RMA Group - Projects
 
 
About Us Services Clients Careers with Us Contact Us Login
© 2024 Resources Management & Advisory. All rights reserved.
PROJECT MANAGEMENT & DEVELOPMENT SOLUTIONS
Success Stories
 

OCULEX ASIA PHARMACEUTICALS PTE LTD

Biopharmaceutical Manufacturing Facility
 
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.

 
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.
 
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.
 
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
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.
 
 
 
 
 
RMA Group
8 Kaki Bukit Avenue 1, #05-05/06/07/08, Singapore 417941
Tel No.: +65 62987159    Fax No. +65 62920459
Email: enquiries@rmagroup.com.sg