What are Conceptualization & Design Services?

Our services provide advanced facility layout planning, modular and prefabricated cleanroom designs, and 3D BIM integration, optimizing workflows, HVAC zoning, and material/personnel movement for GMP-compliant operations.

Why is it Critical?

Optimized facility design ensures product quality, regulatory compliance, and operational efficiency, supporting ISO/GMP classifications and enabling scalable, future-ready pharmaceutical manufacturing.

Our Role in Your Success

As a trusted CRO, Indivirtus Healthcare Services delivers expert-led design solutions, creating compliant, efficient, and scalable facility layouts that meet global regulatory standards.

Our Expert Design Approach

At Indivirtus Healthcare Services, our Conceptualization & Design services are led by experienced engineers and regulatory experts specializing in GMP-compliant facility planning. We utilize 3D BIM modeling to visualize workflows, HVAC zoning, and critical utility paths, ensuring optimized material and personnel movement. Our modular and prefabricated cleanroom designs support ISO/GMP classifications for sterile and non-sterile environments.

Our tailored approach integrates compliance-driven planning with operational efficiency, delivering scalable and future-ready designs that align with global standards and support regulatory audits.

Conceptualization & Design Deliverables

Facility Layout Drawings: Detailed plans for optimized facility design.

3D BIM Models: Advanced visualizations for workflows and utility integration.

Zoning and Classification Maps: ISO/GMP-compliant cleanroom zoning plans.

Utility & Material Flow Diagrams: Optimized paths for efficient operations.

Design Basis Document (DBD): Comprehensive foundation for design execution.

Regulatory Compliance & Global Standards

Our Conceptualization & Design services align with stringent global standards, ensuring your facility is audit-ready and compliant with international markets. By adhering to industry-leading guidelines, we deliver designs that enhance regulatory confidence and operational reliability.

  • GMP: Global good manufacturing practice guidelines for facility design.
  • ISO 14644: Standards for cleanroom classification and performance.
  • EU Annex 1: European guidelines for sterile manufacturing environments.
  • WHO TRS: Global GMP guidelines for quality assurance in facility design.
  • Schedule M (2024): India’s updated GMP requirements for pharmaceutical facilities.

Applications & Use Cases

Our Conceptualization & Design services are essential for pharmaceutical manufacturers developing new facilities or upgrading existing ones to meet GMP and ISO standards. Ideal for sterile and non-sterile environments, our solutions support cleanroom zoning, workflow optimization, and regulatory compliance. Key use cases include designing modular cleanrooms, planning facility expansions, and ensuring compliance for global market approvals.

Why Choose Indivirtus Healthcare

Indivirtus Healthcare Services is a trusted partner for pharmaceutical manufacturers, delivering expert-led design solutions backed by certified engineers and regulatory experts with global experience. Our services ensure scientifically defensible outcomes, rapid delivery, and strict confidentiality to protect your proprietary information.

With a commitment to industry best practices, we empower your facility with compliant, efficient, and scalable designs, driving regulatory success and operational excellence.

Frequently Asked Questions

Frequently Asked Questions

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.