title: To create a cleanroom controlled environment using a mobile air decontamination unit for the preparation of antineoplastic drugs.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  Authors have previously studied some technical and economical aspects to evaluate the feasibility of the MADU option.
  
  
  RESULTS
  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.
authors.affiliation: Centralized Chemotherapy Preparation Unit, Emile Durkheim Hospital, Epinal, France julien.lecordier@ch-ed.fr.
authors.forename: Julien
authors.initials: J
authors.lastname: Lecordier
authors.affiliation: Technical and Logistical Affairs Management, Emile Durkheim Hospital, Epinal, France.
authors.forename: Claire
authors.initials: C
authors.lastname: Plivard
authors.affiliation: Technical Services, Emile Durkheim Hospital, Epinal, France.
authors.forename: Michel
authors.initials: M
authors.lastname: Gardeux
authors.affiliation: Airinspace S.E. Company, Montigny le Bretonneux, France.
authors.forename: Karim
authors.initials: K
authors.lastname: Daouadi
authors.affiliation: Chief Pharmacist, Pharmacy Department, Emile Durkheim Hospital, Epinal, France.
authors.forename: Jean-Jacques
authors.initials: JJ
authors.lastname: Lahet
mesh_terms: D016902:Air Pollution, Indoor / Q000009:adverse effects*; D000970:Antineoplastic Agents / Q000009:adverse effects* / Q000737:chemistry*; D003666:Decontamination / Q000295:instrumentation* / Q000379:methods*; D004780:Environment, Controlled; D005602:France; D006801:Humans
chemical_list: D000970:Antineoplastic Agents
keywords: Chemotherapy; air purification; compunding unit; isolator; manufacturing practice