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Foster Pharma’s Certified Clean Room
Foster’s Bioactive/Pharmaceutical melt extrusion is performed in a cGMP clean room polymer melt extrusion operation within our company’s 45,000 sq. ft. biomedical research and production facility. This dedicated operation includes 900 square feet of class 100,000 rated space. Quartz/epoxy seamless floors, a dedicated fume and dust collection system, interlocked pass-through chamber for materials, and an interlocked gowning room for personnel provide an ideal setting for pharmaceutical processing requirements. Temperature controls of ±2° F and humidity controls maintain a constant operating environment at all times.
Melt extrusion within the clean room is performed by a high precision Leistritz ZSE-27mm twin screw extruder that incorporates cGMP design for medical and pharmaceutical applications. This dedicated extruder includes a processing system that is fully capable of monitoring all important parameters of the extrusion line. Extremely accurate feeding systems ensure constant feed streams and make monitoring simple as the extrusion line runs continuously at our 24/5 operation. Loss-in-weight feeding systems control the constant feed streams, maintaining the highest accuracy, while the compound is tracked through the extrusion line. Virtually every formulation processed by Foster is a unique, customized order.
Foster Pharma’s manufacturing incorporates the highest level of discipline in all aspects of production from clean environments to material handling, and manufacturing to testing and traceability. Quality standards are established to exceed industry standards, which underscores our effort to maintain this level on an ongoing basis.
Key Features of Foster’s Bioactive cGMP Clean Room