A decontamination solution for Lonza
Supporting Lonza to efficiently decontaminate products
Committed to continuous improvement of Cell and Viral Gene Therapy
Lonza is dedicated to continually improving quality and operations in partnership with regulatory agencies. Devoted to actively contributing to the development of quality standards for commercial manufacturing as the field of cell and gene therapy continues to progress.
Lonza is one of the world’s largest healthcare manufacturing organizations. They help pharmaceutical, biotech, and nutrition companies bring their treatments to market, uniting under the vision to bring any therapy to life.
Supporting their customers with technological insight, world-class manufacturing, scientific expertise, process excellence, and innovation.
Lonza enables their customers to develop and commercialize their therapeutic discoveries, allowing patients to benefit from lifesaving and life-enhancing treatments.
Established in 1897 in the Swiss Alps, Lonza now operates across five continents and has a global community of around 18,000 employees, including high-performing teams and individual talent that make a meaningful difference in the communities in which they operate.
PBSC supplied high-quality integrated decontamination chambers to efficiently decontaminate products for use in Lonza’s new facility located in Houston Reach US, facilitating the development and manufacturing of cell and gene therapies.
The new facility opened in 2018 and was the largest dedicated facility of its kind at the time. Its mission was to help developers of cell and gene therapies deliver treatments to patients more quickly and efficiently. In 2021, the FDA approved Lonza Houston for commercial production, and by 2022, the facility was manufacturing three commercial cell and gene therapies.
Products
Solutions/Results
The decontamination solution was successfully commissioned by PBSC during Site Acceptance Testing.
- Inlet and extract air are ducted into the customer HVAC system– By ducting directly to the chamber’s inlet and extract valves, the air intake is temperature and humidity controlled. Lonza utilizes PBSC’s inlet and extract valves, integrating them directly with their HVAC system for optimal environmental control.
- PBSC’s 2 Valve air handling system – Allowing the chamber to control and monitor the operation of the inlet and outlet valves. By utilizing volt-free HVAC signals, Lonza can receive critical information, including HVAC valve status (open/closed) and HVAC freeze alerts.
- BMS I/Os – PBSC’s volt-free signals are available for integration with Lonza’s Building Management System (BMS). This allows Lonza to receive notifications of alarms and other critical information directly through their BMS, ensuring seamless monitoring and response.
- Pressure Relief – The pressure relief HEPA/CAT filter pack enables controlled pressure release from the chamber during a cycle. The actuated valve ensures the chamber can be sealed effectively, while a pressure transmitter provides pressure testing capabilities. This system maintains the integrity and safety of the chamber throughout the decontamination process.
- Thermal printout – The generator provides a physical printout of each gas cycle, ensuring immediate documentation. Additionally, the chamber generates an electronic PDF version, which can be sent to a local laptop or a designated location on Lonza’s server for digital recordkeeping and easy access.
- H₂0₂ Generator – The generator is mounted on the internal central panel of the chamber to effectively distribute vaporized hydrogen peroxide throughout. Stirrer fans, mounted at a high position, aid in this distribution. The bottle housing is integrated into the loading side’s stainless steel external frame, ensuring a streamlined and efficient design.
- Aeration Unit – The aeration unit supports the removal of H₂O₂ during the aeration phase of an H₂O₂ decontamination cycle, thus decreasing the overall cycle period.
- Low level returns – Low-level return plenums extract air from within the chamber, promoting unidirectional airflow during the extraction process, ensuring a controlled, efficient, and clean environment.
Emma Gibbons – Senior Project Manager for PBSC, “We are pleased to have provided Lonza with our decontamination solutions and wish them every success in their future endeavors.”