Our Partnership with LIFE PHARMA

Engineering a High-Compliance, High-Efficiency Environment for USFDA-Approved Manufacturing

Client Overview

LIFE PHARMA is a USFDA-approved pharmaceutical manufacturer dedicated to producing safe, high-quality, and cost-effective pharmaceutical products for global markets.

Specializing in oral solid dosage (OSD) formulations, the company operates under stringent regulatory frameworks to ensure superior safety, efficacy, and compliance.

To expand and strengthen its manufacturing capabilities, LIFE PHARMA required world-class ISO 7 and ISO 8 cleanrooms designed to support large-scale OSD production with absolute control, precision, and regulatory adherence.
They chose us.

The Challenge

Delivering a cleanroom solution for a 7,000 sqm OSD facility demanded meticulous planning, regulatory understanding, and seamless execution. The key challenges included:

• Designing ISO 7 and ISO 8 cleanrooms that meet stringent USFDA, GMP, and global quality standards
  
• Ensuring cleanroom infrastructure supports critical OSD processes such as blending, granulation, compression, coating, and packaging
• Integrating an HVAC system capable of managing precise temperature, humidity, airflow, and pressure differentials
• Ensuring contamination control across large production zones
• Maintaining construction precision at a large scale while coordinating with ongoing facility operations

The mission was clear: design and deliver a future-ready pharmaceutical environment capable of supporting safe, compliant, and high-volume OSD manufacturing.

Our Approach: Precision Engineering for Pharmaceutical Excellence

We assembled a specialized team of cleanroom engineers, HVAC specialists, regulatory consultants, and project managers to design a solution aligned with the highest global standards.

Our strategy focused on optimization, compliance, and seamless integration within the 7,000 sqm production environment.

Cleanroom Design & Construction: ISO 7 & ISO 8

Our engineering and design teams developed cleanroom layouts tailored to OSD production workflows. This included:

• Designing and installing ISO 7 and ISO 8 partitionsto create controlled processing zones
• Establishing layouts that enhance material flow, operator movement, and process segregation
• Using high-quality construction materials to ensure structural integrity, durability, and GMP compliance
• Creating environments capable of maintaining tight particulate controldemanded by OSD manufacturing

This allowed LIFE PHARMA to operate in fully compliant and contamination-controlled conditions essential for USFDA approval.

Advanced HVAC System: Climate Control for High-Precision Manufacturing

To maintain stringent environmental conditions, we delivered a complete HVAC solution that included:

• Designing and installing an advanced air handling systemfor controlled temperature, humidity, and airflow
• Implementing pressure cascades to ensure contamination does not migrate between zones
• Integrating filtration systems to maintain ISO 7 and ISO 8 cleanliness levels
• Commissioning and testing the HVAC system for full regulatory compliance

This HVAC integration ensured reliable environmental control, supporting consistent product quality across all OSD operations.

The Result: A Fully Compliant, High-Performance OSD Facility

The completed facility now delivers:

• ISO 7 & ISO 8 cleanrooms supporting large-scale OSD manufacturing
• A fully integrated HVAC system that maintains strict environmental conditions
• Optimized workflows for production efficiency and operational safety
• Infrastructure aligned with USFDA, GMP, and international pharmaceutical standards

Key Achievements

• Designed and constructed 7,000 sqm of ISO-class cleanroom infrastructure
• Delivered a fully compliant OSD production environment
• Installed a robust HVAC system engineered for precise environmental control
• Ensured seamless integration of systems to support high-volume operations
• Enabled LIFE PHARMA to maintain its position as a global pharmaceutical leader

What This Project Says About Us

This project highlights our ability to:

• Deliver world-class cleanroom infrastructure for highly regulated pharmaceutical environments
• Understand and support complex OSD manufacturing workflows
• Engineer large-scale, contamination-controlled facilities with precision
• Combine compliance, efficiency, and innovation to elevate operational performance

Conclusion

LIFE PHARMA’s upgraded facility stands as a benchmark for global-quality OSD manufacturing, powered by precisely engineered ISO-class cleanrooms and advanced environmental control systems.