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Cleanroom Engineering (ISO 5-8) in Eswatini
Engineering Excellence & Technical Support
Cleanroom Engineering (ISO 5-8) solutions for Bioprocessing & Manufacturing. High-standard technical execution following OEM protocols and local regulatory frameworks.
Advanced HEPA/ULPA Filtration Systems
Implementation and validation of high-efficiency particulate air (HEPA) and ultra-low particulate air (ULPA) filtration systems, ensuring critical environmental controls for ISO 5-8 cleanrooms, vital for pharmaceutical manufacturing and sensitive electronics production in Eswatini.
Precise Airflow and Pressure Control
Design and maintenance of sophisticated airflow management and differential pressure control systems, guaranteeing the integrity of ISO cleanroom classifications (5-8) through precise air changes per hour (ACH) and pressure differentials, crucial for preventing particulate contamination in Eswatini's growing industries.
Comprehensive Contamination Control Strategies
Development and execution of robust contamination control protocols, including particle counting, microbial monitoring, and environmental parameter validation (temperature, humidity), to maintain ISO 5-8 cleanroom standards and support Eswatini's compliance with international quality benchmarks for regulated industries.
What Is Cleanroom Engineering (Iso 5-8) In Eswatini?
Cleanroom engineering, specifically adhering to ISO 5-8 standards, in Eswatini refers to the design, construction, commissioning, and ongoing validation of controlled environments that minimize airborne particulate contamination. These cleanrooms are essential for processes where even minuscule particles can compromise product integrity, safety, or experimental outcomes. The ISO classification system dictates the maximum permissible number of particles of specific sizes per unit volume of air. ISO 5 (formerly Class 100) represents a highly controlled environment with a maximum of 3,520 particles ≥ 0.5 µm per cubic meter, while ISO 8 (formerly Class 100,000) allows up to 3,520,000 particles. The service involves a comprehensive approach encompassing air filtration systems (HEPA/ULPA), differential pressure control, material and personnel flow management, specialized construction materials, environmental monitoring, and stringent operational protocols.
| Service | Description | Who Needs It | Typical Use Cases in Eswatini |
|---|---|---|---|
| Design and Specification | Developing precise blueprints and technical specifications for cleanroom layout, airflow patterns, filtration requirements, and materials to meet specific ISO standards and operational needs. | Companies establishing new manufacturing or research facilities, or upgrading existing ones requiring controlled environments. | Pharmaceutical manufacturers developing sterile drug products; biotechnology firms engaged in sensitive cell culture; research institutions conducting advanced scientific experiments. |
| Construction and Installation | Building the physical cleanroom structure, including walls, ceilings, floors, doors, pass-throughs, and the integration of air handling units, filtration systems, and environmental controls. | Construction firms specializing in controlled environments; end-users overseeing facility development. | Setting up sterile manufacturing suites for medical device production; constructing clean laboratories for food safety testing; building specialized areas for electronics assembly. |
| Commissioning and Validation | Testing and verifying that the constructed cleanroom meets all design specifications and regulatory requirements (ISO, GMP, etc.) through Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). | Quality assurance departments; regulatory compliance officers; validation engineers. | Confirming the performance of a newly installed ISO 7 cleanroom for pharmaceutical packaging; validating an ISO 5 clean booth for critical semiconductor component handling; verifying the environmental controls of an ISO 8 laboratory for cosmetic production. |
| Routine Monitoring and Recertification | Implementing ongoing programs to monitor particulate counts, temperature, humidity, and pressure differentials. Periodic recertification ensures continued compliance with ISO standards. | Facility managers; quality control personnel; maintenance teams. | Daily particulate monitoring in an ISO 6 pharmaceutical production area; quarterly HEPA filter integrity testing for an ISO 5 sterile filling line; annual cleanroom recertification for a food processing facility. |
| Consultancy and Training | Providing expert advice on cleanroom design, operation, and compliance. Offering training programs for personnel on cleanroom protocols and best practices. | Companies seeking to improve cleanroom performance, ensure regulatory compliance, or train staff effectively. | Advising on optimal airflow for an ISO 7 cleanroom in a local brewery's quality control lab; training staff on gowning procedures for an ISO 8 cleanroom in a local cosmetic manufacturer; consulting on retrofitting an existing facility to meet ISO cleanroom standards. |
Key Components of Cleanroom Engineering (ISO 5-8)
- Air Filtration Systems (HEPA/ULPA)
- Pressurization Control and Airflow Management
- Material and Personnel Decontamination/Entry Procedures
- Specialized Construction Materials and Finishes
- Environmental Monitoring and Control (Particulate, Temperature, Humidity)
- Validation and Qualification Protocols (IQ, OQ, PQ)
- Operational Procedures and Training
Who Needs Cleanroom Engineering (Iso 5-8) In Eswatini?
Cleanroom engineering, specifically targeting ISO 5-8 standards, is crucial for a variety of industries in Eswatini that require controlled environments to prevent contamination. These standards are essential for processes where even minute particulate matter can compromise product quality, patient safety, or research integrity. The need spans sectors that handle sensitive materials, manufacture precision components, or conduct critical biological and medical procedures.
| Target Customer/Industry | Specific Departments/Applications | Reason for ISO 5-8 Cleanroom Requirement |
|---|---|---|
| Pharmaceutical Manufacturers | Active Pharmaceutical Ingredient (API) manufacturing, sterile drug product filling, tablet/capsule manufacturing, quality control labs | Preventing microbial and particulate contamination to ensure drug efficacy, safety, and regulatory compliance (e.g., for APIs, sterile injectables, oral dosage forms). |
| Medical Device Manufacturers | Sterile implant manufacturing, assembly of sensitive diagnostic equipment, packaging of critical medical devices | Ensuring product sterility, preventing bioburden accumulation, and maintaining the functionality of precision components. |
| Research and Development Laboratories (Biotechnology, Academia) | Cell culture, DNA/RNA extraction and analysis, sterile media preparation, microbiology labs | Maintaining sterile conditions for sensitive experiments, preventing cross-contamination, and ensuring accurate and reproducible research outcomes. |
| Electronics Manufacturers | Semiconductor fabrication, assembly of sensitive electronic components, cleanroom for microelectronics | Preventing dust and particulate contamination that can cause defects, short circuits, or reduced device performance in microelectronic components. |
| Food and Beverage Processing (Specialized Areas) | Aseptic filling of sensitive food products (e.g., infant formula, dairy), sterile packaging for long-shelf-life products | Minimizing microbial contamination to extend shelf life, prevent spoilage, and ensure consumer safety, especially for high-risk products. |
| Hospitals and Healthcare Facilities | Sterile compounding pharmacies (e.g., for chemotherapy, IV admixtures), operating rooms, microbiology and pathology labs | Preventing airborne microorganisms from contaminating sterile medications, ensuring sterile surgical environments, and maintaining the integrity of diagnostic samples. |
| Diagnostic Laboratories | Clinical diagnostic testing, molecular diagnostics, specimen handling areas | Preventing contamination of patient samples, ensuring the accuracy of diagnostic test results, and maintaining the integrity of sensitive reagents. |
Target Customers for ISO 5-8 Cleanroom Engineering in Eswatini
- Pharmaceutical Manufacturers
- Medical Device Manufacturers
- Research and Development Laboratories (Biotechnology, Academia)
- Electronics Manufacturers
- Food and Beverage Processing (Specialized Areas)
- Hospitals and Healthcare Facilities (Sterile Compounding, Operating Rooms)
- Diagnostic Laboratories
Cleanroom Engineering (Iso 5-8) Process In Eswatini
This document outlines the typical workflow for cleanroom engineering services (ISO 5-8) in Eswatini, from the initial client inquiry through to the successful execution of the project. The process emphasizes collaboration, adherence to international standards, and compliance with Eswatini's regulatory landscape.
| Stage | Description | Key Activities | Deliverables | Eswatini Specific Considerations |
|---|---|---|---|---|
| Inquiry and Initial Consultation | The client contacts the cleanroom engineering company with a requirement for a new cleanroom or upgrade. | Initial discussion of project scope, objectives, industry, and general requirements. Understanding of client's business and regulatory obligations. | Meeting minutes, preliminary understanding of project needs. | Initial understanding of Eswatini's industrial sectors (e.g., pharmaceuticals, food processing, electronics) and any specific local regulations or known industry practices. |
| Needs Assessment and Site Survey | Thorough evaluation of the client's specific requirements and the proposed installation site. | Detailed site visits, measurements, assessment of existing infrastructure (power, HVAC, water), discussion of operational processes, particle count requirements, and desired ISO classification. | Site survey report, detailed list of requirements, preliminary equipment specifications. | Assessment of local site conditions, availability of utilities, and potential logistical challenges within Eswatini. Understanding of local building codes and safety standards. |
| Proposal Development and Quotation | Preparation of a comprehensive proposal outlining the proposed solution and associated costs. | Developing a conceptual design, selecting appropriate materials and equipment, estimating project timelines, and preparing a detailed cost breakdown. | Technical proposal, Bill of Quantities (BoQ), cost quotation, preliminary project schedule. | Pricing considerations for imported materials and equipment. Potential impact of import duties and taxes in Eswatini. Local content considerations where applicable. |
| Contract Negotiation and Agreement | Finalizing the terms and conditions of the project with the client. | Review and negotiation of the proposal, including scope, price, payment terms, warranties, and timelines. Signing of the formal contract. | Signed contract agreement, payment schedule. | Ensuring contract compliance with Eswatini's legal framework for construction and service agreements. Understanding of dispute resolution mechanisms within Eswatini. |
| Detailed Design and Engineering | Developing the final detailed engineering plans and specifications for the cleanroom. | Creating 3D models, CAD drawings, HVAC design, HEPA filter layout, lighting design, electrical schematics, plumbing, and material specifications. Obtaining necessary approvals. | Detailed engineering drawings, specifications for all components, material submittals, BIM models (if applicable). | Adherence to relevant ISO standards (e.g., ISO 14644 series). Consideration of specific Eswatini building regulations and any national standards for construction and safety. Potential need for local architectural or engineering input for permits. |
| Procurement and Manufacturing | Sourcing and acquiring all necessary materials, equipment, and components. | Placing orders with suppliers, manufacturing custom components, quality control checks of materials and equipment. | Procurement orders, manufacturing schedules, quality inspection reports. | Logistics planning for shipping materials and equipment to Eswatini. Managing customs clearance and potential delays. Sourcing locally available materials where feasible and compliant. |
| On-Site Construction and Installation | The physical construction and assembly of the cleanroom at the client's site in Eswatini. | Site preparation, installation of structural elements, wall systems, ceiling grids, flooring, HVAC systems, filtration units, lighting, electrical, and plumbing. Strict adherence to design specifications and safety protocols. | Installed cleanroom infrastructure, progress reports, site safety records. | Managing local labor (if used), ensuring compliance with Eswatini's occupational health and safety regulations. Coordination with local authorities for permits and inspections. Managing the logistics of on-site work, including security and waste disposal in Eswatini. |
| Validation and Commissioning | Testing and verifying that the cleanroom meets the specified performance and cleanliness requirements. | Conducting air velocity measurements, particle counting, pressure differential tests, air changes per hour (ACH) tests, filter integrity tests, and operational checks. Formal validation documentation. | Validation reports, commissioning certificates, as-built drawings, operational manuals. | Ensuring validation procedures align with ISO 14644 standards and client's specific industry requirements. Understanding if Eswatini has specific regulatory bodies that require sign-off on validation. |
| Training and Handover | Educating the client's personnel on the operation and maintenance of the cleanroom. | Training sessions on cleanroom protocols, operation of HVAC and filtration systems, basic maintenance procedures, and emergency response. Formal handover of all documentation and keys. | Training materials, handover documentation, list of trained personnel. | Tailoring training to the specific needs of Eswatini-based personnel. Availability of interpreters if needed. Ensuring documentation is accessible and understandable. |
| Post-Execution Support and Maintenance | Ongoing support and maintenance services for the installed cleanroom. | Scheduled preventative maintenance, emergency repair services, filter replacement, re-validation services, and technical support. | Maintenance contracts, service reports, spare parts inventory. | Establishing a reliable local support network or process for remote support. Availability of spare parts in Eswatini or efficient import procedures for critical components. |
Key Stages in Cleanroom Engineering Process (ISO 5-8) in Eswatini
- Inquiry and Initial Consultation
- Needs Assessment and Site Survey
- Proposal Development and Quotation
- Contract Negotiation and Agreement
- Detailed Design and Engineering
- Procurement and Manufacturing
- On-Site Construction and Installation
- Validation and Commissioning
- Training and Handover
- Post-Execution Support and Maintenance
Cleanroom Engineering (Iso 5-8) Cost In Eswatini
Cleanroom engineering for ISO 5-8 standards in Eswatini involves specialized design, construction, and validation services. The cost is highly variable and depends on numerous factors. These factors influence both the initial setup expenses and ongoing operational costs. It's crucial to obtain detailed quotes from specialized contractors to accurately estimate the investment required. The primary applications for such cleanrooms in Eswatini are likely to be in pharmaceutical manufacturing, medical device production, or research and development sectors where stringent particle control is essential.
| Cleanroom Class (ISO) | Estimated Cost Range (Eswatini Lilangeni - SZL) | Notes |
|---|---|---|
| ISO 8 | SZL 150,000 - SZL 500,000+ | Basic particle control, often for less critical areas. Costs can vary greatly based on size and basic HVAC. |
| ISO 7 | SZL 300,000 - SZL 1,000,000+ | Requires more sophisticated air filtration and higher air change rates than ISO 8. |
| ISO 6 | SZL 500,000 - SZL 1,500,000+ | Increased focus on particle reduction and stringent environmental controls. |
| ISO 5 | SZL 800,000 - SZL 3,000,000+ | Very stringent particle control, requiring advanced HVAC, HEPA/ULPA filtration, and precise environmental monitoring. Often includes critical process equipment integration. |
Key Pricing Factors for Cleanroom Engineering (ISO 5-8) in Eswatini
- Cleanroom Class/ISO Standard: Lower ISO classes (e.g., ISO 8) are generally less expensive than higher classes (e.g., ISO 5) due to less stringent requirements for air filtration, pressure control, and particle counts.
- Size and Footprint: Larger cleanrooms require more materials, labor, and complex HVAC systems, directly impacting the overall cost.
- Room Layout and Complexity: Multi-room configurations, airlocks, gowning areas, and specialized processing zones add to the complexity and cost.
- Ceiling Height: Taller cleanrooms necessitate larger air handling units and more extensive ductwork, increasing material and installation expenses.
- HVAC System Design and Capacity: The number of air changes per hour (ACH), filtration levels (HEPA/ULPA filters), temperature and humidity control, and pressure differentials are critical cost drivers. High ACH and sophisticated filtration for ISO 5 are significantly more expensive.
- Materials and Finishes: The type of wall panels (e.g., modular, hardwall), flooring (e.g., epoxy, vinyl), ceiling tiles, and ancillary materials (e.g., doors, windows, pass-throughs) all influence pricing. Durability, chemical resistance, and ease of cleaning are important considerations.
- Specialized Equipment and Services: Integration of specific process equipment, sterile filtration systems, laminar flow hoods, isolators, and other specialized cleanroom components will add substantial cost.
- Lighting and Electrical Requirements: Cleanroom-specific lighting (e.g., LED, flush-mounted) and electrical installations for sensitive equipment contribute to the overall budget.
- Plumbing and Waste Management: For specific applications, integrated plumbing for sterilization, chemical handling, or waste disposal can increase costs.
- Construction Labor and Expertise: The availability of skilled labor experienced in cleanroom construction in Eswatini can affect pricing. Specialized teams may command higher rates.
- Validation and Certification: The cost of commissioning, testing, and validating the cleanroom to meet ISO standards is a significant component of the total investment.
- Project Management and Design Fees: Professional fees for design, engineering, and project management are factored into the overall cost.
- Location and Site Accessibility: While Eswatini's overall cost of living might be lower than some developed nations, remote project sites or logistical challenges can add to transportation and installation expenses.
- Contractor's Overhead and Profit Margin: Different contractors will have varying overhead structures and profit expectations, leading to price discrepancies.
- Ongoing Maintenance and Operational Costs: While not an initial capital cost, it's important to consider the long-term expenses associated with filter replacement, energy consumption (HVAC), and regular re-validation.
Affordable Cleanroom Engineering (Iso 5-8) Options
Designing and implementing cleanrooms, especially those meeting ISO 5 to ISO 8 standards, can be a significant investment. However, achieving these controlled environments doesn't always require exorbitant costs. This document outlines affordable cleanroom engineering options, focusing on value bundles and effective cost-saving strategies. The goal is to help businesses achieve the necessary environmental control for sensitive processes without compromising on quality or compliance.
| Cost-Saving Strategy | Description | Impact on Cost |
|---|---|---|
| Phased Implementation | Building the cleanroom in stages, starting with the most critical areas and expanding later as budget allows. | Reduces upfront capital expenditure, allows for cash flow management. |
| Standardized Component Selection | Utilizing readily available, standard-sized cleanroom panels, filters, and HVAC components rather than custom-fabricated ones. | Lower material costs due to economies of scale and reduced engineering complexity. |
| Careful Material Selection | Choosing durable, easy-to-clean materials that meet ISO requirements but are not unnecessarily expensive (e.g., certain grades of stainless steel vs. premium alloys, appropriate flooring options). | Reduces initial material procurement costs. |
| Optimized Airflow Design | Designing for efficient unidirectional or mixed airflow patterns that meet ISO standards with minimal air changes per hour (ACH) where feasible, and right-sizing HVAC systems. | Reduces HVAC system size, leading to lower capital and operational (energy) costs. |
| Strategic Gowning Room Design | Designing anterooms and gowning areas to effectively manage particle ingress without requiring the highest ISO classification throughout the entire pre-cleanroom space. | Reduces the overall square footage requiring full cleanroom construction and maintenance. |
| Leveraging Existing Infrastructure | Integrating cleanroom elements into existing building structures and utilities where possible, minimizing new construction. | Significant reduction in site preparation and utility hook-up costs. |
| Long-Term Maintenance Planning | Selecting materials and systems that are easy to maintain and have readily available replacement parts, reducing downtime and future repair costs. | Lower operational and maintenance expenditure over the cleanroom's lifecycle. |
Key Value Bundles for Affordable Cleanroom Engineering
- {"title":"Modular & Pre-engineered Systems","description":"These systems are designed for rapid deployment and can significantly reduce on-site construction time and labor costs. They offer a standardized approach with pre-fabricated panels, integrated HEPA/ULPA filtration, and often include pre-installed lighting and utility connections. Value is derived from speed, reduced site disruption, and predictable costs."}
- {"title":"Hybrid Design Solutions","description":"Combining pre-fabricated modular components for critical areas (e.g., the core cleanroom) with site-built structures for less critical adjacent spaces (e.g., gowning rooms, ante-chambers) can optimize cost. This approach leverages the benefits of modularity where it matters most while utilizing more traditional construction for cost savings in lower-classification areas."}
- {"title":"Retrofit & Upgrade Packages","description":"For existing facilities, instead of building a new cleanroom, consider upgrading existing controlled environments. Value bundles can include targeted HEPA filter installations, improved air handling units (AHUs), sealing of existing spaces, and advanced monitoring systems to achieve the desired ISO class. This often proves more cost-effective than new construction."}
- {"title":"Consultation & Design Optimization Services","description":"Engaging with experienced cleanroom engineers early in the design phase is crucial. Value bundles here include comprehensive site assessment, detailed process analysis, and optimized layout designs that minimize square footage, material usage, and energy consumption, all contributing to lower capital and operational expenditures."}
- {"title":"Energy Efficiency Integration","description":"Bundling energy-efficient HVAC systems, variable speed drives (VSDs) for fans, and optimized lighting solutions with the cleanroom construction can lead to significant long-term operational cost savings. The initial investment is offset by reduced utility bills."}
Verified Providers In Eswatini
In Eswatini, ensuring you receive healthcare from verified and credentialed providers is paramount for your well-being. Franance Health stands out as a leading organization dedicated to upholding the highest standards of medical practice. Their stringent credentialing process and commitment to quality make them the definitive choice for reliable healthcare services in the nation.
| Provider Type | Franance Health Verification Focus | Benefits for Patients |
|---|---|---|
| Doctors (General Practitioners & Specialists) | Medical degree validation, license status, residency completion, board certifications, malpractice history. | Accurate diagnoses, effective treatment plans, access to specialized expertise. |
| Nurses (RNs, ENs, etc.) | Nursing degree/diploma verification, licensure, specialized certifications (e.g., critical care, pediatrics). | High-quality bedside care, patient education, medication management. |
| Pharmacists | Pharmacy degree validation, licensure, understanding of drug interactions and dispensing protocols. | Safe and accurate medication dispensing, patient counseling on prescriptions. |
| Allied Health Professionals (e.g., Physiotherapists, Radiologists) | Relevant degree/diploma, licensure, specific modality certifications. | Comprehensive rehabilitation services, accurate diagnostic imaging and interpretation. |
Why Franance Health Credentials Matter:
- Rigorous Verification: Franance Health employs a multi-stage verification process for all its healthcare professionals. This includes thorough background checks, confirmation of educational qualifications from accredited institutions, and verification of licenses and certifications with relevant regulatory bodies.
- Experience and Competence: Beyond academic achievements, Franance Health assesses the practical experience and demonstrated competence of providers. They ensure that practitioners have a proven track record of delivering effective and ethical patient care.
- Adherence to Ethical Standards: A core component of Franance Health's credentialing is an evaluation of a provider's commitment to ethical medical practice. This includes their understanding and adherence to patient rights, confidentiality, and professional conduct.
- Continuous Professional Development: Franance Health encourages and monitors its providers' engagement in ongoing learning and professional development. This ensures that practitioners remain up-to-date with the latest medical advancements, technologies, and treatment protocols.
- Patient Safety Focus: Ultimately, Franance Health's credentialing process is designed with patient safety as the utmost priority. By partnering with verified providers, patients can have greater confidence in the quality and safety of the care they receive.
- Access to Top-Tier Professionals: By choosing a Franance Health-affiliated provider, you are connecting with some of the most skilled and reputable healthcare professionals in Eswatini, ensuring you receive care from experts dedicated to your health.
Scope Of Work For Cleanroom Engineering (Iso 5-8)
This Scope of Work (SOW) outlines the engineering services required for the design, installation, and commissioning of a cleanroom facility meeting ISO 5 to ISO 8 standards. The project encompasses all aspects of cleanroom engineering, from conceptual design and detailed engineering to validation and documentation, ensuring compliance with relevant industry standards and regulatory requirements.
| Standard/Specification | Description | Applicability (ISO Class) |
|---|---|---|
| ISO 14644-1:2015 | Cleanrooms and associated controlled environments – Part 1: Classification of air cleanliness | ISO 5, ISO 6, ISO 7, ISO 8 |
| ISO 14644-2:2015 | Cleanrooms and associated controlled environments – Part 2: Monitoring and measuring to demonstrate fitness for purpose of cleanroom | ISO 5, ISO 6, ISO 7, ISO 8 |
| ISO 14644-4:2018 | Cleanrooms and associated controlled environments – Part 4: Design, construction and start-up | ISO 5, ISO 6, ISO 7, ISO 8 |
| ISO 14644-5:2004 | Cleanrooms and associated controlled environments – Part 5: Operations | ISO 5, ISO 6, ISO 7, ISO 8 |
| ISO 14644-7:2004 | Cleanrooms and associated controlled environments – Part 7: Separated or integral clean air devices | ISO 5, ISO 6, ISO 7, ISO 8 |
| ASHRAE 170 | Ventilation of Health Care Facilities | Relevant for pharmaceutical/medical applications within ISO classes |
| cGMP (Current Good Manufacturing Practices) | FDA regulations for pharmaceutical manufacturing | ISO 5, ISO 6, ISO 7, ISO 8 (depending on process step) |
| IEST RP-CC001.6 | HEPA and ULPA Filters | ISO 5, ISO 6, ISO 7, ISO 8 |
| IEST RP-CC002.3 | Environmental Monitoring | ISO 5, ISO 6, ISO 7, ISO 8 |
| IEST RP-CC006.3 | Cleanroom Design | ISO 5, ISO 6, ISO 7, ISO 8 |
| NFPA 90A | Standard for the Installation of Air-Conditioning and Ventilating Systems | General building safety for HVAC systems in all ISO classes |
Technical Deliverables
- Conceptual Design Report (CDR)
- Basic Design Report (BDR)
- Detailed Engineering Drawings and Specifications (including HVAC, electrical, piping, architectural, and instrumentation)
- Equipment Specifications and Procurement Support
- Construction Supervision and Quality Control Plan
- Installation Qualification (IQ) Protocol and Report
- Operational Qualification (OQ) Protocol and Report
- Performance Qualification (PQ) Protocol and Report
- Validation Master Plan (VMP)
- As-Built Drawings
- Operations and Maintenance Manuals
- Training Materials for Operations and Maintenance Personnel
- Cleanroom Performance Test Reports (particle counts, air changes per hour, pressure differentials, air velocity, temperature, humidity)
- Certifications and Compliance Documentation
Service Level Agreement For Cleanroom Engineering (Iso 5-8)
This Service Level Agreement (SLA) outlines the response times and uptime guarantees for Cleanroom Engineering services supporting ISO Class 5 to ISO Class 8 cleanrooms. This agreement is designed to ensure the continuous and optimal functioning of critical cleanroom environments.
| Service Level | Response Time (Business Hours) | Uptime Guarantee | Definition |
|---|---|---|---|
| Critical Support (Class 5-6) | 1 hour | 99.9% | Immediate threat to product or personnel safety, or significant process disruption. |
| High Priority Support (Class 7) | 2 hours | 99.5% | Potential for minor product loss or process inefficiency, but not immediate critical impact. |
| Standard Support (Class 8) | 4 business hours | 99.0% | Routine maintenance, minor adjustments, or non-urgent issues that do not impact core operations. |
| Preventative Maintenance | Scheduled, adherence to agreed schedule | N/A (contributes to overall uptime) | Scheduled maintenance activities performed to prevent failures. |
Scope of Services
- Preventative maintenance and calibration of HEPA/ULPA filters.
- Environmental monitoring system (EMS) support and troubleshooting.
- Air shower, pass-through, and gowning room maintenance.
- HVAC system performance verification and adjustments.
- Cleanroom integrity testing (e.g., smoke testing, airflow visualization).
- Emergency repair services for critical cleanroom components.
In-Depth Guidance
Frequently Asked Questions
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