Displaying 1–19 of 19 results for James Agalloco, Agalloco

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Video tutorials

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Loaded Chamber Temperature Distribution Studies

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Why heat distribution tests are an artifact of the past rather than a truly useful contemporary tool according to James Agalloco, Agalloco & Associates.

Empty Chamber Studies (aka Much Ado About Nothing)

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Recommendations for executing empty chamber studies for sterilization qualification/validation

Maximum and Minimum Loads in Steam Sterilization

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Establishing a cycle development strategy that fulfills regulatory requirements

Paradise Lost

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Misdirection in the implementation of isolation technology

Aseptic Processing: Origins to Current Day Technology

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Aseptic Processing: Origins to Current Day Technology Presented by James Agalloco, Agalloco & Associates Presentation Length - 16 minutes, 09 seconds

Uncommon Sense in Execution of Process Simulations

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There are a number of areas where interpreting published information and applying it in the real world has proven to be problematic.

Process Validation Guidance: A Bad Fit for Aseptic Processing?

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“Science-based” is well and good, but FDA’s guidance may create confusion.

Maintaining Integrity: Effects of SIP Sterilization on PTFE Valve Diaphragms

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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.

Flexible Pharma: Puzzling Out the Plant of the Future

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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.

Great Expectations, Wrong Parameters

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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.

Mobile Isolators Drive Kentucky’s New Aseptic Facility

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Slated to open this fall, the University of Kentucky’s 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?

Teams from Arecibo, Pearl River Honored with Team of the Year Gold Awards

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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 Manufacturing’s 2006 Team of the Year awards.

What is Advanced Aseptic Processing?

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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.

Fill 'Em Up

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Extending the Validated Workplace

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Isolator Systems Take On Clean Rooms

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