To create a cleanroom controlled environment using a mobile air decontamination unit for the preparation of antineoplastic drugs

To use a mobile air decontamination unit (MADU) for a microbial destruction and decreased particle burden making a cleanroom controlled environment in a Centralized Chemotherapy Preparation Unit (CCPU). Good manufacturing practices (GMP) in France specify that the ambient air in the vicinity of a cl...

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Bibliographic Details
Published inJournal of oncology pharmacy practice Vol. 22; no. 1; p. 151
Main Authors Lecordier, Julien, Plivard, Claire, Gardeux, Michel, Daouadi, Karim, Lahet, Jean-Jacques
Format Journal Article
LanguageEnglish
Published England 01.02.2016
Subjects
Air Pollution, Indoor - adverse effects
Antineoplastic Agents - adverse effects
Antineoplastic Agents - chemistry
Decontamination - instrumentation
Decontamination - methods
Environment, Controlled
France
Humans
France
air purification
manufacturing practice
Chemotherapy
compunding unit
isolator
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Summary:To use a mobile air decontamination unit (MADU) for a microbial destruction and decreased particle burden making a cleanroom controlled environment in a Centralized Chemotherapy Preparation Unit (CCPU). Good manufacturing practices (GMP) in France specify that the ambient air in the vicinity of a class III biosafety cabinet (isolator) complies with air cleanliness ISO 8 level in CCPU. This guideline has a significant impact because implementing a dedicated air handling unit (AHU) brings some engineering constraints and generates substantial additional costs. Authors have previously studied some technical and economical aspects to evaluate the feasibility of the MADU option. Using a MADU was the chosen option. Qualification of the CCPU showed that results were in compliance with the French GMP. After one year of use, the efficiency of the MADU was confirmed. According to these results, using a MADU constitutes a beneficial option for CCPU previously equipped with an isolator when compared to renovation work involving a standard built-in AHU.
ISSN:1477-092X
DOI:10.1177/1078155214565125