Instrument IQ/OQ Support

Automatic Integrity Testing Validation

This program provides on-site installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) in order to validate your automatic filter integrity tester. Unlike automatic integrity testing, manual integrity testing is prone to a high degree of operator subjectivity and influenced by many testing variables. These factors can cause inconsistent and inaccurate test results.

Automatic integrity tests have become the preferred method of integrity testing for biopharmaceutical processing. Automatic testing provides consistent, accurate and reproducible results that are not altered by operator subjectivity. These characteristics facilitate validation of automatic integrity testing.

Key Benefits

• Test protocol generation (IQ, OQ)
  
• On-site qualification testing
  
• Recommendations for PQ/ongoing maintenance
  
• Comprehensive qualification report supplied upon completion

Why Is Qualification Needed?

Millipore performs extensive product qualification testing prior to market release. This testing includes independent hardware, software and integrated system testing. Despite this detailed qualification, regulatory agencies require the end user to validate automatic integrity testing instruments in the environment where they are used.

A Millipore Validation Specialist will provide protocols and on-site services to expedite required automatic integrity tester validation. Millipore will work with the end user to conduct test protocols including IQ and OQ. As part of this validation service, Millipore Validation Specialists will provide protocols and a comprehensive final report documenting all testing and results. Recommendations will be made for testing worst-case and normal operating conditions of the instrument, Performance Qualification (PQ) and on-going maintenance.

Areas Evaluated

IQ

• Documentation Review
  
• Utilities Review
  
• Materials of Construction Review
  
• Instrumentation/calibration
  
• Software verification/maintenance

• Password security
  
• Error handling
  
• Test accuracy, reproducibility, sensitivity
  
• Disaster recovery
  
• Data storage accuracy

TFF System Validation Support

Tangential flow filtration is a common unit operation in biopharmaceutical manufacturing. As part of manufacturing process validation, TFF systems must be fully qualified, including installation qualification (IQ), operation qualification (OQ), and performance qualification (PQ).