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Projects

Wet Process Manufacturing Suites Design

Renovations improve process flows, mitigate risks, and increase product yields.
  • Interior view of production room showing moveable racks, stainless steel work surfaces, and control systems - Gannett Fleming.

    New environmental controls and process flows have dramatically increased product yields.

  • Several large, stainless steel freezers along a corridor within the facility - Gannett Fleming.

    Relocated freezers streamline raw material flow and reduce contamination risks.

  • Glass doors with signs indicating the status of an enclosed sterile manufacturing lab - Gannett Fleming.

    The new layout and room finishes make it easier to maintain sterile manufacturing labs.

  • Green monitor displaying temperature, humidity and room pressurization data being collected for individual manufacturing labs - Gannett Fleming.

    New electronic data historians replace existing chart recorders to archive temperature, humidity and room pressurization data.

  • Open panel showing the interior of a rooftop air handler controller - Gannett Fleming.

    Engineers wrote and executed cGMP compliant Installation and Operational Qualifications (IOQs) for HVAC systems.

  • Computer screen displaying a three-dimensional image of an air handling unit with buttons to monitor and control various functions - Gannett Fleming.

    Engineers designed a new Graphical User Interface to provide user-friendly access to air handling unit controls.

Client
Confidential Client
Location
New Jersey
Our Role
Architecture, Mechanical, Electrical, Project Management, Commissioning, Validation
Data
Size:
2,300 square feet
Construction Cost:
$2.5 million
Completed:
2014
Type:
Renovation
Duration:
7 months
Outcomes
  • Renovations dramatically increased product yields from 48 percent to 97 percent
  • Streamlined process flows reduce contamination risks for in-process materials
  • Temperature, humidity, and pressurization controls ensure a safe manufacturing environment
  • New layout and finishes make manufacturing spaces easier to clean and maintain
  • Remote HVAC air distribution and balancing provisions allow for system rebalancing without disturbing clean rooms. 

As a global leader in medical technology, our client provides physicians with innovative products used in neurosurgery, orthopedic, reconstructive, and general surgery. Its New Jersey facility produces collagen products for a variety of sensitive medical applications, including wound healing, soft tissue repair, and bone regeneration. 

Biotechnology manufacturing environments must be carefully controlled to ensure the safety and efficacy of collagen-based products. Problems with pressurization and relative humidity can trigger unwanted biological activity, contamination, and low product yields. Gannett Fleming worked with the client to redesign its wet processing manufacturing suites and improve environmental controls in order to boost productivity.

What We Did

Gannett Fleming provided programming, design, project management, and documentation consulting services for renovations to improve mechanical systems, material flow, and plant efficiency. By reconfiguring the receiving area, the unloading process was streamlined. Frozen tissue now moves directly into the appropriate quarantine freezers prior to quality testing, eliminating the need to move materials twice and reducing the risk of contamination. New easy-to-clean room finishes, including laminated walls, a pre-engineered ceiling with HEPA filters, and epoxy floors, comply with ISO 7 requirements and ensure a sterile environment. New lighting and reconfigured spaces also create more user-friendly work areas.

Engineers developed air balancing and room pressurization plans that include instrumentation and ISO classifications in compliance with Food and Drug Administration documentation standards. New HVAC air balancing provisions also allow above roof room-by-room air system rebalancing without disturbing clean rooms. Gannett Fleming designed and commissioned a new HVAC system that includes air handlers, steam generators, exhaust fans, a process chilled water skid, and VFD fan-powered HEPA filter units. The new control systems continually monitor temperature, humidity, and pressurization in individual rooms, and a series of colored lights informs operators if requisite room conditions are satisfied before cGMP materials are exposed to the environment. The updated controls have dramatically improved product yields from 48 percent pre-renovation to 97 percent post-renovation.

Key Features

  • New cGMP compliant control system uses an open protocol JAVA based PLC to reduce programming and service costs
  • New HVAC, monitoring, and control systems assure proper temperature, humidity, and pressurization to reduce the risk of product contamination
  • System of colored lights indicates whether individual room conditions are safe for manufacturing
  • Relocated storage freezers eliminate the need to move raw materials twice prior to manufacturing.

Similar Projects: Commercial/Industrial, Facilities, Commercial/Industrial: Life Sciences, Facilities: Life Sciences