Cleanroom production

All Medical Solutions' cleanrooms are classified in accordance with ISO 14644 Class 7 or 8, which means the concentration of viable and non-viable airborne particles, temperature and humidity are controlled. All staff and materials enter through dedicated airlocks, staff are specifically trained to work in these environments and follow special gowning and hygiene procedures when entering and leaving.

In addition to classified cleanroom production, Nolato offers production in environments that are controlled but not classified. Such manufacturing environments have more basic ventilation and fewer restrictions but still apply best practice to reduce contamination. 

Our Engineered Solutions business area uses cleanrooms for processing surface-sensitive components, for example during painting or metallization.

Most of Medical Solutions' manufacturing sites offer production in classified cleanroom environments, as this is a prerequisite for products in contact with human tissue or fluids and products used for diagnostic or laboratory purposes.

We offer microbiological and environmentally controlled, contamination-free production without RNase, DNase, human DNA or PCR inhibitors. Products with such requirements are often found in the diagnostics and laboratory sectors. 

The infrastructure, machinery and auxiliary equipment inside the cleanrooms adhere to specific cleanroom standards to ensure surfaces can be easily kept clean. Maintenance of cleanroom infrastructure, such as replacement of all HEPA filters, is planned well in advance to minimize the impact on production.