title: Aseptic simulation test for cytotoxic drug production in isolators.
abstract: OBJECTIVE
  The results of a media-fill test (MFT) study to validate processes for cytotoxic drug preparation inside and outside aseptic compounding isolators are presented.
  
  
  METHODS
  Using an MFT protocol adapted to institution-specific production conditions, the pharmacy team at a hospital in France performed a series of tests to verify the efficacy of decontamination and sterile compounding procedures, as required by French compendial standards, while assessing the performance of its team of 12 isolator operators; all operators were tested on three occasions, producing 10 MFT samples per test for a total of 30 samples per operator. The team also tested alternative compounding systems (i.e., two closed-system transfer devices and a classic spike system) for use during power outages or other emergencies precluding drug preparation within isolators. MFTs were performed using a standard tryptone soy broth-based test kit under worst-case conditions.
  
  
  RESULTS
  The hospital's facilities for cytotoxic drug preparation were found to be in conformance with applicable sterility standards. Bacterial growth was not detected in any of the MFT samples produced by isolator operators during the study (total n = 360). In one instance, an MFT sample prepared using a closed-system transfer device was found to be contaminated due to improper cleaning of the medication vial, highlighting the importance of strict adherence to proper decontamination procedures.
  
  
  CONCLUSIONS
  A hospital's practices for preparation of sterile products according to applicable good manufacturing guidelines, as well as emergency procedures for cytotoxic drug preparation outside isolators, were validated by the results of an MFT study.
authors.affiliation: Amandine Savry, Pharm.D., Ph.D., is Pharmacist; Florian Correard, is Pharmacy Intern; and Youssef Bennis, Pharm.D., Ph.D., is Pharmacist, Oncopharma Unit, Pharmacy Department, La Timone University Teaching Hospital, Marseille, France. Sophie Roubaud, Pharm.D., is Pharmacist, Plein Ciel Clinic, Mougins, France. Laurence Gauthier-Villano, Pharm.D., is Pharmacist, Oncopharma Unit, Pharmacy Department, La Timone University Teaching Hospital. Pascale Pisano, Pharm.D., Ph.D., is Pharmacist, Pharmacology Laboratory, Faculty of Pharmacy, Aix Marseille University, Marseille. Bertrand Pourroy, Pharm.D., Ph.D., is Pharmacist, Oncopharma Unit, Pharmacy Department, La Timone University Teaching Hospital.
authors.forename: Amandine
authors.initials: A
authors.lastname: Savry
authors.forename: Florian
authors.initials: F
authors.lastname: Correard
authors.forename: Youssef
authors.initials: Y
authors.lastname: Bennis
authors.forename: Sophie
authors.initials: S
authors.lastname: Roubaud
authors.forename: Laurence
authors.initials: L
authors.lastname: Gauthier-Villano
authors.forename: Pascale
authors.initials: P
authors.lastname: Pisano
authors.forename: Bertrand
authors.initials: B
authors.lastname: Pourroy
mesh_terms: D000970:Antineoplastic Agents / Q000138:chemical synthesis / Q000592:standards; D003603:Cytotoxins / Q000138:chemical synthesis / Q000592:standards*; D004339:Drug Compounding / Q000379:methods / Q000592:standards*; D004340:Drug Contamination / Q000517:prevention & control*; D006801:Humans; D016273:Occupational Exposure / Q000517:prevention & control / Q000592:standards; D010607:Pharmacy Service, Hospital / Q000379:methods / Q000592:standards*
chemical_list: D000970:Antineoplastic Agents; D003603:Cytotoxins