The need to comply with the environmental quality requirements set for clean rooms and controlled environments used in industrial sectors is having an increasing effect on facility design. Consequently, it is essential to be aware of the various solutions available and their technical and economic pros and cons. The most technologically advanced solution is not always the best solution — the best solution is the one that takes operating, maintenance and monitoring costs fully into account and meets requirements for the lowest possible investment.
Controlled environment designs and specifications must be submitted for validation prior to implementation. It is therefore not only necessary to detail user and functional requirements from the very beginning, but also to ensure the supplier meets the documentary requirements.
Collaboration between the various organisational departments involved in the project is essential. It is especially important for the Engineering and Validation departments to work together to develop the Master Validation Plan that will be one of the project's key documents.
The client must define the supplier's responsibilities in each project phase — Installation Qualification, Operational Qualification and Process Qualification.