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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.

Why choose Distek for your Validation and Qualification Services?

Distek provides a large variety of service and validation offerings. All qualifications include cGMP documentation with evidence and verification according to the most recent USP/ASTM specifications. After execution of the applicable tests, Distek's validation engineer will prepare a comprehensive final report. All Distek field service engineers are industry professionals, thoroughly trained and certified with hands on experience. Distek has been an ISO 9001 certified since 2002.

  • Installation Qualification (IQ) Provides documented evidence to verify that the system was received in good condition and meets manufacturer’s specifications. The IQ certifies that the system is set up and installed correctly in an appropriate environment and properly prepared for the operational and performance qualifications. Installation Qualification should be performed at installation or after an instrument relocation.
  • Mechanical Qualification (MQ) Verifies that the mechanical performance of the dissolution system meets specifications, is functioning properly, and is available for further performance qualification, if applicable. Services include comprehensive testing of the instrument using specialized, certified validation tools to ensure that the equipment meets current Good Manufacturing Practices (cGMP) standards. The test is executed in accordance with the more rigorous ASTM E2503-XX and/or USP Toolkit Procedure.
  • Performance Verification Test (PVT) Formerly referred to as the Prednisone “Calibrator Tablet” Performance Qualification (PQ), this test ensures that the apparatus meets system suitability test requirements per USP <711> guidelines. The PVT employs USP 10mg Prednisone tablets and reference standards. This process assures reliability of dissolution results that reflect the quality of the drug product.
  • Operational Qualification / Performance Verification (OQ / PV) Verifies that the system is functioning correctly and that all critical operational parameters are within specifications. An OQ report makes certain your laboratory equipment performs within the manufacturer’s operational guidelines and supplies the documented evidence needed to meet the requirements of regulatory agencies.
  • Preventative Maintenance (PM) Servicing of equipment to confirm continued proper operation per the manufacturer’s specifications including the replacement of certain parts, inspections, adjustments, documenting all the critical steps performed and more. Annual or semi-annual preventative maintenance (PM) visits help ensure the accuracy of your analytical results and increases instrument uptime, all while reducing repair costs.
  • Validation Contracts Offer priority, pre-planned scheduling which eliminates worry and allows analysts to focus on analytical results, not the validation of the instruments. Prescheduled annual or semi-annual qualification and preventive maintenance services help avoid downtime and optimize performance. 
  • Multi-Vendor Services Allows access to our expertise and qualification services for both Distek and non-Distek equipment. Eliminates the hassle of maintaining multiple vendors.
  • Training Ranges from basic familiarization to advanced user training which can be tailored to your specific needs. Our knowledgeable trainers and consultants use their firsthand experience to help you manage your team’s requirements. We offer virtual and on-site, one-on-one or group training.  
  • Technical Support Our technical support staff is made up of highly experienced service engineers and validation experts that are on-call and ready to support your team with technical issues or questions over the phone, email, and Live Chat.
  • Set Up Includes instrument unboxing and installation for your delivered product.
  • On-site or Deport Repair Factory trained specialists are available to provide instrument repairs onsite at your location or in our facility.
  • Validation Tool Recalibration Performed in house by our trained technicians. All tools arrive ready-to-use with National Institute of Standards and Technology (NIST) traceable calibration certificates. 

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.

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