Case Study: Building a Sterile Compounding Facility for Precision IV Medications
Our Partnership with IV Compounding Pharmacy
Creating a Controlled, High-Accuracy Environment for Sterile Medication Preparation
Client Overview
IV Compounding Pharmacy is a specialized healthcare facility dedicated to formulating intravenous medications tailored to the unique needs of patients. Operating within a high-risk pharmaceutical domain, the pharmacy adheres to strict international sterility and quality standards to ensure safety, precision, and efficacy in every compounded solution.
Their mission:
To deliver lifesaving IV formulations through uncompromising quality control and advanced compounding practices.
They chose FTS Cleanrooms to build a sterile compounding environment that meets the highest regulatory expectations.
The Challenge
Designing and constructing a sterile compounding facility is one of the most demanding cleanroom projects in the healthcare sector. This project required meticulous planning and flawless execution due to:
- Stringent Sterility Requirements:
IV medications must be prepared in ISO-classified environments with controlled airflow, temperature, and particulate levels. - Complex System Integrations:
Seamless coordination of HVAC, BMS, EMS, cleanroom equipment, and electrical systems was essential for safe operations. - Zero-Compromise Quality Standards:
The facility needed to comply with advanced pharmaceutical regulations governing aseptic compounding and sterile drug preparation.
The mission was clear:
Build an environment where sterility, precision, and safety operate in perfect harmony.
Our Approach: Engineering a Pharmacy-Grade Sterile Environment
We deployed a specialized team of cleanroom designers, HVAC engineers, validation experts, and project managers to transform the pharmacy’s space into a world-class sterile compounding facility.
Conceptual & Technical Design Built for Absolute Sterility
We began by analyzing the pharmacy’s workflow, compounding processes, and equipment requirements.
Our design framework focused on:
- Creating controlled environments for aseptic IV preparation
- Ensuring smooth workflow from gowning to sterile compounding
- Integrating cleanroom materials with seamless finishes to avoid contamination
- Planning system controls to support both efficiency and safety
The result:
A conceptual design that aligned operational needs with regulatory excellence.
Precision Construction & Systems Integration
After finalizing the engineering and layouts, we executed a multi-layered installation that included:
Cleanroom Partitions
High-grade partitions designed for sterility, cleanability, and long-term durability.
High-Performance HVAC System
A specialized HVAC system engineered to maintain strict control over:
- Temperature
- Humidity
- Airflow patterns
- Pressure differentials
- Particle filtration
Energy Management System (EMS)
Integrated to optimize energy consumption and ensure efficient system operation.
Building Management System (BMS)
Configured to monitor and control critical cleanroom parameters, providing real-time oversight and alarm systems.
Cleanroom Equipment & Flooring
Supply and installation of all essential equipment and pharmaceutical-grade flooring with seamless finishes.
Electrical Systems
Complete electrical work including:
- Power distribution
- Lighting
- Emergency backup integrations
- Support for specialized pharmaceutical equipment
Every component was aligned with USP, GMP, and aseptic compounding standards.
Validation & Commissioning: Ensuring Complete Regulatory Compliance
To ensure the facility met all performance standards, our team conducted:
- Functional testing of all cleanroom systems
- Environmental monitoring
- Airflow and pressure validation
- Documentation for compliance audits
The facility was fully validated and ready for sterile medication production.
The Result: A Fully Compliant, High-Precision Compounding Facility
With our integrated approach, IV Compounding Pharmacy now operates in a sterile, safe, and high-efficiency environment built to support:
- Accurate IV medication preparation
- Regulatory compliance with stringent pharmaceutical standards
- Controlled, monitored, and stable cleanroom conditions
- Optimized workflow and operational excellence
Key Achievements
- Delivered a fully integrated sterile compounding cleanroom
- Implemented HVAC, BMS, EMS, and electrical systems with seamless compatibility
- Ensured total compliance with pharmaceutical cleanroom regulations
- Provided end-to-end engineering, installation, commissioning, and validation
- Enabled the client to prepare IV medications with enhanced safety and precision
What This Project Says About Us
This project demonstrates our ability to:
- Build sterile facilities where patient safety is the core priority
- Integrate high-complexity systems with precision engineering
- Deliver turnkey cleanroom solutions for healthcare and pharmaceutical environments
- Meet the most stringent regulatory requirements with confidence
Conclusion
The IV Compounding Pharmacy project stands as a testament to our commitment to engineering environments where sterility, safety, and precision coexist seamlessly. By combining advanced systems with meticulous design and validation, we delivered a facility that empowers safe and reliable IV medication preparation.
We don’t just build cleanrooms.
We build environments where patient safety begins.






