Whenever you consider asceptic processing a cleanroom qualification is an elementary part of you quality assurance. Its goal is to ensure that low contamination production conditions are generated and maintained throughout operations according to the cleanroom class as specified in ISO and GMP guidelines.
Rhumbline Consultancy develops detailed plans for the comprehensive qualification, requalification and monitoring of the cleanrooms and coordinates all the measurements and analyzes at all steps.
Once cleanroom certification takes place, we can coordinate ongoing routine monitoring services needed to maintain compliance as part of a complete environmental monitoring program. We can provide support for the development of cleanroom procedures, alert and action limits and training programs.