The technical guidance for HEPA/ULPA filters in powder injection cleanrooms is a highly specialized and systematic task. Powder injections are high-risk sterile products, and maintaining a clean environment is crucial for product quality. Below is a concise framework for comprehensive technical guidance covering the entire lifecycle from selection to disposal.
I Core Objectives and Principles
1 Objective Ensure the cleanroom air environment continuously meets GMP and GB 50073 standards with core areas like filling zones typically achieving ISO 5 Grade A standards
2 Principles
Risk Management Prioritize reducing contamination and cross-contamination risks
Compliance All selections installations tests and management must comply with GMP and regulatory requirements
Lifecycle Cost Aim for the lowest Total Cost of Ownership TCO not just low purchase prices
Data-Driven Decisions Base decisions on monitoring data and validation results not on experience alone
II Detailed Technical Guidance
Phase 1 Design and Selection
1 Demand Analysis and Assessment
Evaluate layout airflow patterns and temperature humidity requirements
Determine filter efficiency grades for different cleanroom classes eg H14 for Grade A B H13 for Grade C D
Calculate rated airflows for HVAC units and FFUs
2 Filter Selection Recommendations
Efficiency and resistance Recommend high-efficiency low-resistance filters with MPPS efficiency certification eg H13 H14 per EN 1822
Filter media Suggest ultra-fine glass fiber or high-quality electrostatic filter media assessing chemical resistance and charge stability
3 Product Structure
Sealed construction Emphasize the importance of frame sealing techniques to ensure leak-free performance
Frame material Recommend rust-resistant corrosion-resistant materials like anodized aluminum stainless steel or galvanized frames
Phase 2 Installation Commissioning and Validation
1 Installation Supervision
Timing Install after all interior work and initial cleaning are complete
Personnel and tools Trained operators in cleanroom attire using specialized tools
Installation Ensure proper sealing and symmetrical tightening to prevent leaks
2 On-Site Testing and Validation IQ OQ
Integrity testing leakage test A mandatory and critical test using PAO or DOP aerosol and a photometer for scanning
Standards Leakage rate must not exceed 0.01 at any point
Additional tests Airspeed volume pressure differential and cleanliness level verification
Phase 3 Operation Maintenance and Replacement
1 Daily Monitoring
Differential pressure monitoring Install and monitor pressure gauges daily
Environmental monitoring Continuous particle and microbial monitoring
2 Replacement Strategy
Terminal resistance method Replace when resistance doubles or airflow cannot be adjusted to required levels
Periodic replacement Consider replacement after prolonged use eg over 1 year based on environmental monitoring
Emergency replacement Immediate replacement for failed integrity tests or physical damage
3 Replacement SOP Develop a detailed standard operating procedure for safe isolation disinfection removal installation and validation
Phase 4 Management and Training Support
1 Documentation Assist in establishing a filter management file system with detailed records for each unit
2 Personnel Training Train relevant staff on filter principles importance replacement procedures and emergency response
III Value Proposition
Compliance Risk Reduction Ensure continuous GMP compliance and successful audits
Product Quality Assurance Prevent powder contamination from air pollution safeguarding patient safety
Cost Optimization Extend filter life and reduce energy and spare parts costs through scientific selection and precise replacement strategies
Professional System Establishment Help build a scientific standardized and traceable management process enhancing team expertise
In summary the technical guidance for HEPA/ULPA filters in powder injection cleanrooms is a professional safeguard ensuring the critical air purification system remains robust and reliable
Post time: Sep-20-2025