Cleanroom Facility Design and Renovations

Cleanrooms must be built or renovated correctly in order to provide safe, high-quality preparations to patients. Hospitals and pharmacies need to meet USP standards (e.g.; <795>, <797>, <800>) while 503B outsourcers, cell & gene labs, and drug manufacturers must meet CGMP and follow pertinent FDA guidance and CFRs. Since this type of project is expensive and can take many months to complete, you want to make sure it gets done right the first time. We take the guesswork out of designing and building compliant cleanroom facilities—engineered to minimize contamination & support high-quality drug production.

 

What We’ll Do

 

  • Develop the Cleanroom Layout & Specs

  • Offer a Selection of Build-Out Teams

  • Support the Cleanroom Build-Out Project

  • Identify Appropriate Equipment & Materials

  • Design the Workflow & Customize SOPs

  • Train Key Personnel

  • Conduct an Inspection Readiness Audit