Services

Commissioning, Qualification and Validation

 

UTILITIES

  • Water Systems (RO / WFI)

  • Compressed Gasses (Air, CO2, N2)

  • Steam (Plant, Pure)

BIOTECH EQUIPMENT

  • Bioreactors / Fermentors

  • MF / UF Skids

  • Chromatography Skids

STERILE 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

SOLID DOSAGE EQUIPMENT

  • Mills and Grinders

  • Granulators

  • Fluid Bed Dryers

  • Mixers, Blenders and Homogenizers

FILLING / PACKAGING EQUIPMENT

  • Packaging Equipment / Lines

  • Filling Machines

  • Vision Systems

  • Lyophilizers

SYSTEMS / PROCESSES

  • Clean-In-Place (CIP)

  • Steam-In-Place (SIP)

  • Biodeactivation / Kill Systems

  • HVAC

  • Environmental Monitoring

  • Process Validation

LABORATORY EQUIPMENT

  • HPLC, GC, FTIR, TOC, LAL

  • Incubators

  • Refrigerators / Freezers

  • Autoclaves / Ovens

VALIDATION

  • Risk Analysis / Assessments

  • Master Plans

  • Entire Facility Validations

    • Utilities

    • Production / Manufacturing Equipment

    • Laboratory Equipment

    • Computer Systems / Software

    • SIP / CIP

    • Process Validation

  • Site / Factory Acceptance Testing

  • Start up and Commissioning

Steam Quality Testing

 

Maine Validation, LLC has all of the necessary equipment and expertise to conduct Steam Quality Testing at your 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 KRA’s three decades of temperature mapping experience allow us to quickly and efficiently perform all of your temperature mappings.