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503B Cleanroom for Outsourcing and Repackaging Facility
As a registered 503B Outsourcing Facility with the Food and Drug Administration (FDA), this company specializes in drug compounding for ophthalmic and inhalation products. Mecart was selected by this southeastern contract development manufacturer (CMO) for their cleanroom project. Spanning nearly 3,000 square feet, the GMP-compliant cleanroom includes several fill suites, Personnel Airlocks (PAL), Material Airlocks (MAL), pass throughs, eyewash stations, and dedicated areas for visual inspection, labeling, packaging, staging and cartoning. There is also both an ISO 7 and ISO 8 corridor. Flush-mounted windows and automatic opening doors complete the state-of-the-art installation. A custom HVAC system was pre-assembled in our plant to provide quicker delivery and installation for the client.
Our timelapse video shows why clients keep choosing Mecart for their modular cleanroom. Built with heavy-duty panels, the cleanroom is structurally sound with a fully walkable ceiling. Cleanroom ceilings do much more than just enclose the clean room. Many of the fixtures and equipment necessary to keep the cleanroom functioning are housed or accessed via the cleanroom ceiling, such as this client’s interior lights, which are changeable from the exterior of the cleanroom – on the roof of the clean room.
FDA registered 503B Outsourcing Facilities can provide customized pharmaceuticals to surgery centers, hospitals and medical facilities. Patients being served by 503B facilities are assured that every batch of medication has been tested for endotoxins, sterility, and potency. Additionally, thanks to testing guidelines under cGMP compliance, 503Bs can offer longer beyond-use dating.