Contamination Control Strategy (CCS) Advisory Service

Model: Advisory Service

Booth No: N1102

Characteristic

Particle Measuring Systems Advisory Services provide expert contamination control and sterility assurance consulting for pharmaceutical, biotechnology, aseptic manufacturing, and cleanroom environments. Our experts help customers build a comprehensive Contamination Control Strategy (CCS) to improve product quality, regulatory compliance, and manufacturing performance.

With over 50 years of contamination monitoring expertise and continuous collaboration with global regulatory agencies, PMS helps customers stay aligned with the latest requirements, including EU GMP Annex 1, ISO 14644, ISO 14698, and FDA 21 CFR Part 11. Services include:

Environmental Monitoring Risk / Gap Assessments to review monitoring strategies and sampling point design.
Contamination Control Strategy (CCS) Development for individual processes or full facilities.
Environmental Monitoring Trend Analysis to define alert and action limits and reduce OOS events.
Cleaning and Disinfection Strategy development based on facility and process needs.
Gowning and Personnel Contamination Control optimization.
Aseptic Process Simulation / Media Fill support for validation and risk identification.
Sterility Assurance Audits / Mock Audits to prepare for regulatory inspections.
Particle Loss Measurement Studies aligned with ISO 14644-21 to evaluate transport tubing losses.

In addition, PMS offers Training Services and Performance Optimization Services to improve employee expertise and optimize contamination monitoring systems.

With PMS Advisory Services, customers can reduce contamination risks, improve audit readiness, accelerate product release, and build a stronger sterility assurance program.