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.
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.
The Evolution of Airborne Particle Counters
By Michael Clouse
The new ISO standard increases the repeatability between units as a whole for all manufacturers.
Trapping Airborne Molecules -- Part 2: Mechanisms
By Barbara Kanegsberg, Ed Kanegsberg
Clean air and gases are critical for many industrial processes.
Airborne Particle Monitoring: Satisfying The Changing Demands in Regulations and Methods
By Joe Gecsey
Today’s user is often faced with the challenge of meeting several international standards and regulatory guidances as well as performing sampling for airborne particles in a consistent and reproducible manner.
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.
Air Sampler Qualification According to ISO 14698 NORM
By S. Hamdi, Q. Desjonquères
In November 2007, the ISO TC/209 working group decided to revise the current version of the ISO 14698 norm (Cleanrooms and associated controlled environments – Biocontamination Control).
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.
Airborne Security
By Frank Stamatatos, Aaron Ayer
Particles in a cleanroom environment must be removed. Particles that can reproduce themselves can become a difficult part of the problem to address.
Point of View: The Problem Is, We Can’t See the Problem: Or……Our Eyes Deceive Us
By Howard Siegerman, Ph.D.
Given that many companies need pristine surfaces for the manufacture of defect-free products, one might well ask why, forty years later, we should still be facing contamination issues and related product failures due to lack of proper wiping and surface cleaning?
Sources of Viable Contamination and Update on Cleanroom and Controlled Environmental Standards
By John Broad, Barbara Kanegsberg, Ed Kanegsberg
While not all organisms are harmful, minimizing viable contaminants is generally desirable. Such contamination may include bacteria, fungi, algae, protozoa, and viruses.
Particle Monitoring: The Bugs You Can't See
By Jason Kelly
How automated monitoring systems can increase contamination protection and save you time and money.
Testing Compressed Air Lines For Microbiological Contamination
By Rudy Pina
An air impaction microbial assessment of your air supply may indicate you have unwanted inhabitants in your compressed air system.
Controlling Bacteria In Industrial Applications
By Ron Abramshe
The what, why, and how of industrial bacteria control in aqueous storage of synthetic diamond suspensions or non-organic suspensions.
Instantaneous Microbial Detection
By Chuck Bolotin
An optical technology has been developed that can determine the quantity and size of particles in liquid or air, and simultaneously determine whether each particle is inert or biologic, all in real time.
The Status of Particle Measurement
By Steve Silverman
An insightful Q&A with Steven Kochevar, an Aerosol/Vacuum/Gas Applications Specialist at Particle Measuring System, Inc. in an interview conducted by Bartlett Bay Consulting.
Effects of Moisture on the Purification of Compressed Air
By Russel J. Holmes, Daniel Alvarez, Jr., Joseph Rotter, Allan Tram
A method was developed to measure hydrocarbons to 1 part-per-trillion (ppt) concentration levels with a gas chromatograph and flame ionization detector (GC/FID). This method was used to measure purifier siloxane removal efficiencies from air under both dry and humid conditions.
Chromatography Systems: Part 2 - Chromatography Concepts
By Barbara Kanegsberg, Ed Kanegsberg
In the context of contamination control, we concentrate on chromatography for separation and identification; chromatography can also be used to purify product.
Pharmaceutical Industry Cleanroom Monitoring: Viable and Non-Viable Particle Detection
By Jason Kelly
Let us take a closer look at the way the cleanroom environment is monitored to verify the existence or nonexistence of particles both viable and non-viable.
Grading Techniques, Analysis and Standardization of Micron Materials
By Ron Abramshe
This article is centered on the methodologies of fine particle grading, or known in the industry as micronization.
Microbial Monitoring of Controlled Environments and Alert and Action Limits
By Matthew Hanson, Gregg Mosley
This article is written in order to address some areas of misunderstanding within the medical manufacturing industry regarding measurements of microbial contamination in cleanroom theaters as promoted in some documents.
Life Sciences: Fingerprinting Bacterial Strains Usin Ion Mobility Spectrometry
By R.T. Vinopal Ph.D., R. F. Debono Ph.D., J.R. Jadamec
Ion mobility spectrometry (IMS), which as a means of compound analysis/identification, has been with us since the early 1970s, is currently at the heart of a number of IMS-based products for the trace detection of narcotics, explosives, toxic industrial chemicals (TICs) and chemical warfare agents.
