Life Sciences
Art & Technology
By Barbara Kanegsberg, Ed Kanegsberg, Chris Stavroudis
On the surface, critical cleaning/contamination control and art conservation seem worlds apart.
Cleanrooms and Energy
By Barbara Kanegsberg, Ed Kanegsberg
Cleanrooms are expensive, and energy consumption is a major cost item in operation and maintenance.
Changes Affecting EU GMP and The FDA's CGMP Non-Viable Particle Cleanliness in Cleanrooms
By Tony Harrison
What the revisions to ISO 14644 may mean to your cleanroom
Water Under The Bridge -- In Process Monitoring, Part 2
By Barbara Kanegsberg, Ed Kanegsberg
Manufacturing problems can lead to large costs of rework or can result in product becoming scrap. Immediate detection of problems is a key to increasing productivity and decreasing costs.
Future Requirements Demand Improved Contamination Control
By Wolfgang Eißler, Roland Grözinger
Upgrading an immersion scanner manufacturing facility for increased cleanliness
Water Under The Bridge -- In Process Monitoring Part 1
By Barbara Kanegsberg, Ed Kanegsberg
Problems associated with contaminated product and out-of-limit processes drive up manufacturing costs and wreak havoc with such elusive notions as competitive advantage and profitability.
Hand Hygiene In Controlled Environments
By Herbert N. Prince, Ph.D.,, Daniel L. Prince, Ph.D.
Studies with topical antiseptics against bacteria and viruses inform the choice of rapid kill agents for hand sanitization.
Extrapolate To Production: Quality and Economics
By Barbara Kanegsberg, Ed Kanegsberg
Let us assume there is a promising prototype for a critical product, a prototype for which we have reached the “ah-ha” moment.
The Human Element
By Damon Larkin
Minimizing contamination risks in sterile gowning
Trapping Airborne Molecules -- Part 2: Mechanisms
By Barbara Kanegsberg, Ed Kanegsberg
Clean air and gases are critical for many industrial processes.
Gaseous Decontamination for Critical Environments
By Jim Polarine, Claire Fritz
Hydrogen peroxide vapor systems can address large scale contamination challenges.
Trapping Airborne Molecules: Molecular Filters, Gas Purifiers - Part 1
By Barbara Kanegsberg, Ed Kanegsberg
“AMC filters don’t work.” “We don’t need to trap AMC’s.” These facile sentiments impede progress in critical applications.
Airborne Molecular Contamination Part 3 - Head It Off
By Barbara Kanegsberg, Ed Kanegsberg
AMC can be a “silent poisoner” of your process. Poisons sap strength — including product quality and profits.
Airborne Molecular Contamination, Part 2: Detecting AMC
By Barbara Kanegsberg, Ed Kanegsberg
"How do I know if I have AMC?" Hopefully, you are not suspicious of airborne molecular contamination because of poor yield or customer complaints
Spots Before Your Eyes
By Barbara Kanegsberg, Ed Kanegsberg
Particles on your critical components can impact performance of the final product or the next step in the build process.
The Right Extraction
By Barbara Kanegsberg, Ed Kanegsberg
For aerospace, medical, electronic, pharmaceutical, and other critical applications, direct surface analysis is not always informative or feasible. To validate cleaning, you must design and justify an appropriate extraction protocol. This involves selecting the correct extraction chemical(s) and the correct extraction techniques.
Keeping Product Clean In and Out of the Cleanroom -- (Part 1) The Interface
By Kevina O’Donoghue, Barbara Kanegsberg, Ed Kanegsberg
Are you aware that incorrect materials transfer could pose one of the biggest potential sources of contamination within a cleanroom?
When Worlds Don't Collide--But Ought To
By Barbara Kanegsberg, Ed Kanegsberg
Pharmaceutical and medical device manufacturers tend to operate in separate worlds.
Effective Use of Alcohol Hand Sanitizers
By Hillard Witt
Eliminating the risk of cross-contamination in pharmaceutical production areas, R&D labs, cleanrooms, and support areas includes effective methods for hand sanitization.
Combination Devices
By Barbara Kanegsberg, Ed Kanegsberg
Combination devices that meld traditional medical devices with drugs or bio-logics pose additional challenges and quality requirements in a number of areas, such as surface definition, contamination control, and management of active components.
XPS or AES? (Part II)
By Barbara Kanegsberg, Ed Kanegsberg
X-ray photoelectron spectroscopy (XPS) and Auger electron spectroscopy (AES) are two analytical techniques to identify trace amounts of surface contaminants. However, perhaps you don’t care how it works. You want to know if you should use one, the other, both, or neither to help you analyze the source of contamination.
Find the Contaminant by Perturbing the Surface: XPS and Auger (Part 1)
By Barbara Kanegsberg, Ed Kanegsberg
You are faced with low yields, field failure, customer complaints, and regulatory agency complaints. Avoiding poor quality, decreased profits, and losses to the competition requires that you find the source of the problem and fix it, immediately.
Minimizing Viable and Non-Viable Contamination: Standards and Guidelines For Medical Device Manufacturers
By John Broad, Barbara Kanegsberg
Controlling both viable and non-viable contamination is essential to medical device performance and reliability. As the complexity of device design increases, so does the process of assuring that viable and non-viable contamination is controlled during manufacturing.
Control Strategies For Fungal Contamination In Cleanrooms
By Paul Lopolito, Carol Bartnett, Jim Polarine
Pharmaceutical, biotech, and medical device cleanrooms today are faced with the increasing prevalence of molds that can lead to environmental monitoring excursions.
The Winding Road to Automation
By Barbara Kanegsberg, Ed Kanegsberg
Automation is touted as the “magic bullet” to preventing contamination problems. We often assume that automation improves the process by removing the people.