I. Enclosure Structure

The enclosure structure of biopharmaceutical cleanroom engineering forms the foundational infrastructure ensuring a clean environment, primarily including walls, ceilings, doors, and windows. These structures are constructed with specialized materials featuring excellent airtightness, corrosion resistance, and easy cleanability, effectively isolating external contaminants and maintaining internal cleanliness. The design of enclosure structures must comply with GMP standards, ensuring no dead corners or dust accumulation, providing reliable physical barriers for pharmaceutical production.

II. Flooring Engineering

Flooring engineering is crucial in biopharmaceutical clean environments, typically using materials such as epoxy self-leveling and PVC rolls that are wear-resistant, anti-slip, and anti-static. These floors feature seamless connections, chemical corrosion resistance, and easy cleaning and disinfection, meeting the stringent requirements for flatness and cleanliness in cleanrooms. Flooring engineering must also consider details like drainage slopes and moisture-proof treatments to ensure compliance with the special needs of pharmaceutical production environments.

III. HVAC Equipment

HVAC equipment is the core system for maintaining a clean environment, ensuring cleanliness through high-efficiency filtration, temperature and humidity control, and airflow organization. Biopharmaceutical cleanroom engineering employs HVAC systems equipped with HEPA filters capable of removing 99.97% of 0.3μm particles. The system must also provide precise temperature and humidity control to meet the requirements of different pharmaceutical production processes while achieving energy-efficient operation.

IV. Ventilation System

The ventilation system in biopharmaceutical cleanroom engineering performs critical functions such as air exchange, pressure control, and contaminant removal. System design must follow unidirectional airflow principles, ensuring air moves from clean zones to less clean zones. Key areas must maintain positive or negative pressure to prevent cross-contamination. The ventilation system should also incorporate energy-saving designs, such as heat recovery units, to reduce operational costs.

V. Electrical System

The electrical system provides safe and reliable power supply and intelligent control for biopharmaceutical cleanroom engineering. System design must meet explosion-proof and anti-static requirements, using cleanroom-specific lighting and sockets. Automated control systems can monitor environmental parameters in real-time, such as temperature, humidity, pressure differentials, and cleanliness levels, ensuring continuous compliance with standards. The electrical system must also include emergency power supplies to guarantee uninterrupted operation of critical equipment.

VI. Purified Water System

The purified water system is a vital support system in biopharmaceutical production, providing purified water and water for injection that meets pharmacopoeia standards. The system includes process units such as pretreatment, reverse osmosis, EDI (electrodeionization), and distillation to ensure water quality meets specified chemical and microbiological standards. The purified water system must use sanitary-grade stainless steel piping, design circulation loops to prevent stagnant water sections, and incorporate online monitoring systems for real-time water quality parameter tracking.