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.

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.

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.

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.

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.

Nanotech Safety
By Dr. David W. Hobson
How the new regulatory environment will affect manufacturers in the U.S. and abroad

Compelling PELS
By Ed Kanegsberg, Barbara Kanegsberg
Worker safety, product quality, and productivity are likely impacts of a new process for setting workplace Permissible Exposure Limits (PELs). PELs are almost certain to be far lower and more stringent.

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?

Point of View: The Cleanroom Audit
By Howard Siegerman, Ph.D.
Some might say that a discussion of audits in April is more than a coincidence — and they would be right. But what better time to address such an important andsensitive topic?

Two Challenges in Contamination Control of Combination Devices
By Barbara Kanegsberg, Ed Kanegsberg
By incorporating the dose in the device rather than mixed or measured at the time of use, mixing and dosing errors can be better controlled. To achieve the social and economic benefits of combination devices, many challenges must be addressed.

Combination Devices
By Barbara Kanegsberg, Ed Kanegsberg
Combination devices that meld traditional medical devices with drugs or bio-logics pose additional challenges and quality requirements in a number of areas, such as surface definition, contamination control, and management of active components.

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.