Core Objectives:
1. Zero Contamination: Prevent external contaminants and internal biological risks during replacement.
2. Zero Leakage: Ensure the integrity of newly installed filters and sealing systems.
3. Compliance: Adhere to GMP, biosafety regulations, and all relevant standards.
4. Verifiability: Ensure all steps are recordable, traceable, and verifiable.
Technical Service Process
Phase I: Pre-Replacement Preparation
1. Assessment and Planning:
Collaborate with equipment and QA departments to assess needs and develop a detailed SOP.
Identify risks related to biosafety, cross-contamination, and environmental control.
Prepare for isolation, disinfection, and waste disposal.
2. Filter Selection:
Confirm filter specifications and review qualifications of new filters.
Conduct on-site verification of installation frames.
3. Personnel and Material Preparation**:
Train personnel on biosafety and SOPs.
Prepare PPE, tools, and materials for the replacement process.
Phase II: Replacement Execution
1. System Shutdown and Isolation: Turn off HVAC systems and isolate the work area.
2. Disinfection: Thoroughly disinfect the filter housing and surrounding areas.
3. Old Filter Removal: Safely remove and package the old filter.
4. New Filter Installation: Install the new filter with proper sealing and tightening.
Phase III: Post-Replacement Verification
1. Integrity Testing: Conduct leak tests using PAO or DOP generators.
2. System Commissioning: Restore HVAC systems and conduct environmental monitoring.
3. Documentation and Release: Compile all records and obtain QA approval.
Deliverables:
Risk assessment report.
Filter replacement SOP.
Filter selection confirmation report.
On-site operation records.
Old filter disposal records.
Conclusion:
Choosing a technical service provider with extensive GMP compliance experience, biosafety operational experience, a professional technical team, advanced detection equipment, and a complete documentation system is crucial. This ensures the replacement process is foolproof, safeguarding vaccine safety and production compliance.
