Control Non-Viable Particle in clean rooms
Palash Chandra Das
SME In - Sterility Assurance Engineering | investigation | Risk Management | Regulatory inspection & Compliance (USFDA, EU) | Manufacturing science and technology | R&D | Quality | Validation | CAPA |
The root cause of a higher particle count in a clean room can be attributed to various factors, and identifying the specific cause often requires a systematic investigation. Here are some common reasons for an increased particle count in a clean room:
1. Contamination Sources:
- Personnel: Human activities can introduce particles into the clean room. This includes shedding of skin particles, hair, or clothing fibers.
- Equipment: Malfunctioning or improperly maintained equipment can release particles. This includes HVAC systems, manufacturing equipment, or any tools used in the clean room.
2. Air Handling and Filtration Issues:
- HVAC System: Inadequate ventilation or filtration problems in the HVAC system can lead to increased particle levels. Malfunctioning filters, leaks, or improper air balance can contribute.
- Filter Maintenance: Regular maintenance of air filters is crucial. Dirty or damaged filters can allow particles to bypass and circulate within the clean room.
3. Material Handling and Storage:
- Raw Materials: Contaminated raw materials or improper storage can introduce particles into the clean room during manufacturing processes.
- Packaging and Handling: Packaging materials or handling procedures that generate particles can contribute to contamination.
4. Cleanroom Design and Construction:
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- Facility Design: Poor clean room design may lead to areas of stagnant air or difficulty in maintaining proper airflow patterns.
- Construction Materials: The materials used in the construction of the clean room may generate particles if they are not suitable for cleanroom environments.
5. Cleaning Procedures:
- Cleaning Agents: Inappropriate cleaning agents or methods may leave residues or generate particles.
- Frequency of Cleaning: Infrequent or improper cleaning practices can contribute to particle buildup over time.
6. Personnel Training and Practices:
- Training: Inadequate training of personnel on cleanroom protocols and practices can result in unintentional contamination.
- Proper Attire: Failure to wear appropriate cleanroom attire, or using damaged attire, can introduce contaminants.
7. Environmental Factors:
- Outside Contamination: Environmental factors such as construction activities, nearby industrial processes, or weather conditions can contribute to increased particle levels.
To pinpoint the root cause, it is essential to conduct a thorough investigation, which may involve monitoring, testing, and analyzing various aspects of the clean room environment. Regular audits, monitoring equipment performance, and implementing corrective actions based on findings can help maintain a controlled and clean environment.