CH2M HILL

Biotechnology & Bioprocess

CH2M HILL's experience in biotechnology/bioprocess industries focuses on helping you solve process problems while reducing costs and enhancing competitiveness and profitability. We work with you to identify critical issues during design to ensure that your time to market is minimized after the initial capital is invested.

Our expertise in Biotechnology & Bioprocess includes:

• Containment
• Biosafety
• Environmental monitoring
• Process design
• Closed systems
• Cleanability (CIP/SIP)
• Heat removal systems for large batch fermentation
• High efficiency harvesting/product recovery and purification
• Waste inactivation systems
• Facility design
• Defined areas for different manufacturing and testing activities
• Use of cGMP materials and surfaces
• Unidirectional flow of material, product, and personnel

Current Good Manufacturing Practices (cGMP)

To successfully implement the design of a fully validatable pharmaceutical facility, it is essential that the design team have a detailed understanding of the regulatory requirements of the nation where the facility will be constructed and where the manufacturer's product will be sold. Further, it is often necessary to review special features of a project at the beginning stages with the FDA, or its counterparts in Europe and Asia, to ensure that they are carried out in a manner that assures regulatory approval.

CH2M HILL has developed a professional staff with an extensive knowledge of regulatory requirements throughout the world including the United States, the European Economic Community, and the Pacific Rim. Our in-house cGMP expertise ensures that your project will meet or exceed all applicable regulatory requirements for production equipment, piping design and layout, materials construction, movement of materials and personnel, control of environmental conditions, clean in-place and sanitation systems, and critical utilities such as purified water, clean steam, and air.

Modular Systems

CH2M HILL has specific expertise in identifying and implementing a wide range of modular and disposable solutions for both chemical and biotechnology manufacturing facilties. Modular solutions can also extend to the laboratory; with specific clean room and lab work space applications. Our ability to objectively select the right solution for your project provides significant value without compromising technical excellence.

Packaging

Our expertise in the entire fill/finish/package arena is second to none. With a unique combination of manufacturing technologists, process engineers, and packaging specialists, we are able to develop state-of-the-art solutions to your finishing problems.

Process Design

Our process design experience covers the full range of pharmaceutical processing, from bulk products to fill/finish. Because of our years of commitment servicing the pharmaceutical industry, we have developed a large staff with specific pharmaceutical process and manufacturing expertise.

We also have extensive experience and depth of resources with the "building side" of process design, including such inherently process-related activities as the design of HEPA ceilings, GMP spaces, laminar flow air supply systems, process exhaust, and emissions control systems.

Regulatory Compliance

CH2M HILL takes a comprehensive view of all your compliance needs for FDA approval: from installation, operation, and performance qualifications to cGMP/QSR audits, CFR computer system audits, and documentation reviews. We not only create your validation master plan but also offer all the resources you need to execute an integrated commissioning and qualification program, including training for your personnel in compliance principles, preparation, and execution. Our risk-based approach is in line with FDA expectations and ensures an efficient program with assured compliance. In addition, we offer a full slate of compliance related consulting services to set the stage for a fully validated operation.

Systems Integration

CH2M HILL integrates process control, automation, materials handling, and related systems to help your operations increase efficiency and reduce costs. Services include hardware and software specification, procurement, and installation. Since it deals with the very nervous system of your plant, systems integration is a crucial factor for improving throughput as well as information management in your operations.

Environmental Management

CH2M HILL can help you manage all aspects of site, ecological, and natural resource stewardship, including planning, assessment and investigation, cleanup, monitoring, operations and maintenance, and total utility management.

We craft strategies for you that integrate regulatory, technical, financial, project delivery, and risk management solutions. This results in cost-effective characterization and remediation and environmentally defensible and ecologically sustainable solutions.

Integrated Water Management

CH2M HILL provides integrated water management services that span the full envelope of an industrial facility from water resources management and planning, engineering, and construction through full operations. Our knowledge of manufacturing and production processes; the intricacies of water, wastewater, and storm-water management and treatment; and the complexity of operating and maintaining treatment facilities are unique among our engineering and construction competitors.

The services that we provide include:

• Waste minimization and regulatory negotiation/permitting
• Integrated water management
• Urgent response
• Holistic capital expansion
• Contract operations