Manufacturing, Aseptic Processing

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.

The many benefits of disposable technologies, such as significant savings in time, labor and capital, as well as ease of scalability and flexibility, have led to the growing trend of adopting disposable technologies in bioprocess manufacturing processes.

It is important to ensure that flow decay during processing is comparable to that observed during retention studies.

Steam traps are part of a steam-in-place system. The current design allots 18 in. of vertical leg for condensate backup. A design with a sensitive bellows has been proven in laboratory tests to need only 6 in. of vertical leg during the 15 min. of 121?C sterilization. Loads of 1 to 27 lb/h are covered by the capability of the new trap, equivalent to required steam for vessels 20 to 40,000 L.

Disposables require less space than conventional equipment, and they can be assembled offsite into complete process trains.

A symposium at the AAPS National Biotechnology Conference in Boston, June 19-22, 2006, addressed key concerns and new developments in manufacturing biologic products in a sterile environment.

On August 12, 2003, Johnson & Johnson began recalling certain batches of its anemia drug, Eprex (epoetin alfa, sold as Procrit in the US), in most countries outside of the United States.

Disposables can be used for media preparation, clarification, filling in downstream processes . . .

In the pharmaceutical industry, ultrafiltration (UF) membranes are used extensively in the downstream purification of recombinant proteins or monoclonal antibodies. However, the fouling of membranes after a unit operation?especially when recombinant proteins or monoclonal antibodies are highly concentrated?is a common problem. Typically, normalized water permeability (NWP) of a membrane can be reduced to about 20 percent of its original permeability at the end of an ultrafiltration-diafiltration (UF-DF) operation.