1. Personnel:
Contaminants: Skin flakes, hair, respiratory droplets, clothing fibers.
Prevention:
Strict gowning protocols (e.g., gloves, masks, gowns).
Personnel training on aseptic techniques.
Regular health checks and hygiene practices.
2. Airborne Particles:
Contaminants: Dust, microbial spores, particulate matter.
Prevention:
HEPA filtration in HVAC systems.
Maintaining positive pressure in cleanrooms.
Regular air quality monitoring.
3. Surfaces and Equipment:
Contaminants: Residual product, cleaning agents, microbial contamination.
Prevention:
Use of non-porous, easy-to-clean materials.
Regular cleaning and disinfection schedules.
Validated cleaning protocols.
4. Materials and Components:
Contaminants: Contaminated raw materials, packaging, and tools.
Prevention:
Sterilization of incoming materials.
Proper storage in clean, controlled environments.
Use of sterile transfer techniques.
5. Water Supply:
Contaminants: Microbial contamination, endotoxins, particulates.
Prevention:
Use of purified water systems.
Regular monitoring and maintenance of water systems.
Filtration and sterilization processes.
6. Operators and Procedures:
Contaminants: Procedural errors, inadequate training.
Prevention:
Comprehensive training programs.
Standard operating procedures (SOPs).
Continuous monitoring and feedback.