Foster-Miller offers the pharmaceutical and biotech industries state-of-the-art laboratory and manufacturing automation and robotic solutions based upon a comprehensive integration of mechanical, electrical and software disciplines. For decades we have serviced pharmaceutical, biotech, medical device and biomedical companies, including Abbott Labs, Baxter Healthcare, Bayer, G. D. Searle, Glaxo, Johnson & Johnson, Medtronic, Roche Vitamins and the Cleveland Clinic Foundation. We add value to vendors (OEMs) who support pharmaceutical and biotech manufacturers by designing and fabricating custom add-on technology solutions for their equipment.  In addition, we provide our engineering services to pharmaceutical and biotech suppliers by designing and fabricating custom equipment that they use to manufacture their products.

Foster-Miller offers our FDA-regulated clients custom solutions that are based on innovative, emerging technology, and span the entire drug development continuum ranging from early discovery laboratory testing systems through late stage commercialization systems. Our cutting edge, automated solutions encompass all levels of systems, from stand-alone work cells to fully integrated enterprise solutions, including:

• Fully automated laboratory workcells used for sample preparation, handling and dispensing; stability, in-process and release testing.
• Fully integrated manufacturing workcells used for processing, assembly, packaging and cleaning.
• Laser-guided robotic sample transfer vehicles.
• Validated, GXP/Part 11-compliant, automated laboratory control systems,including bar code tracking systems.
• Turnkey Process Analytical Technology (PAT).
• Manufacturing/assembly systems for diagnostic test kits.
• Cold chain technology for the storage and transfer of temperature-sensitive products.
• Novel analytical chemistry instrumentation, including custom software and integration.
• Technology for the fusion of multiple analytical data sets into a single data set.

Foster-Miller carefully examines clients’ specific technical needs and business challenges then, working closely with their subject-matter experts as a cohesive team, we solve their problems by providing a unique engineering solution. Foster-Miller’s pragmatic approach includes a thorough evaluation of existing technologies that may be automated and integrated to provide an off-the-shelf solution; however, our forte is to provide a truly innovative solution that exceeds a client’s specific requirements and expectations. When a company cannot overcome a challenge using currently available technology, Foster-Miller can be counted on for a novel, practical approach that takes advantage of new technology, drawing upon our extensive and proven experience across a variety of industries.

Foster-Miller’s clients benefit from increased product quality, process efficiency, productivity, safety, and product differentiation with the ability to mitigate compliance risk and control costs. Our goal is to provide our customers with unique, technologically-advanced solutions that they can use today and will be in service for years to come.

Product Quality

FDA expects companies to develop, manufacture and provide the end user community with high quality, efficacious, and safe products. R&D, manufacturing, and QC processes impact these attributes. The equipment, instrumentation and systems used for these processes must add value to the process assuring that process specifications are consistently met so that the products’ pre-determined quality attributes are consistently met. Foster-Miller’s laboratory and manufacturing systems are designed, developed, built, tested, and validated to exceed the highest standards so that they contribute to the quality of the FDA-regulated products being manufactured.

Process Efficiency

FDA expects that companies understand the processes that they employ to develop, manufacture, test and store their products. Variations to a process must be understood so that their impact can be evaluated and their risk managed. Foster-Miller’s laboratory and manufacturing systems are designed to include PAT to measure and capture this vital, real-time data so that timely and informed decisions can be made. Increased process efficiency will result in higher quality, decreased waste, rework and retesting, enabling companies to control their costs.

Productivity

By understanding a process and utilizing high quality equipment, instrumentation and systems designed for its intended use, productivity can be optimized. Benefits include decreased process and cycle times and, combined with decreased waste, rework and retesting, provides increased yields and additional time for staff to perform their other functions. Foster-Miller’s automated systems increase productivity as well as decrease costs by replacing manual, repetitive activities allowing staff to perform more important activities.

Safety

Many processes and equipment involve an employee’s exposure to chemicals, biological agents, machinery, high pressures and temperatures, and a host of other risks. Properly designed, manufactured and maintained processes and equipment reduce an employee’s risk of injury. A fundamental, but sometimes overlooked, step in the design process is a risk assessment. Foster-Miller evaluates all potential types of risk, including operator safety, so that the appropriate measures can be identified and incorporated into the design, thus assuring safe operation.

Product Differentiation

FDA-regulated industries are very competitive and product differentiation and end user perception are very important. Foster-Miller’s solutions allow companies to differentiate their products from competing products contributing to increased branding, loyalty and market share.

Compliance Risk

FDA enforces its Good Laboratory Practice (GLP), Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP) regulations and expects companies to understand their processes and utilize equipment that was designed specifically for the process that it performs. Automated equipment and the software used to control the equipment must be designed and developed following a formal software development life cycle methodology such a GAMP4. These processes must be validated and all equipment qualified. Equipment also needs to be periodically maintained including calibration, maintenance, cleaning and re-validation following documented procedures. In combination, these activities reduce the potential risks associated with the process and equipment. Foster-Miller’s formal development lifecycle includes written procedures for requirements and specifications, software development, hardware configuration management, change control, risk management, validation, testing, etc. These disciplines contribute to a high quality, validatable and compliant solution.

Control Costs

A well-designed, developed and understood process that is executed using a well-designed, developed, built, and maintained equipment, instrument and/or system will enable a company to increase its efficiency and productivity while reducing the costs associated with process deviations and product that does not meet its pre-determined quality attributes. Every automated technology solution provided by Foster-Miller is designed and built with the intention and goal to reduce the manufacturing/testing costs while increasing product quality.

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