Cleanroom Facility Design and Renovations
Cleanrooms must be built or renovated correctly in order to provide safe, high-quality compounded preparations to patients. Hospitals and 503A pharmacies need to meet USP <795>, USP <797> and USP <800> standards while 503B outsourcing facilities must meet CGMP and follow 21 CFR 211. 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. Let us take the guess work out of designing a compliant cleanroom facility that will be engineered well to produce quality compounds and reduce the potential for contamination.
What We’ll Do
Develop the Cleanroom Layout & Specs
Select the Builder
Manage the Cleanroom Build-Out Project
Identify Appropriate Equipment & Materials
Design the Workflow & Customize Compounding SOPs
Train Key Personnel on Compounding
Prepare for & Conduct an Inspection Readiness Audit