Regulations/Standards

Microelectronics

More Transparency...But For Whom?

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

To achieve reasonable surface quality in critical cleaning applications, manufacturers need effective cleaning options, including aggressive solvents.

Testing Consumable Products For Cleanrooms

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

An environmental sampling process that employs technology, ensures cleanroom efficiency and security.

Airborne Molecular Contamination, Part 1: Silent Poison

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

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)

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

ISO, Federal, FDA, USP and scientific guidance for microbiological and manufacturing personnel

What the Administrative Procedures Act Means to You

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

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

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

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

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

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

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

This column is the third of a series designed to inform, report, comment, and challenge, even agitate.

VOC Management -- EPA's Dual System

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

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

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

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

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

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

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

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

Why does the SNAP program exist, and for what purpose?