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Meeting standards and exceeding production for DPTE-BetaBag®

Pharmaceutical Production
Pharmaceutical Production
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Meeting standards and exceeding production for DPTE-BetaBag®

Since beginning her career as an Operator in the 1990s, Cleanroom Supervisor Karine Piquot has studied every aspect of cleanroom production at Getinge, the world’s largest supplier of aseptic transfer solutions.

Increasing manufacturing capabilities by 20% in one year — without sacrificing quality — is no easy task. That’s why we rely on the expertise of knowledgeable, longtime employees like Karine Piquot to guide our improvements in capacity and quality.

Karine is a Cleanroom Supervisor overseeing daily operations and production of the single-use DPTE-BetaBag® at Getinge’s manufacturing site in Vendôme, France. In 2019, she and her team focused on multiple important aspects of production: increasing capacity, efficiency, and quality.

Process challenges

Between 2018 and 2019, DPTE-BetaBag® production increased nearly 15% to meet customer demand. Crucially, this increase in output goes hand-in-hand with efforts to improve overall efficiency and streamline processes, while ensuring that cGMP (current Good Manufacturing Practice) standards are met at all times. 

“We have implemented ‘Just-In-Time’ production measures, which improve efficiency between supplier and manufacturer to improve response times between manufacturers and customers,” Karine explains. Just-in-time production also encourages every employee to analyze current processes and offer suggestions for improvement.

“These new approaches speed up turnaround time for orders. We can reduce the need for storage space while driving down overall costs for customers,” says Karine. “We are also improving efficiency by insourcing production steps of the Tyvek® version of our single-use bag from the supplier to Vendôme.” 

The new production line equipment was installed in summer 2019, and the first pre-series produced by Karine’s team was successfully validated. Production began in early 2020, with four operators recruited to run the new equipment.

Attention to detail

These improvements required Karine to nearly double the size of her cleanroom team. “It takes a certain type of employee to be successful in this type of environment,” Karine explains. “As it’s unusual to find people with work experience in cleanrooms, we focus on the requisite skills: be rigorous, flexible and give 100% concentration to the work,” emphasizes Karine. 

Cleanroom protocols at Getinge are meticulous, with every product subjected to the same strict processing on a daily basis. At the beginning of each shift, Operators are required to open a folder and reread the process of the particular task they’re assigned to. This is to refresh their memory of the task procedure – no matter how many times they’ve performed the task, or how many years they’ve worked in the cleanrooms. “While it might sound repetitive,” says Karine, “it’s important for us to ensure the very highest quality product for our customers.”

She notes that hiring can be a challenge. “Not everyone can adapt to working in such strictly controlled conditions, with special clothing and precise times for entering and leaving the workspace.” However, she adds, when a new employee is able to complete the full training, she knows it means they take a certain satisfaction from work that helps to save lives. “The team is working in a clean environment and making products that are very important. They’re all very proud of their work and the improvements that we’ve been able to achieve over the past year.”

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