Cleanroom Qualification According to DIN EN ISO 14644 and DIN 1946

The requirements for a cleanroom are exceptionally high for good reason. Cleanrooms enable sensitive development and production processes or ensure proper patient care and treatment in a contaminant-free environment. Since room air can carry numerous germs and pollutants, Igienair offers comprehensive cleanroom qualification services in compliance with DIN EN ISO 14644 and DIN 1946.

More Information:

• Types of Qualification
• Process Overview
• Why Choose Igienair

Our professional testing procedures and precise cleanroom qualifications guarantee hygienic operation in accordance with the Workplace Ordinance (ArbStättV) and the Operational Safety Ordinance. Rely on our standard-compliant assessments to precisely qualify cleanrooms and operating rooms. We are happy to prepare a tailored offer for you!

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Types of Cleanroom Qualification Services Offered:

1. Cleanroom Qualification or Testing According to DIN EN ISO 14644
Igienair ensures the protection of sensitive electronic components by verifying the air cleanliness in your cleanroom. From airflow patterns to filter integrity checks, every aspect is thoroughly examined. This guarantees that your cleanroom remains certified and free of foreign particles. A detailed report documenting all results is provided to ensure legal compliance and peace of mind.

2. Operating Room (OR) Qualification or Testing According to DIN 1946
Our work ensures hygienic conditions within operating rooms. Comprehensive hygiene checks, air quality assessments, and airflow inspections are conducted. Following this, we deliver a detailed report of the cleanroom testing. Strict adherence to infection control regulations ensures that your OR is ready for unrestricted medical use.

How Does Cleanroom Qualification Work?

At Igienair, we adhere to DIN EN ISO 14644-1, which outlines the requirements for measuring particle concentrations and categorizing cleanrooms into nine ISO classes. Additionally, we incorporate DIN EN ISO 14644-3:2006-3, VDI 2083-3:2005-07, and DIN 1946 for OR qualifications into our process to ensure a comprehensive assessment.

This approach allows us to determine whether your cleanroom meets the necessary requirements for its intended use.

Key Elements of Cleanroom Qualification Measurements:

• Room Climate Parameters
  We assess essential environmental factors such as temperature, differential pressure, humidity, and relative humidity to ensure optimal air conditions.

• Airborne Particle Concentration
  Using the cleanroom classifications outlined in DIN EN ISO 14644, we measure particle concentrations per square meter, ranging from 0.1 µm to 5 µm in size (ISO classes/GMP).

• Air Exchange Rate
  Ensuring the air exchange rate meets or exceeds the hygienic minimum rate of 0.3/h. We also perform laminar flow measurements to prevent particle deposition on surfaces.

• Protection Level for ORs
  Operating rooms, classified as cleanrooms, must also meet stringent hygiene requirements under the Infection Control Act. We perform airflow visualizations, rigorous hygiene inspections, and adhere to standards such as DIN 1946-4:2018-09, DIN EN ISO 14644-3:2006-3, and VDI 2083-3:2005-07.

Our Comprehensive Service Portfolio Includes:

• Air Pressure Measurements
• Recovery Time Testing
• Detailed Evaluation and Documentation of Cleanroom Qualification

Leverage our extensive expertise in HVAC systems for the qualification of cleanrooms and operating rooms. Contact us for a tailored proposal to ensure your facilities meet the highest standards of cleanliness and compliance.