SingleUse Bioprocess Systems / Millipore Corporation / Plastics Industry Inc. / Thermo Fisher Scientific / Sartorius Stedim Biotech SA / Pall Life Sciences / GE Healthcare / Advanced Scientifics Inc. / /
Country
United States / / /
Event
Product Issues / /
Facility
American National Standards Institute / / /
IndustryTerm
technology committee / subsequent processing / absorbed energy / radiation energy / equivalent product / biopharmaceutical manufacturing / manufacturing conditions / large single-use systems / products / pharmaceutical industry / prototype systems / controlled products / process buffer feed solutions / dosimetry technologies / culture media / ingle-use bioprocess manufacturing systems / bioprocess systems / bioprocess applications / typical biotechnology process / reduced-scale product / sterile product / biopharmaceutical process development / stainless steel holders / biopharmaceutical manufacturers / nonsterile finished bulk active pharmaceutical ingredient / to bioprocess systems / biopharmaceutical industry / bioprocess manufacturing / gamma-irradiated single-use bioprocess systems / manufacturing processes / laboratory operator / actual products / manufacturing process / biotechnology drug industry / large systems / biopharmaceutical manufacturing process applications / health care products / aseptic processing / sterile products / upstream processing / health-care products / ethylene oxide gas sterilization / stainless steel / active pharmaceutical ingredient / measurement devices / chemical properties / closedloop systems / http /
Society of the Plastics Industry / American National Standards Institute / BPSA Technology Committee / AAMI TIR / International Organization for Standardization / American Society for Testing and Materials / Irradiation and Sterilization Subcommittee / Association for the Advancement of Medical Instrumentation / /
Person
Brett Judd / Isabelle Uettwiller / Jerold Martin / Jeff Carter / Charles Artandi / Walton Van Winkle / Suraj Baloda / Melissa Hockstad / Ernie Jenness / Kent Smeltz / DONALD GRUENER / / /
Position
validation engineer / chair / technology committee / subcommittee chair / president / senior technical director / director / filtration R&D / producer / corporate quality manager / senior engineer / author / director / regulatory affairs / senior vice president / representative / director regulatory affairs / /
Product
sample handling / /
ProvinceOrState
Massachusetts / /
Technology
Radiation / X-ray / biotechnology / API / dosimetry technologies / html / process control / simulation / drug development / /
C H A P T E R TWO Guide to Irradiation and Sterilization Validation of SingleUse Bioprocess Systems