Cleanroom
Cleanrooms are essential for sensitive production processes where controlled environmental conditions are required. We support you in ensuring cleanroom quality according to applicable standards – with precise measurements, validated testing procedures, and GMP-compliant documentation.
This ensures that cleanroom tests are both technically correct and fully covered from a regulatory perspective.
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DPhE determines the air change rate in accordance with DIN EN ISO 14644-3 to ensure that it meets your requirements and contributes to the reduction of particle contamination.
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DPhE verifies environmental parameters on-site according to DIN 13779:2007 as well as the applicable workplace guidelines.
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HEPA/ULPA filters are essential for low-particle cleanrooms. We determine their integrity using filter leak tests and optical particle counters according to DIN EN ISO 14644-3 to ensure compliance with acceptance criteria.
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•Cleanrooms in the pharmaceutical sector are classified according to the degree of air purity, as required by standards such as ISO 14644 and the EC Guide. The classification of airborne particles is carried out in 1/m³ and is compared and assigned according to regulatory frameworks.
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•In Grade A cleanrooms according to EU GMP (Annex 1:2022), laminar flow or TMS fields are used to generate a low-turbulence displacement flow (TAV) and ensure maximum air purity. DPhE measures the flow velocity and its uniformity according to DIN EN ISO 14644.
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•The room differential pressure test confirms the ability of the cleanroom to maintain the specified pressure. DPhE performs these measurements according to ISO 14644, evaluates, and documents the results. The filter differential pressure provides information about the air throughput and the condition of the filter medium. DPhE records the initial pressure drop after installation and checks it regularly to detect blockages or damage at an early stage.
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DPhE implements the specifications for determining the recovery time according to ISO 14644-3 in a compliant, practical, and transparent manner. For the test, the particle concentration of the room air is specifically increased to a defined level of 1:100 or 1:10. We then continuously record the recovery time of the room using an optical particle counter (OPC). The measurement results are systematically documented and evaluated in a traceable manner based on the particle number concentration.
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In the pharmaceutical and biotechnology industries, machines and systems can lead to increased noise exposure.
DPhE performs sound level measurements with calibrated measuring devices at defined measuring points, providing evidence according to standards that the noise exposure in your work environment meets occupational health and safety requirements.
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Sufficient and evenly distributed lighting is crucial for safe and precise work, especially in production and on escape routes. DPhE measures illuminance according to standards (e.g., DIN EN 12464-1) with a lux meter at defined measuring points. Based on this, we create a floor plan and assess the uniformity of the lighting in your premises.
Further Services
Legal Compliance
Reliable testing according to standards and law
Efficiency
Short response times, fast results
Flexibility
Modular booking – from individual tests to complete packages
Compatibility
Smooth integration into your processes