Logo-ISOPlan   Consultancy for medical and healthcare companies

                                                                             An international pass for the manufacturer

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ISO 13485, ISO 9001



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