PrimeGMP delivers complete engineering solutions for pharmaceutical, biotech, and healthcare manufacturing facilities — covering the full lifecycle from project initiation → conceptual design → basic engineering → detailed engineering → qualification readiness.
Whether you are building a new GMP facility or upgrading an existing one, our engineering team ensures technical accuracy, regulatory compliance, operational efficiency, and long-term scalability.

1. Project Initiation — Building the Right Foundation

A successful pharmaceutical engineering project begins with structured planning and GMP-focused decision-making.
PrimeGMP works closely with your team to define:

• Project objectives, production capacity & scalability expectations
• Process improvement opportunities and workflow optimization
• Regulatory, GMP, and compliance expectations (USFDA, EU, WHO, PIC/S)
• Risk assessment and mitigation strategies
• Investment planning, budgeting, and feasibility analysis

PrimeGMP Consultancy Support Includes:

• Comprehensive risk assessments
• Detailed process assessments
• Toxicological evaluations
• GMP audits & compliance checks

This stage ensures long-term operational efficiency and a strong foundation for the full project lifecycle.

2. Conceptual Engineering (Concept Design)

Concept designs are developed based on URS, production requirements, and global GMP best practices.

Our Conceptual Design Covers:

• Facility layout & workflow optimization
• Cleanroom zoning & contamination control strategy
• Concept-level HVAC design (temperature, RH & pressure cascade)
• Utility system planning:
  • PW / WFI / Pure Steam
  • Compressed Air & Nitrogen
  • Chilled Water / Steam
• On-site logistics, material flow & storage strategy
• Preliminary energy consumption & operational cost estimation

3. Capacity Planning (Integrated Into All Phases)

PrimeGMP ensures that engineering designs support the required throughput, utility load, and future expansion, including:

✔ Correct Equipment Sizing

• Based on batch size, throughput, scale-up needs & process flow
• Supports both current and projected demand

✔ Adequate Utility Capacity

• Purified Water (PW)
• Water for Injection (WFI)
• HVAC load (sensible + latent)
• Clean Steam generation & distribution
• Clean Air (CA) / Compressed Air
• Nitrogen (N₂) capacity & redundancy

✔ Proper Material Movement & Storage Space

• Raw material & RM quarantine areas
• Finished goods storage
• Pallet movement & forklift pathways
• Buffer storage for high-throughput manufacturing

✔ Scalability for Future Expansion

• Space planning & modular layout options
• Utility expansion provisions
• Equipment upgrade compatibility

This ensures the facility remains compliant, flexible, and investment-ready for future market demands.

4. Basic Engineering (BEP)

• Architectural layouts & zoning
• HVAC design basis
• Initial P&IDs
• Utility schematics
• Load calculations & equipment requirement sheets
• Preliminary project schedule & costing

5. Detailed Engineering (DEP)

• Final cleanroom & facility layouts
• Detailed HVAC ducting diagrams
• Final P&IDs, isometrics & utility distribution
• Electrical cable routing & panel designs
• Equipment specifications & tender support
• Construction-ready drawings & documentation

6. Cleanroom & Facility Engineering

• Grade A/B/C/D layouts
• Pressure cascade & contamination control design
• Airflow strategy & HEPA integration
• Alignment with EU Annex 1 (2022)

7. Utility System Design

• PW / WFI generation & loop design
• Pure Steam networks
• Clean Compressed Air & Nitrogen
• CIP/SIP conceptual & detailed design
• Chilled water, boiler steam & HVAC integration

8. Equipment Engineering & Project Support

• URS development
• Vendor evaluation & bid comparison
• FAT/SAT support
• Installation supervision & qualification readiness

9. Engineering Aligned With GxP Standards

• WHO, EU, USFDA, PIC/S compliance
• ISPE Baseline approach
• Risk-based (ICH Q9) engineering
• Qualification-ready deliverables