Manufacturing, Aseptic Processing

Aug 01, 2015
BioPharm International
Process maps and risk assessments are among the valuable tools operators can apply to reduce the risk of microbial contamination.
Jul 20, 2015
By BioPharm International Editors
Baxter has initiated a voluntary recall of two lots of IV solutions due to the potential presence of particulate matter.
Jul 01, 2015
BioPharm International Multimedia
By BioPharm International Editors
Bill Hartzel, Director Strategic Execution, Advanced Delivery Technologies at Catalent Pharma Solutions, spoke with BioPharm International about blow-fill-seal for aseptic processes.
Jul 01, 2015
BioPharm International
Humans represent the greatest risk for microbial contamination in an aseptic process.
Jun 19, 2015
By BioPharm International Editors
NIH provides an interim corrective action plan to correct deficiencies found in its Clinical Center Pharmaceutical Development Section.
Jun 05, 2015
Drug quality issues have forced the National Institutes of Health to shutter its in-house facility for producing clinical supplies for certain clinical trials.
Jun 04, 2015
By BioPharm International Editors
FDA cites 17 observations including air handling, quality control, and deficient microbial monitoring at NIH’s Clinical Center Pharmaceutical Development Section.
Jun 01, 2015
BioPharm International
By BioPharm International Editors
Hamilton’s EasyFerm Bio biocompatible pH sensor is designed for CIP, sterilization up to 140 °C, autoclavable temperature, and a pressure range up to 6bar.
Jun 01, 2015
BioPharm International
By BioPharm International Editors
Meritech’s CleanTech 2000SCA Automated Handwashing System delivers a 12-second wash and rinse cycle that removes 99.98% of dangerous pathogens from bare skin and gloves.
Jun 01, 2015
BioPharm International
Removal of microorganisms is crucial when working with biologics. Sterile filtration offers a reliable, safe, and effective way to ensure product integrity.
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