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CLEAN ROOM DESIGN - APPLICATION OF ISO 14644 STANDARD
ISOplan
assists companies in the design of clean rooms. The application
of ISO 16644-4 is sometimes difficult for the manufacturer.
An improper design leads to an improper investment and to a lose
of a lot of time.
ISO Cleanroom Standards
- ISO-14644-1 Classification of Air Cleanliness
- ISO-14644-2 Cleanroom Testing for Compliance
- ISO-14644-3 Methods for Evaluating & Measuring Cleanrooms & Associated Controlled Environment
- ISO-14644-4 Cleanroom Design & Construction
- ISO-14644-5 Cleanroom Operations
- ISO-14644-6 Terms, Definitions & Units
- ISO-14644-7 Enhanced Clean Devices
- ISO-14644-8 Molecular Contamination
- ISO-14698-1 Biocontamination: Control General Principles
- ISO-14698-2 Biocontamination: Evaluation & Interpretation of Data
- ISO-14698-3 Biocontamination: Methodology for Measuring Efficiency of Cleaning Inert Surfac
ISOplan assists companies in :
Conceptual Design
- Process Specific Requirements
- Space Availability & Requirements
- Equipment Requirements
- Space Classification Requirements
- Personnel and Product Flow (Cross Contamination)
- Raw Materials Path
- Waste Products Path
- Contamination (Particulate Versus Microbial)
- Commissioning
- Validation (Critical & Non Critical Systems)
- Standard Operating Procedures, SOP
- Schedule & Costs
Detailed Design
- Room Layouts
- Utility Requirements
- HVAC Requirements
- Air Changes Per Hour (Air Flow Diagrams)
- Room Pressurization Requirements
- Room Finishes, Clean ability
- Costs (Operating Versus Capitol)
- Specifications
Project Delivery with qualified partners
- Construction Management
- Permits
- Scopes of Work
- Contractor Qualification
- Bidding
- Scheduling
- Execution
- Commissioning
- Validation
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Consultancy for medical and healthcare companies
Scriveteci