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Validation & Qualification

Validation & Qualification

About

Why would you risk missing your important research deadlines due to invalidated instruments? Avoid a quality control disaster for your facility and let Scientific Calibration give you back your time and peace of mind!

Here at Scientific Calibration, we have over 25 years of experience validating and qualifying lab instruments to ensure they're working properly and fit your intended purposes, so you can get back to reaching your scientific goals.  With our equipment qualification services, you can be confident that your facility's instruments are installed, operating, and performing according to the manufacturer’s specifications. By fulfilling your lab’s preventative maintenance requirements, we can increase your lab's efficiency, reduce lost time due to equipment failures, decrease long-term equipment costs, and extend the life of your most crucial laboratory assets.

Installation Qualification

Installation qualification protocol verifies the proper delivery, installation, and configuration of your new instrument. This can include ensuring that necessary files have been loaded and the equipment has been properly installed according to manufacturer requirements. 

Installation Qualification often includes:

  • Facility & Environmental Requirements (including necessary floor space, power supply, ambient temperature, etc.)
  • Examining instruments and components for damage 
  • Checking software system installation and accessibility
  • Verifying connections and communication with peripheral devices

Operational Qualification

Operational Qualification is a collection of tests used to verify that the instrument is functioning according to the manufacturer's requirements in a variety of conditions. Operational Qualification is usually performed after installation qualification but before the system is released for use.

Operational Qualification often includes:

  • Temperature Control Systems 
  • CO2 Controls
  • Pressure and Vacuum Control
  • Humidity Levels and Control
  • Card Readers and Access Systems
  • Fan Controls and Speed

Performance Qualification

Performance qualifications are a collection of tests performed to verify that an instrument performs consistently and reliably under simulated real-world conditions, similar to those present in the lab facility the instrument will be used in.

Performance Qualification often includes:

  • Tests to ensure consistent quality and accuracy
  • Temperature Mapping
  • Open Door Testing
  • Process Validation
  • Testing functionality and safety

Consistency is important in performance qualification, therefore PQ test frequency is usually much higher than operational qualification. Testing can be performed each time the instrument is used or scheduled at regular intervals.

Equipment We Validate

Our skilled technicians have extensive experience validating the following equipment:

  • Autoclaves
  • Balances
  • Biosafety Cabinets
  • Bioreactors
  • Centrifuges
  • Chromatography Equipment
  • Dry Baths
  • Refrigerators
  • Freezers
  • Incubators
  • Ovens
  • Thermal Cyclers
  • Ultra-Low (-20°C, -80°C) Refrigerators
  • Water Baths

Don't see your equipment listed? Contact us for a full list of lab equipment we service. 

When Should My Equipment Be Validated?

Instruments should be regularly tested to confirm high-quality performance and to identify possible performance problems due to normal use or potential component failure. Times when it's most important to validate or qualify your facility's equipment include:

  • At the initial installation
  • After relocating the instrument
  • After additions, changes, or upgrades to the system
  • After planned maintenance
  • After a critical repair
 
Ready to get your lab equipment validated or qualified? Request a Quote and we'll get back to you as soon as possible.