Switzerland +41 91 980 33 18 - info@adeodata.eu / Italy +39 02 967 209 33 - info@adeodata.eu Company Consultancy Product Careers QUALIFICATION OF DEPARTMENTS WITH CONTROLLED CONTAMINATION We provide the qualification service of production departments or controlled contamination laboratories. This requires specialized and multidisciplinary skills, which are the assets of our staff. If it is in fact relatively easy to reuse a validation protocol for a room or an equipment, it is not certain that this is aligned with the requirements of the new versions of rules and standards that are issued: 2009 EN 1822-1 (UNI EN 1822-1: 2010), High efficiency air filters (EPA, HEPA and ULPA). Part-1 Classification, performance testing, marking 2015 ISO 14644-1, Cleanrooms and associated controlled environments. Part-1 Classification of air cleanliness by particle concentration 2015 ISO 14644-2, Cleanrooms and associated controlled environments. Part-2 Monitoring provide evidence of cleanroom performance related to air cleanliness by particle concentration EudraLex - Volume 4 - Good Manufacturing Practice (GMP) guidelines, ANNEX 1: Manufacture of Sterile Medicinal Products ENGINEERING CHANGES Adeodata is able to provide support to companies even in the event of engineering changes: department layout change, new department, equipment change, insertion of a new machinery, change of utilities, movement of equipment with or without modification of the intended use. Support for engineering changes COMPETENCE AND EXPERIENCE Right here Adeodata makes the difference. Adeodata established the figure of the SME - Subject Matter Expert, a person dedicated to: study the regulations (and related updates); update internal standards, also in light of the experiences on the latest generation of qualified equipment; instruct all consultants on these standards. The figure of the SME for Adeodata is the basis of the quality system procedures, certified ISO 9001: 2015. INSTRUMENTS The instrumentation of Adeodata is regularly calibrated. Its software is validated and used in accordance with Data Integrity requirements. AREAS OF APPLICATION IN ADDITION TO PHARMA: Medical Devices Cosmetics Veterinary Ask for a consultancy Stay tuned! Follow us on Linkedin I authorize the processing of my personal data 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 Cookies policy | Privacy policy © 2019 Adeodata. All rights reserved. Designed and developed by Carrara Communication