Biopharmaceuticals & Life Sciences
Automation and Systems Integration
Harris Group`s process automation team can help design efficiencies into your manufacturing processes. We understand the life sciences industry: PAT, computer system validation, radio frequency identification and OEM compliance.
Facility Design
Harris Group offers a wide range of engineering and architectural design services to solve your facility design challenges. We combine our highly integrated multi-discipline team to establish your requirements up front, and then deliver to the time line and budget established. We understand the need for effective project execution. Our customers have experienced a scarcity of money, resources and time, which has become the norm in our modern business climate. Harris Group is aware of your situation. Our project execution addresses these challenging times with a proven approach including our time-tested methodology, highly integrated multi-discipline team, and focused customer working relationships.
Process Engineering
Harris Group has extensive experience in the design, installation and renovation of biopharmaceutical and pharmaceutical facilities. From bacterial and antibody reactors to chemical Active Pharmaceutical Ingredients (API) production, our expertise includes laboratory and pilot plant facilities for research and production from gram to multi-kilo clinical batch and scale-up to commercial manufacturing plants.
Regulatory Compliance
Harris Group has developed a professional staff with an extensive knowledge of regulatory requirements. Our in-house cGMP expertise ensures that your project will meet or exceed all applicable regulatory requirements for process validation including 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. We also support our customers with assistance in quality assurance programs and documentation in support of FDA and EU submissions.