title: Microbial growth tests in anti-neoplastic injectable solutions.
abstract: The Institut Gustave-Roussy (IGR) Department of Clinical Pharmacy (DCP) ensures the annual preparation of about 30 000 therapeutic batches of anti-neoplastic agents. High performance thin-layer chromatography (HPTLC) allows postproduction quality control of these batches. Although the centralized chemotherapy manufacturing unit has been recently ISO 9001:2000 certified, it was considered to improve the quality level of manufactured batches even further. The viability of micro-organisms (bacteria and fungi) in appropriate sterile media containing various anti-neoplastic agents at therapeutic concentration was assessed to demonstrate the lack of contamination during our manufacturing process in the isolator. After 14 days of incubation in these media, the results show the absence of contamination of the manufactured batches. This leads us to conclude that using sterile drugs and sterile medical devices in a sterile isolator allows the manufacture of sterile therapeutic batches with excellent confidence.
authors.affiliation: Department of Clinical Pharmacy, Institut Gustave-Roussy, 39 rue Camille Desmoulins, 94805 Villejuif Cedex, France.
authors.forename: Isabelle
authors.initials: I
authors.lastname: Paris
authors.forename: Angelo
authors.initials: A
authors.lastname: Paci
authors.forename: Jean-Baptiste
authors.initials: JB
authors.lastname: Rey
authors.forename: Philippe
authors.initials: P
authors.lastname: Bourget
mesh_terms: D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage / Q000737:chemistry; D000970:Antineoplastic Agents / Q000032:analysis*; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage / Q000737:chemistry; D001412:Bacillus subtilis / Q000254:growth & development; D001419:Bacteria / Q000737:chemistry / Q000254:growth & development*; D002176:Candida albicans / Q000254:growth & development; D002945:Cisplatin / Q000008:administration & dosage / Q000737:chemistry; D003561:Cytarabine / Q000008:administration & dosage / Q000737:chemistry; D004339:Drug Compounding; D004340:Drug Contamination / Q000517:prevention & control*; D004349:Drug Packaging; D005047:Etoposide / Q000008:administration & dosage / Q000737:chemistry; D005472:Fluorouracil / Q000008:administration & dosage / Q000737:chemistry; D005658:Fungi / Q000737:chemistry / Q000254:growth & development*; D007262:Infusions, Intravenous; D019999:Pharmaceutical Solutions; D013242:Sterilization
chemical_list: D000964:Antimetabolites, Antineoplastic; D000970:Antineoplastic Agents; D000972:Antineoplastic Agents, Phytogenic; D019999:Pharmaceutical Solutions; D003561:Cytarabine; D005047:Etoposide; D002945:Cisplatin; D005472:Fluorouracil