Validation

We’ve been providing validation services for the pharmaceutical industry in the UK for over 20 years. Our validation client base is large and varied, ranging from small businesses with a standalone benchtop unit through to large conglomerates with multiple storage chambers and walk-in rooms.

Our validation services for new and existing customers include:

  • On-site Installation, Operational and Performance Qualification (IQ-OQ-PQ) utilising our custom protocols and providing initial machine data for customer and regulatory audits
  • On-site Performance Verification (PV) conducted one year after initial IQ-OQ-PQ and annually thereafter. Our PV service includes ‘as found’ testing prior to interventional, critical instrument and preventative maintenance checks and final temperature and humidity datalogging studies. Use of this service allows an auditable machine history to be compiled for regulatory purposes
  • Performance Qualification via temperature and humidity mapping studies

We also perform on-site validation of third party equipment e.g. pharmaceutical units, blood banks, refrigerators, freezers, ultra-low temperature freezers and temperature sterilisation processes.

Tried and trusted validation capabilities

  • Only 21 CFR part 11 compliant datalogging systems are used for total data assurance
  • Datalogger measurements with 18 PT100 temperature sensors and 12 capacitive humidity sensors (sensor arrangement for each 21 CFR part 11 compliant equipment set). For larger installations, we are able to conduct performance testing with 36 PT100 temperature measurement sensors and 12 capacitive humidity sensors
  • UKAS traceable datalogging systems:  30 channel logging systems, 18 PT100 sensors, annually calibrated at 0°C, +25°C, +30°C, +40°C, +50°C. 48 channel datalogging system, 18 PT100 sensors calibrated 0°C, +25°C, +30°C, +40°C, +50°C, additional 18 PT100 sensors calibrated at -80°C, 0°C, +90°C and +180°C. Custom levels are available upon request
  • Unwitnessed testing as standard
  • Our engineers carry extensive parts and equipment Each vehicle is installed with a full racking system for maximum parts and equipment storage     
  • Photostability light mapping studies can be conducted at nine points on one, two or three planes
  • Validation of current, historical (units dating back to the mid 1990’s) and third party units
  • In the event of an unexpected equipment issue arising on-site, same visit repairs can be achieved
  • *Datalogger pre and post UKAS calibration
  • *Witnessed testing

* Special or prior arrangement only

If you would like further information regarding validation, please telephone Weiss Technik UK on +44 1495 305555 or email service@weiss-uk.com

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