Bauabläufe der Biopharmazeutischen Reinraumtechnik

Erstellt 06.04

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.

Frequently Asked Questions (FAQ)

1. Do Food Processing Facilities Need Cleanrooms?

2. The Importance and Global Applicability of Installing Air Showers in Food Processing Plants

3. In-depth Analysis of the Specifications of High-Efficiency Air Supply Outlets and Their Corresponding Air Volumes

4. Global Cleanroom Cooperation Proposal

5. Unlocking the Outstanding Mysteries of the FFU Test Bench

6. Calculation Method of Cooling Capacity in Clean Room

7. The Selection of Air Conditioning Control Systems for Cleanrooms

8. Convenient Food Factory Pass Windows: Strengthening Food Safety Barriers and Significantly Boosting Production Efficiency with a Core Solution

9. What is an Air Shower? Understand How It Purifies Air in One Article

10. Common Issues and Solutions for Food Factory Changing Rooms

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