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Verified Service Provider in Mali
HEPA Filtration Installation & Validation Support Service in Mali
Engineering Excellence & Technical Support
HEPA Filtration Installation & Validation Support Service High-standard technical execution following OEM protocols and local regulatory frameworks.
Expert HEPA Installation & Commissioning
Our certified technicians ensure precise HEPA filter installation and meticulous commissioning for optimal airborne particle capture and air quality, adhering to stringent international standards in Mali's unique environmental conditions.
Advanced Validation & Performance Monitoring
We provide comprehensive validation services, including airflow, pressure differential, and particle count testing, to guarantee your HEPA filtration systems are performing at peak efficiency and meeting all regulatory requirements in Mali.
Tailored Maintenance & Support Solutions
Offering proactive maintenance plans and responsive support for HEPA filtration systems, we minimize downtime and ensure sustained operational effectiveness, protecting critical environments and public health across Mali.
What Is Hepa Filtration Installation & Validation Support Service In Mali?
HEPA (High-Efficiency Particulate Air) filtration installation and validation support service in Mali refers to the professional provision of expertise and resources for the proper implementation and verification of HEPA filtration systems within various facilities. This service ensures that HEPA filters are correctly installed, functioning optimally, and meeting established performance standards for air purification and contaminant removal.
| Who Needs HEPA Filtration Installation & Validation Support Service in Mali? | Typical Use Cases |
|---|---|
| Healthcare Facilities: Hospitals, clinics, operating rooms, isolation wards, laboratories (biosafety levels, diagnostic testing). Essential for infection control and preventing the spread of airborne pathogens. | Pharmaceutical Manufacturing: Cleanrooms for drug production, sterile filling, and packaging. Critical for maintaining product sterility and preventing cross-contamination. |
| Research Laboratories: Biotechnology, chemical, and biological research facilities. Required for containing hazardous aerosols and protecting sensitive experiments. | Semiconductor Manufacturing: Ultra-clean environments for microchip fabrication. Essential for preventing particulate contamination that can ruin delicate electronic components. |
| Industrial Manufacturing: Facilities requiring controlled environments to protect products or processes from airborne contaminants (e.g., food processing, precision engineering). | Cleanroom Environments: Any facility requiring a controlled atmosphere with minimal airborne particles, irrespective of the industry. |
| Public Buildings and High-Occupancy Spaces: Airports, government buildings, and large assembly areas where air quality is a concern for public health and comfort, especially in post-pandemic scenarios. | Data Centers: To maintain a dust-free environment that can interfere with sensitive electronic equipment. |
| Emergency Response and Disaster Management: Setting up temporary clean environments or ensuring air purity in critical infrastructure during health crises or environmental contamination events. | Specialized Manufacturing: Industries where fine particulate control is paramount for product quality and safety. |
This Service Typically Involves:
- Site Assessment and Design Consultation: Evaluating the specific needs of the facility, determining optimal HEPA filter placement, and designing the filtration system configuration. This includes airflow calculations, pressure drop analysis, and selection of appropriate filter types and housing.
- Procurement and Supply Chain Management: Sourcing and supplying certified HEPA filters, pre-filters, sealing materials, and necessary ductwork or containment structures, ensuring compliance with international standards (e.g., EN 1822, IEST RP-CC001).
- Installation and Integration: The physical installation of HEPA filters into HVAC systems, local exhaust ventilation (LEV) systems, or standalone air purification units. This includes proper sealing techniques to prevent bypass, ensuring airtightness of the filtration housing.
- System Commissioning: Post-installation checks to verify electrical connections, airflow rates, and operational parameters of the installed filtration system.
- Validation and Performance Testing: Conducting rigorous testing to confirm the HEPA filter's efficiency in removing particulate matter down to specified micron sizes (e.g., 99.97% of particles 0.3 microns in diameter). This often involves aerosol injection and sampling techniques.
- Leak Testing (e.g., DOP/PAO testing): Performing qualitative or quantitative tests to identify and seal any leaks in the filter media, frame, or housing, ensuring that the air passes through the filter media and not around it.
- Documentation and Reporting: Providing comprehensive documentation of the installation process, validation test results, calibration certificates, and maintenance recommendations. This is crucial for regulatory compliance and quality assurance.
- Training and Knowledge Transfer: Educating facility personnel on the operation, basic maintenance, and filter change procedures for the installed HEPA filtration systems.
- Ongoing Support and Maintenance Planning: Offering advice on scheduled filter replacement, system performance monitoring, and troubleshooting.
Who Needs Hepa Filtration Installation & Validation Support Service In Mali?
In Mali, the need for HEPA (High-Efficiency Particulate Air) filtration installation and validation support is crucial for environments demanding the highest air quality standards. This service ensures that HEPA filters are correctly installed and performing optimally to remove airborne contaminants like bacteria, viruses, dust, and allergens. This is particularly important in sectors where the health and safety of individuals, or the integrity of processes, are paramount.
| Target Customer Segment | Key Departments/Areas Requiring Service |
|---|---|
| Healthcare | Operating Theatres, Intensive Care Units (ICUs), Isolation Rooms, Pharmacies, Laboratories (Microbiology, Pathology), Emergency Departments |
| Pharmaceutical & Biotech | Cleanrooms (Class A, B, C, D), Manufacturing Suites, R&D Labs, Quality Control Labs, Sterile Filling Areas |
| Research & Academia | Biological Safety Cabinets (BSCs), General Research Laboratories, Specialized Scientific Labs (e.g., Genetics, Virology) |
| Manufacturing & Industrial | Cleanrooms for electronics assembly, Semiconductor fabrication areas, Food processing clean zones, Precision engineering workshops |
| Government & Public Health | Disease Surveillance Centers, Quarantine Facilities, Public Health Laboratories, Emergency Response Centers |
| Transportation | Airport lounges (premium areas), Immigration and Customs control points (for air quality management) |
| Hospitality | Executive Suites, Spa and Wellness Centers, Air handling units serving critical guest areas |
| Education | Advanced Science Laboratories, Specialized Research Labs |
Target Customers and Departments in Mali Requiring HEPA Filtration Installation & Validation Support Service:
- {"heading":"Healthcare Facilities","description":"Hospitals, clinics, diagnostic laboratories, and isolation wards require HEPA filtration to prevent the spread of airborne infections, protect immunocompromised patients, and maintain sterile environments for surgical procedures."}
- {"heading":"Pharmaceutical and Biotechnology Companies","description":"Manufacturing facilities, research laboratories, and cleanrooms within these sectors need HEPA filtration to ensure product sterility, prevent cross-contamination, and maintain the integrity of sensitive experiments and production processes."}
- {"heading":"Research Institutions and Universities","description":"Laboratories involved in biological research, chemical analysis, and other sensitive scientific work benefit from HEPA filtration to protect researchers from hazardous airborne particles and to maintain controlled experimental conditions."}
- {"heading":"Critical Manufacturing and Industrial Sectors","description":"Industries like electronics manufacturing, food and beverage processing, and precision engineering often have cleanroom requirements to prevent product contamination and ensure the quality of finished goods."}
- {"heading":"Government and Public Health Agencies","description":"Institutions responsible for public health monitoring, disease control, and ensuring safe public spaces may require HEPA filtration in specific facilities or for outbreak response."}
- {"heading":"Airports and Transportation Hubs","description":"To improve passenger health and comfort, and to mitigate the spread of airborne pathogens in high-traffic areas."}
- {"heading":"Hotels and Hospitality Sector","description":"High-end hotels and resorts may offer HEPA-filtered air in suites or common areas to cater to guests with allergies or respiratory sensitivities, and to enhance overall guest experience."}
- {"heading":"Educational Institutions (Specific Areas)","description":"While not widespread, specialized laboratories or science departments within universities and schools might require HEPA filtration for advanced research or teaching activities."}
Hepa Filtration Installation & Validation Support Service Process In Mali
This document outlines the comprehensive workflow for HEPA filtration installation and validation support services provided in Mali, from initial client inquiry to final project execution and handover. The process is designed to ensure efficient, compliant, and high-quality HEPA system implementation, adhering to international standards and local regulations where applicable.
| Phase | Key Stages | Activities | Deliverables | Key Stakeholders | Timeline (Indicative) |
|---|---|---|---|---|---|
| 1: Inquiry & Initial Consultation | Initial Contact & Needs Assessment | Client submits inquiry (email, phone, website). Initial meeting (virtual or in-person) to understand project scope, facility type, HEPA requirements (e.g., cleanroom class, specific contaminants), existing infrastructure, and budget. Preliminary risk assessment. | Initial understanding of client needs, confirmation of service applicability, preliminary scope outline. | Client, Service Provider Sales/Technical Team | 1-3 Business Days |
| 2: Site Assessment & Proposal Development | On-site/Remote Assessment & Scope Refinement | Detailed site survey to assess installation space, airflow, power supply, existing HVAC system, and potential challenges. Review of architectural drawings and technical specifications. Refinement of project scope based on site assessment. | Detailed site assessment report, refined technical requirements, finalized project scope. | Client Facilities Team, Service Provider Technical Team, Project Manager | 3-7 Business Days |
| Proposal and Quotation Generation | Development of a comprehensive proposal including technical solution, equipment specifications, installation plan, validation strategy, timeline, cost breakdown, and terms & conditions. | Formal proposal, detailed quotation, preliminary project plan. | Service Provider Technical Team, Project Manager, Finance Department | 5-10 Business Days | |
| 3: Contract & Planning | Proposal Review & Negotiation | Client reviews proposal and quotation. Discussions and negotiations on scope, cost, and timeline. Clarification of any queries. | Agreed-upon scope, revised proposal (if applicable). | Client, Service Provider Sales/Project Management | 2-5 Business Days |
| Contract Finalization & Signing | Formalization of the agreement through a signed contract, outlining all terms, responsibilities, payment schedules, and legal aspects. | Signed Service Agreement/Contract. | Client Legal/Procurement, Service Provider Legal/Management | 3-7 Business Days | |
| Detailed Project Planning | Development of a comprehensive project plan, including detailed installation schedule, resource allocation, risk management plan, communication plan, and validation protocol. | Detailed Project Plan, Risk Register, Communication Matrix, Validation Protocol. | Project Manager, Service Provider Technical Team, Client Representative | 5-10 Business Days | |
| 4: Procurement & Logistics | Equipment & Material Procurement | Ordering of HEPA filters, housings, ductwork, sealant, testing equipment, and other necessary materials based on finalized specifications. | Procured HEPA filters, housings, and associated materials. | Procurement Department, Project Manager | Variable (depends on lead times, typically 2-8 weeks) |
| Logistics & Site Preparation Coordination | Arrangement of transportation of equipment and materials to Mali. Coordination with the client for site access and necessary preparations (e.g., power, workspace). | Arranged logistics, confirmation of site readiness. | Logistics Coordinator, Project Manager, Client Facilities Team | Ongoing (integrated with procurement) | |
| 5: Installation & Pre-Validation Testing | Site Mobilization & Preparation | Service provider team mobilizes to the site. Final site preparation and safety checks. | Mobilized team, confirmed site safety. | Installation Team, Project Manager, Site Safety Officer | 1-2 Business Days |
| HEPA System Installation | Installation of HEPA filters, housings, and associated ductwork or integration into existing HVAC systems, following approved plans and manufacturer guidelines. | Installed HEPA filtration system. | Installation Team, Site Supervisor | Variable (depends on system complexity, typically 3-15 Business Days) | |
| Pre-Validation Checks & Sealant Curing | Visual inspection of all connections, checks for air leaks (e.g., using smoke pencils), and ensuring sealant curing times are met. | Pre-validation checklist completed, leak test results (preliminary). | Installation Team, Quality Control Personnel | 1-2 Business Days (integrated) | |
| 6: Validation & Testing | Filter Integrity Testing (FIT) | Performing the HEPA filter integrity test (e.g., scan test) to ensure no leaks between the filter media and the housing, and around the housing seal. | Filter Integrity Test (FIT) report. | Validation Technicians, Project Manager | 1-3 Business Days |
| Airflow & Differential Pressure Measurements | Measuring and verifying airflow rates and differential pressures across the HEPA system and within the controlled environment to meet design specifications and regulatory requirements. | Airflow and differential pressure measurement reports. | Validation Technicians, Project Manager | 1-2 Business Days | |
| Particle Count Testing (if applicable) | Conducting particle count tests to verify the cleanroom class or specified air cleanliness levels achieved by the HEPA filtration. | Particle count test report. | Validation Technicians, Client Representative | 1-2 Business Days | |
| Performance Review & Gap Analysis | Review of all test results against the validation protocol and specified requirements. Identification of any deviations or non-conformances. | Preliminary validation report, identified deviations. | Validation Team Lead, Project Manager, Client Representative | 1-2 Business Days | |
| 7: Documentation & Handover | Validation Report Compilation | Compilation of all test data, certificates of conformity for filters, installation records, and assessment of results into a comprehensive validation report. | Draft Validation Report. | Validation Team Lead, Project Manager | 3-5 Business Days |
| Client Review & Approval | Presentation of the draft validation report to the client for review and feedback. Addressing any client queries or concerns. | Client feedback, agreed-upon amendments to the report. | Project Manager, Client Representative | 2-4 Business Days | |
| Final Report & Certificate Issuance | Issuance of the final, approved validation report and any relevant certificates (e.g., Installation Qualification (IQ), Operational Qualification (OQ) certificates). | Final Approved Validation Report, IQ/OQ Certificates. | Project Manager, Service Provider Management | 1-2 Business Days | |
| Project Handover | Formal handover of the validated HEPA system and all documentation to the client. | Signed handover confirmation. | Project Manager, Client Representative | 1 Business Day | |
| 8: Post-Installation Support & Training | Client Training | Providing training to the client's operational and maintenance staff on the proper use, cleaning, and basic maintenance of the HEPA filtration system. | Trained staff, training materials. | Service Provider Technical Trainer, Client Staff | 1-2 Business Days |
| Warranty & Maintenance Support | Providing information on warranty terms and offering ongoing maintenance and support services as per the service agreement. | Warranty documentation, service agreement (if applicable). | Service Provider Customer Support, Project Manager | Ongoing |
HEPA Filtration Installation & Validation Support Service Process in Mali
- Phase 1: Inquiry & Initial Consultation
- Phase 2: Site Assessment & Proposal Development
- Phase 3: Contract & Planning
- Phase 4: Procurement & Logistics
- Phase 5: Installation & Pre-Validation Testing
- Phase 6: Validation & Testing
- Phase 7: Documentation & Handover
- Phase 8: Post-Installation Support & Training
Hepa Filtration Installation & Validation Support Service Cost In Mali
Securing HEPA filtration installation and validation support services in Mali involves a range of costs influenced by several key factors. These services are crucial for maintaining air quality in sensitive environments such as healthcare facilities, laboratories, and industrial settings, ensuring compliance with stringent health and safety regulations. The pricing is not standardized and can vary significantly based on the project's scope, the complexity of the installation, the expertise of the service provider, and the geographical location within Mali.
| Service Component | Estimated Cost Range (XOF - West African CFA franc) | Notes |
|---|---|---|
| Site Assessment & Design | 100,000 - 500,000 | Varies based on complexity and site size. Includes initial consultations and technical drawings. |
| HEPA Filter Unit (per unit) | 250,000 - 1,500,000+ | Depends heavily on filter efficiency (e.g., H13, H14), size, and manufacturer. Includes pre-filters. |
| Installation Labor (per technician, per day) | 50,000 - 150,000 | Skilled labor is essential. Daily rates can fluctuate. |
| Ductwork/Integration Modifications | 100,000 - 1,000,000+ | Highly project-dependent. Can involve significant structural or HVAC work. |
| Validation & Testing (per system) | 200,000 - 750,000 | Includes leak tests, airflow measurements, differential pressure monitoring, and certification. |
| Project Management | 50,000 - 200,000 | Covers coordination, scheduling, and overall project oversight. |
| Travel & Logistics (per trip) | 30,000 - 150,000 | For sites outside major urban centers. Influenced by distance and mode of transport. |
| Total Project Cost (Small to Medium Scale) | 1,000,000 - 5,000,000+ | This is a rough estimate for a basic installation and validation for a few filter units. Large-scale or complex projects can far exceed this. |
Key Pricing Factors for HEPA Filtration Installation & Validation Support in Mali
- Scope of Work: The number of HEPA filters to be installed, the size and type of the filtration units, and the complexity of the ductwork or air handling unit integration all directly impact the cost.
- Site Assessment & Design: Pre-installation site surveys, air quality testing, and the development of a tailored filtration design contribute to the overall service fee.
- Equipment Costs: The price of the HEPA filters themselves, along with any necessary pre-filters, housing, or custom fabrication, is a significant component of the total expenditure.
- Installation Labor: The hourly rates or project-based fees for qualified technicians and engineers performing the physical installation, including any necessary modifications to existing HVAC systems.
- Validation & Testing: This includes the critical stages of performance testing (e.g., filter integrity testing, airflow measurements, differential pressure monitoring) and certification, which require specialized equipment and trained personnel.
- Geographical Location: Accessibility to the installation site within Mali can affect logistical costs, including transportation of equipment and personnel. Remote or difficult-to-access locations may incur higher charges.
- Service Provider's Reputation & Expertise: Highly experienced and reputable companies with a proven track record in HEPA filtration installations and validations may command higher fees due to their specialized knowledge and reliability.
- Urgency of Service: Emergency or expedited installation and validation services may be subject to premium pricing.
- Ongoing Maintenance & Support: While not strictly installation and validation, some service packages may include initial maintenance plans or long-term support contracts, which would influence the initial pricing.
- Regulatory Compliance Requirements: The stringency of specific industry or health regulations in Mali might necessitate more rigorous validation protocols, thereby increasing costs.
Affordable Hepa Filtration Installation & Validation Support Service Options
Our Affordable HEPA Filtration Installation & Validation Support Service is designed to provide cost-effective solutions for ensuring optimal air quality in your facility. We understand that implementing and validating HEPA filtration can represent a significant investment, and our service bundles and cost-saving strategies are tailored to maximize your return on investment while minimizing upfront and ongoing expenses. We offer a tiered approach to installation and validation, allowing you to select the level of service that best fits your budget and specific needs. Our expert team ensures that all installations meet stringent regulatory requirements and that validation processes are comprehensive and efficient. By leveraging our expertise and streamlined methodologies, you can achieve compliance and superior air filtration without breaking the bank.
| Cost-Saving Strategy | Description | Benefit |
|---|---|---|
| Multi-Unit Discounts | Receive reduced pricing for installing HEPA filters in multiple locations or rooms simultaneously. | Significant savings on labor and material costs for larger projects. |
| Off-Peak Scheduling | Schedule installations and validation during non-peak hours or slower periods for your facility. | Potentially lower service rates and less disruption to your operations. |
| Preventative Maintenance Packages | Opt for recurring maintenance plans to proactively address filter performance and extend lifespan. | Reduces the likelihood of costly emergency repairs and unexpected downtime. |
| Bundled Installation & Validation | Combine your installation and validation services into a single, integrated package. | Streamlined process, reduced administrative overhead, and potential package discounts. |
| Extended Filter Warranties | Inquire about extended warranty options on HEPA filters. | Provides peace of mind and protection against premature filter failure. |
| Energy-Efficient Filter Options | Consider selecting HEPA filters with lower pressure drop. | Reduces energy consumption for your HVAC system, leading to ongoing cost savings. |
| Phased Implementation | For larger projects, consider a phased approach to installation and validation. | Spreads the cost over a longer period, making it more manageable for your budget. |
Value Bundles Explained
- {"title":"Basic Essentials Bundle","description":"Ideal for smaller facilities or those with existing filtration knowledge. Includes standard HEPA filter installation, basic leak testing, and a post-installation air quality check. Cost-effective for essential compliance."}
- {"title":"Standard Compliance Bundle","description":"Our most popular option, offering a balance of affordability and thoroughness. Includes professional HEPA filter installation, comprehensive leak testing with certified equipment, and initial validation report generation. Ensures robust compliance."}
- {"title":"Premium Performance Bundle","description":"For facilities requiring the highest level of assurance and ongoing support. Includes all features of the Standard Compliance Bundle, plus advanced validation techniques, personalized performance reporting, and a first-year maintenance consultation. Maximizes long-term efficiency and compliance."}
- {"title":"Customizable Solutions","description":"We understand that every facility is unique. We offer the flexibility to tailor any bundle to your specific requirements, ensuring you only pay for the services you need."}
Verified Providers In Mali
In Mali's evolving healthcare landscape, identifying trustworthy and credentialed providers is paramount. Franance Health stands out as a leading organization committed to ensuring the highest standards of care. This document outlines Franance Health's credentials and explains why partnering with them represents the most effective and reliable choice for healthcare services in Mali.
| Benefit | Why Franance Health Excels | Impact for Patients/Partners |
|---|---|---|
| Reliability and Trustworthiness | Franance Health's comprehensive vetting and accreditation processes ensure that all their associated providers are legitimate and meet high professional standards. | Patients can have confidence in receiving safe, effective, and ethical medical care. Partners can rely on a dependable network for healthcare provision. |
| Quality of Care | Their commitment to quality assurance, continuous professional development, and patient feedback guarantees that providers are up-to-date with best practices and patient needs. | Improved health outcomes, higher patient satisfaction, and a reduced risk of medical errors. |
| Accessibility and Efficiency | Through technological integration and streamlined administrative processes, Franance Health aims to make healthcare services more accessible and efficient. | Easier appointment scheduling, faster service delivery, and a more convenient patient journey. |
| Ethical Standards | A strong emphasis on ethical medical practices and a patient-centric philosophy ensures that patient rights and well-being are always at the forefront. | Patients feel respected, informed, and empowered in their healthcare decisions. |
| Comprehensive Healthcare Solutions | Franance Health's broad network and commitment to community health offer a well-rounded approach to healthcare in Mali. | Access to a wide range of services and proactive health initiatives contributing to a healthier Malian population. |
Franance Health's Core Credentials and Commitments
- Accreditation and Regulatory Compliance: Franance Health adheres to all Malian national healthcare regulations and is actively pursuing or has achieved recognized accreditation from relevant governmental and international health bodies. This signifies a commitment to operational excellence and patient safety.
- Rigorous Provider Vetting: All healthcare professionals associated with Franance Health undergo a stringent vetting process. This includes verification of medical licenses, educational qualifications, professional experience, and background checks, ensuring only highly competent and ethical practitioners are part of their network.
- Quality Assurance Framework: Franance Health implements a robust quality assurance framework encompassing regular performance reviews, patient feedback mechanisms, and continuous professional development programs for its providers. This dedication to ongoing improvement guarantees a consistently high level of care.
- Ethical Practice and Patient-Centric Approach: A core tenet of Franance Health is an unwavering commitment to ethical medical practices and a patient-centric approach. This means prioritizing patient well-being, confidentiality, and informed consent in all aspects of their service delivery.
- Technological Integration and Innovation: Franance Health embraces technological advancements to enhance healthcare delivery. This includes leveraging secure digital health records, telemedicine capabilities where appropriate, and efficient administrative systems to streamline patient experiences.
- Community Engagement and Health Education: Beyond direct medical services, Franance Health actively engages with local communities, promoting health awareness and providing educational resources. This holistic approach contributes to better health outcomes for the wider population.
Scope Of Work For Hepa Filtration Installation & Validation Support Service
This Scope of Work (SOW) outlines the services to be provided for the installation and validation support of HEPA (High-Efficiency Particulate Air) filtration systems. The services encompass all necessary activities to ensure the successful integration, operational readiness, and documented validation of the HEPA filtration units according to established industry standards and client-specific requirements. The objective is to achieve and maintain optimal air quality and containment as per regulatory and operational needs.
| Deliverable Name | Description | Standard Specification Reference | Acceptance Criteria |
|---|---|---|---|
| Site Assessment Report | Detailed report of existing conditions, infrastructure, and recommendations for optimal HEPA filtration system integration. | Client's Site Assessment Template / ISO 14644-1 (General cleanliness context) | Report accurately reflects site conditions and provides actionable recommendations for installation. |
| HEPA Filter Pre-qualification Data | Documentation confirming HEPA filters meet specified efficiency and integrity requirements prior to installation. | ISO 29463-1 (General requirements for HEPA filters), Manufacturer's Certificate of Conformance | Filters meet or exceed specified DOP/PAO efficiency and are free from visible defects. |
| Installation Qualification (IQ) Report | Documented verification that the HEPA filtration system and its components have been installed correctly according to design specifications and drawings. | cGMP (21 CFR Part 211/820), ISPE Baseline Guide, Client IQ SOP | All installation parameters (e.g., serial numbers, material of construction, connections, sealing) verified and documented as satisfactory. |
| Leak Testing Report | Results from leak testing the HEPA filter installation to ensure no bypass of the filter media. | ISO 14644-3 (Methods for leak testing of filter installations) | Leakage rate below the acceptable limit (e.g., < 0.01% of total airflow as per ISO 14644-3 Annex B). |
| Airflow and Pressure Differential Report | Measurements of airflow rates and pressure differentials across the HEPA filter system to confirm design performance. | ISO 14644-2 (Monitoring of cleanroom conditions), Client's Airflow SOP | Measured airflow and pressure differentials are within +/- 10% of design specifications. |
| Operational Qualification (OQ) Report | Documented verification that the installed HEPA filtration system operates as intended within its specified operating ranges. | cGMP (21 CFR Part 211/820), ISPE Baseline Guide, Client OQ SOP | System functions (e.g., fan speed control, pressure monitoring, alarms) operate within defined parameters during various operational states. |
| Particulate Counting / Air Quality Validation Report (if applicable) | Data demonstrating the effectiveness of the HEPA filtration in achieving the required air cleanliness class. | ISO 14644-1 (Classification of air cleanliness), ISO 14644-2 (Monitoring), Client's Air Quality SOP | Measured particle counts meet the specified ISO cleanroom class requirements for the designated zones. |
| As-Built Drawings | Updated drawings reflecting the final installed configuration of the HEPA filtration system. | Client's Drawing Standards | Drawings accurately represent the final installation and all modifications made during the project. |
| Training Material and Session Record | Documentation and record of training provided to client personnel on the operation, routine maintenance, and basic troubleshooting of the HEPA filtration system. | Client's Training SOP | Training materials are comprehensive, and attendance records are maintained. |
Key Activities and Deliverables
- Site assessment and pre-installation survey
- Procurement and delivery of HEPA filtration units and associated hardware
- Mechanical and electrical installation of HEPA filter housings, filters, and related ductwork/connections
- Pre-qualification of HEPA filters
- Leak testing of HEPA filter installations
- Airflow and pressure differential measurements
- Particulate counting and air quality validation
- Development and execution of Validation Master Plan (VMP) and Installation Qualification (IQ)/Operational Qualification (OQ)/Performance Qualification (PQ) protocols
- Generation of Installation Qualification (IQ) report
- Generation of Operational Qualification (OQ) report
- Generation of Performance Qualification (PQ) report (if applicable, based on scope)
- As-built drawings and documentation updates
- Training for client personnel on operation and maintenance
- Post-installation support and troubleshooting
Service Level Agreement For Hepa Filtration Installation & Validation Support Service
This Service Level Agreement (SLA) outlines the guaranteed response times and uptime commitments for the HEPA Filtration Installation & Validation Support Service. This SLA is a part of the Master Service Agreement (MSA) between [Your Company Name] and [Client Company Name].
| Service Component | Service Level Objective (SLO) | Uptime Guarantee | Notes |
|---|---|---|---|
| On-site Installation Support | Response Time: Within 4 business hours of ticket submission for critical issues (system down, facility shutdown). Within 8 business hours for non-critical issues (performance degradation, scheduling inquiry). | N/A (Installation is a project-based service with defined timelines.) | Business hours are defined as Monday to Friday, 9:00 AM to 5:00 PM [Client's Time Zone], excluding public holidays. |
| On-site Validation Support | Response Time: Within 4 business hours of ticket submission for critical issues (failed validation, immediate compliance risk). Within 8 business hours for non-critical issues (scheduling validation, documentation request). | N/A (Validation is a project-based service with defined timelines.) | On-site presence is subject to technician availability and travel time. Emergency on-site dispatch may incur additional fees as per the MSA. |
| Remote Support & Troubleshooting | Response Time: Within 2 business hours for critical issues. Within 4 business hours for non-critical issues. | 99.5% availability during agreed-upon support hours (Monday-Friday, 8:00 AM - 6:00 PM [Client's Time Zone]). | Remote support relies on the client providing adequate remote access and network connectivity. |
| Documentation & Reporting | Response Time: Within 2 business days for standard validation reports. Within 5 business days for comprehensive installation documentation. | N/A | Turnaround times may extend for complex or large-scale projects. |
Scope of Service
- On-site installation support for HEPA filtration systems.
- On-site and remote validation services for installed HEPA filtration systems.
- Troubleshooting and repair assistance for HEPA filtration systems.
- Preventative maintenance scheduling and execution (if applicable, as per separate maintenance agreement).
- Documentation and reporting related to installation and validation.
- Technical consultation regarding HEPA filtration performance and compliance.
In-Depth Guidance
Frequently Asked Questions
Phase 02: Execution
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