GMP Compliance Design for Cleanrooms in Aseptic Pharmaceutical Manufacturing
The core requirements for cleanrooms in aseptic pharmaceutical manufacturing are GMP compliance, prevention of cross-contamination, and full traceability. Our dedicated design for this scenario focuses on the following three key modules, precisely matching WHO/EU GMP standards and practical production needs:
I. GMP Full-Process Compliance Design (Anchored to WHO/EU GMP Core Requirements)
From design and construction to operation, the entire process adheres to GMP standards to ensure the compliance of aseptic manufacturing:
Structural Compliance: Adopting a zero-dead-angle design (rounded corners, smooth seamless floors/walls, materials are corrosion-resistant 316L stainless steel or antibacterial color steel plates) to avoid dust accumulation and microbial growth, meeting GMP requirements for cleanrooms to be "easy to clean and free of hygiene dead corners";
System Compliance: The ventilation, filtration, and disinfection systems are designed in a coordinated manner to meet GMP requirements for "verifiable air purification processes." All equipment (such as filters and fans) is selected from compliant products that meet pharmaceutical industry standards;
Document Compliance: Providing complete GMP documentation. Validation documents (including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)) support audit traceability, meeting the stringent EU GMP requirements for "full-process traceability."
II. Negative Pressure Isolation Module (Key Control of Contamination Diffusion) A negative pressure isolation system is installed for high-risk areas in aseptic preparation production (such as weighing rooms, sampling rooms, and areas handling highly active materials):
Core Parameters: The negative pressure value in key areas is consistently ≤-10Pa (adjustable as needed), creating a pressure gradient relative to adjacent clean areas to prevent high-risk materials (such as dust and active ingredients) from diffusing into ordinary clean areas;
Supporting Design: Equipped with an independent exhaust system (discharged after filtration by a HEPA filter) to prevent contaminants from entering the atmosphere or recirculating air; a buffer room (airlock) is set up to form an airflow barrier of "ordinary clean area → buffer room → negative pressure isolation area," further preventing cross-contamination.
III. Online Particle Monitoring System (Real-time Cleanliness Assurance) Monitors the sterile environment throughout the entire process, ensuring continuous compliance with cleanliness standards during production:
Monitoring Accuracy: Real-time capture of airborne particles ≥0.3μm in diameter, maintaining a stable cleanliness level of ISO 5 (GMP Grade A). Data is simultaneously displayed on on-site screens and the central control system.
Functional Adaptability: Supports continuous monitoring and automatic data recording (storage period ≥1 year). Triggers audible and visual alarms in case of abnormalities (e.g., exceeding particle count limits). Also features data export functionality, meeting GMP requirements for "real-time cleanliness monitoring and traceability."
Layout Logic: Monitoring points cover key operational areas (e.g., filling stations, material transfer channels), ensuring full controllability of the cleanliness status of core production processes.