Integra is a prominent player in the global medical device manufacturing sector. In need of assistance, they collaborated with Genesis AEC to breathe new life into their medical transfer suite design. During this project, we integrated advanced lyophilizing equipment and essential utility support systems across various specialized chambers.
The renovation project encompassed several key areas within the medical transfer suite, each thoughtfully redesigned to enhance functionality and efficiency. One of the pivotal components of the suite was Blister Tray Stack Assembly Room 440. This room, featuring an ISO 7 classified space spanning 600 square feet, was reimagined to optimize and streamline the intricate blister tray assembly process.
Wash Room 613 and its neighboring areas, including the Used Tray Wash, Air Lock, and Conveyor Feed Room, collectively covering 500 square feet, were all reconfigured to adhere to ISO 7 standards. These sections critically ensure the thorough cleaning and sanitation of equipment and trays before they proceed for further usage.
The Packaging Area Room 652, with an expansive 1,950 square feet and classified under ISO 7, emerged as the nerve center of the packaging operations. Within this space, sterilized products are systematically packed, preparing them for distribution to medical facilities and beyond.
The project also included the LYOMechanical Area 1040 and the Shipping/Receiving Area. Although unclassified, these areas are crucial components of the suite’s operations. Covering 1,250 square feet, the LYOMechanical Area 1040 houses all the integral mechanical elements that facilitate the lyophilization process. Adjacently, the Shipping/Receiving Area ensures a seamless inflow and outflow of products, playing a vital role in maintaining the overall operational flow of the suite.
Through the incorporation of advanced equipment and careful design considerations, the renovated medical transfer suite design certainly stands as a testament to innovation and efficiency in the field of medical device manufacturing.
Glossary
- Lyophilizing: Also known as freeze-drying. It’s a process that dehydrates products, making them more stable for longer periods.
- ISO 7: Refers to an air cleanliness standard in cleanrooms and controlled environments.