Explore key questions on contamination control strategies to support regulatory compliance and risk management in ...

Advanced biologics and patient-specific therapies reduce opportunities for terminal sterilization, elevating proactive microbial risk control and integrating QC microbiology into CCS authorship, risk ...

A Contamination Control Strategy (CCS) identifies and evaluates contamination risks, explores mitigation options, and sets out plans for corrective and preventive actions. Its implementation addresses ...

The mass production of pharmaceuticals has significantly evolved since the industrial fabrication of synthetic drugs towards the end of the 19 th century 1 with efficient developments in process ...

A CCS is mandated by EU and US regulations and ICH guidelines to ensure product safety and compliance in pharmaceutical manufacturing. Key CCS elements include monitoring, validation, contamination ...

In medical testing and laboratory settings, pumps are needed to move biological samples such as blood, serum, cells, and proteins. However, these same samples can contaminate a pump’s internal ...

The authors evaluated the effectiveness of adhesive mats, contamination control flooring, and shoe covers in decreasing the presence of microbial agents on animal holding room floors and footwear.