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Optimized operations for reliable biomanufacturing
Reliable facility operations are vital for consistently delivering safe, high-quality biopharmaceuticals. Samsung Biologics employs a comprehensive facility maintenance strategy to prevent the deterioration of critical infrastructure that could impact the production process. From meticulous planning to standardized work processes and a plant reliability management program, Samsung Biologics aims to minimize downtime and maintain efficient operations while ensuring uncompromised product quality.
Minimizing downtime, maximizing efficiency
Unplanned downtime in biopharmaceutical manufacturing can lead to production delays and potentially affect product quality. Samsung Biologics mitigates these risks by implementing condition-based maintenance (CBM), which focuses on real-time equipment monitoring. Traditional time-based maintenance adheres to a regular schedule regardless of whether there are signs of equipment wear and tear. In contrast, CBM is a preventive strategy that responds to real-time equipment performance. The company has taken the latter approach to maximize production efficiency by preemptively identifying and addressing potential issues.
“Through real-time monitoring, our teams can flexibly manage the maintenance schedule for each piece of equipment, optimizing resource use and minimizing operational disruptions. It reduces the time for procedures like derouging and passivation while helping to avoid unexpected equipment failures and production disruptions,” said Woochung Lee, Director of Facility Planning.
Maintenance activities are carried out during production breaks, such as product changeover periods. Critical systems, such as heating, ventilation, and air conditioning and water for injection, are inspected and managed during these intervals to optimize production time and extend the lifespan of essential equipment. High-efficiency particulate air filters in cleanrooms, which originally lasted up to two years, now achieve a lifespan of up to six years with an increased filter size.
Additionally, to further support uninterrupted operations, the company has implemented an enhanced redundancy system — if one system encounters an issue, another can immediately take over, ensuring continuous production without delay. Such efforts have allowed the company to significantly minimize downtime, enhancing overall efficiency.
Standardization and digitalization for operational consistency
Standardizing processes is another crucial element for consistency and precision in operations. Samsung Biologics created comprehensive standard operating procedures (SOPs) for maintaining key production equipment, such as bioreactors and centrifuges. These SOPs help maintain uniformity and minimize the risk of deviations that could impact product quality.
The company also uses a standardized tool management system for cleanrooms to ensure the required tools are readily available and prevent production delays. Furthermore, Samsung Biologics digitally records maintenance processes through an enterprise asset management system. Digitalizing good manufacturing practice forms and reports enhances accuracy by reducing human error and enables efficient and timely decision-making.
Samsung Biologics also leverages a robust facility monitoring platform (FMP) to support the continuous oversight of critical environments. The FMP consolidates data from interconnected systems, enabling efficient monitoring of utility equipment and key environmental parameters, such as temperature, humidity, and differential pressure. This digitalized approach allows real-time oversight of equipment conditions and sets off pre-detection alarms to quickly identify potential issues and reduce response times. “With FMP, we can precisely track operating parameters and detect deviations before they impact the production process. This enables us to maintain a stable environment for biomanufacturing and consistent product quality,” said Hyunji Kim, Senior Engineer in the Automation Group.
Sustaining operational excellence with overall production reliability
Samsung Biologics’ plant reliability and management strategy is essential for the long-term continuity of its manufacturing facilities. With a typical operational lifespan of 25 to 30 years for biomanufacturing plants, maintaining the integrity and functionality of critical equipment is crucial to meet global quality standards.
In this regard, Samsung Biologics aims to extend the lifespan of its assets by proactively identifying equipment issues and implementing preventive measures.
“Our goal is to maintain operational continuity,” Lee added. “Through meticulous planning and a focus on long-term equipment health, we ensure sustained production while minimizing the risk of breakdowns. This not only reduces environmental risks but also guarantees compliance with the industry’s stringent regulatory standards.”
Samsung Biologics is dedicated to operational excellence through a proactive and innovative approach to facility maintenance. By integrating advanced maintenance solutions, the company seeks to minimize potential disruptions while maximizing the lifespan and efficiency of its critical infrastructure. This forward-thinking approach enables the optimization of manufacturing facilities for consistent, high-quality production and reduces risks that could impact delivery timelines or product integrity. As demand for high-quality biopharmaceuticals increases, Samsung Biologics will continue investing in innovative infrastructure and maintenance planning to further enhance its role as a reliable CDMO partner in the global biopharmaceutical industry, supporting clients in effectively and safely delivering life-saving treatments to patients worldwide.
Please contact us for more information about Samsung Biologics’ service offerings.
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Reliable facility operations are vital for consistently delivering safe, high-quality biopharmaceuticals. Samsung Biologics employs a comprehensive facility maintenance strategy to prevent the deterioration of critical infrastructure that could impact the production process. From meticulous planning to standardized work processes and a plant reliability management program, Samsung Biologics aims to minimize downtime and maintain efficient operations while ensuring uncompromised product quality.
Minimizing downtime, maximizing efficiency
Unplanned downtime in biopharmaceutical manufacturing can lead to production delays and potentially affect product quality. Samsung Biologics mitigates these risks by implementing condition-based maintenance (CBM), which focuses on real-time equipment monitoring. Traditional time-based maintenance adheres to a regular schedule regardless of whether there are signs of equipment wear and tear. In contrast, CBM is a preventive strategy that responds to real-time equipment performance. The company has taken the latter approach to maximize production efficiency by preemptively identifying and addressing potential issues.
“Through real-time monitoring, our teams can flexibly manage the maintenance schedule for each piece of equipment, optimizing resource use and minimizing operational disruptions. It reduces the time for procedures like derouging and passivation while helping to avoid unexpected equipment failures and production disruptions,” said Woochung Lee, Director of Facility Planning.
Maintenance activities are carried out during production breaks, such as product changeover periods. Critical systems, such as heating, ventilation, and air conditioning and water for injection, are inspected and managed during these intervals to optimize production time and extend the lifespan of essential equipment. High-efficiency particulate air filters in cleanrooms, which originally lasted up to two years, now achieve a lifespan of up to six years with an increased filter size.
Additionally, to further support uninterrupted operations, the company has implemented an enhanced redundancy system — if one system encounters an issue, another can immediately take over, ensuring continuous production without delay. Such efforts have allowed the company to significantly minimize downtime, enhancing overall efficiency.
Standardization and digitalization for operational consistency
Standardizing processes is another crucial element for consistency and precision in operations. Samsung Biologics created comprehensive standard operating procedures (SOPs) for maintaining key production equipment, such as bioreactors and centrifuges. These SOPs help maintain uniformity and minimize the risk of deviations that could impact product quality.
The company also uses a standardized tool management system for cleanrooms to ensure the required tools are readily available and prevent production delays. Furthermore, Samsung Biologics digitally records maintenance processes through an enterprise asset management system. Digitalizing good manufacturing practice forms and reports enhances accuracy by reducing human error and enables efficient and timely decision-making.
Samsung Biologics also leverages a robust facility monitoring platform (FMP) to support the continuous oversight of critical environments. The FMP consolidates data from interconnected systems, enabling efficient monitoring of utility equipment and key environmental parameters, such as temperature, humidity, and differential pressure. This digitalized approach allows real-time oversight of equipment conditions and sets off pre-detection alarms to quickly identify potential issues and reduce response times. “With FMP, we can precisely track operating parameters and detect deviations before they impact the production process. This enables us to maintain a stable environment for biomanufacturing and consistent product quality,” said Hyunji Kim, Senior Engineer in the Automation Group.
Sustaining operational excellence with overall production reliability
Samsung Biologics’ plant reliability and management strategy is essential for the long-term continuity of its manufacturing facilities. With a typical operational lifespan of 25 to 30 years for biomanufacturing plants, maintaining the integrity and functionality of critical equipment is crucial to meet global quality standards.
In this regard, Samsung Biologics aims to extend the lifespan of its assets by proactively identifying equipment issues and implementing preventive measures.
“Our goal is to maintain operational continuity,” Lee added. “Through meticulous planning and a focus on long-term equipment health, we ensure sustained production while minimizing the risk of breakdowns. This not only reduces environmental risks but also guarantees compliance with the industry’s stringent regulatory standards.”
Samsung Biologics is dedicated to operational excellence through a proactive and innovative approach to facility maintenance. By integrating advanced maintenance solutions, the company seeks to minimize potential disruptions while maximizing the lifespan and efficiency of its critical infrastructure. This forward-thinking approach enables the optimization of manufacturing facilities for consistent, high-quality production and reduces risks that could impact delivery timelines or product integrity. As demand for high-quality biopharmaceuticals increases, Samsung Biologics will continue investing in innovative infrastructure and maintenance planning to further enhance its role as a reliable CDMO partner in the global biopharmaceutical industry, supporting clients in effectively and safely delivering life-saving treatments to patients worldwide.
Please contact us for more information about Samsung Biologics’ service offerings.
Related content
Samsung BIO Insight Optimized facilities for flexible, agile manufacturing
Samsung BIO Insight Applying advanced manufacturing technology to complex biomedicines