Pharma Facility Quality Audits: A Primer for Design Teams
By Scott Overton
Here is a familiar demand: “Show me where in the regulations it says to do that!” If you’ve spent any time in Quality, working on a facility or equipment project in the pharmaceutical industry, you have certainly had that put to you at some point.
Point of View Enhancing the Facility Monitoring Program
By Barbara Done
Regarding the article in the June issue there is another, often forgotten, aspect of the monitoring program, which is the witness plate sampling and counting method as described in IEST-STD-CC1246D.
Ask the Facilities Guy: Key Elements in Facility Maintenance Plans
By Richard Bilodeau, PE
Question: What are the key elements I should include in my facility maintenance plan to ensure a “clean power” supply?
Process Validation and the New Compliance Challenge
By Bikash Chatterjee
The issuance of the new FDA Process Validation Guidance in January of this year is a significant event for several reasons.
An Overview of Contamination Control Guidance Documents
By Jan Eudy
Understanding and incorporating cleanroom standards and practices in a cleanroom management program.
FDA Process Validation
By Wai Wong
In January 2011, the FDA issued its newest guidance for Process Validation for industry and it is quite a departure from the previous guidance released in 1987.
On the Journey to Net-Zero: An Approach to Increasing Energy Efficiency in Laboratories
By Gordon P. Sharp
It is a well-known fact that laboratories consume extraordinary amounts of energy—as much as three times the energy of regular office space.
New ISO Cleanroom Standards: What Will They Mean For Pharma?
By Heidi Parsons
International experts have made significant changes to ISO’s airborne cleanliness classification standard—and now is the time for industry to comment.
The Winds of Change: FDA Flexes Its Muscles
By Bikash Chatterjee
To a regulatory and compliance professional, FDA citations are a part of the landscape. Granted, no one welcomes such a situation, but ensuring regulatory compliance is the core of what we do on a daily basis.
New Sampling and Classification Methods Set in Revised ISO 14644 Cleanroom Standards
By Roberta Burrows, CAE, Diana Granitto
The highly anticipated revisions to the world’s bedrock cleanroom standards are now available from IEST, the Secretariat for ISO Technical Committee 209 (ISO/TC 209): Cleanrooms and associated controlled environments.
IEST Source For Information
By Jan Eudy
Comparing features and benefits of cleanroom consumable products is confusing. How do I interpret the test values reported by each company to assure I am getting the right product for my cleanroom application?
The Performance Conundrum
By Bikash Chatterjee
In my last editorial I spoke about the challenges facing the FDA and industry with regard to the effectiveness of the current regulatory structure.
Point of View: Gauging Regulatory Effectiveness
By Bikash Chatterjee
That the pharmaceutical and biotech industry is in a state of flux is undeniable.
Beyond NIST-Traceability: What Really Creates Accuracy
By Bruce McDuffee
“NIST-traceable” is often invoked as though it has some sort of magical metrological power, imparting accuracy to all it touches.
The Devil Is In The Details
By Bikash Chatterjee
Consolidation on a massive scale amongst the elite of the U.S. pharmaceutical industry raises questions about how to remain competitive.
Meeting The Global Compliance Challenge
By Bikash Chatterjee
There can be no doubt that the last decade for the pharmaceutical and biotech industry has been full of extraordinary change.
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.
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.
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.
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).
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.
Nanotech Safety
By Dr. David W. Hobson
How the new regulatory environment will affect manufacturers in the U.S. and abroad
Converting From an Uncontrolled Space to a Cleanroom
By Jan Eudy
Our company is shifting focus from the manufacturing of medical device components in a controlled environment to manufacturing in a certified ISO Class 8 environment.