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User Requirement Specifications

A User Requirement Specification (URS) brings together system requirements from multidisciplinary sources to support system design, commissioning & qualification (C&Q), operations and maintenance. Within the commissioning and qualification process, it is a fundamental document that identifies the product and process requirements for the system.

Co-creating User Requirement Specifications (URS) in a pre-engineered way

User requirements related to product quality are based on product knowledge (CQAs), process knowledge, regulatory requirements and site quality requirements. The product and process requirements in the URS serve as input for the commissioning & qualification process.

ABN Cleanroom's engineering team provides support in compiling an URS document. According to our experience, an interaction between the product and process knowledge of the client on one hand, and the engineering expertise of ABN engineers on the other hand is highly effective for co-creating the URS. Our URS approach includes:

  • Data integrity requirements
  • Data storage/display requirements
  • Alarm requirements, with identification of the critical alarms
  • System automation requirements

The URS, which may be further detailed during early project phases provides the foundation for the Basis of Design (BOD) and becomes a reference to establish a system that is suitable for the intended purpose. ABN Cleanroom Technology assists in setting up the URS in function of the lifecycle of the cleanroom system –from development through sustainable operations up to the decommissioning of the cleanroom system.

cGMP regulation

  • European Pharmacopeia (EP) - WHO , Guidelines for Pharmaceuticals
  • Eudralex volume 4 part I, II, annexes 1,2,11 and 15
  • Eudralex volume 4 part IV (ATMP)
  • cFDA regulations

Guidelines/norms

  • ISPE Volume 5 - Commissioning & qualification
  • ISPE GAMP records & data integrity
  • ASTM E2500-13 standard guide
  • ICH guidance (ICH Q7,Q8,Q9 and Q10)
  • ISO 17141:2020 Bio contamination control
  • ISO 14644 Part 1 to 16
  • NEN-EN-IEC 60812 (FMEA & FMECA)
  • NEN-EN 1822-1 (High efficiency air filters)
  • NEN-EN-ISO 13408-1 (Aseptic processing)
  • NEN-EN-IEC 31010 (Risk assessment techniques)
  • NEN-EN 16310 (Engineering services)
  • NEN-ISO 15686-5 (Life-cycle costing constructions)
  • NEN-EN-IEC 60300-3-3 (Dependability management)
  • ISO 55010 (alignment of (non)financial functions in AM)
  • ISO 55000(1/2) AM (Asset management)
  • NEN-EN 15221-5 (Facility management)
  • NEN-EN-IEC 61025 (Fault tree analysis)
  • ISO 13485:2016 (Medical devices)

Questions about our pre-engineered cleanroom thinking?

We’re happy to talk cleanrooms, the benefits of pre-engineered cleanroom design, and can help you get started with your concept or project. Simply contact us. We’ve helped companies as small as startups to the global pharma companies figure out the best fit for their production process. We can help you too.

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