Microelectronics
More Transparency...But For Whom?
By John B. Durkee, Ph.D., P.E.
In my 25-year career with a major global chemical company I learned a few things... the flow of information between suppliers and EPA is mostly unidirectional. However, transparency in regulation favors the public and is good policy.
Point of View: Cal/OSHA Standards Board: 5 ppm PEL for n-propyl bromide
By Barbara Kanegsberg
To achieve reasonable surface quality in critical cleaning applications, manufacturers need effective cleaning options, including aggressive solvents.
Testing Consumable Products For Cleanrooms
By Jan Eudy
It is recommended that when comparing cleanroom consumable products manufactured by several vendors that all products be tested at the same lab, with the same test method, and by the same technician. What test methods are recommended for cleanroom consumable products?
Putting Paper in the Past
By Michael Clouse
An environmental sampling process that employs technology, ensures cleanroom efficiency and security.
Airborne Molecular Contamination, Part 1: Silent Poison
By Barbara Kanegsberg, Ed Kanegsberg
Airborne Molecular Contamination (AMC) can be a "silent poisoner" of your process and product. AMC is any unwanted organic or inorganic molecule that is carried by the air to the surface of the product.
Long Overdue: Revisions To The TSCA
By John B. Durkee, Ph.D., P.E.
EPA's new Chemical Assessment and Management Program (ChAMP) will fulfill commitments made in 2007 with North American partners Canada and Mexico to share information about chemical hazards.
Thinking Outside The Box (Or At Least Outside The SEM)
By Ed Kanegsberg, Barbara Kanegsberg
Most manufacturers have access to SEM/EDX; and it provides useful information. However, sometimes we expect more from SEM/EDX than the technique is capable of providing, such as molecular identification of a specific organic residue.
Detection of Microorganisms and Particulates in Controlled Environments
By Herbert N. Prince, Ph.D.,, Daniel L. Prince, Ph.D.
ISO, Federal, FDA, USP and scientific guidance for microbiological and manufacturing personnel
What the Administrative Procedures Act Means to You
By John B. Durkee, Ph.D., P.E.
The Administrative Procedures Act (APA) is the reason that no exposure limit was required in EPA’s 2007 Significant New Alternatives Policy (SNAP) ruling on n-propyl bromide (n-PB). In keeping with the APA, the ruling contained only a recommendation for an exposure limit.
Are We There Yet? Monitoring Contamination With IMS
By Ed Kanegsberg, Barbara Kanegsberg
To monitor surface cleanliness, manufacturers desire a technique that yields results quickly, has a low recurring cost, identifies the presence of a specific contaminant, can detect low levels, and is quantitative.
Why Exposure Limits Can Have Little to Do With Hazards
By John B. Durkee, Ph.D., P.E.
This column is about partial truth: Most believe that a lower exposure limit means a chemical is more toxic, and should be avoided for just that reason. That analysis is partially true.
For Regulation of Nanotechnology: See The FDA
By John B. Durkee, Ph.D., P.E.
Today, we don't know how the changing surface and size properties affect toxicity. Standards aren’t yet available for detecting or measuring these materials.
Diffuser Models For Airflow Simulation
By Jelena Srebric, Ph.D., Andrew Manning, Qingyan Chen, Ph.D.
Accurate simulation of the airflow and heat transfer in cleanrooms is highly dependent on the diffuser, yet diffusers have traditionally been very difficult to model.
Safe Nanotechnology: Overcoming Challenges and Assessing Risk in Bringing Applications to Market
By Dr. Steffi Friedrichs, Barry Bark, Ph.D.
Frequently hailed as the next general-purpose technology, nanotechnologies promise to enable technological breakthroughs, which will impact the entire global economy in a way beyond that of the steam engine and electricity.
Fungal, Chemical, and Fire Resistance of PVDF Foams and Polymers
By Ron Partridge
Covering exposed surfaces with PVDF polymer provides a high-purity “inert” surface which does not support the growth of microorganisms and provides the resistance needed to withstand the harsh chemicals used for cleaning and sterilization.
EPA's VOC Regulations -- We Get The Regulations We Allow
By John B. Durkee, Ph.D., P.E.
This column is the third of a series designed to inform, report, comment, and challenge, even agitate.
VOC Management -- EPA's Dual System
By John B. Durkee, Ph.D., P.E.
For more than two decades, scientists have attempted to measure and model the relationship between ozone formation and emission of VOCs.
Where and What to Test: From Purified Bulk Drug Substance to Sterile Liquid Final Drug Product
By John Dobiecki, Alex Mello
This article will discuss the typical routine sampling and testing requirements associated with the aseptic processing of a biopharma-ceutical from the perspective of a contract aseptic manufacturer.
Civics 102
By John B. Durkee, Ph.D., P.E.
This column is not about critical cleaning. It’s about how your government works. It’s about what you have to know to manage chemicals, which most of us managing critical cleaning work have to do.
Point of View: Safety Shoes
By Patrick Smyth
The steel toecap safety overshoe has been around for a long time. Its origins lie in the marriage between the venerable rubber galosh and a steel toecap similar to those used in many of today’s safety boots. That has changed now because of a number of developments.
Factoring Business Continuity and Risk Management in Aseptic Product Development
By Tej Poonai, Bikash Chatterjee
We will discuss how the current FDA guidance for product development can integrate the concept of business continuity into the planning process, affording organizations the ability to lay the foundation for flexibility in the operating plan, if the situation warrants it.
Breakthrough Insulation for Tubing in Controlled Environments
By Tuna Sava
There have been many improvements to all of the aspects that make and keep a cleanroom clean — except one. Insulation materials have lagged behind and remained at status quo in the life sciences industry that normally thrives on innovation.
The Advent of Rapid Microbiological Methods: Background, Applications, and Validation
By Peter R. Ball, Loris Arbizzani,, Christopher J. Mach
RMM instruments have been on the market for a number of years, but recent developments, such as performance improvements and cost reductions in the technology, have made them more attractive than in the past.
Eight Great Things Manufacturing Engineers Must Know About Leak Testing Equipment
By David Rizzo, D.P.M.
Must quality engineers and product managers always be at odds? The former seeks perfection while the latter pushes for greater throughput.
News You Can Use: Changes In The EPA's SNAP Program
By John B. Durkee, Ph.D., P.E.
Why does the SNAP program exist, and for what purpose?
