Displaying 1–19 of 19 results for James Agalloco, Agalloco
Why heat distribution tests are an artifact of the past rather than a truly useful contemporary tool according to James Agalloco, Agalloco & Associates.
Recommendations for executing empty chamber studies for sterilization qualification/validation
Establishing a cycle development strategy that fulfills regulatory requirements
Misdirection in the implementation of isolation technology
Aseptic Processing: Origins to Current Day Technology Presented by James Agalloco, Agalloco & Associates Presentation Length - 16 minutes, 09 seconds
There are a number of areas where interpreting published information and applying it in the real world has proven to be problematic.
Science-based is well and good, but FDAs guidance may create confusion.
As PTFE diaphragms are subjected to more aggressive sterilization and cooling conditions, they are more prone to failure from cracking, splitting, deformation and SIP steam-induced blisters.
The need to improve agility and reduce financial risk is driving new approaches to plant design and operation, and the use of new technologies. Industry experts look at the future pharmaceutical plant from all angles.
By failing to assess what is truly critical to safety, revised steam quality requirements fly in the face of common sense and a generation of sterilization science.
Slated to open this fall, the University of Kentuckys new Center for Pharmaceutical Science and Technology uses mobile isolators to allow both potent and nonpotent compounds to be processed in the same room at the same time. Can this technology be used for full-scale manufacturing?
The judges have spoken, though not unequivocally, as teams from Merck in Arecibo, Puerto Rico, and Wyeth in Pearl River, N.Y., have been named Gold Award winners in Pharmaceutical Manufacturings 2006 Team of the Year awards.
Authors James Agalloco, James Akers and Russell Madsen argue that only technologies that eliminate direct contact with operators should be considered advanced if the term is not to degenerate into a commercial catch phrase.