Aseptic/Sterile Processing

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.
Feb 27, 2017
By Pharmaceutical Technology Editors
The company is voluntarily recalling one lot of Edex due to a lack of container closure integrity.
Feb 27, 2017
By Pharmaceutical Technology Editors
Avella issued a nationwide recall of sterile products produced at the Advanced Pharma Houston location due to inaccurate labeling.
Feb 16, 2017
By Pharmaceutical Technology Editors
FDA sent a warning letter to Sato Pharmaceutical Co., Ltd. after inspectors found deviations in the facility’s aseptic processes.
Feb 15, 2017
By Pharmaceutical Technology Editors
The company has voluntarily recalled all lots of of human chorionic gonadotropin because of a lack of sterility assurance.
Feb 15, 2017
PTSM: Pharmaceutical Technology Sourcing and Management
By Pharmaceutical Technology Editors
The agency sent a warning letter to Resonance Laboratories Pvt. Ltd. after an inspection found possible contamination problems.
Feb 02, 2017
Pharmaceutical Technology
Susan Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses how to ensure sterility when manufacturing small-scale parenteral batches.
Jan 25, 2017
By Pharmaceutical Technology Editors
The company issues a voluntary nationwide recall due to the presence of particulate matter in a single vial.
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