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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)

Instrumentation
Adeodata's instrumentation is regularly calibrated. Relevant software is validated and is used in accordance with Data Integrity requirements.

 

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

Adeodata S.r.l.
Via E. Mattei, 2

22070 Bregnano (CO)

 

 

Registered office: Via Carducci, 32 — 20123 Milano

VAT Nr. 05617310965    REA 1834791 Milano   PEC adeodata@pec.it

Adeodata SA
Via Calgari, 2

CH 6900 Lugano

IDI CHE-112.203.579

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