Microbial growth tests in anti-neoplastic injectable solutions.
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.
Paris
Isabelle
I
Department of Clinical Pharmacy, Institut Gustave-Roussy, 39 rue Camille Desmoulins, 94805 Villejuif Cedex, France.
Paci
Angelo
A
Rey
Jean-Baptiste
JB
Bourget
Philippe
P
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
D000964:Antimetabolites, Antineoplastic; D000970:Antineoplastic Agents; D000972:Antineoplastic Agents, Phytogenic; D019999:Pharmaceutical Solutions; D003561:Cytarabine; D005047:Etoposide; D002945:Cisplatin; D005472:Fluorouracil