Paperaseptic pharmaceutical manufacturing Risk Assessments as a Process Quality Assurance Tool

Particle Counting Fundamentals and Applications Handbook

Particle contamination can impact product quality, process performance, yield, reliability, and regulatory compliance in contamination-sensitive manufacturing environments. Effective contamination control requires more than measuring particle levels. It demands an understanding of particle sources, behavior, transport mechanisms, and interactions with manufacturing processes. This handbook explores the fundamentals of particle technology, contamination-control strategies, cleanroom design, filtration, and particle measurement, providing practical insight into detecting, monitoring, and controlling particles in air, liquids, and gases.

PaperUSP 797 Revision

USP 797 Revision and Impact

The published changes to the chapter are to continue preventing harm through microbial contamination, excessive bacterial endotoxins and inappropriate quality of ingredients. Additionally, USP 797 was updated to reduce risk associated with unintended physical and chemical contaminants, as well as variability in intended strength. Currently, USP 797 is enforceable by the U.S. Food and Drug Administration, as well as 28 State Boards of Pharmacy.

PaperCleanroom Validation and Qualification

Data Management Series 2 – Risk Analysis of a Facility Monitoring System

An effective risk analysis provides Facility Monitoring System (FMS) users with the peace of mind that their data is secure and their system operative even in the event of an unforeseen situation. Here we discuss how to perform a risk analysis of an FMS system that uses the architecture of industrial automation design.

PaperFilling Line Contamination

Microbial & Particle Risk Assessment of a Cleanroom & Filling Line Contamination

Filling Line Contamination can be generally avoided through an effective contamination monitoring system, starting with a risk assessment.Ā 

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