POST-CLEANROOM CONSTRUCTION QUALIFICATION

The Commissioning phase begins post-construction and concentrates on qualifying all systems and their functionality within the modular cleanroom. For a Pharmaceutical application this will form part of the Installation (IQ) and Operational Qualification (OQ). For all other industries a standard commissioning plan will be drafted and test certificates will be produced alongside a detailed Operational & Maintenance (O&M) manual.

ISO Accredited Cleanroom Verification Checking CLEANROOM VERIFICATION CHECKS

The cleanroom commissioning plan will cover a series of verification checks on key components, systems and plant – such as:

  • HVAC
  • Electrical, network
  • Lighting
  • EMS
  • BMS
  • Other critical utilities

The cleanroom performance will be verified through ISO 14644 validation and associated testing.

Aftercare Services Cleanroom Validation

Upon conclusion of all cleanroom builds an ISO 14644 validation is conducted to verify cleanroom performance and adherence to classification guidelines. The critical testing point is to ensure that the airborne particle counts are in line with the allowable tolerances as set out in ISO 14644-1. All other testing is to provide supporting data to confirm the performance specification of the environment. Cleanroom Validation testing could include any or all of the following:

  • Air velocity and volumetric flow rate measurement
  • Room differential pressure testing
  • Airborne particle counting
  • Temperature & humidity monitoring
  • Light & sound level measurement

CLEANROOM DOCUMENTATION PORTFOLIO

For all non-cGMP-rated projects, standard cleanroom commissioning documentation will apply. A far greater level of detail is required for qualification of cGMP facilities, following strict protocols and defined standards. This portfolio of documentation includes the compilation and execution of a Design Qualification (DQ), Installation Qualification (IQ) and Operational Qualification (OQ). These documents are produced as a call and response to the User Requirement Specification (URS) and aim to objectively answer all requests with supporting evidence.

Furniture & Equipment Klensys Cleanroom Hardware

Does your cleanroom require a stainless steel furniture fit-out? Maybe it’s some lab-grade Trespa gear you require? Laminar flow units? Biosafety cabinets? Transfer hatches? Whatever it is, Klensys Cleanroom Hardware will have the solution. Browse the range now.