprise, while individuals can view and respond to conditions in their area of responsibility.

4. Compliance Documentation and Reporting:

• Sonicu's temperature monitoring solutions facilitate compliance with regulatory requirements, such as the FDA’s Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP).
• Comprehensive and continuous data logging and monitoring (plus reporting)functionalities generate audit-ready reports, demonstrating adherence to temperature control standards and regulatory guidelines.
• Failure to comply with regulatory standards can result in product recalls, fines, and damage to a company's reputation.

5. Customizable Monitoring Parameters:

• Sonicu's platform allows users to define and customize temperature thresholds and monitoring parameters based on specific product requirements and regulatory standards.
• This flexibility ensures that temperature monitoring protocols align with the unique needs of each pharmaceutical product, optimizing product quality and safety.
• Users can even set up warning thresholds so they are alerted when the temperature is approaching an excursion.

6. Integration with Existing Systems:

• Sonicu's temperature monitoring solutions seamlessly integrate with existing infrastructure and systems, including building management systems (BMS) via a wireless device that can communicate via Modbus or BACnet.
• This integration streamlines data management processes and enhances operational efficiency by consolidating temperature monitoring data with other critical business information.

7. Scalability and Adaptability:

• Sonicu's platform is scalable and adaptable to accommodate the evolving needs of pharmaceutical companies, from small-scale operations to large, multi-site facilities.
• As companies expand their operations or introduce new product lines, Sonicu's temperature monitoring solutions can easily scale to meet growing demand and evolving regulatory requirements.

8. Proactive Risk Management:

• By providing early warnings of temperature deviations, Sonicu's temperature monitoring solutions enable proactive risk management and preventive maintenance.
• This proactive approach minimizes the likelihood of temperature-related failures, reduces product losses, and enhances overall operational resilience.

Here are some case studies that help underline how Sonicu is helping healthcare facilities, hospitals, and pharmacies effectively monitor temperatures:

Indiana University Health: Enterprise Hospital For Temp, Humidity, Air Pressure

Cryopoint: Ultra Low Cold Storage, Research, Lab 

Hancock Regional Hospital: Enterprise Hospital Environmental Monitoring

Temperature monitoring is not merely a regulatory requirement but a fundamental imperative that underpins the mission of the biotech and pharmaceutical industries to improve human health and well-being.

Sonicu's temperature monitoring solutions offer a comprehensive and technologically advanced approach to temperature management in the biotech and pharmaceutical industries.

By leveraging Sonicu's platform, healthcare facilities, hospitals, pharmacies, and other organizations can ensure the integrity, safety, and compliance of their temperature-sensitive products throughout the entire supply chain, ultimately enhancing patient safety and advancing public health objectives.