Manufacturing

New product reviews for May 2012.

The author discusses potential opportunities to improve the patient experience through formulation and delivery device technologies.

Poland's government aims to make the Eastern European country a biotech powerhouse.

Advances in palladium-catalyzed hydrogenation, visible-light photocatalysis, and chemocatalyisis for heterocycles are some recent developments.

Industry, the public sector, and individuals can play an important role in creating solutions.

This paper examines the process of gamma irradiation of plastic materials used as part of single-use disposable systems in the pharmaceutical and biotechnology sectors, with a focus on validation requirements.

In this technical forum, experts describe different methods of rapid microbial testing and their applications.

As the French Presidential campaign is underway, and politicians collaborate with businesses to revive a flagging economy, the pharmaceutical industry seizes the chance to lobby for equitable taxation to give the sector a much-needed boost.

An analytical technique that is receiving increased attention in the pharmaceutical industry is atomic force microscopy. We interview Mark Leaper from the UK's De Montfort University to find out more about this technology.

The authors assert that the current gulf between aseptic processing and terminal sterilization can be bridged by re-examining fundamental regulatory philosophies for sterile-product manufacturing.

Closed-vial technology is an alternative to traditional glass vial filling that reduces the risk of contamination for the patient, simplifies the filling process, and provides easier handling for healthcare providers.

The authors provide a review of test methodology and standards, including current industry and regulatory proposals, for biological indicator growout times.

If a product does not have its own antimicrobial properties, then a preservative must be used to ensure microbiological safety.

There are various theories about how to scale up a solid dosage coating operation in a pan coater. This article provides a basic process understanding and scale-up theory based on first principles.

Readers share their views on bioprocessing challenges, equipment use, and outsourcing trends in our annual bioprocessing equipment and processing survey.

My network failed and I had to scrap my batch because my historian did not collect the required data. How do I upgrade the reliability of my network to maintain data continuity if my network fails again?

Using blow–fill–seal technology to form and fill a plastic container in a continuous process addresses sterile packaging issues such as package defects, contamination, and process validation.

The growing use of high-potency APIs is leading to changes in how the pharmaceutical industry looks at containment.

PharmTech's monthly newsletter, Equipment and Processing Report, reviews the Editor's Picks for the April 2012 edition from AdvantaPure and Fitzpatrick Company.

FDA has released a final guidance describing cGMP for preparing media fills for validation of aseptic preparations for positron emission tomography drugs.

As part of an ongoing collaboration into tabletting science, I Holland and the UK's University of Nottingham have launched a two-year programme to investigate the cause of tabletting sticking.

On Mar. 29, 2012, the Generic Pharmaceutical Association reiterated its call for Congress to move forward with user-fee proposals for generic drugs and biosimilar products.

With around 80% of APIs manufactured outside the US, many in developing nations without strong regulatory oversight.

Pharmaceutical Technology's annual survey on equipment and machinery reveals the spending levels and type of spending made in 2011 and planned for 2012.

In Part III of a three-part article, the authors examine various degradation routes of APIs, impurities arising from interactions in formulations, metabolite impurities, various analytical methods to measure impuritie, and ways to control impurities.

Critical issues that should be considered when scaling up a hot-melt extrusion process.

Collaboration can begin with a conversation.

With financing constrained, biotechnology firms must find ways to sustain innovation.

Contract API manufacturers and fine-chemical producers roll out capacity and service expansions.

How to use geographic diversification and legacy technology transfers to avoid product shortages.