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1) Personnel
Contaminants: Skin flakes, hair, respiratory droplets, clothing fibers. (Contamination in an Aseptic)
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.
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