Aseptic Fill and Finish
Bio-Concept’s aseptic manufacturing facility meets FDA (Food and Drug Administration) cGMP (current Good Manufacturing Practices) and EU (European Union) requirements for Phase 1 and 2 clinical trial product manufacture. The aseptic fill facility is monitored, controlled and recorded in real-time and serviced with our own WFI (Water for Injection) system. The HVAC (heating, ventilation, and air conditioning) system uses 99.99% efficiency HEPA (High-Efficiency Particulate Absorption) filters and is housed in an easily serviced mezzanine above the fill suite and below our roof, eliminating weather related malfunctions that can be prevalent in the New England region.
The flow of personnel and materials (raw material, in-process and final products and equipment) through our facility has been carefully designed, minimizing contamination and mix-ups, and follows cGMPs (current Good Manufacturing Practices).
With more than 20 years of experience in pharmaceutical research and manufacturing, Bio-Concept Laboratories understands the specific challenges aseptic fill-finish and manufacture presents.