Pharmaceutical & Biotech

Right Expertise & Experience

Since 1997, Applied Control Engineering, Inc. (ACE) has been working in the pharmaceutical and biotech industries, giving us the necessary perspective to complete your project in a way that supports both business needs and addresses regulatory concerns.

Customers include a majority of the Big 10 Pharma as well as a number of biotech and life science companies, such as GlaxoSmithKline, Wyeth, and Amgen.

Our expertise spans from lab, pilot and full-scale processing to packaging lines and warehousing.

Supporting Your Regulatory Compliance

ACE knows that for our customers meeting FDA regulations is not optional. We understand the requirements introduced by working in regulated environments, including 21 CFR Part 11, and can also offer services to support a risked-based approach to validation.

Our ISO 9000-based quality standards ensure that the systems we program perform to specifications and are properly documented to withstand the scrutiny of federal regulators.

In addition, our quality system incorporates current GAMP best practice guidance and directs the methodologies we employ during design, development, and validation.

Project Experience

ACE has a wide range of project experience in the pharmaceutical and biotech industries including:

  • Bioreaction
  • Blending
  • Clean-In-Place (CIP)
  • Drying
  • Fermentation
  • Filling
  • Filtration
  • Formulation
  • Granulation
  • Lyophilization
  • Packaging
  • Stability chamber monitoring
  • Sterilization-In-Place (SIP)
  • Tabletting
  • WFI systems
  • USP water systems