COMMISSIONING, QUALIFICATION & VALIDATION

Maine Validation, LLC has 30+ years’ experience working in the pharmaceutical, medical device, biotech, animal health, cosmetic, and tissue industries. At Maine Validation we work with our clients to deliver the highest quality services. All our services are based on a philosophy of integrity and excellence through personalized, experienced resources. We have worked with large multinational corporations and small biotech startups so whether your project is a new facility or a small expansion, Maine Validation will provide prompt, cost effective, superior services. At Maine Validation our goal is not simply to deliver the best services, but to ensure that our customers meet their goals.

 

Contact Us

P.O. Box 501
Harpswell, ME 04079

gary@mainevalidation.com
(207) 319-2586

Services


Commissioning, Qualification, and Validation

 

Utilities

  • Water systems (RO / WFI)

  • Compressed gasses (Air, CO2, N2)

  • Steam (Plant, Pure)


Biotech Equipment

  • Bioreactors / Fermenters

  • MF / UF Skids

  • Chromatography


Sterilizing Equipment

  • Autoclaves / Sterilizers

  • Depyrogenation Ovens / Tunnels

  • Glassware / Parts / Stopper Washers


Automation / Computer Equipment

  • PLCs and Computer Software Applications

  • SCADA Systems

  • Building / Facility Management

  • 21CFR Part 11 Assessment / Remediation

  • LIMS



Steam Quality Testing

 

Maine Validation, LLC has all of the necessary equipment and expertise to conduct Steam Quality Testing at our facility!

Maine Validation’s expert staff can provide steam quality testing in order to meet the Health Technical Memorandum (HTM-2010) and European standard (EN-285). Maine Validation’s SQT service can assist in identifying adverse steam conditions that may be negatively impacting product quality, productivity, downtime, and energy use.


Temperature Mapping

 

Using the latest in wireless data logger technology as well as traditional wired applications, Maine Validation’s three decades of temperature mapping experience allow us to quickly and efficiently perform all of your temperature mappings.