Cleanroom Planning It’s All in the Details: Planning Cleanrooms, But Doing it Right!

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Glatt Ingenieurtechnik GmbH

DÜPERTHAL Sicherheitstechnik GmbH & Co. KG

TRM Filter d.o.o.

GMP requirements for low-particle manufacturing conditions can only be met with cleanrooms. An essential success factor for new buildings and conversions, holistic cleanroom planning with expert support brings together various engineering disciplines and interfaces to showcase why the devil is in the detail.

Cleanroom technology is the be all and end all in pharmaceutical production; yet, there’s a lot to consider when planning new cleanrooms, which is why, right from the start, companies that are redesigning or converting their cleanroom ideally involve an experienced planner as a partner. At this early stage, it is particularly important to define the technical specifications, URS (User Requirement Specifications), standard operating procedures and other customer-specific documents that describe and define the project criteria. Current GMP regulations and country specific requirements must also be acknowledged, so that engineering can take all requirements into consideration.

Once the “requirements catalog” for the project has been drawn up, the real challenge begins: the coordinated interaction of the various disciplines. Detailed consultations with the cleanroom experts at regular and closely timed intervals are absolutely essential. After all, every element must meet strict requirements to comply with cleanroom conditions — from electrical installations and furniture to any fixture that directly touches or penetrates the wall, ceiling or floor.