PHARMACEUTICAL FACILITY

Grade A&B Pharmaceutical Cleanrooms (Design-Build)

Sanford, NC
Completed 2022
Cleanroom interior
HVAC system

Project Overview

We partnered with Cleanroom Construction Associates, Hodess Cleanroom Construction and Gamewell Mechanical to deliver a turn-key Design-Build 60,000 square foot pharmaceutical cleanroom facility for a leading pharmaceutical company. The project involved creating Grade A (ISO Class 5) and Grade B (ISO Class 7) cleanroom environments compliant with FDA cGMP and EU GMP Annex 1 requirements.

Key Features

  • ISO Class 5 (Grade A) and ISO Class 7 (Grade B) cleanrooms with unidirectional airflow and cascading pressure control
  • Redundant HVAC systems with 24/7 monitoring for temperature, humidity, and pressure differentials
  • Fully validated systems with comprehensive IQ/OQ/PQ documentation
  • Specialized process chilled water systems for bioreactors and purification equipment
  • Two (2) new custom 25,000 CFM make-up air handling units
  • Thirteen (13) custom recirculation air handling units (8,000-32,000 CFM)
  • Hazardous exhaust system with N+1 redundancy
  • Ethanol exhaust system with N+1 redundancy
  • Dedicated tool exhaust systems (N+1 redundancy)
  • General exhaust fans (N+1 redundancy)

Challenges & Solutions

The facility required maintaining tight environmental controls (±0.5°C temperature and ±3% RH) while accommodating large heat loads from process equipment.

Our solution incorporated precision air handling units with proportional-integral-derivative (PID) control algorithms and rapid response cooling coils to maintain stability during equipment heat load fluctuations.

Structural Integration Challenge

The facility was built inside an existing two story shell building. All our mechanical systems had to be supported independently from the original building structure. Our design included custom pipe racks that were prefabricated off site and shipped in sections to the facility. Coordinated shipping splits for custom air handling units to fit down narrow service corridors. The AHU installation was closely coordinate with the prefabricated pipe rack installation. All utilities were installed successfully and without issue.

Project Details

Client

Leading Biotech Company

Size

60,000 sq ft

Completion

June 2022

Services

  • Cleanroom Design
  • HVAC Validation
  • Process Piping
  • Building Automation

HVAC Systems

  • (2) × 25,000 CFM MAUs
  • (13) Recirc AHUs (8K-32K CFM)
  • Hazardous Exhaust System (N+1)
  • Ethanol Exhaust System (N+1)
  • Dedicated Tool Exhaust systems (N+1)
  • General Exhaust Fans (N+1)

Technical Specifications

HVAC Systems

  • (2) × 25,000 CFM make-up air handling units
  • (13) custom recirculation AHUs (8,000-32,000 CFM)
  • Hazardous Exhaust System (N+1) + Ethanol Exhaust System (N+1)
  • Dedicated Tool Exhaust Systems (N+1) + General Exhaust System (N+1)
  • HEPA filtration (99.99% @ 0.3μm)
  • Temperature control: ±0.5°C
  • Humidity control: ±3% RH

Utilities

  • Chilled water (40°F supply)
  • Nitrogen and CO2 distribution (PSI as required)
  • Emergency power (N+1 configuration)

"Essential Engineering delivered a facility that exceeded our expectations. Their attention to detail in cleanroom design and validation was instrumental in our successful FDA inspection."

John Smith

Director of Facilities, Client Company

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