Controlled Environment Planning is Everything: Avoiding Mistakes in Cleanroom Construction

Related Vendors

Glatt Ingenieurtechnik GmbH

DÜPERTHAL Sicherheitstechnik GmbH & Co. KG

Elementar Analysensysteme GmbH

It’s hard to imagine a pharmaceutical industry without cleanrooms, which have to meet increasingly stringent requirements. From the very beginning of a project, companies should involve an experienced planner to build or redesign a cleanroom. Coordinated communication between the various suppliers then ensures both efficient implementation and regulatory compliance.

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 (SOPs) and other customer-specific documents that describe and define the project criteria. Current good manufacturing practice (cGMP) regulations and country specific requirements must also be acknowledged, so that engineering can take every requirement 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 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.