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.
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.
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.
Aseptic Environment Monitoring: Manage Your Risk
For Aseptic Environment Monitoring, a risk assessment helps to meet the expectations of auditors.
Risk assessment consists of the identification of hazards and the analysis and evaluation of risks associated with exposure to those hazards. The risk assessment of particle and microbiological contamination of the product and its components should take into account the following aspects: …
Risk Assessments as a Process Quality Assurance Tool
Environmental contamination control is a critical component of sterile pharmaceutical manufacturing, and Risk Management is necessary to ensure that the correct control practices are in place. The Risk Management process is a series of steps, including risk assessment, that allows for a deeper understanding of the manufacturing environment. Removing, reducing, or monitoring activities associated with a product or process to mitigate risk may be the result of such an assessment. This qualitative risk assessment can be transformed into a quantitative evaluation using modern risk analysis tools and procedures; these tools deliver the fully documented rationale behind the path chosen.
Key Factors for Optimizing Microbial Air Sampling
Microbial air sampling in pharmaceutical manufacturing relies on surface, passive, and active methodsāeach using media like agar to capture microbial growth. While techniques vary, accurate results depend on collection efficiency. This paper focuses on active air sampling and how to optimize performance across all methods.
