Evaluation of peracetic acid permeation during flash sterilization through pharmaceutical plastic polymers used in cytotoxic reconstitution units.
Peracetic acid (PAA) permeation in flash sterilization was studied using three different plastic infusion bags made of polypropylene and polyethylene, filled with glucose 5% or NaCl 0.9%. The pH was measured and acetic acid (AA) and PAA concentrations were made by reverse phase high-performance liquid chromatography (RP-HPLC). PAA was derivatized by oxidation of methyl tolyl sulfide (MTS) into methyl tolyl sulfoxide (MTSO) detected by ultraviolet (UV) absorbance at 230 nm. The technique has a sensitivity of 0.3 microg x L(-1) and was highly specific. Results showed that pH measurements remain constant and demonstrated the absence of PAA permeation, which was confirmed by the absence of AA permeation regardless of the brand tested, with both unwrapped and overwrapped infusion bags, when flash sterilization is applied. These results allow flash sterilization to be performed with unwrapped infusion bags without any risk of drug degradation by PAA. This makes compounding safer and easier, which improves productivity.
Havard
Laurent
L
Pharmacy, Hôpital Européen Georges Pompidou, 20-40 rue Leblanc, 75015 Paris. laurent.havard@hop.egp.ap-hop-paris.fr
Fellous-Jerome
Joelle
J
Bonan
Brigitte
B
Pradeau
Dominique
D
Prognon
Patrice
P
D000970:Antineoplastic Agents / Q000592:standards*; D002851:Chromatography, High Pressure Liquid; D004355:Drug Stability; D007260:Infusion Pumps / Q000592:standards*; D008422:Materials Testing; D010463:Peracetic Acid / Q000737:chemistry*; D010539:Permeability; D020959:Polyethylene / Q000737:chemistry; D011108:Polymers / Q000737:chemistry*; D011126:Polypropylenes / Q000737:chemistry; D013242:Sterilization / Q000379:methods* / Q000592:standards
D000970:Antineoplastic Agents; D011108:Polymers; D011126:Polypropylenes; D020959:Polyethylene; D010463:Peracetic Acid