Cleanroom Validation & Testing

Validation

Airklenz Validation specializes in providing independent clean room validation services and our in-house team can develop site specific IQ / OQ documentation. Airklenz have been involved in a wide range of clean room testing with clients in the pharmaceutical.

• Counts of particles with particle size of 0,1µm to 5µm
• Integrity controls of HEPA and ULPA filters
• Calculating of the number of air changes by means of accubalance , pitot-tube meter or anemometer
• Measurement of differences in pressure between different rooms or with respect to a fixed reference
• Measurement of humidity and temperature
• Classification of the room by means of a particle test in accordance to ISO 14644-1and FED Standard 209E
• Recovery test in accordance to ISO 14644-1 and FED Standard 209E
• Light measurement
• Measurement of sound volume
• Microbiological samples
• Registering of the profile of airflow

Airklenz carry out annual or bi-annual validation of laminar airflow devices, microbiological safety cabinets, fan filter unit, dispensing and sampling booth and isolators.

Tests carried out on these devices include:

• Filter integrity testing (DOP testing)
• Sampling for airborne particles
• Airflow – Differential Pressures
• Airflow – Volumes and Air Change rates
• Airflow – Uniformity analysis
• Airflow – Visualisation
• Temperature & Humidity Test
• Display analysis ongoing validation of these devices is critical to protect both personnel and product.
• Ensures initial and continued equipment compliance to required standards.
• Ensures safety of personnel operating the equipment.
• Ensures the product remains uncontaminated.

• HEPA filter inspection and replacement
• Carbon Filter saturation cabinet tests
• Isolators
• Clean rooms
• Powder Control Booths
• Down flow and Containment Booths
• Extract air cabinets
• Air Handling Unit filters
• Safety cabinets
• Fume Cupboards and Microbiological Safety Cabinets
• Clean Air Workstations
• Vertical Laminar Flow Modules
• O.S.H.H./L.E.V. checks
• Operating Theatre filtered flow systems
• Dust Extractor Units

This test determines the quality of the client’s clean room. We can test for the relevant sized particles in rooms of ISO Class 9 to ISO Class 4. Test reports are generated in the format of the relevant standard (EU GMP, FED 209E, ISO 14644).

airklenz use the most up-to-date particle counters on the market.

• Ensures the clean room is operating within design Parameters and relevant standards.
• This test will document any emerging contamination trends. (Cleaning personnel can be guided to these areas)

Airklenz carry out the following environmental testing in clean rooms:

• Noise levels
• Temperature / humidity mapping
• Luminance levels
• Air volumes / air change rates.
• Room pressure differentials
• Room recovery rates

Airklenz have generated and executed numerous IQ /OQ protocols for new clean rooms. These protocols provide documented evidence that the installed clean room meets and operates within the design specification and regulatory standards.

During execution of these protocols site SOPs, maintenance procedures and equipment manuals are also reviewed to ensure best practice is met.

• Ensures that the system has been installed in line with the design drawings.
• Ensures that the system operates in line with the design specification.
• Ensures that the clean room meets the relevant regulatory standards and client specifications