Mikart Case Study – HVAC for Pharmaceutical facilities

 

INTRODUCTION

Mikart, Inc., located in Atlanta, GA, offers a full range of integrated services, technology and support for the development, manufacturing and packaging of solid dose and non-sterile liquid pharmaceuticals for clients that include PhRMA, specialty pharma, and biotech companies. Obtaining US Food and Drug Administration approval and maintaining compliance is paramount to ensure safe and adaptive business operations. Air quality, air flow and environmental conditions are key parameters that must be monitored and sustained to ensure FDA compliance and Mikart, Inc. needed a customized air-handling solution for their pharmaceutical packaging and cleanrooms.

CHALLENGE

The packaging room required a consistently-controlled pressure differential to comply with US Food and Drug Administration regulations. Mikart also stores 55-gal drums of alcohol, requiring a room that could withstand an explosion, demanding a stable temperature and pressure balance. In general, pharmaceutical handing facilities include areas that must remain cleaner than surrounding areas and kept under specific pressurization to reduce the chance of airborne contamination. This is achieved by utilizing a HVAC system that both mechanically pushes and ventilates air from that same space. The performance, maintenance and monitoring of the air handling system in pharmaceutical manufacturing and packaging is critical to achieve the stringent minimum environmental conditions as outlined by the Food and Drug Administration. Additionally, air balance and pressure between processing rooms and the external environment is equally important to comply and maintain an aseptic packaging environment. Chemical handling and storage practices are equally as critical to comply with quality, safety and environmental requirements. Without a proper HVAC system in place, Mikart risked loss of their FDA certification and ability to operate.

THE R&D MECHANICAL SOLUTION

Mikart had previously attempted to decrease the room pressure by manipulating the outside pressure to adjust air flow coming into the room. This in-house strategy proved unstable and unreliable for a long-term, permanent solution. R&D Mechanical Services was contracted to evaluate and propose a customized HVAC solution to improve the pressurization in the packaging room. R&D Mechanical Services, Inc. captured existing conditions of key parameters (i.e. temperature, humidity, pressures, filtration, and airflow) and conducted two trials over a two-week period to determine how much air needed to be ventilated from the packaging room. Utilizing built-in pressure monitors and temporary fans, R&D Mechanical Services, Inc. monitored room pressure by incrementally adjusting fan speeds. Once ideal conditions were established, system requirements and setpoints were developed and R&D Mechanical Services, Inc. engaged a mechanical engineer to design a more precise, permanent solution based on the results of the trial. Upon design completion and equipment purchases, R&D Mechanical Services, Inc. coordinated with a roof contractor to complete a two-day installation limiting disruption to business operations. Installation was followed by testing and commissioning of the ventilation units.

RESULTS

In addition to achieving required room conditions, R&D Mechanical Services, Inc. was able to achieve repeatability by retrofitting an additional 4 out of 7 rooms with new ventilation systems to maintain the required pressure differential. MiKart has maintained their compliance with FDA regulations and continues to provide safe, quality, and aseptic packaging solutions to their clients.