Rules and regulations in cleanrooms
Strict focus on compliance with the regulations
Numerous regulations prescribe the requirements for mobile products for the individual purity classes in ISO- and GMP-conform cleanrooms. The goal is to be familiar with these regulations and to understand how to comply with them. The most important regulations are the European GMP guideline (EU-GMP-RL), ISO 14644, VDI 2083, and product-specific regulations such as e.g., the German Pharmaceuticals Act (AMG) and the Medicinal Devices Act (MPG).
Process reliability and reproducibility
Through a general operator-independent design of our systems and the integrated protection against operating errors, our products achieve the maximum level of process reliability and therefore the results are also reproducible. We don't just believe this, we measure it.
A predetermined cleaning process must deliver an expected result in cleanrooms; in other words, it must be reproducible. The confirmation of this is the validation. In order to ensure this, a reproducible process, an unambiguous description of the processes as well as the inspection reports that document the validity of the processes are required.
In ISO 14644-5, it says that all mobile equipment must be appropriate to meet the needs for the cleanliness level of the room. Our top systems and products have been tested for their cleanroom compatibility and awarded with the "Tested Device" by the Fraunhofer IPA.
Hygienic design means that surfaces and moveable parts do not spread contamination and must also be easy to clean. Our systems for cleanroom cleaning are developed and manufactured as per these recommendations. In addition, cleanliness, processing and particle emission are tested and certified.
Our cleanroom products for GMP areas are entirely autoclavable. System trolley, components and textiles can therefore be introduced into A/B areas in a sterile fashion.
Our mop covers King GMP, MicroSicuro CR/A and the single-use mop King CR Wiper Mop S have been tested and certified as a TESTED DEVICE by the Fraunhofer Institute for Production Technology and Automation IPA in terms of their own particle emission.
For our textiles we have – depending on the area of application – the verification of their energy efficiency (provided through Fraunhofer IPA) as well as research reports pertaining to their germ-reducing effects and tests.
Compatibility / Material compatibility
Due to their function, cleaning materials must be permanently resistant towards chemicals. For the components of the cleaning trolleys and textiles, we have material compatibility tests that were performed using the standard cleaning and disinfection agents.
As with all producible processes, the cleaning of cleanrooms is also subject to the economic factor. For our EasyMop process, we were – for example – able to substantiate an increase in productivity by between 18 and 22 per cent over standard systems.
In the handling of chemicals and water it is always important to reduce the use of resources. High-performance textiles aid immensely in achieving this since they have a higher cleaning performance, thereby reducing the water consumption and use of chemicals. We have cloths in our product range that carry the Nordic environmental seal (Nordic Swan).