1. Overall Cleanroom Planning and Construction
① Graded Cleanroom Design: Based on production process requirements, we create Class B, C, and D cleanrooms. Through optimized airflow (unidirectional and turbulent), precise temperature and humidity control (temperature 20-24°C, humidity 45%-65%), and pressure gradient design (10-15 Pa), we ensure cross-contamination of microorganisms and dust particles.
② Customized Special Functional Areas: For sterile preparation and biological product workshops, we install isolators and RABS (Restricted Access Barrier Systems) to reduce the risk of manual intervention. Cell therapy and gene therapy workshops are equipped with low-volatile materials and specialized purification equipment to meet biosafety requirements.
2. Air Purification and Pollution Control
① High-Efficiency Filtration System: We utilize HEPA (High Efficiency Particulate Air) and ULPA (Ultra-High Efficiency Particulate Air) filters with filtration efficiencies exceeding 99.99%, intercepting microorganisms, viruses, and fine particles. Activated carbon filters are also used to remove harmful gases such as VOCs.
② Dynamic Monitoring and Disinfection: Deploy online particle counters and airborne microbial samplers for real-time cleanliness monitoring, utilize hydrogen peroxide dry mist sterilization and ultraviolet (UV) circulation disinfection systems to ensure a sterile environment.
3. Process Support and Equipment Integration
① Process Piping Optimization: Design a stainless steel piping system that meets GMP requirements, employing automated welding technology to reduce welding contamination, and deploy Cleaning in Place (CIP) and Sterilization in Place (SIP) systems to ensure piping cleanliness and sterilization.
② Equipment Interoperability: Integrate the exhaust and purification systems of freeze dryers, fillers, bioreactors, and other equipment to prevent contamination from spilling out of equipment while ensuring balanced airflow between devices.
4. Validation and Compliance Services
① Validation Support: Provide full-process validation services, including DQ (Design Qualification), IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification), to ensure cleanroom and system compliance with regulations such as FDA, EMA, and NMPA.
② Compliance consulting: Assist pharmaceutical companies in interpreting the latest GMP, ISO 14644 and other standards, develop compliant cleanroom management and maintenance plans, and reduce production risks.