Life Sciences
Critical New Product Development
By Kathy E. Harrington, Curtis L. Harrington
There are a number of critical timing issues that new product introducers should consider as they attempt to capture intellectual property rights and facilitate early sales.
Controlled Environments in Canada: A Business Perspective
By Rob Nightingale
Canada has not been immune to the economic downturn of the past year. Even so-called recession proof industries have felt the effects of the decline, including pharmaceutical manufacturing.
Lean Sustainability: Extending the Operational Excellence Paradigm
By Bikash Chatterjee
There can be no mistaking that we are entering a new era in the pharmaceutical and biotech marketplace.
Green Cleaning
By Barbara Kanegsberg
Green, environmentally-preferred, sustainable, biobased, safe — the terms are sometimes used interchangeably. However, their meaning and interpretation really depend on one’s viewpoint.
Controlled Environments in Canada
By Rob Nightingale
Government initiatives provide leadership and other benefits to the pharmaceutical and biotech industries.
Achieving True EH&S In Controlled Environments
By Matt Kopecky
What most organizations require is corporate-level, stringent process control.
Ergonomically Speaking
By Bill Fleming
Operator interface systems for controlled environments are becoming more user-friendly.
Exhausting Your Options
By Kenneth J. Fisher
Facilities and purchasing managers can achieve positive results for fire safety and occupant health and safety while capturing cost efficiencies through green system material selection.
Integrating Business Continuity as Part of Strategic Planning
By Bikash Chatterjee
Business Continuity Planning has emerged as a central component to overall corporate well-being that all sectors of business recognize.
Point of View: Commitment to Workplace Health & Safety
By Scott Lawson, M.S.
When trying to effect a change in the culture of your organization, it is important to identify your core values and honor those values in every aspect of your business and services.
Auditing: Resources For Managing Vendor Oversight
By Thomas Menighan, RPh, MBA, Chris Ward
We looked at audits of vendors, like software developers and automated processes, and to distributor audits for supply chain integrity. A common thread in successful audits is the maintenance of sound audit practices, standards, and guidelines.
Document Integrity In The Life Sciences: An Industry At Risk
By Dirk Karsten Beth
Document integrity and security are critical to ensure compliance and approval for life science companies. Amazingly, the industry has chosen systems that put their documents at risk of loss, tampering, and regulatory penalties.
Powder Metallurgy: Problems of an Economically Friendly Technology
By Dr. D.D. Radev
This article is devoted to powder metallurgy (PM) and the peculiarities of that branch of materials science. The technological and economical advantages of PM methods compared with traditional metallurgical processes for production of metal products are discussed.
Point of View: Human Factors Engineering Applied to Controlled Environments
By Edmond Israelski, Ph.D.
Human Factors Engineering (HFE) is a discipline originating in World War II that includes in the design process data about human capabilities and limitations, as well as methods from the behavioral sciences to make products and processes,safe, effective, efficient, and usable.
Fire-Resistant Foams For Pharmaceutical And Semiconductor Cleanrooms
By Ron Partridge
Fluoropolymer foams are high performance closed-cell foams based on polyvinylidene fluoride (PVDF) that bring new materials solutions to the life sciences and semi-conductor industries.
Developing a Cleanroom Disaster Prevention Plan
By Jan Eudy
How does one prepare, respond, and recover a cleanroom operation from a natural disaster?
Speeding Up the Patent Process
By John B. Durkee, Ph.D., P.E.
Is ‘breaking the patents’ "good" because it shows how governments can protect their citizens in a time when crisis is perceived? Or is it "bad" because it is simple theft of property (intellectual property)?
Designing A Results-Oriented Training Program for Cleanroom Operators
By Elaine Kopis Sartain
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.
Toxicological Risk Assessment for Medical Devices - What Is It?
By Barbara Kanegsberg, Dr. David Albert, Ed Kanegsberg
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.
Cleanroom Fire Prevention
By Vincent Degiorgio
Because computer chips are so susceptible even to the tiniest speck of dust, cleanrooms, historically, have been difficult areas to protect from fires. Contamination from a fire, no matter how small, could potentially puta chip maker out of business for weeks—if not permanently.
Standing Operating Procedure: Logbooks/Sheets for Contamination Control Cleaning
By Geoffrey Robinson
Let me preface this article with an explanation of my approach to the simplification of contamination control cleaning SOPs (standard operating procedures) and their associated log books/sheets.
Integration of Copper R&D Processing
By Steven Reder, Jayanthi Pallinti, Michael Gatov
This paper discusses the incorporation of a copper/low-K research and development line into an existing high volume production facility. The main goal of the project was to accomplish the advanced materials (including Cu and Low K) start-up with a minimal budget.
Wet Bench Fire Safety: Code Development and Material Selection Criteria
By Gary Dennis
Several large semiconductor cleanroom fires in Asia and the potential for a large number of fire losses annually in wafer fab production have led to an entirely new philosophy and to guidelines for the selection of cleanroom materials of construction.