AMCBP Helps Compounding Facility Meet cGMP Regulations
AM Cleanroom Build and Performance (AMCBP) was hired to propose a new cleanroom facility for a 503B outsourcing compounding facility. During the site walk to discuss plans for the new design-build project, Robert Logston, Cleanroom Division Leader, observed that the company’s existing facility was not compliant with Current Good Manufacturing Practice (cGMP) regulations.
Because the customer was ready to process in the existing facility, the cleanroom project team quickly assembled a new proposal for the required repairs and upgrades.
The cleanroom team installed coving at all wall-floor and wall-wall intersections, caulked joints, and relocated the door and window to increase efficiency. We also installed a stainless steel hands-free sink, added a hands-free door opener, and performed minor repairs to the existing ceiling and floor.
“We were able to mobilize a project team to fast-track completion of the project, bringing the compounding facility into cGMP compliance quicker than the customer expected,” said Robert Logston, Cleanroom Division Leader.
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