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Facility Validation Support

GMP Laboratory Testing / Microbiology / Facility Validation Support

Pace Analytical Life Sciences provides clients with a comprehensive range of analytical services to support the validation of pharmaceutical facilities. Our analytical testing services provide support for the validation of purified water systems, clean steam systems, compressed gases and clean rooms. We can help our clients’ commission new facilities, perform on-going qualification services as well as decommission existing facilities. All of this work is performed in strict compliance to cGMP requirements following USP, EP, JP, ISO or client specific requirements. We have extensive experience in purified water testing, clean steam testing, USP purified water system validation, DI water system validation, compressed gas testing and clean room testing.

The facility validation support services that we provide for Purified Water Systems and for Clean Steam Systems are:

  • TOC
  • Conductivity
  • pH
  • Calcium
  • CO 2
  • Sulfate
  • Ammonia
  • Ammonium
  • Nitrite
  • Nitrate
  • Hardness
  • Iron
  • Manganese
  • Chromium
  • Residue on Evaporation
  • Heavy Metals
  • Oxidizable Substances
  • Potassium Permangenate Reducing Substances
  • Microbial Limits
  • Endotoxins
  • Particulates
  • Sterility

The facility validation support services that we provide for Compressed Gases (Compressed Air, Medical Air, Argon, Carbon Dioxide and Nitrogen) are:

  • Moisture (Dew Point)
  • Hydrocarbons
  • Pressure
  • Oil Mist
  • Water and Oil
  • Identification
  • Purity
  • Oxygen Content
  • NO 2/NO
  • Carbon Monoxide
  • Sulfur Dioxide
  • Hydrogen Sulfite
  • Ammonia
  • Triethylamines
  • Carbon Dioxide
  • Particulates
  • Endotoxins
  • Microorganisms

The facility validation support services that we provide for Clean Rooms are:

  • Particles – Airborne (0.3 mm – 5 mm)
  • Surface Swabs – TOC
  • Surface Swabs – Microorganisms
  • Contact Plates
  • Airborne Microorganisms – Settling Plates
  • Airborne Microorganisms – Active Samplers (RCS)

Pace Analytical Life Sciences brings years of experience performing facility validation projects. We can provide on-site sample collection services and we can provide sample containers at no charge. We bring the highest level of quality and attention to detail to our clients to assure that their facility validation programs are successfully executed.

We are FDA registered, DEA registered, cGMP compliant and ISO/IEC 17025 accredited.