Manufacturing, Aseptic Processing

New injection-delivery systems with multiple closure points pose challenges for container closure integrity testing.

A novel approach to sterile drug product manufacturing uses a single-use assembly in a multi-product final filling suite with isolator technology.

Tandem Diabetes Care expands its voluntary recall of select lots of insulin cartridges used with t:slim insulin pump.

Drug Quality and Security Act gives FDA authority over compounding pharmacies.

Wolfgang Weikmann of Vetter Pharma discusses the implementation of quality by design in sterile manufacturing.

ATMI has invested in sterile-connector and sterile-fill technology developed by Medical Instill Technologies.

FDA receives adverse event reports related to calcium gluconate infusions.

Vetter has ready-to-submit documentation for this service in Common Technical Document (CTD) formats for the US, Europe and Japan.

Third compounding pharmacy recalls products due to FDA inspection.

NIBRT's Ray O'Connor provides an overview of aseptic processing.

Ray O'Connor, an operations consultant with NIBRT, addresses aseptic processing, including how to avoid contamination, and cleanroom best practices. Posted May 2012.

The International Society for Pharmaceutical Engineering (ISPE) will soon publish an update for its guide to sterile-product manufacturing facilities. The new publication will replace the original guide, ISPE Baseline Guide: Sterile-Product Manufacturing Facilities, and contain practical information about technological advances in sterile manufacturing.

Use it label-free, or add labels to detect contaminants in solution.

How this Big Pharma company successfully implemented disposable technologies in its manufacturing plant.

Many factors must be considered when choosing a sterile connector for a given process.

The European Medicines Agency (EMEA) has granted license approval to Bayer HealthCare LLC (Bayer, Berkeley, CA) for its new sterile filling facility on its Berkeley, CA, campus.

The industry needs to open up to validation failures.

Recent problems with food and pharmaceutical ingredients sourced from China highlight a major disadvantage of our complex international supply chains for food and drug ingredients. A global supply chain offers more opportunities for accidental contamination as well as intentional adulteration and counterfeiting. Sticking to minimal requirements may not be enough.

A case study investigated the root cause of failures in sterile filtration by evaluating the effects and interactions of four operating parameters.

The heparin safety crisis puts a spotlight on manufacturing processes and regulatory oversight.

Need a standard to follow? Just ask, What would Genentech do?

Best practices from Big Biotech, including how to handle new product introductions.

The US Pharmacopeia (Rockville, MD, USP, www.usp.org) recently announced that the implementation period for its USP­–NF general notices statement requiring all manufacturers to conform to recently revised residual solvent standards in General Chapter <467> has been extended from July 1, 2007 to July 1, 2008.

Membrane-based chromatography technologies sometimes offer advantages over resin-based technologies.

Although contaminants and other parameters may be main causes of filter breakdown, some nanofilters still remove viruses at high Log Reduction Value (LRV).

The HSV-1 and HVP-2 titers were determined by the inoculation of test solutions into Vero cell cultures and calculated using the Reed M?ench method.

NovAseptic mixers from Millipore (www.millipore.com/bioprocess) are designed for a variety of mixing applications in the pharmaceutical and biotechnology industries and are magnetically driven, which minimizes contamination risk.