Power plants are engineered with precision down to the smallest detail, yet one critical variable is often considered too ...

Process design kits consist of a set of files that typically contain descriptions of the basic building blocks of the process. They are expressed, algorithmically, as Pcells. These descriptions are ...

Once upon a time, integrated circuits (ICs) were built by the same companies that designed them. The design of an IC was tightly integrated with the manufacturing processes available within each ...

Designers rely on the accuracy of Process Design Kits (PDK¡¦s) for their IC designs. This paper describes independent verification of the PDK accuracy using a low-cost Die Level Process Monitor (DLPM) ...

Appropriate use of sound science applied at critical junctures will improve efficiency in the high-wire act of drug development. Pharmaceutical companies walk a tightrope in early drug development.

Following in the footsteps of the other review programs at the US Food and Drug Administration's (FDA) Office of Pharmaceutical Science, the Office of Biotechnology Products (OBP) is currently in the ...

Planning ahead for design transfer and using it as a management tool results in a smoother, less costly transition from development to production. Terry Zenner It has become popular to say that all ...

The author reviews the draft guidance on process validation, its QbD applications, and its potential impact on sterile manufacturing operations. Individuals working in pharmaceutical sterile ...

Successful risk management is essential to the design and development of safe and effective medical devices. Unfortunately, it is too often viewed by manufacturers as an isolated activity that must be ...