Practical considerations for aseptic gowning in contamination control strategies

Sterile product manufacturing is a critical process that requires the application of stringent controls and compliance with specific requirements to minimize the risks of contamination. Personnel introduce particles and microbes shed from skin, hair, and clothing. A comprehensive Contamination Control Strategy (CCS) must therefore evaluate all factors that could allow personnel to introduce contaminants into the process.

As highlighted in the most recent version of EU GMP Annex 1 (2022), a CCS should be implemented to identify and analyze the overall risk of contamination in the facility and to propose and review appropriate mitigating actions (e.g., corrective and/or preventive action plans). Within a pharmaceutical CCS, all potential sources of contamination must be considered, with personnel consistently recognized as one of the most significant contributors to risk.

Key “personnel” factors that can pose microbiological or particulate contamination risks include, at minimum:

• Gowning
• Qualification and training
• Flow
• Intervention
• Personnel monitoring

Key learning points:

• Assessing Personnel-Related Contamination Risks
• Gowning
• Other Personnel Factors
• How to develop a CCS that includes these crucial considerations