Cleanroom Qualification and Compliance

Cleanrooms are validated and then certified to a chosen class of ISO 14644-1. Each class of ISO 14644-1 has its unique requirements that must be made for a facility to be classified in the specified classification. Validation of a new cleanroom follows a specified lifecycle. The life cycle comprises five phases each of which accomplishes particular tasks to control variation in the modular environment.

Being in compliance means you must control ambient conditions in production, laboratory and storage areas to ensure product quality.

CLEANROOM QUALIFICATION & COMPLIANCE

Mivado GlobalPerformance provides necessary instruments and resources to support the extensive GMP measures and data collection for cleanroom qualification. We carry out all qualification tests in accordance with all GxP guidelines and ISO 14644. In addition to cleanroom qualification, we also carry out tests and qualifications of safety cabinets, isolators and other clean air systems.
We support you from the conception and planning of the qualification phases (DQ, IQ, OQ, PQ), the implementation of risk management in accordance with the requirements of ICH Q9/ EU-GMP, cGMP and Health Canada GUI-0001 guidelines through to maintenance services and re-qualification measures. In the process, we will support you with your individual measurements or take over the complete project management.

Cleanroom Qualification

  • ISO standard or GMP guideline requirements
  • Validation frequency requirements, including annual and interim testing
  • URS, risk assessment and monitoring plan
  • Design Qualification (DQ),
  • Commissioning, validation and calibration of monitoring systems
  • Installation Qualification (IQ),
  • Operational Qualification (OQ)
  • Performance Qualification (PQ) 

Validation is a documented evidence that shows a high degree of assurance that a manufacturing process will consistently yield a product of repeatable high quality

Safety and compliance

  • Individual measurements of temperature and relative air humidity
  • Mapping in cleanroom areas
  • Definition of critical monitoring points
  • Verification of differential pressure cascades
  • Differential pressure measurement on the filter
  • Determination of the incoming air volume flow
  • Calculation of the air exchange rate
  • Flow visualization
  • Determination of the flow velocity 
  • Classification measurement/determination of the particulate purity class
  • Recovery time measurement/recovery test

Environmental Monitoring

  • Classification measurement (microbiological)
  • Air testing (active air germ collection or sedimentation)
  • Surface testing (direct sampling/contact test)
  • Inspection of staff (in sterile areas)
  • Determination of sampling points, frequencies and action limits
  • Sampling
  • Analysis in a GMP-certified laboratory
  • Determination of total bacterial count
  • Identification of germs (up to genus or species)
  • Advice on OOS and OOT results
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