Introduction to Construction Steps of Biopharmaceutical Clean Engineering
(1). Preliminary Preparation Phase
1. Project Planning and Design: Complete the layout design, airflow organization, and cleanliness classification of the cleanroom according to GMP requirements and production process needs.
2. Material and Equipment Procurement: Strictly select cleanroom-compliant building materials, HVAC units, HEPA filters, and other key equipment.
3. Construction Team Training: Provide specialized training for construction personnel on cleanroom construction standards and contamination control measures.
(2). Main Construction Phase
1. Building Structure Construction: Complete the main structure of the facility, paying special attention to dust-proof and leak-proof treatments.
2. Enclosure Installation: Use clean materials such as color steel plates to construct walls and ceilings, ensuring airtightness.
3. HVAC System Installation: Install and commission ductwork, HEPA filters, FFUs, and other equipment.
(3). Clean System Implementation
1. Floor Treatment: Install epoxy self-leveling or PVC flooring suitable for cleanrooms.
2. Electrical System Installation: Ensure lighting, sockets, and automation control systems meet explosion-proof and anti-static requirements.
3. Process Piping Installation: Install and validate purified water, water for injection (WFI), and clean gas piping systems.
(4). Testing and Validation Phase
1. Cleanliness Testing: Conduct particle counting and microbial sampling tests.
2. System Validation: Perform DQ/IQ/OQ/PQ validation for HVAC, water systems, and other critical systems.
3. Final Acceptance: Compile complete construction documentation and pass GMP compliance inspections.
(5). Post-Construction Maintenance
1. Develop Maintenance SOPs: Establish standard operating procedures for regular filter replacement and environmental monitoring.
2. Ongoing Personnel Training: Ensure operators are familiar with cleanroom behavior protocols.
3. System Optimization: Adjust parameters such as pressure differentials and air changes based on production needs.