Cleanroom qualification and confirmation of existing cleanroom qualifications
Overall, cleanroom qualification is a comprehensive concept that combines various aspects such as safety, hygiene and quality control. By carefully planning, implementing and monitoring all relevant measures, laboratories and production facilities can continuously improve their cleanroom conditions and ensure the safety and quality of their products.
Particles
Ensuring the highest quality standards in various industries such as medical technology, micro-electronics and pharmaceuticals is of crucial importance. A key parameter that requires special attention in cleanrooms is particle measurement.
Air flow and calculation of the air exchange rate
Medical devices are subject to similarly stringent requirements as pharmaceuticals. We support you in product analysis as well as in the planning, testing and optimization of your production conditions.
Differential pressure / displacement flow
Maintaining the specified differential pressure between the cleanroom, the airlocks and their surroundings is essential. The controlled displacement flow ensures that the air quality of the cleaner area is not contaminated by cross-flows when openings are made in the cleanroom.
Temperature and relative humidity
Temperature and humidity control are two important parameters in the qualification of cleanrooms. The focus here is on the comfort of cleanroom employees. The focus here is particularly on cleanroom clothing. The temperature and humidity in a cleanroom can have a significant influence on process stability.
Sound pressure
Measuring the sound pressure in a cleanroom is primarily for the comfort of the employees. The sound pressure should be measured in the cleanroom state “as built” (completion) or “at rest” (idle) as part of a cleanroom qualification.
Leak-free filters
The quality and performance of filters in cleanrooms play a crucial role in maintaining cleanroom classification and ensuring the purity of the air. An important component in the qualification of cleanrooms is checking that HEPA filters are leak-free to ensure that no impurities or particles can enter through leaks.
Recovery time
The qualification of a cleanroom is a crucial process to ensure that the air quality meets the required standards. The term “recovery time” refers to the ability of a cleanroom to quickly return to its original state after a malfunction.
Microbiological air analysis
Microbiological air testing is an important part of cleanroom qualification as it helps to monitor and ensure the quality and cleanliness of a cleanroom and the maintenance of hygiene standards.
Microbiological surface examination
Microbiological surface tests are an important part of cleanroom qualification, as they help to monitor and ensure the quality and cleanliness of a cleanroom.
Microbiological workplace testing
Microbiological workplace tests are an important part of cleanroom qualification, as they help to monitor and ensure the quality and cleanliness of a cleanroom.
Compressed gas quality
The quality of compressed gases plays a decisive role in the area of cleanroom qualification. In accordance with the DIN EN ISO 8573 standard, various requirements are placed on the quality of compressed gases to ensure that they are suitable for use in cleanrooms.
Optional services
In modern cleanrooms, laboratories and production facilities where sensitive samples are processed or sensitive products are manufactured or analyzed, cleanroom qualification plays a crucial role.