Pharma Block Consultancy & Facility Setup
⭐ PROJECT DESCRIPTION
A pharmaceutical manufacturer in Dehradun required end-to-end consultancy and engineering support for setting up a new production block, cleanroom facility, oncology block, and utility building.
The project involved converting a raw area into a fully functional, regulatory-compliant pharma block capable of supporting oncology formulation and general pharma operations.
The client assigned Adhyntra Pvt Ltd to deliver a complete solution — including GMP layout design, HVAC & cleanroom engineering, piping design, utility planning, equipment integration, and on-site execution support.
This was a complete turnkey consultancy project, from concept to validation readiness.
⭐ PROJECT PROCESS / APPROACH
1️⃣ Requirement Study & Concept Design
- Detailed study of process flow, equipment list & production capacity
- Evaluation of oncology-specific containment requirements
- Identification of cleanroom grades & pressure zones
- Space planning for production, packaging, QA/QC & utilities
- Safety & compliance review (US-FDA / WHO / Schedule M)
2️⃣ GMP Layout Development
Designed complete layouts for:
- Production block
- Oncology block (high containment, segregated movement)
- Cleanroom areas (ISO Class 7/8)
- Dispensing, granulation & blending zones
- Primary & secondary packaging
- Material & personnel flows with correct airlocks
- Utility building: AHU area, boiler, chiller, compressor, scrubber
Key GMP elements:
- Unidirectional flow planning
- Cross-contamination control
- Pressure cascade hierarchy
- Hygienic zoning & airlocks
- Material storage strategy
3️⃣ HVAC & Cleanroom Engineering
- AHU capacity calculation & selection
- HEPA-based filtration system design
- Room pressure mapping for oncology + general areas
- Duct routing, airflow balancing & fresh air load design
- Temperature & RH control strategy
- Cleanroom paneling specifications
- Air change rate calculation
Delivered:
- HVAC layouts
- Ducting drawings
- AHU placement/design
- Cleanroom zoning plan
4️⃣ Utility Engineering & Piping Design
Generated complete P&IDs and routing for:
- Purified water system
- Hot & chilled water
- Compressed air & vacuum
- Steam & condensate
- Scrubber/Exhaust system
- Chemical handling lines (if required for oncology)
Piping Deliverables:
- Isometrics
- Utility routing
- Support & hanger layout
- Bill of materials
5️⃣ Equipment Planning & Installation Support
- Equipment GA drawings
- Nozzle orientation & foundation planning
- Equipment movement path planning
- Tie-in points for all utilities
- Material of construction selection for oncology
Supervision & coordination with:
- Electrical
- HVAC
- Piping teams
6️⃣ Documentation & Validation Preparation
- URS / DDS preparation
- Quality & engineering documentation
- HVAC qualification protocols
- Room readiness & environmental validation support
- As-built drawings
⭐ WORK SCOPE
- ✔ Production block design (GMP compliant)
- ✔ Cleanroom & oncology facility layout
- ✔ Utility building design
- ✔ HVAC & Cleanroom Engineering
- ✔ Complete utility P&IDs
- ✔ Piping layout & isometrics
- ✔ Cross-contamination & containment strategy
- ✔ Equipment layout & installation support
- ✔ Documentation (URS/DDS/IQ/OQ support)
- ✔ On-site coordination & execution guidance
