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Drug compounding is the preparation of a medical formulation to meet the specific needs of a patient that cannot be met with commercially available products. This may be done for many reasons such as to change a delivery method, to avoid a non-active ingredient to which the patient is allergic, or to provide an exact dose that is not commercially available. Compounding may also be done for medically optional reasons, such as preference of flavor or texture, or dietary restrictions.

503A compounding pharmacies are those that compound according to prescriptions specific to a patient only for home use and in small batches. 503A’s are required by state boards of pharmacy to comply with USP 795, 797, USP 800, and other guidelines. 

503B compounding pharmacies may manufacture large batches with or without patient specific prescriptions with these medicines intended to be sold to and used within healthcare facilities. 503B’s are required by state boards of pharmacy and the US Food and Drug Administration to comply with USP 795, 797, USP 800, along with FDA cGMP guidelines. 

Germfree’s bioGO USP 797/800 compliant biocontainment cleanrooms are, pre-designed and adaptive to provide an offsite built, process ready solution for compounding pharmacy applications, available in 3 primary platform technologies:

·        Mobile (mobile trailer/vehicle platform)

·        Module (self-contained cleanroom module platform)

·        Modular Cleanrooms (integrated, interconnected, multi-module, structural building platform)

Germfree’s advanced process and biosafety equipment is purpose built to meet client user requirements and includes:

·       Class II Biological Safety Cabinets

·       Cleanroom Pass-Throughs

·       Laminar Flow Hoods

·       Compounding Aseptic Isolators

·       Powder Containment Hoods

·       Radiopharmacy Compounding Aseptic Containment Isolator

·       Radiopharmacy Class II Biological Safety Cabinets

·        Cleanroom Tables, Shelves, and Workstations

Speak with an Expert today to learn more about how Germfree can amplify your process.

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Robust Experience

Germfree consistently delivers exceptional Pharmacy compliant products around the globe. Browse the grid below to see a selection of relevant past projects:

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Germfree BioPharmaceutical Trailer
Pharmacy Trailer II at Sundown