What is the purpose of facility layout optimization in pharma plants?
Facility layout optimization ensures material and personnel flow is compliant with GMP, reduces cross-contamination risks, and improves operational efficiency.
What are the benefits of using modular and prefab design?
Modular and prefab designs significantly reduce on-site construction time and support scalable cleanroom installations with minimal disruption.
How does BIM support pharmaceutical facility design?
Building Information Modeling (BIM) provides a digital representation of the facility to detect design clashes, simulate HVAC flow, and support efficient construction planning.
Why is cleanroom zoning important?
Cleanroom zoning ensures controlled environments by segmenting areas based on cleanliness class, pressure differential, and HVAC design to comply with GMP and ISO 14644 standards.
Can you support regulatory-compliant conceptual designs globally?
Yes, our designs comply with global GMP regulations including EU Annex 1, WHO TRS, Schedule M, and ISO 14644, ensuring inspection readiness worldwide.
What do Conceptualization & Design services include?
Our services include facility layout planning, modular and prefabricated cleanroom designs, 3D BIM modeling, HVAC zoning, and utility/material flow optimization, ensuring GMP-compliant operations.
Who benefits from Conceptualization & Design services?
Pharmaceutical manufacturers developing new facilities or upgrading existing ones, particularly those requiring GMP and ISO-compliant cleanroom designs, benefit from our tailored solutions.
How do these services ensure regulatory compliance?
Our services align with GMP, ISO 14644, EU Annex 1, WHO TRS, and Schedule M (2024), ensuring facility designs meet global regulatory standards and are audit-ready.
What deliverables are provided with the service?
Clients receive facility layout drawings, 3D BIM models, zoning and classification maps, utility and material flow diagrams, and a design basis document (DBD).
Can the design services be customized for our facility’s needs?
Yes, our services are tailored to your facility’s specific operational and regulatory requirements, ensuring practical and compliant design solutions.
How do the services support cleanroom zoning and scalability?
We provide modular cleanroom designs and zoning maps aligned with ISO/GMP classifications, ensuring scalability and compliance for both sterile and non-sterile environments.