Our Partnership with Wockhardt Bio AG

A Landmark Cleanroom Transformation for a Global Leader in Biopharmaceuticals

Client Overview

WockhardtBio AG stands at the forefront of global pharmaceutical and biopharmaceutical innovation. Their specialized focus on Oncology Injectables puts them in a domain where precision is non-negotiable, sterility is sacred, and the slightest deviation can impact patient lives.

At their flagship UAE site, the team set out to build a next-generation advanced manufacturing facility dedicated to the production and packaging of 4th-generation dry powder injectable formulations, products that rank among the most demanding in sterile pharmaceutical manufacturing.

To bring this vision to life, they needed a partner with the same intensity, technical discipline, and ambition.
They chose us.

The Challenge

For us, this project represented more than a technical assignment. It was a mission requiring engineering courage and absolute zero margin for error. Every decision, every airflow calculation, every micron of seal integrity mattered.

The major challenges included:

• Constructing ISO 6, 7 & 8 cleanroom zones with uncompromising precision
• Achieving flawless containment and sterility for oncology-grade injectables
• Creating a GMP-aligned, modular, future-ready production ecosystem
• Integrating HVAC, BMS/EMS, utilities, and process flows without disrupting existing operations
• Executing complete qualification cycles for regulatory readiness
• Designing an environment where innovation could operate without interruption

We knew that this facility would not just support manufacturing but would safeguard the integrity of life-saving treatments as well.

Our Approach: Turning Vision Into a Validated Reality

We deployed a multidisciplinary team of cleanroom designers, HVAC engineers, validation experts, and pharmaceutical system specialists. Our approach blended advanced engineering, risk-based design, and deep collaboration with WockhardtBio AG’s technical leadership.

1. Conceptual Design Built for the Future

We started by fully decoding their production philosophy, process flow, risk hotspots, contamination pathways, HVAC dependencies, clean-to-black transitions, everything.

From this, we developed a conceptual design that featured:

• Contamination-proof personnel and material pathways
• Product-protection strategies tailored for oncology injectables
• Modular layouts for future scalability
• Airflow & pressure design mapped precisely for ISO 6, 7 & 8 environments

The resulting blueprint met both today’s objectives and anticipated tomorrow’s expansion strategies.

2. Precision Engineering at Every Level

Once the vision was set, we built its backbone through:

• Basic Engineering
• Detailed Engineering
• Modular Cleanroom Partitioning

We selected high-performance, GMP-compliant materials engineered for airtightness, efficient sanitation cycles, and long-term operational durability. Every wall, every seam, every cove joint served one purpose, and that was unbroken sterility.

3. Intelligent HVAC & Environmental Control

Oncology injectables demand extraordinary environmental consistency, so we delivered a system that performs like a precision instrument.

Our HVAC design ensured:

• HEPA-filtered, contamination-resistant airflow
• Optimized pressure cascades
• Real-time thermal & humidity stability
• Balanced room recovery times and air change rates

Each parameter was tuned to maintain ISO cleanliness 24/7, without fluctuation.

4. BMS/EMS: A Facility That Monitors Itself

We equipped the facility with a fully integrated Building Management System (BMS) and Environmental Monitoring System (EMS) capable of:

• Continuous monitoring of critical parameters
• Real-time alerts for deviations
• Complete regulatory traceability
• Predictive maintenance insights

The environment essentially became self-aware, reducing human error and enhancing operational certainty.

5. Flawless Installation, Commissioning & Validation

Our installation teams executed the deployment of:

• Cleanroom equipment
• Pass boxes and air showers
• Contamination-control modules
• Specialized pharmaceutical-grade fixtures

Once installed, we conducted:

• IQ – Installation Qualification
• OQ – Operational Qualification
• PQ – Performance Qualification

We moved forward only when every metric exceeded the required benchmarks. For us, compliance is a baseline, not only a target.

The Result: A Benchmark Facility for Global Oncology Manufacturing

The outcome of our collaboration is a world-class cleanroom ecosystem that empowers WockhardtBio AG to manufacture 4th-generation oncology injectables with unmatched sterility, precision, and efficiency.

Key Achievements

• Delivered high-performance ISO 6, 7 & 8 cleanrooms
• Achieved flawless regulatory compliance and qualification
• Enabled high-precision sterile production for oncology-grade dry powders
• Integrated HVAC + BMS/EMS into a unified intelligent environment
• Increased workflow efficiency and facility throughput
• Built a modular, scalable infrastructure ready for future expansions

The facility now stands as a regional benchmark, setting new standards for sterile oncology injectable production.

What This Project Says About Us

This project is a demonstration of who we are and what we stand for.

• We don’t just engineer cleanrooms.
  We engineer confidence.
• We don’t just deliver projects.
  We deliver competitive advantage.
• We don’t just meet GMP standards.
  We consistently exceed them.

Our work with WockhardtBio AG highlights:

• Our ability to manage high-risk, high-precision pharmaceutical projects
• Our deep understanding of oncology injectable environments
• Our specialty in building complete turnkey cleanroom ecosystems
• Our strength in validation, engineering, and contamination control
• Our belief that great science requires great environments

Conclusion

By combining strategic design, advanced modular engineering, airtight environmental control, and rigorous validation, we delivered a facility built for the next generation of pharmaceutical innovation.

This partnership proves that when precision, innovation, and purpose align, extraordinary outcomes are possible.

We are proud to have played a role in strengthening the future of oncology injectable manufacturing and even prouder that our engineered environments will support medicines that save lives.

We’re not just building cleanrooms.
We’re building the future of advanced pharmaceutical manufacturing.