- Production Facilities and Controls requires specially designed cleanrooms, HEPA-filtered air systems, and restricted personnel access to maintain aseptic conditions.
- Production Facilities and Controls also include rigorous environmental monitoring, validated sterilization processes, and regular maintenance of sterile equipment.
Production Facilities:
- Clean Rooms: Controlled environments with regulated temperature, humidity, and particulate levels to prevent contamination.
- Laminar Air Flow Hoods: Provide a sterile environment for aseptic processing.
- Automated Systems: Minimize human intervention and reduce contamination risks.
- Dedicated Equipment: Separate machinery for different stages to prevent cross-contamination.
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Controls:
- Environmental Monitoring: Regular testing for airborne particles, microbial contamination, and other environmental factors.
- Personnel Hygiene: Strict protocols for gowning, handwashing, and behavior to maintain sterility.
- Process Validation: Ensuring that manufacturing processes consistently produce products meeting quality standards.
- Good Manufacturing Practices (GMP): Adhering to regulatory guidelines to ensure product quality and safety.
- Documentation and Traceability: Comprehensive records of production batches, ingredients, and processes for accountability and regulatory compliance.
Thank you for reading from Firsthope's notes, don't forget to check YouTube videos!
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