Articles

11/01/2005

We have come to think of the demand for greater identification of potential contaminants combined with impatience with incomplete data and intolerance of any risk as the “Kanegsberg uncertainty principle.”


10/01/2005

The intent of this article is to demystify ISO certification and to summarize the key differences between ISO 9000 and ISO 13485 quality standards.


10/01/2005

AMC is gaining an ever-increasing focus as semiconductor manufacturers, hard disk drive makers, aerospace equipment firms, and other leading edge technology producers face product degradation and yield loses attributed to this form of contamination.


10/01/2005

It has been said that one person can make a difference. In an aseptic operation, the risk is that this difference will lead to a negative outcome.


10/01/2005

With new products and new processes, there is the need for a better understanding not only of the identity of the residue but of the significance of the residue.


10/01/2005

Without a doubt, the most difficult situations with which I have been asked to contribute involve removing polymer-like materials from valuable surfaces.


10/01/2005

Controlled Environments commends these individuals on their technical and industry knowledge and their willingness to provide insight and guidance so that all can benefit from an exchange of information.


09/01/2005

There are several methods for producing water-for-injection (WFI). This article provides an overview of the key features of each technology and important issues for consideration.


09/01/2005

Everyone understands the need for some level of controlled environment. What seems to be missing is that many installations do not take into account the need to review materials of construction for the basic components being used in these facilities.


09/01/2005

The new nanotech R&D facility will further Georgia Tech’s plans to be a competitive player on the level with Massachusetts Institute of Technology, Cornell University, University of California,Berkeley, and other nationally renowned institutions.


09/01/2005

Currently available filters have limitations; Nanotube-based filters have the potential to address these limitations.


09/01/2005

Environmental affairs are driving, and will continue to drive, all contamination control operations we undertake—including critical cleaning.


09/01/2005

This editorial is about what a change in U.S. policy regarding regulation of VOC might mean, and what you might want to happen.


08/01/2005

There are numerous factors to consider in packaging; some obvious, some not so obvious.


08/01/2005

How an air knife and ionizing bar removed particles and eliminated static attraction.


08/01/2005

Many factors must be considered in handling an automated packaging system ranging from meeting FDA requirements to speed and consistency.


08/01/2005

What are the pros and cons of constructing an on-premise cleanroom garment laundry?


08/01/2005

This month's column concludes a short refresher about industrial hygiene in critical cleaning.


08/01/2005

The Symposium on Cleanliness of Implants was an information-laden, thought-provoking session consisting of fourteen contributed reports and studies on cleaning methodologies and analytical methods to assess cleanliness.


07/01/2005

Welcome to the first issue with our new name, Controlled Environments.


07/01/2005

A great deal of discussion revolved around the concept that a microorganism could become resistant to a disinfectant. Here is where the first bit of clarification is required. A microorganism will not become resistant to much of anything.


07/01/2005

The commissioning process verifies the following: what was specified was installed; that it functions properly; and that it was successfully turned over to the user.


07/01/2005

When selecting an air sampling method, you must consider both the benefits as well as the associated challenges.


07/01/2005

Thia column and the next are a quick review of industrial hygiene—about how the human body can defend itself against bodily contact with hazardous chemicals and what happens when it doesn't.


07/01/2005

There may be advantages to applying the principles of lean manufacturing to cleaning, contamination control, and surface quality and to extending those principles so that they are adopted at companies that precede the final manufacturing facility.