Thermal mapping & qualification of HVAC systems in warehouse at 3PL provider
A global courier service player wanted to modify its existing warehouse to meet their own healthcare standards so that it could serve as storage and distribution space for among others pharmaceutical products, medical devices and cosmetics. A key requirement for these types of products is the proof of temperature-controlled storage.
With a team of more than 20 specialists in thermal mapping, our experienced Validation & Testing consultants have the required expertise to control, monitor, and record temperature and humidity.
VALIDATION OF +18,500M² STORAGE SPACE
The warehouse includes a main compartment of 17,700 m², a mezzanine of approximately 800 m² and a cooled area of about 1853 m² with a closed cold chain lock of 307 m². It uses a Building Automation System (BAS) for temperature and humidity monitoring, with electronic data storage and alarm systems, while a separate Building Management System (BMS) regulates the HVAC and cooling systems.
These systems are designed and validated according to GAMP 5 and EU GMP Annexes 15 & 11, maintaining a temperature between 15°C and 25°C and humidity below 60% in the warehouse. The cool area must remain between 2°C and 8°C, with specific activation points for the cooling systems to manage these temperatures.
THERMAL MAPPING
Thermal mapping involves documenting, implementing and evaluating the validation of temperature-controlled units (CTUs) and warehouses. This is crucial for the preservation of time- and temperature-sensitive pharmaceutical products. Primarily, thermal mapping aims to ensure that the temperature and/or humidity levels in temperature-controlled units meet the required specifications.
PHASED PROJECT APPROACH
Agidens provides the complete validation of the entire warehouse, including the cooled area and cold chain interlock. For the validation, three separate protocols were established, two for the non-cooled areas divided into the BAS installation and the HVAC installation (warehouse), and one for the cooled area and cold chain interlock. To achieve a fully qualified warehouse as quickly as possible, a phased project approach was employed.
PHASE 1
Due to limited energy capacity, the control and monitoring installation was initially partially commissioned. In phase 1, the focus was on temperature regulation and monitoring temperature and humidity, without control over relative humidity. All temperature and relative humidity sensors were positioned correctly, connected to the system and calibrated.
Since the HVAC installation was not yet fully operational (no dehumidification) and the relative humidity was not yet under control, the alarms for the humidity sensor were deactivated.
PHASE 2
During phase 2, when full energy capacity was available, the entire installation was commissioned. Temperature and humidity were controlled and monitored. During this phase, the humidity alarm was also activated, and the HVAC and BAS systems became fully operational.
By dividing the project into two phases, not all installation and operational qualification tests could be performed in the first phase. As a result, the protocol execution was also divided into two phases.
IQ- & OQ VALIDATION
The validation tests are divided into two types: Installation Qualification (IQ) and Operational Qualification (OQ).
Installation Qualification (IQ)
In the IQ tests, we extensively check the technical and maintenance documentation related to the installation. This includes verifying the installation itself, as well as the identification, security and calibration of devices, hardware, wiring, cabling and sensors.
For sensors, we also check the alarm thresholds for temperature and humidity, and compare the physical location of the sensors with their software-based input location. We additionally check signal ranges and continuity.
Operational Qualification (OQ)
The OQ tests focus on verifying the Standard Operating Procedures (SOPs), which include the use of systems, preventive maintenance and emergency procedures. We simulate a power outage to see if all devices and sensors remain functional during a brief failure.
We also assess whether the software for the BAS sensors operates correctly, including the generation of reports, critical alarms,and warnings sent via email and/or phone. We check whether data is preserved and supplemented during interruptions in the connection between controllers and servers.
In both the cooler and the warehouse, we conduct temperature and humidity measurements, with additional tests in the cooler such as the open door test and a warm-up study. Finally, we test the operation of the air handling units and cooling systems by creating a need for cooling, heating or dehumidification.
CONTACT US FOR MORE INFORMATION
This thermal validation project demonstrates Agidens’ expertise in ensuring compliance with the storage and distribution of temperature-sensitive products, taking into account existing systems and infrastructure. We like to collaborate closely with our clients in the context of optimizing the project approach, aiming for the most efficient path to a compliant project.
Interested in our comprehensive validation approach? We would be happy to explain it in more detail.
