Cleanroom Design
Deciphering The Regulations For Facility Design and Environmental Control
By Wai Wong
With the FDA under fire in recent years regarding the quality of inspections, the effect on biotech, pharmaceutical, and medical device companies has been to err on the safe side of regulatory requirements by proving more evidence wherever they can.
Winning The Gold
By Richard A. Bilodeau
Successful Cleanroom Design Strategies in Today’s LEED World
Actionable Steps to Building A Sustainable Business
By Aaron Fowles
Simple steps that any business can take to reduce their overall impact on the environment
NIST Advanced Measurement Laboratory Complex
By Ahmad Soueid, AIA, LEED® AP
The Project that Broke New Ground in Nanoscale Research
Nanotechnology Research Requires a Different Breed of Laboratories and Cleanrooms
By Ahmad Soueid, AIA, LEED® AP
It would be nice to be able to build a typical laboratory and command that “thou shall conduct nanoscale research here.” However, as nanoscale research evolves so must the architecture and building technologies.
The China Quality Challenge
By Bikash Chatterjee
After a recent trip to China, I returned more impressed than ever with the rapid level of development within the major markets there.
USP 797 Cleanroom Design
By Heather Wylie
Pharmacists can be in control of their cleanroom environment by understanding the critical elements.
The Bottom Line on Buying a Cleanroom System
By Rick Dobson
What questions, as a potential buyer, do you need to ask to ensure your performance specification will be met?
Nanotechnology Cleanroom - Design on A Dime
By Raymond K. Scheider
The tight budget of today’s nanotechnology facility start-ups makes the need for small scale cleanroom solutions as important as ever.
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?
Predicting The Future: a Model for Integrating Facility and Strategic Planning
By Bikash Chatterjee
With a typical production and maintenance lifetime measured in decades, the decision to devote capital resources to build a development or manufacturing facility is a significant investment that carries long reaching implications for any business.
Facility Considerations
By Jan Eudy
Our Quality Management team has determined that we need to convert from a controlled environment to a cleanroom environment. Where can I find information to design and build a cleanroom?
A Roadmap for Lean Facility Design
By Bikash Chatterjee
In terms of strategic impact, applying Lean manufacturing principles to facility design elevates the investment of a new facility to its correct place in an organization’s strategic plan, because it maximizes value and efficiency.
Basic Cleanroom Protocol
By Jan Eudy
Can you please recommend a basic protocol program for cleanrooms?
Point of View: Where’s the Magic?
By Raymond K. Scheider
The flexibility of cleanroom suppliers at all levels to adapt to a customer base with a new vocabulary and mindset will be the key to future success and growth (and, in fact, to survival).
Case Study: Pharmaceutical Lab Construction
By Michael Perciali
Have you heard these statements in our industry? “Give me an isolator and I can run cGMP products in a parking lot.”
Tutorial: Building A Cleanroom
By Lee Baldwin
Cleanroom construction begins with the floors, walls, and ceilings. This article focuses on the necessary specifications for these cleanroom components to ensure maximal cleanliness and minimal contamination.
The Green Clean Laboratory
By Raymond K. Scheider
The notion of sustainable construction as “those materials and methods used to upgrade, construct, and maintain a structure that meets the needs of the present without compromising the ability of future generations to meet their own needs” has been percolating through society for some time now.
Building A Clean Research Laboratory
By Steve Yellin, Don Acker
When approaching the project of building a research lab, there are many questions that need to be answered.
Airflow Modeling Simulation Optimizes Cleanroom Design
By Andrew Manning
A case study illustrating the use of airflow modeling software in the design of a pharmaceutical cleanroom.
High-Performance Door Systems for Cleanrooms
By Randy Mathis
Cleanroom doors are as important as air filtration and air distribution in cleanroom design.
Installing ESD Flooring in an Operational Cleanroom
By David Long
Options for installing ESD flooring in an existing operational facility withminimal impact on contamination and production.
Commissioning and Qualification of Existing Facilities and Systems
By John R. Butterfield
The commissioning process verifies the following: what was specified was installed; that it functions properly; and that it was successfully turned over to the user.
Case Study
By Susan Cleary
A life-sciences company needed to expand its manufacturing operations, as it could no longer manage its data with a paper-based system. Within six months, it had to select, install, and validate a system that would be able to handle an increasing amount of data.
Case Study: Cambrex Biosciences Process Development Lab Expansion
By Tim Loughran, Michael Wisler, Susan Boggs
An Exercise in Constructive Value Engineering