Issue

Process analytical technology is intended to make pharmaceutical manufacturing more efficient, but are the right people aware of PAT’s benefits?

Up until a few years ago, sterile and apyrogenic water could only be produced by distillation. Due to rapid progress in membrane technology, and especially in the field of ultrafiltration (UF), an alternative is now available that is as reliable as distillation but offers the additional advantage of being much more economical.

“Clean, clean, clean... Disinfect, disinfect, disinfect!” The mantra for microbial control in cleanroom environments may not be the only solution for controlling problem-causing microorganisms.

Two leading contamination-control organizations-The Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) and the Parenteral Drug Association (PDA)-have announced new leadership.

News snippets from the world of contamination control.

Filter and technical molded-component manufacturer Filtertek (www.filtertek.com) has opened a new 1,700-square-foot medical manufacturing cleanroom at its Filtertek de Mexico facility in Juarez.

Contamination-control challenges may reach unprecedented levels with Intel Corp.’s (www.intel.com) massive, one-million-square-foot 300 mm fab now under construction in Arizona. Included in the complex will be 184,000 square feet of cleanroom space-about the size of four football fields.

Able Laboratories Inc. (www.ablelabs.com), which in July had filed Chapter 11 bankruptcy in hopes of restructuring while it worked with the Food and Drug Administration (FDA; www.fda.gov) to settle regulatory issues that led to the recall of its products and suspension of all manufacturing operations, has decided instead to sell the business and its assets to one or more third-party purchasers.

Higher cleanroom standards and more space for development of its LMS IPRO3 mask metrology technology have prompted Leica Microsystems (www.leica-microsystems.com) to replace its existing cleanroom with a nearly 2,000-square-foot facility that will be used for system assembly and integration as well as for customer acceptance tests.

Ongoing research by Nanobac Life Sciences (www.nanobaclifesciences.com) has led to the discovery of the structure and pathogenic characteristics of nanobacteria that it says can lead to coronary artery disease and other plaque-related diseases.

To hear Paul Westbrook tell it, the fab being built by Texas Instruments, Inc. (TI; www.ti.com) in Richardson, Texas, reflects his own personal experience.

The cleanroom has developed as an essential part of the process of manufacturing medical devices, electronics and pharmaceuticals.

As an addicted viewer of the cable advertisement/news networks, I’m keenly aware of the growing infatuation these organizations have with themselves.

Probably the most critical element of the controlled environment along with the actual practices observed while manufacturing and packaging the product, in this case CSPs, is the need for a routine cleaning and disinfecting of the environment and its components, equipment, etc.

Flat-panel displays (FPDs) are a high-growth segment of the cleanroom industry, particularly in Asia.

Each month, CleanRooms bring you a collection of the latest product innovations in the contamination-control industry.

In just about every clean manufacturing process, filtration is an integral part of ensuring that the process, and ultimately the final product, is free of contaminants. Whether it’s single or multistage, coarse or fine, small-scale or industrial filtration that’s required, there are a host of products and technologies to choose from. This month, we’ve compiled a selection of some of the newest filtration products now on the market.