Introduction
In pharmaceutical manufacturing, particularly in aseptic processing, personnel are a significant source of contamination. The human body continuously sheds skin particles and microorganisms, which can compromise sterile environments if not properly controlled. Gowning procedures, therefore, are critical barriers that minimize the risk of contamination introduced by operators in classified cleanroom areas.
Regulatory guidelines such as EU GMP Annex 1, US FDA Guidance on Sterile Drug Products, and ISO 14644 require that personnel entering aseptic areas follow strict gowning protocols, including the use of sterile garments, masks, gloves, and eye protection, as well as validated procedures for donning and doffing. These controls are essential to ensure unidirectional flow, air cleanliness, and product sterility.
However, improper gowning practices—whether due to poor technique, non-compliance, inadequate training, or unsuitable garments—can result in serious contamination risks. Common issues include:
- Incorrect donning sequence leading to contamination of sterile garments
- Use of non-sterile or damaged gowning materials
- Exposed skin or hair due to improper gown fitting
- Gowning in unclassified or uncontrolled areas
- Lack of validation or periodic verification of gowning procedures
Failures in gowning discipline can contribute to microbial excursions, batch contamination, media fill failures, and regulatory observations (e.g., FDA 483s, EU GMP non-compliances). In some cases, such events may lead to product recalls, production downtime, or loss of market authorization.
This risk assessment is conducted to systematically evaluate the risks associated with improper gowning in aseptic areas, using structured tools such as 6M analysis (Man, Machine, Method, Material, Measurement, Milieu) and FMEA (Failure Mode and Effects Analysis). The focus is to:
- Identify points of failure in gowning procedures and materials
- Assess the impact of human behavior and gown quality on aseptic conditions
- Evaluate training effectiveness and compliance monitoring
- Determine the risk to product quality and patient safety
- Recommend mitigation strategies including retraining, environmental monitoring, and gowning validations
The outcome of this assessment will contribute to enhancing aseptic practices, reducing contamination risks, and ensuring full compliance with global regulatory standards for sterile manufacturing.
