Nutraceutical Manufacturing Plant -GMP-Compliant
Project Desciption
A nutraceutical company required a compact 4000 sq. ft GMP-compliant manufacturing facility, designed to meet regulatory guidelines for hygienic processing, controlled environment, and product quality. The client needed a complete turnkey setup, including cleanroom layout, AHU design, equipment installation, and validation support.
Despite the limited space, the objective was to create an efficient production flow—covering dispensing, blending, granulation, capsule/tablet processing, packaging, and controlled storage—while maintaining full GMP & hygiene compliance.
Adhyntra delivered an optimized, compliant, and high-performance facility meeting all operational and regulatory expectations.
⭐ PROJECT PROCESS / APPROACH
1️⃣ Site Assessment & Layout Planning
- Detailed study of available 4000 sq. ft area
- Space utilization planning for maximum efficiency
- GMP-based zoning:
- Raw material area
- Production zones
- Packaging zone
- Airlocks
- Storage & utility area
- Optimized personnel & material flow to avoid cross-contamination
2️⃣ Cleanroom & GMP Compliance Engineering
- Identification of clean zones & hygiene classes
- Wall/ceiling panel specifications
- PU flooring recommendation
- Pressure differential & room classification mapping
- Validation-ready layouts
3️⃣ HVAC & AHU System Design
- AHU sizing & selection
- Duct routing within compact height
- HEPA filtration (ISO Class 8/7 depending on process)
- Pressure cascade design
- Fresh air, return air, exhaust balancing
- Comfortable working conditions + regulatory compliance
4️⃣ Equipment Installation & Qualification
Installed and qualified the following (as per client scope):
- Blenders
- Granulators
- Capsule/Tablet processing machinery
- SS Utility line connection points
- Packaging line equipment
Qualification Support Provided:
- URS preparation
- DQ/IQ/OQ documentation
- Equipment calibration records
- As-built layout files
5️⃣ Area Validation & Documentation
- Air velocity, airflow pattern & filter integrity testing
- Pressure differential mapping
- Temperature & RH qualification
- Area validation reports as per GMP
-
Cleanroom certification support
6️⃣ Turnkey Supervisory Support
- Vendor coordination
- Installation supervision
- Material selection & procurement assistance
- Final walkthrough & handover documentation
⭐ WORK SCOPE (Detailed)
- ✔ GMP Facility Layout Design
- ✔ Cleanroom & Zoning Planning
- ✔ HVAC & AHU System Engineering
- ✔ HEPA, ducts, pressure cascade setup
- ✔ Equipment installation & alignment
- ✔ Equipment qualification – IQ/OQ
- ✔ Area validation & documentation
- ✔ Final GMP compliance check
