QUALIFICATION OF CONTROLLED CONTAMINATION DEPARTMENTS

We provide the qualification service of production premises and contamination-controlled laboratories. This requires specialized and multidisciplinary skills, which are the assets of our staff.

While it is relatively easy to reuse a room or equipment validation protocol, it may not necessarily be aligned with the requirements of new versions of standards and norms that are issued:

• EN 1822-1 (UNI EN 1822-1: 2010), High efficiency air filters (EPA, HEPA and ULPA) - Part 1: Classification, performance testing, marking (2009)
• ISO 14644-1, Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness based on particle concentration (2015)
• ISO 14644-2, Cleanrooms and associated controlled environments - Part 2: Monitoring provides evidence of cleanroom performance in relation to air cleanliness by particle concentration (2015)
• Eudralex Vol.4 - EU Guidelines for Good Manufacturing Practice of Medicines for Human and Veterinary Use, Annex 1: Manufacture of Sterile Medicines (2022)

Learn more about our instrumentation

Support for engineering changes
Adeodata can provide support to companies in the case of engineering changes: change of department layout, new department, change of equipment, insertion of a new machinery, change of utilities, moving of equipment with or without change of use.

Support for engineering changes