Verified Service Provider in Egypt
Cleanroom Engineering (ISO 5-8) in Egypt
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 HVAC & Air Filtration Solutions
Designing and implementing state-of-the-art HVAC systems with HEPA/ULPA filtration, precise temperature and humidity control, and differential pressure management, exceeding ISO 5-8 standards for critical environments across Egypt's burgeoning pharmaceutical, electronics, and research sectors.
Cleanroom Construction & Material Science Expertise
Expertise in the selection and installation of specialized cleanroom construction materials (e.g., modular wall systems, anti-static flooring, coved transitions) optimized for ease of cleaning, chemical resistance, and adherence to stringent ISO 5-8 cleanroom protocols, ensuring contaminant-free zones for sensitive manufacturing processes in Egypt.
Validation & Commissioning Services
Comprehensive validation and commissioning services for new and existing ISO 5-8 cleanrooms in Egypt, including air change rate testing, particle count monitoring, airflow pattern analysis, and filter integrity testing, guaranteeing operational compliance and the integrity of controlled environments.
What Is Cleanroom Engineering (Iso 5-8) In Egypt?
Cleanroom engineering, particularly within the ISO 5 to ISO 8 classification range, refers to the design, construction, operation, and maintenance of controlled environments specifically engineered to minimize airborne particulates, microbial contamination, and other contaminants. These environments are critical for processes where even minute contamination can compromise product integrity, yield, or safety. In Egypt, as with global standards, this involves a holistic approach encompassing facility design, HVAC system specification and validation, material selection, operational protocols, and personnel training. The primary objective is to achieve and maintain a defined airborne particle count per unit volume of air, adhering to internationally recognized standards such as ISO 14644. ISO 5 (formerly Class 100) represents a higher level of cleanliness than ISO 8 (formerly Class 100,000), with progressively fewer allowable particles per cubic meter of air. The 'engineering' aspect signifies the rigorous scientific and technical application of principles to achieve and sustain these controlled conditions.
| ISO Class | Maximum Permissible Particles/m³ (≥0.5 µm) | Typical Applications |
|---|---|---|
| ISO 5 | 3,520 | Pharmaceutical sterile product manufacturing (aseptic filling), semiconductor fabrication (critical steps), advanced medical device assembly. |
| ISO 6 | 35,200 | Pharmaceutical non-sterile manufacturing, biological research laboratories, some advanced electronics assembly. |
| ISO 7 | 352,000 | General pharmaceutical manufacturing, biotechnology, cosmetic manufacturing, food processing (sensitive stages). |
| ISO 8 | 3,520,000 | General laboratory environments, packaging areas, less critical electronics assembly, some medical device packaging. |
Key Components of Cleanroom Engineering (ISO 5-8)
- Facility Design and Construction: Includes layout, material selection for surfaces (walls, floors, ceilings) that are non-shedding and easily cleanable, airlocks, and appropriate door/window systems.
- HVAC System Design and Validation: Crucial for air changes per hour (ACH), airflow patterns (laminar, unidirectional, or turbulent), filtration (HEPA/ULPA), pressure differentials between zones, temperature, and humidity control.
- Air Filtration: Utilization of High-Efficiency Particulate Air (HEPA) filters (removing 99.97% of particles 0.3 micrometers in diameter) or Ultra-Low Penetration Air (ULPA) filters (even higher efficiency) to purify incoming and recirculated air.
- Particle Monitoring and Control: Regular measurement of airborne particle counts using calibrated particle counters to verify compliance with ISO class standards.
- Contamination Control Protocols: Strict procedures for gowning, material transfer, cleaning, and waste disposal to prevent the introduction and spread of contaminants.
- Personnel Training and Behavior: Educating personnel on proper cleanroom etiquette, gowning procedures, and contamination awareness is paramount.
- Equipment and Furnishings: Selection of equipment and furnishings that are cleanable, non-shedding, and designed for use in controlled environments.
- Validation and Qualification: Rigorous testing and documentation to demonstrate that the cleanroom consistently meets its design specifications and performance criteria.
Who Needs Cleanroom Engineering (Iso 5-8) In Egypt?
Cleanroom engineering, particularly at ISO 5-8 standards, is crucial for a wide range of industries in Egypt that require controlled environments to prevent contamination. These standards ensure a high level of purity, which is essential for product quality, safety, and research integrity. The demand for these services spans several key sectors, driven by both domestic needs and Egypt's growing role as a manufacturing and research hub.
| Industry Sector | Key Departments / Applications | Typical ISO Classes Required (Examples) | Primary Concerns Addressed |
|---|---|---|---|
| Pharmaceuticals & Biotechnology | Sterile Manufacturing (API production, formulation, filling, packaging), Aseptic Processing, Cell Culture, Biologics Production, R&D Labs | ISO 5, ISO 6, ISO 7, ISO 8 | Microbial contamination, cross-contamination, particulate contamination, ensuring sterility, product efficacy and safety |
| Electronics & Semiconductor Manufacturing | Wafer fabrication, assembly, testing, cleanroom laundries | ISO 5, ISO 6, ISO 7, ISO 8 | Particulate contamination, electrostatic discharge (ESD) control, product defects, yield improvement |
| Medical Device Manufacturing | Sterile device production, implant manufacturing, diagnostic equipment assembly, critical component cleaning and packaging | ISO 5, ISO 7, ISO 8 | Microbial contamination, particulate contamination, ensuring biocompatibility, regulatory compliance |
| Aerospace & Defense | Precision component manufacturing, optical assembly, sensitive electronics assembly, satellite component integration | ISO 5, ISO 6, ISO 7, ISO 8 | Particulate contamination, outgassing, surface integrity, reliability under extreme conditions |
| Food & Beverage (Specialty) | Sterile packaging, infant formula production, high-purity ingredient processing, sensitive food additive manufacturing | ISO 7, ISO 8 | Microbial contamination, spoilage, product safety, extended shelf-life |
| Research & Development Laboratories | Advanced materials science, nanotechnology research, genetic engineering, microfluidics, sensitive analytical testing | ISO 5, ISO 6, ISO 7, ISO 8 | Experimental integrity, prevention of contamination of samples and equipment, accuracy of results |
| Cosmetics & Personal Care (High-End/Sterile) | Sterile filling, high-potency ingredient handling, sensitive product formulation, quality control testing | ISO 7, ISO 8 | Microbial contamination, product stability, consumer safety, brand reputation |
Target Customers & Departments Requiring ISO 5-8 Cleanroom Engineering in Egypt
- {"title":"Pharmaceuticals & Biotechnology","description":"This sector is a primary driver for cleanroom technology. Maintaining aseptic conditions is paramount for drug manufacturing, sterile product packaging, and the production of biologics. Research and development (R&D) in biotechnology also heavily relies on controlled environments for cell culture, genetic engineering, and analytical testing."}
- {"title":"Electronics & Semiconductor Manufacturing","description":"The production of sensitive electronic components, microchips, and other semiconductor devices necessitates ultra-clean environments to prevent particulate contamination that could lead to product defects and failures. Even at lower ISO levels (e.g., ISO 7-8), these spaces are critical for assembly and testing."}
- {"title":"Medical Device Manufacturing","description":"Sterile medical devices, implants, diagnostic equipment, and surgical instruments must be manufactured in environments that prevent microbial and particulate contamination. ISO 5 and ISO 7 are commonly required for critical areas."}
- {"title":"Aerospace & Defense","description":"Precision components used in aircraft, satellites, and defense systems require high levels of cleanliness during manufacturing and assembly to ensure reliability and performance in demanding conditions. This includes optical components, sensitive electronics, and propulsion systems."}
- {"title":"Food & Beverage (Specialty/High-Purity)","description":"While not all food and beverage production requires such stringent cleanrooms, specific areas involved in sterile packaging, infant formula production, and high-purity ingredients may necessitate ISO-classified environments to ensure product safety and shelf-life."}
- {"title":"Research & Development Laboratories","description":"Universities, government research institutions, and private R&D facilities engaged in advanced scientific research (e.g., materials science, nanotechnology, advanced chemistry) often require controlled environments for experimental setups, sample preparation, and analysis."}
- {"title":"Cosmetics & Personal Care (High-End/Sterile)","description":"The production of high-end, sterile cosmetic products, particularly those intended for sensitive skin or containing active pharmaceutical ingredients (APIs), may require ISO-classified cleanrooms for certain manufacturing and filling processes."}
Cleanroom Engineering (Iso 5-8) Process In Egypt
This document outlines the typical workflow for Cleanroom Engineering services specializing in ISO 5-8 cleanrooms in Egypt, from the initial inquiry to the successful execution and handover.
| Phase | Stage | Key Activities | Deliverables/Outcomes | Typical Timeline (Egypt Context) |
|---|---|---|---|---|
| 1: Inquiry & Initial Consultation | Initial Contact | Client submits an inquiry detailing project scope, cleanroom class requirements (ISO 5-8), industry, geographical location, and preliminary budget. Initial meetings (on-site or virtual) to understand specific needs, applications, and regulatory requirements (e.g., Egyptian GMP, FDA). | Understanding of project requirements, initial feasibility assessment, high-level scope definition. | 1-2 Weeks |
| 1: Inquiry & Initial Consultation | Site Survey & Assessment | Thorough on-site assessment of the proposed location, including existing infrastructure (HVAC, power, water), structural integrity, available space, and potential challenges. | Detailed site survey report, identification of potential integration points and constraints. | 1-2 Weeks (concurrent with initial consultation) |
| 2: Design & Proposal Development | Conceptual Design | Development of preliminary cleanroom layout, airflow concepts (e.g., unidirectional, non-unidirectional), air change rates, filtration strategies (HEPA/ULPA), and system architecture. Selection of appropriate materials and finishes. | Conceptual design drawings, preliminary equipment list, system overview. | 2-4 Weeks |
| 2: Design & Proposal Development | Detailed Design | Generation of detailed engineering drawings (architectural, mechanical, electrical, plumbing), specifications for all components, HVAC system design calculations, cleanroom performance simulations, and energy consumption estimates. | Full set of detailed design drawings and specifications, Bill of Materials (BOM). | 4-8 Weeks |
| 2: Design & Proposal Development | Proposal & Quotation | Preparation of a comprehensive technical and commercial proposal including detailed scope of work, design basis, proposed solution, project schedule, cost breakdown, warranty information, and terms & conditions. Negotiation and refinement of proposal. | Approved technical and commercial proposal, Letter of Intent/Contract agreement. | 2-4 Weeks (post-design completion) |
| 3: Pre-Construction & Procurement | Procurement | Sourcing and ordering of all materials, equipment (e.g., air handling units, filters, cleanroom panels, doors, pass boxes), and specialized components from approved vendors. Logistics and import considerations for Egypt. | Secured materials and equipment, confirmed delivery schedules. | 6-12 Weeks (can overlap with detailed design) |
| 3: Pre-Construction & Procurement | Permitting & Approvals | Obtaining necessary local permits and approvals from relevant Egyptian authorities (e.g., Ministry of Health, Ministry of Environment, local municipalities) for construction and operation. | Issued construction and operational permits. | 4-12 Weeks (highly variable based on local regulations) |
| 4: Construction & Installation | Site Preparation | Mobilization of the construction team, setting up site offices and storage, temporary utilities, and ensuring site safety protocols are in place. | Ready and safe construction site. | 1-2 Weeks |
| 4: Construction & Installation | Cleanroom Construction | Installation of cleanroom walls, ceilings, floors, doors, pass boxes, and other structural elements using specialized construction techniques to ensure airtightness and ease of cleaning. | Structurally complete cleanroom enclosure. | 4-10 Weeks |
| 4: Construction & Installation | HVAC System Installation | Installation of air handling units (AHUs), ductwork, diffusers, grilles, HEPA/ULPA filters, and associated controls. Balancing and initial testing of airflow. | Fully installed and partially tested HVAC system. | 4-8 Weeks (overlaps with cleanroom construction) |
| 4: Construction & Installation | Electrical & Plumbing Installation | Installation of lighting, power outlets, data cabling, emergency power systems, and necessary plumbing for clean processes (if applicable). | Functional electrical and plumbing systems within the cleanroom. | 2-4 Weeks (overlaps with other installations) |
| 5: Validation & Commissioning | System Commissioning | Testing and verification of all installed systems (HVAC, electrical, plumbing, controls) to ensure they operate according to design specifications. Initial performance tests. | Commissioned systems, preliminary performance data. | 2-4 Weeks |
| 5: Validation & Commissioning | Cleanroom Validation | Comprehensive validation testing including air particle counts (ISO classification), airflow velocity and uniformity, pressure differentials, temperature and humidity control, HEPA filter integrity testing (DOP/IOA), and air changes per hour (ACH). | Validation report demonstrating compliance with ISO 5-8 standards. | 2-4 Weeks |
| 5: Validation & Commissioning | Requalification (if applicable) | For existing cleanrooms, requalification to re-validate performance after modifications or scheduled intervals. | Requalification report. | 1-3 Weeks |
| 6: Handover & Post-Construction Support | Client Training | Training of client's personnel on cleanroom operation, maintenance procedures, cleaning protocols, and emergency procedures. | Trained client personnel, training documentation. | 1 Week |
| 6: Handover & Post-Construction Support | Project Handover | Formal handover of the completed cleanroom, including all documentation (as-built drawings, O&M manuals, validation reports, warranties) and keys. | Fully operational and certified cleanroom, comprehensive project documentation. | 1 Week |
| 6: Handover & Post-Construction Support | Warranty & Maintenance | Provision of warranty period and ongoing maintenance services as per contract. Support for any issues arising post-handover. | Continued operational integrity of the cleanroom. | Ongoing |
Cleanroom Engineering (ISO 5-8) Process in Egypt: Inquiry to Execution
- Phase 1: Inquiry & Initial Consultation
- Phase 2: Design & Proposal Development
- Phase 3: Pre-Construction & Procurement
- Phase 4: Construction & Installation
- Phase 5: Validation & Commissioning
- Phase 6: Handover & Post-Construction Support
Cleanroom Engineering (Iso 5-8) Cost In Egypt
Cleanroom engineering for ISO 5-8 standards in Egypt involves a significant investment, with costs varying based on several key factors. These factors dictate the complexity of the design, the quality of materials used, the extent of specialized equipment, and the required level of validation and certification. Understanding these elements is crucial for accurate budgeting and project planning. The pricing ranges provided are indicative and can fluctuate based on market conditions, supplier negotiations, and project-specific nuances.
| Cleanroom Class (ISO) | Estimated Cost Range (EGP/sqm) | Notes |
|---|---|---|
| ISO 8 | 15,000 - 30,000 | Basic cleanroom construction with standard filtration (e.g., MERV 13), moderate air changes. Suitable for general electronics assembly or less sensitive applications. |
| ISO 7 | 25,000 - 50,000 | Improved filtration (HEPA), higher air change rates, more stringent control of temperature and humidity. Used in some pharmaceutical manufacturing and biological applications. |
| ISO 6 | 40,000 - 70,000 | Higher performance HEPA filtration, very precise environmental control, and robust air management systems. Common in advanced pharmaceutical and medical device manufacturing. |
| ISO 5 | 60,000 - 120,000+ | ULPA filtration often required, extremely high air change rates, highly controlled temperature, humidity, and pressure differentials. Essential for aseptic processing, semiconductor manufacturing, and high-purity environments. Costs can escalate significantly with specialized equipment and automation. |
Key Pricing Factors for Cleanroom Engineering (ISO 5-8) in Egypt
- Cleanroom Class and Size: Higher ISO classifications (e.g., ISO 5) demand stricter particle control, requiring more sophisticated filtration systems (HEPA/ULPA filters), advanced air handling units (AHUs), and precise air change rates, leading to higher costs than lower classes (e.g., ISO 8). The overall square footage and height of the cleanroom also directly impact material and equipment expenses.
- Materials and Finishes: The choice of wall panels, flooring, ceilings, and doors significantly influences cost. Materials like modular panels (e.g., HPL, steel), epoxy flooring, and specialized gasketed ceiling tiles offer superior performance and durability but come at a premium compared to standard construction materials.
- HVAC System Design and Complexity: The design of the air conditioning, ventilation, and filtration system is a major cost driver. This includes the number and type of AHUs, the capacity of cooling/heating, the complexity of ductwork, the integration of air showers, and the precise control of temperature, humidity, and differential pressure.
- Specialized Equipment and Services: Depending on the application (e.g., pharmaceutical, semiconductor, medical device manufacturing), specific equipment might be required. This can include laminar flow hoods, pass boxes, safety cabinets, gowning rooms, and complex interlocks. The installation and integration of these systems add to the overall cost.
- Validation and Certification: Rigorous testing and validation (IQ, OQ, PQ) to meet ISO standards are essential and often represent a substantial portion of the project budget. This includes particle counting, air velocity measurements, HEPA filter integrity testing, and environmental monitoring system calibration.
- Ancillary Areas: The scope of the project often includes surrounding areas like gowning rooms, buffer zones, control rooms, and airlocks, which require cleanroom construction and environmental controls, adding to the total cost.
- Contractor Expertise and Reputation: Experienced cleanroom engineering firms with a proven track record in Egypt may command higher fees due to their expertise, quality of work, and ability to navigate local regulations and ensure compliance.
- Project Timeline and Urgency: Expedited project timelines can sometimes lead to increased costs due to overtime labor and prioritized material procurement.
Affordable Cleanroom Engineering (Iso 5-8) Options
Achieving ISO 5-8 cleanroom standards is crucial for many industries, including pharmaceuticals, microelectronics, and healthcare. While cleanroom construction can be a significant investment, there are strategic approaches and 'value bundles' that make these essential environments more affordable. This guide explores cost-saving strategies and offers insights into optimizing cleanroom engineering without compromising critical performance.
| Value Bundle | Description | Typical ISO Classes Supported | Cost-Saving Benefit | Key Components |
|---|---|---|---|---|
| Entry-Level ISO 8 Kit | A pre-packaged solution for basic clean environments, focusing on essential filtration and structural integrity. | ISO 8 | Significantly lower upfront investment, rapid deployment. | Modular wall panels, basic HEPA filtration, standard lighting, simple gowning bench. |
| Modular ISO 7 Accelerator | Combines modular construction with optimized airflow for improved particle control and energy efficiency. | ISO 7 | Reduced installation time and labor, lower operational energy costs. | Prefabricated cleanroom modules, VSD-equipped fans, optimized HEPA filter placement, higher-grade flooring. |
| Scalable ISO 5 Foundation | A robust base system designed for future upgrades and higher performance, incorporating infrastructure for advanced control. | ISO 5 (with potential for upgrades) | Future-proofing, deferred higher-cost upgrades, flexible power and data infrastructure. | Reinforced structural framing, enhanced HVAC capacity, integrated power/data raceways, basic cleanroom interlocks. |
| Energy-Smart ISO 6 Package | Focuses on reducing operational expenditure through intelligent energy management within an ISO 6 environment. | ISO 6 | Lower long-term utility bills, reduced carbon footprint. | Energy-efficient LED lighting, VSDs on AHUs, optimized ACH controls, high-efficiency HEPA filters. |
Key Cost-Saving Strategies for Affordable Cleanroom Engineering (ISO 5-8):
- Modular & Prefabricated Systems: Opting for modular cleanroom walls, ceilings, and floors can dramatically reduce on-site construction time, labor costs, and material waste compared to traditional stick-built methods. These systems are often designed for rapid assembly and disassembly, offering flexibility for future expansions or relocations.
- Smart Airflow Management: Implementing optimized HEPA/ULPA filter layouts, variable speed drives (VSDs) for fans, and intelligent control systems can significantly reduce energy consumption. Proper airflow design minimizes the number of air changes per hour (ACH) required while still meeting ISO class requirements, leading to lower operational costs.
- Strategic Material Selection: Choosing durable yet cost-effective materials for walls, flooring, and ceilings is vital. For example, materials like vinyl or linoleum flooring, painted drywall (properly sealed), or certain types of sandwich panels can provide the necessary cleanability and durability for lower ISO classes (e.g., ISO 7-8) without the premium cost of specialized cleanroom materials.
- Phased Construction & Scalability: Instead of building the entire cleanroom to the highest required standard from day one, consider a phased approach. Start with the core critical areas and design the infrastructure (e.g., HVAC capacity, power) to accommodate future expansion to higher ISO classes or larger footprints as your needs grow.
- Standardized Designs & Kits: Leveraging pre-engineered cleanroom kits or standard design templates that meet common ISO class requirements can streamline the design and procurement process, reducing engineering hours and potential for custom-design overages.
- Energy-Efficient Lighting & Utilities: Employing LED lighting, low-flow water fixtures (where applicable), and energy-efficient equipment within the cleanroom environment contributes to lower operational expenses over the lifespan of the facility.
- Long-Term Maintenance Planning: Incorporating ease of maintenance into the initial design can prevent costly repairs and downtime. This includes specifying accessible components, durable finishes, and designing for easy cleaning and filter replacement.
Verified Providers In Egypt
In Egypt's rapidly evolving healthcare landscape, identifying trustworthy and competent medical providers is paramount for individuals seeking quality care. Verified providers stand out due to their adherence to stringent standards, commitment to patient safety, and demonstrated expertise. Franance Health has emerged as a leading entity in this regard, meticulously credentialing healthcare professionals and institutions across Egypt. This verification process not only ensures that patients receive care from qualified individuals but also fosters a sense of security and confidence in the healthcare system.
| Provider Type | Franance Health Verification Criteria | Benefits to Patients |
|---|---|---|
| Physicians | Medical degree from accredited institutions, board certification (where applicable), verifiable years of experience, clean disciplinary record, participation in continuing medical education. | Access to specialists with proven expertise, assurance of up-to-date medical knowledge, reduced risk of misdiagnosis or suboptimal treatment. |
| Hospitals & Clinics | Accreditation from recognized bodies, adherence to international standards of patient care and safety, qualified medical staff, advanced technology and equipment, robust infection control measures. | Access to comprehensive medical services in a safe and well-equipped environment, consistent quality of care across different departments, improved patient outcomes. |
| Diagnostic Centers | State-of-the-art equipment, qualified radiologists and technicians, adherence to quality control and calibration standards, timely and accurate report generation. | Reliable diagnostic results essential for effective treatment planning, access to advanced imaging and testing capabilities, confidence in diagnostic accuracy. |
Why Franance Health Credentials Matter:
- Rigorous Screening: Franance Health employs a comprehensive evaluation process that goes beyond basic licensing, assessing qualifications, experience, and ethical conduct.
- Specialized Expertise: The credentialing covers a wide spectrum of medical specialties, ensuring that patients are connected with the most appropriate and skilled practitioners for their specific needs.
- Commitment to Quality: Verified providers by Franance Health are committed to upholding the highest standards of medical practice, patient care, and continuous professional development.
- Patient Safety Focus: The verification process prioritizes patient safety by scrutinizing protocols, facility standards, and adherence to best practices in healthcare delivery.
- Enhanced Trust: For patients, a Franance Health credential serves as a strong indicator of a provider's reliability and competence, reducing the anxiety associated with choosing medical care.
Scope Of Work For Cleanroom Engineering (Iso 5-8)
This document outlines the Scope of Work (SOW) for Cleanroom Engineering services, specifically focusing on facilities compliant with ISO 5 through ISO 8 standards. The SOW encompasses all phases from initial design and consultation through to validation and commissioning. It details the technical deliverables expected from the engineering partner and outlines the standard specifications that will govern the project execution.
| Deliverable Category | Specific Deliverables | Associated ISO Class | Standard Specifications / References |
|---|---|---|---|
| Design & Engineering | Process Flow Diagrams (PFDs) | ISO 5-8 | Company Standard D-001, ISO 14644-1:2015, relevant industry best practices |
| Design & Engineering | Piping & Instrumentation Diagrams (P&IDs) | ISO 5-8 | Company Standard D-002, ISO 14644-1:2015 |
| Design & Engineering | 3D Equipment & Facility Layout Drawings | ISO 5-8 | Company Standard D-003, ISO 14644-1:2015 |
| Design & Engineering | HVAC System Design (Airflow, filtration, temperature, humidity control) | ISO 5-8 | ASHRAE Standards, SMACNA HVAC Design Manual, ISO 14644-1:2015, ISO 14644-4:2001 |
| Design & Engineering | Electrical System Design (Power distribution, lighting, control systems) | ISO 5-8 | NEC (National Electrical Code), IEC Standards, relevant local codes |
| Design & Engineering | Material & Equipment Specifications (Cleanroom panels, doors, windows, HEPA filters, air showers, etc.) | ISO 5-8 | Manufacturer Datasheets, ISO 14644-5:2004, IEST RP-CC002.4, IEST RP-CC007.1 |
| Design & Engineering | Cleanroom Construction Detailing (Junctions, seals, interfaces) | ISO 5-8 | ISO 14644-4:2001, Manufacturer installation guidelines |
| Design & Engineering | Utility Design (Process gases, WFI, DI water, vacuum, compressed air) | ISO 5-8 | Company Standard U-001, relevant USP/EP standards for pharmaceutical applications |
| Procurement & Fabrication | Bill of Materials (BOM) | ISO 5-8 | Company Standard P-001 |
| Procurement & Fabrication | Vendor Qualification Reports | ISO 5-8 | Company Standard P-002, ISO 14644-1:2015 |
| Procurement & Fabrication | Fabrication Drawings & Weld Maps (if applicable) | ISO 5-8 | Company Standard P-003, ASME B31.3 (for piping) |
| Installation & Construction | Construction Schedule & Look-Ahead Schedules | ISO 5-8 | Company Standard C-001 |
| Installation & Construction | Site Supervision Reports | ISO 5-8 | Company Standard C-002 |
| Installation & Construction | Material Handling & Storage Procedures | ISO 5-8 | Company Standard C-003, IEST RP-CC003.4 |
| Validation & Commissioning | Commissioning Plan | ISO 5-8 | Company Standard V-001, ISPE Baseline Guide Series |
| Validation & Commissioning | FAT (Factory Acceptance Test) Protocols & Reports | ISO 5-8 | Company Standard V-002 |
| Validation & Commissioning | SAT (Site Acceptance Test) Protocols & Reports | ISO 5-8 | Company Standard V-003 |
| Validation & Commissioning | IQ (Installation Qualification) Protocols & Reports | ISO 5-8 | Company Standard V-004, ISPE Baseline Guide Series |
| Validation & Commissioning | OQ (Operational Qualification) Protocols & Reports | ISO 5-8 | Company Standard V-005, ISPE Baseline Guide Series |
| Validation & Commissioning | PQ (Performance Qualification) Protocols & Reports | ISO 5-8 | Company Standard V-006, ISPE Baseline Guide Series |
| Validation & Commissioning | Airflow Visualization Studies | ISO 5-8 | ISO 14644-3:2019 |
| Validation & Commissioning | Particle Count Testing | ISO 5-8 | ISO 14644-1:2015, ISO 14644-3:2019 |
| Validation & Commissioning | Airborne Molecular Contamination (AMC) Testing | ISO 5-7 | IEST RP-CC034.1 |
| Validation & Commissioning | Viable Particle Monitoring | ISO 5-8 | ISO 14698-1:2003, relevant pharmacopoeial requirements |
| Validation & Commissioning | Differential Pressure Monitoring | ISO 5-8 | ISO 14644-1:2015 |
| Validation & Commissioning | Temperature & Humidity Mapping | ISO 5-8 | Company Standard V-007 |
| Documentation & Handover | As-Built Drawings | ISO 5-8 | Company Standard H-001 |
| Documentation & Handover | O&M Manuals | ISO 5-8 | Company Standard H-002 |
| Documentation & Handover | Training Materials & Records | ISO 5-8 | Company Standard H-003 |
| Documentation & Handover | Final Project Report | ISO 5-8 | Company Standard H-004 |
Key Phases of Cleanroom Engineering Services
- Conceptual Design & Feasibility Study
- Detailed Design & Engineering
- Procurement & Fabrication Oversight
- Installation & Construction Management
- Validation & Commissioning
- Documentation & Handover
Service Level Agreement For Cleanroom Engineering (Iso 5-8)
This Service Level Agreement (SLA) outlines the response times and uptime guarantees for engineering services provided for ISO Class 5-8 cleanroom environments. This agreement is designed to ensure the continuous and efficient operation of critical cleanroom facilities.
| Service Level | Response Time Guarantee | Uptime Guarantee |
|---|---|---|
| Critical System Failure (e.g., HVAC shutdown impacting ISO Class 5) | 1 Hour (within business hours, 24/7 for critical on-call support) | 99.9% (for critical HVAC and filtration systems) |
| Significant Performance Degradation (e.g., particle count exceeding acceptable limits) | 4 Business Hours | 99.5% (for overall cleanroom operational parameters) |
| Routine Maintenance and Engineering Support Requests | 8 Business Hours | N/A (Scheduled maintenance is not considered downtime) |
| Consultation and Design Services | 2 Business Days | N/A |
Scope of Services Covered
- Design and Engineering Consultation for ISO Class 5-8 Cleanrooms
- HVAC System Design and Optimization for Cleanroom Environments
- Filtration System Integration and Specification
- Airflow Management and Control System Engineering
- Environmental Monitoring System Design and Implementation
- Contamination Control Strategy Development
- Validation and Verification Support for Cleanroom Systems
- Troubleshooting and Performance Optimization of Existing Cleanroom Infrastructure
In-Depth Guidance
Frequently Asked Questions
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