Aseptic/Sterile Processing

May 09, 2017
By Pharmaceutical Technology Editors
FDA sent a warning letter to Pharmaceutic Labs, LLC for deficiencies in producing sterile drugs.
May 02, 2017
Pharmaceutical Technology
Robotic fill/finish systems reduce human intervention, improve flexibility, and allow more gentle handling of containers.
May 01, 2017
The type of water for pharmaceutical use is determined by USP testing.
Apr 13, 2017
By Pharmaceutical Technology Editors
Bosch’s new system for the production of water for injection uses membrane processing and ultrafiltration.
Apr 10, 2017
By Pharmaceutical Technology Editors
Watson-Marlow Fluid Technology Group’s ASEPCO Weirless Radial diaphragm valves eliminate dead legs and product entrapment.
Apr 01, 2017
Pharmaceutical Technology
A chlorine dioxide sterilization cycle was developed for a novel split-valve aseptic powder transfer device.
Mar 13, 2017
By Pharmaceutical Technology Editors
The patented SKAN NANOX Catalysts enable higher efficiency breakdown of hydrogen peroxide at lower temperatures for shorter decontamination cycles.
Mar 02, 2017
Pharmaceutical Technology
The manufacture of highly active or highly hazardous pharmaceutical substances involves a complex interplay between the required threshold values, such as the permitted daily exposure (PDE), which is used to calculate the occupational exposure limit (OEL) and the maximum carry-over from one product to the next. In addition to these threshold values, a risk assessment of the overall process and the associated containment transfer systems, cleaning, and staff training are also important. An account of this complex interplay and how it can be successfully implemented has now been published in the first edition of the International Society for Pharmaceutical Engineering (ISPE) Germany/Austria/Switzerland (D/A/CH) Affiliate's Containment Manual. This article discusses principles of containment, risk assessment, process requirements, technical systems, and other aspects of containment discussed in the manual.
Mar 01, 2017
Pharmaceutical Technology Europe
The article reviews strategies for firms with or without existing in-house capacities and the pros and cons for outsourcing bio/pharmaceutical development and manufacturing.
Feb 28, 2017
By Pharmaceutical Technology Editors
The agency cited the company’s Kansas facility with CGMP violations similar to problems found at other Hospira facilities.
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