Designing an aseptic area involves creating a highly controlled environment to prevent contamination in processes such as pharmaceutical manufacturing, healthcare, or lab work.
Key Considerations of Designing of aseptic area
1. Regulatory Compliance:
Follow guidelines from bodies like FDA, EMA, WHO, and standards like ISO 14644.
2. Cleanroom Classification:
Define based on maximum particle counts (ISO Class 5-8).
3. Layout and Design:
Unidirectional Flow: Prevent cross-contamination.
Zoning: Establish areas with increasing cleanliness levels.
Airlocks: Maintain pressure differentials.
Separate Flows: Distinct entry/exit for personnel and materials.
4. HVAC System:
HEPA Filtration: Remove particulates.
Air Changes: Ensure adequate air changes per hour (ACH).
Pressure Control: Positive pressure in clean zones.
Temperature/Humidity: Maintain specified levels.
5. Surface Materials:
Use non-porous, smooth, and easily cleanable materials.
Coving: Smooth transitions at floor-wall junctions.
6. Equipment and Furnishings:
Choose designs that minimize dust accumulation and are easy to clean.
7. Lighting:
Sufficient, non-heat-generating, and easy-to-clean lighting.
8. Personnel and Material Handling:
Gowning Procedures: Strict protocols for personnel.
Material Transfer: Use sterile techniques.
9. Cleaning and Maintenance:
Regular, rigorous cleaning and disinfection schedules.
10. Monitoring and Validation:
Environmental Monitoring: Regular checks for contaminants.
Validation: Ensure all processes meet cleanliness standards.
Four Main Grades of Cleanrooms
1. Grade A:
For high-risk operations (e.g., laminar flow hoods).
Highest cleanliness standards.
2. Grade B:
Background for Grade A areas.
Supports aseptic preparation and filling.
3. Grade C:
Clean areas for less critical stages (e.g., solution preparation).
4. Grade D:
Areas for final cleaning and preparatory steps.
Design Example
Floor Plan Layout
1. Gowning Area:
Personnel change into cleanroom attire.
2. Airlock:
Maintains pressure differentials.
3. Aseptic Core Area:
Main cleanroom for critical operations.
4. Material Airlock/Pass-Through:
For decontaminated materials.
5. Support Areas:
Storage and waste management.
Workflow
1. Entry:
Separate airlocks for personnel and materials.
2. Processing:
Conducted in aseptic core with strict protocols.
3. Exit:
Designated routes for personnel and waste.