IV COMPOUNDING PHARMACY

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.