Success Stories |
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OCULEX ASIA PHARMACEUTICALS PTE LTD |
Biopharmaceutical Manufacturing Facility |
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PROJECT DESCRIPTION |
RMA Projects undertook the project as the constructor providing CSA (Civil, Structural and Architectural) service, M&E (Mechanical and Electrical) services as well as Process Utilities services. Participation of this project was from the conceptual design phase and included validation activities.
Oculex Asia Pharmaceuticals is a biopharmaceutical manufacturing facility set up to manufacture a series of intra-ocular drugs and is largely a finishing facility with research and development capabilities. Production spaces are mainly designed as low humidity clean biopharmaceutical clean rooms for the manufacture of powder based products. |
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Duties included programming, development of layouts for the entire facility including the process areas, process support operations, P&IDs as well as project and construction management. RMA projects also assisted in the preparation and development and execution of Installation Qualification and Operational Qualification documents. |
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PROJECT HIGHLIGHTS |
- Early participation in the project allows for the implementation of a fully computerized documentation system allowing for all drawings and design documentation to be tracked and updated via computers thus saving time and cost for approvals and documentation.
- Clever manipulation of space and process flow concepts resulting in the optimization of production area and reduced production support areas. Ratio of space utilization has been reduced from a norm of 1:5 to 1:3.
- Developing a design and construction plan that provides maximum flexibility for the owners to increase and convert production spaces to suit production of future new products.
- Fast track construction management system which not only takes into account procurement issues but also regulatory applications and approvals. Project was completed in 3 months
- Identifying and increasing the power availability to the facility by 2 times to accommodate the requirements of the owners.
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FEATURES |
Specific activities accommodated within the facility are as follows;
- Low humidity clean rooms for manufacture of antibiotics and steroids
- Analytical laboratories
- Microbiology laboratory
- Sterility Testing laboratory
- Research and Development laboratories
- Stability rooms
- Technologies for production
- Exploratory and pre-clinical
- Logistics and controls
- Administration
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Issues addressed included the segregation of steroids and antibiotics manufacturing, Biosafety level 2 and 3 small scale productions taking into account critical issues of cross contamination within close quarters, high levels of flexibility in operations and equipment configurations and flexible utility hook-ups for mobile equipment. |
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