Cold Chain Monitoring during Transport

Cold Chain Logistics and Continuous Monitoring Systems from Kaye

An unbroken cold chain encompasses all measures to ensure a constant temperature for temperature-sensitive products from the time of manufacture to the time of use. In various industries, an uninterrupted cold chain is crucial for ensuring the quality of transported and stored products. Examples of this can be found in the food sector, but particularly in the GxP-regulated environment. We have all witnessed the issues surrounding the distribution of COVID-19 vaccines and the challenges in maintaining a sufficient and continuous cold chain for temperature-sensitive vaccines to the end user.

An unbroken cold chain consists of a series of temperature-controlled and monitored production, storage, and distribution activities, along with the associated equipment and logistics that must maintain a very narrow temperature range depending on the product.

Key Stages in the Cold Chain Process include:

1. Manufacturing:
   Defined environmental conditions and temperatures must already be maintained during manufacturing.
2. Interim Storage:
   Storage of intermediate and finished products in controlled environments.
3. Distribution Centers:
   Final storage and preparation for transport.
4. Transport:
   Temperature-controlled logistics to the end user or another distribution center.

Solutions from Kaye

Kaye offers continuous monitoring systems for end- and interim storage as well as distribution centers, providing a crucial component for regulatory compliance. In general, all critical storage parameters can be connected to the continuous monitoring system. In the context of the cold chain, these primarily include:

• Temperature Monitoring:
  Ensuring constant temperatures to maintain product integrity.
• Relative Humidity Monitoring:
  Preventing the deterioration of products due to moisture.

By using Kaye monitoring systems, you can ensure that your products are always stored under optimal conditions to guarantee their quality and safety.

Advantages of Kaye's Continuous Monitoring Systems:

• Regulatory Compliance:
  Considers all current standards and regulations in the GxP environment.
• Real-Time Data:
  Instant access to current environmental parameters.
• Alarm Systems:
  Immediate notifications if predefined thresholds are exceeded/underachieved.
• Data Logging and Reporting:
  Comprehensive documentation for regulatory compliance.
• High-Precision Sensors:
  Ensuring accurate measurements of critical parameters.
• Scalability:
  Solutions that can be tailored to any operational size.
• Data Security and Data Integrity:
  Ensured by GxP-validated software and firmware.
• Unrestricted Data Access:
  Through integration into a GxP-compliant AWS Cloud.
• Hardware/Software/Service:
  Everything from a single source and directly from the manufacturer. We support your project from the planning phase to IQ/OQ/PQ and the regular calibration of the Kaye sensors used, including re-qualification of the complete monitoring system.
• Continuous Development:
  Both hardware and software evolve to meet changing requirements and regulations.

Continuous Monitoring of Critical Process Parameters

Continuous monitoring of critical process parameters is an indispensable part of validating these processes. Sensors and data loggers continuously capture the process parameters, and this data is archived as part of the quality documentation. This not only ensures compliance with legal requirements but also guarantees that the products remain in optimal condition at all times.

Technological Solutions from Kaye

Kaye offers the Kaye LabWatch IoT, a GxP-compliant solution for a continuous monitoring system in the cold chain process. These modern monitoring technologies ensure process security and high operational efficiency, ultimately improving the quality and integrity of products in temperature-controlled storage and distribution.

Contact Us

If you have any questions, contact us directly or reach out to one of our certified dealers in your country.

Kaye – Your Partner for All Questions Relating to Thermal Validation of Critical Applications and Continuous Monitoring of Critical Process Parameters in the GxP Environment.

Kaye Solutions for Environmental Monitoring

• Kaye LabWatch IoT

• Kaye LabWatch Pro

• Kaye ValProbe II 

• Kaye NetPac II

Application at a Glance

Continuous monitoring and regular validation of various application areas such as storage environments, cold rooms, LN2 tanks, tissue banks, and more are fundamental components of a GMP-compliant quality system. Critical parameters such as temperature and relative humidity are essential components of the necessary documentation to ensure the integrity and safety of products in these environments. Other important critical process parameters like pressure or CO2 expand the spectrum of parameters to be measured depending on the application.

The Importance of Continuous Monitoring and Validation

In various industries, especially in the pharmaceutical and biotechnological sectors, continuous monitoring of environmental parameters is crucial and therefore regulated by guidelines and standards specific to the GxP environment. This includes not only monitoring the parameters but also setting up alarm systems that notify when critical thresholds are reached. This allows for immediate intervention to prevent potential damage to stored goods and ensure compliance with regulatory standards such as ISO and GMP.

Critical Environmental Parameters (Depending on the Application):

• Temperature: Essential for maintaining the integrity of temperature-sensitive products such as vaccines.
• Relative Humidity: Critical for preventing the deterioration of products due to moisture. Keyword: Stability tests according to ICH.
• Pressure/Differential Pressure: Important in personnel or material airlocks in cleanroom environments to ensure the purity and integrity of the surroundings.
• Light Intensity: Monitoring light intensity to ensure compliance with specific requirements, especially in laboratories and production facilities.
• Door Contacts: Recording the status of doors to ensure critical environments are properly sealed and protected from external influences.
• CO₂: Important in incubators and other controlled environments to ensure an optimal atmospheric composition.
• And others

Depending on the specific application, further parameters can be monitored. Essentially, any values that can directly or indirectly affect the quality of the final product.

Monitoring these parameters is crucial to ensure the prescribed conditions for each application and to guarantee GMP-compliant quality assurance. Kaye offers a variety of sensors combined with a recognized continuous monitoring and alarm system that is known for its reliability and meets all regulatory requirements.

Applications for Continuous Monitoring Systems

• Warehouses: Ensuring the specified storage conditions.
• Repositories: Protecting valuable and sensitive materials.
• Blood/Tissue Banks: Maintaining the viability of biological samples.
• Laboratories: Ensuring accurate and reliable experimental conditions.
• Cold Rooms: Storing temperature-sensitive semi-finished and finished products in a constant temperature environment.
• Stability Chambers: Monitoring the conditions crucial for stability studies.
• LN₂ Tanks: Ensuring extremely low temperatures required for certain biological samples.
• Animal Rooms: Providing a controlled environment for laboratory animals.
• Pharmacies: Ensuring the safety and efficacy of stored medications.
• And more

Advantages of Kaye's Continuous Monitoring Systems

• Regulatory Compliance: Adheres to all current standards and regulations in the GxP environment.
• Real-Time Data: Immediate access to current environmental conditions.
• Alarm Systems: Instant notifications when predefined thresholds are exceeded/subceeded.
• Data Logging and Reporting: Comprehensive documentation for regulatory compliance.
• High-Precision Sensors: Ensuring accurate measurements of critical parameters.
• Scalability: Solutions that can be tailored to any size of operation.
• Data Security and Data Integrity: Ensured by GxP-validated software and firmware.
• Unrestricted Data Access: Through integration into a GxP-compliant AWS Cloud.
• Hardware/Software/Service: Everything from a single source and directly from the manufacturer. We support your project from the planning phase to IQ/OQ/PQ and the regular calibration of the Kaye sensors used, including re-qualification of the entire monitoring system.
• Continuous Development: Both hardware and software to comply with changing directives and regulations.

Continuous Monitoring of Critical Process Parameters

Continuous monitoring of critical process parameters is an indispensable part of the validation of these processes. Sensors and data loggers continuously capture the process parameters, and this data is archived as part of the quality documentation. This not only ensures compliance with legal requirements but also guarantees that products remain in optimal condition at all times.

Kaye's Technological Solutions

Kaye offers the Kaye LabWatch IoT, a GxP-compliant solution for continuous monitoring systems. These state-of-the-art monitoring technologies ensure process security and high operational efficiency, ultimately improving the quality and integrity of pharmaceutical products.

Contact Us

If you have any questions, contact us directly or get in touch with one of our certified dealers in your country.

Warehouse Monitoring Solutions - Warehouse Mapping

• Kaye LabWatch IoT

• Kaye LabWatch Pro

• Kaye ValProbe II 

• Kaye NetPac II

Warehouse mapping is defined by regulatory guidelines as a seasonal requirement to ensure that storage conditions are maintained at defined specifications. Performing this crucial operation relies significantly on Warehouse Operations and calls for robust systems such as the Storage Mapping process. This is a very critical step in ensuring your products and assets are kept safe and within the threshold of standards while stored in your facility.

That’s why it’s important to perform a warehouse mapping study using equipment that is built to withstand and detect any type of temperature change inside your facility. This aspect of warehouse operations and storage mapping is key in upholding product integrity. These temperature changes usually occur during large swings in exterior temperature. Even though the internal temperature change may be minuscule, it could lead to threatening changes in temperature-sensitive materials.

At least twice per year, usually once in the winter and once in the summer, it’s important to protect your temperature and humidity-sensitive products by performing a thermal warehouse mapping of your storage, chambers, freezers, refrigerators, or warehouse by using a Kaye RF ValProbe®II temperature data logger. Warehouses should utilize storage mapping to keep track of product placements and monitor environmental conditions. Oftentimes, the heat of the summer months and frigid cold of the winter can change the temperature and conditions of your storage facility enough to impair or even damage products. Scheduling a routine, bi-annual warehouse mapping is one of the best ways to prevent issues with your GMP systems.

When preparing for a warehouse mapping, there are many factors you must first think about. It’s vital that you plan ahead to determine the number of studies you’ll be doing, the length of the study, acceptable temperature for safe and allowable operation, quantity and types of sensors needed and the locations of the sensors. Additionally, you will need to have a good understanding of the size of your facility, temperature swings, hot spots or heat envelope locations, as well as airflow of both storage and foot traffic areas.

Then it is important to have a proper procedure ready to execute the mapping and analyzing the results. Using the right equipment can give users a drastic advantage when performing a thermal mapping. The hardware being used is important, and as equally important is the software. What good is the data if you aren’t able to read it easily and interpret what it’s telling you? That’s where the Kaye RF ValProbe II system is a standout.

The Kaye RF ValProbe's will continuously monitor your facility's temperature and give you an instant readout, making it simple for you to understand your site's conditions. The new ValProbe RF II data loggers that Kaye created is a significant upgrade from our earlier ValProbe RF I. The Kaye RF ValProbe II wireless data logger integrates breakthrough RF Mesh technology with enhanced technology for Thermal Validation.

During a warehouse mapping, the probes can be easily placed throughout the facility and read using our intuitive software on any PC or smartphone. Learn more about our warehouse mapping solutions by visiting the Kaye RF ValProbe®II page. When you’re ready for a demonstration or if you have questions, don’t hesitate to reach out to one of our expert account managers.

If you’re not ready to purchase equipment yet, view our rental solutions here to find which products will work best when doing a warehouse mapping of your facility.

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