Expertise Validation & Testing Cleanroom validation

Validation for cleanrooms & operating rooms

Cleanrooms, GMP-critical areas, operating rooms,and flow benches fall under mandatory international regulations such as EU, FDA, ISO 14644 or ISO 12469, PIC/s, and GMP Annex 1. This entails an obligation for initial validation and periodic revalidation. Agidens provides advice, support and execution of validation tests.

Our Testing & Inspection Services consultants are experts in performing designated qualification tests and help verify that installations comply with international regulations. Together, we develop a protocol for the qualification of new installations (as-built) and periodic qualifications.

Types of tests

  • Air volume measurements
  • Differential pressure measurements
  • HEPA filter integrity test with photometer or particle counter
  • Air velocity and flow rate measurements
  • Particle concentration measurements (dust classification)
  • Recovery test or reestablishment time test
  • Microbiological sampling (surface sampling and active and passive air sampling)
  • Room finishing
  • P&ID checks
  • Airflow patterns (visualization and recording)
  • Temperature and relative humidity measurements
  • Light and sound measurements

Project flow

User requirements define the acceptance criteria and the measurement methods used to determine them. These qualification tests depend on the validation master plan, the applicable regulations, and the design of the cleanroom, production area, operating room, or LAF cabinet. Testing is performed according to the applicable guidelines.

Upon request, Agidens also provides advice on preparing the validation master plan or the validation protocol for the installation.

Ellen Van Der Plas Sales Manager Life Sciences at Agidens


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