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Boundary and airlock design issues in aseptic facilities.
1Kling-Lindquist Partnership, Inc., Philadelphia, Pennsylvania.
Journal of Parenteral Science and Technology : a Publication of the Parenteral Drug Association
|November 11, 1991
Summary
Aseptic facility design requires enhanced containment strategies to protect products, workers, and the environment from contamination. This involves focusing on physical barriers and airlocks as critical control points.
Area of Science:
- Pharmaceutical engineering
- Biopharmaceutical manufacturing
- Facility design
Background:
- Increasing use of hazardous biopharmaceuticals and powder derivatives in aseptic processing.
- Traditional aseptic facility design focuses on product protection, neglecting broader containment needs.
- Need for comprehensive contamination control encompassing product, personnel, and environmental safety.
Purpose of the Study:
- To broaden the definition of containment in aseptic facility design.
- To emphasize the importance of physical boundaries in contamination control.
- To highlight the role of airlocks as key control points in aseptic areas.
Main Methods:
- Review of design principles for physical boundaries in aseptic facilities.
- Analysis of airlock functionality as contamination control points.
- Focus on integration of containment strategies within facility architecture.
Main Results:
- Containment must extend beyond product protection to include worker and environmental safety.
- Physical boundaries (walls, ceilings, doors) are crucial for separating aseptic and non-aseptic zones.
- Airlocks serve as essential control points for managing contamination flow.
Conclusions:
- Aseptic facility design must adopt a holistic containment approach.
- Robust physical barriers and well-designed airlocks are fundamental for effective contamination control.
- Future aseptic facility designs should prioritize integrated containment solutions for comprehensive safety.