The planning and design of HVAC systems for EU GMP Annex 1-compliant cleanroom facilities continue to be a core element of new construction and renovation projects.
This presentation examines relevant aspects from technical planning and GMP perspective considering different viewpoints and practical experience, while discussing possible solutions.
The intended use of pharmaceutical cleanroom facilities can significantly impact the technical planning. Intensive coordination and consultation between all stakeholders are essential in order to ensure GMP-compliant routine operations.
Air flow management in the cleanroom is a key success factor and is defined during the planning stage through technical design. The air-flow elements must be positioned optimally, taking into account later operational conditions.

How can air flow volume (formerly air change) be designed and qualified? What has proven effective in practice?
Can planning be optimised through simulation and subsequent verification through visualisation?
How can reduced operation be implemented and qualified in a compliant manner?
How can commissioning and qualification be efficiently coordinated and combined?