Riassunto
In questo capitolo si esaminano, in conformità con le Norme di Buona Preparazione dei Radiofarmaci per Medicina Nucleare [1], le principali componenti di un ambiente classificato, sia secondo le normative europee [2] sia secondo le linee guida specifiche, in particolare ISO 14644 (parti 1, 2, 4 e 5) relativamente ai contaminanti particolati non vitali [3–6] e ISO 14698 relativamente alle contaminazioni da microrganismi vivi [7–9].
This is a preview of subscription content, log in via an institution to check access.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
Preview
Unable to display preview. Download preview PDF.
Bibliografia
Farmacopea Ufficiale della Repubblica Italiana, XII ed. Norme di Buona Preparazione dei Radiofarmaci per Medicina Nucleare
EudraLex — The rules governing medicinal products in the European Union. Volume 4 — EU Guidelines for good manufacturing practices (GMP) for medicinal products for human and veterinary use Annex 1: Manufacture of sterile medicinal products (revision November 2008) http://ec.europa.eu/health/files/eudralex/vol-4/2008_11_25_gmp-an1_en.pdf
International Organization for Standardization. ISO 14644 Cleanrooms and associated controlled environments — Part 1: Classification of air cleanliness
International Organization for Standardization. ISO 14644 Cleanrooms and associated controlled environments — Part 2: Specification for testing and monitoring to prove continued compliance with ISO 14644-1
International Organization for Standardization. ISO 14644 Cleanrooms and associated controlled environments — Part 4: Design, construction and start-up
International Organization for Standardization. ISO 14644 Cleanrooms and associated controlled environments — Part 5: Operations
International Organization for Standardization. ISO 14698 Cleanrooms and associated controlled environments — Biocontamination control. Part 1: General principles and methods
International Organization for Standardization. ISO 14698 Cleanrooms and associated controlled environments — Biocontamination control. Part 2: Evaluation and interpretation of biocontamination data
International Organization for Standardization. ISO 14698 Cleanrooms and associated controlled environments — Biocontamination control. Part 3: Measuraments of the efficiency of processes of cleaning and/or disinfection of inert surfaces bearing biocontaminated wet soiling or biofilms
International Society for Pharmaceutical Engineering (1999) ISPE Baseline Pharmaceutical Engineering Guides — Volume 3: Sterile Manufacturing Facilities, First Edition Jan 1999
European Committee for Standardization. EN 1822-1 High efficiency air filters (EPA, HEPA and ULPA) — Part 1: Classification, performance testing, marking
World Health Organization (1995) Manuale di biosicurezza in laboratorio (edizione italiana a cura dell’Istituto Superiore di Sanità). Annali dell’Istituto Superiore di Sanità vol. 31, suppl. al n. 2
Author information
Authors and Affiliations
Rights and permissions
Copyright information
© 2011 Springer-Verlag Italia
About this chapter
Cite this chapter
Temperini, S., Orlandini, S. (2011). Soluzioni tecnologiche per il mantenimento delle classificazioni ambientali. In: La qualità nella preparazione dei radiofarmaci. Imaging & formazione, vol 6. Springer, Milano. https://doi.org/10.1007/978-88-470-2020-7_7
Download citation
DOI: https://doi.org/10.1007/978-88-470-2020-7_7
Publisher Name: Springer, Milano
Print ISBN: 978-88-470-2019-1
Online ISBN: 978-88-470-2020-7
eBook Packages: MedicineMedicine (R0)