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Articles

Parameters for steam-sterilization autoclave overkill cycles should be chosen based on process understanding.

Choosing Overkill Cycle Parameters

R&D and engineering director at ATMI Life Sciences

The rapid uptake of single-use vessels for use in bioprocessing applications has made assuring integrity that much more crucial; helium integrity testing can be used to test integrity and prevent failures.

Helium Integrity Testing of Single-Use Vessels

RABS is a flexible barrier system that maximizes product control but minimizes operator interaction when best practices are followed.

Best Practices for Restricted Access Barrier Systems in Aseptic Manufacturing

Geoff Carr is the Director of Analytical Development at Patheon located in Mississauga, Ontario. His email is geoff.carr@patheon.com.

The author describes how liquid chromatography-mass spectrometry works and explains some of its advantages and disadvantages, particularly compared to high-performance liquid chromatography.

Using Tandem LC-MS for Cleaning Validation

Warehouse layout and personnel training are crucial to successfully implementing a warehouse management solution.

Solving Common Problems in Warehouse Management

A screening method aligned with USP 1660 guidance predicts glass delamination in primary packaging for parenterals.

Evaluating Parenteral Packaging for Glass Delamination

A screening method predicts delamination in primary packaging.

Crushing, fracturing, and bending tests quantify hardness.

Measuring Tablet Hardness: A Primer

Loss-in-weight feeders provide high accuracy for batch or continuous processes.

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