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Validation and Qualification

Distek is committed to providing its customers with the most consistent, traceable results needed to satisfy regulatory requirements.

Distek is committed to providing its customers with the most consistent, traceable results needed to satisfy regulatory requirements.  Much like our philosophy for designing quality instruments, Distek's Validation Service Group utilizes highly skilled chemists and technicians that undergo comprehensive training and certification in all aspects of validation services.  Our product is our people, each of which had an unparalleled commitment to both customer service and assuring that your instrument is performing according to industry specifications.

 

  • Installation Qualification (IQ)  Will verify the system meets specifications as well as certifies the system is set up and installed correctly, in the right environment and ready for operational qualifications and performance qualifications.
  • Mechanical Qualification (MQ)  Certification that the mechanical performance of the system meets specifications and that the system is available for further performance qualification.
  • Performance Verification Test (PVT)  Ensures the system meets system suitability test requirements per USP <711> guidelines using USP tablets and reference standards.
  • Operational Qualification / Performance Verification (OQ / PV)  Verifies the system is functioning and that all critical operational parameters are within specifications while supplying the evidence needed to meet the requirements of regulatory agencies and makes certain your laboratory equipment performs within specified guidelines.
  • Preventative Maintenance (PM)  Servicing of equipment to confirm continued proper operation per the manufacturer’s specifications including the replacement of parts, inspection and replacement of electronic components, connections, switches, motors and more.
  • Multi-Vendor Services  Provides expertise and qualification services for Distek and non-Distek equipment. Contact Distek for specific instrument services.
  • SOP Writing  Saving valuable time and money, the validation services team can provide SOP’s to qualify your instruments as well as train your staff to execute them.
  • Validation Contracts  Eliminate worry while keeping costs down.
  • On-site or Deport Repair  Factory trained specialist who can provide repair at your lab or in our facility.
  • Training  Familiarization of your laboratory instrument delivered to one or many lab personnel.

All services may be customized to meet specific requirements. For more information, please contact your Distek representative or complete and submit the Service and Support Contact Form.

Instrument type* IQ PM OQ PV PVT USP Toolkit MQ ASTM-MQ
Content Uniformity Yes Yes Yes - - - -
Dissolution
Apparatus 1 and 2 Yes Yes - - Yes Yes Yes
Apparatus 3 and 7 Yes Yes - - - - -
Dissolution Auto Sampler Yes Yes Yes - - - -
Dissolution Media Preparation Yes Yes Yes - - - -
Dissolution Vessel Washer Yes Yes Yes - - - -
Disintegration Yes Yes Yes - - - -
Friability Yes Yes Yes - - - -
Hardness Yes Yes Yes - - - -
Tapped Density Yes Yes Yes - - - -
UV Fiber Optic Dissolution Yes Yes Yes Yes - - -
UV/Vis Spectrophotometer Yes Yes Yes Yes - - -

* Please contact your Distek representative for more information concerning your specific make and model.

Request Support

Technical Service and Validation Support Form is provided by Distek to make contacting our company easier.