RT Journal Article
SR Electronic
T1 Evaluation of Peracetic Acid Permeation during Flash Sterilization through Pharmaceutical Plastic Polymers Used in Cytotoxic Reconstitution Units
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 258
OP 264
VO 59
IS 4
A1 Havard, Laurent
A1 Fellous-Jerome, Joelle
A1 Bonan, Brigitte
A1 Pradeau, Dominique
A1 Prognon, Patrice
YR 2005
UL http://journal.pda.org/content/59/4/258.abstract
AB 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 (RPHPLC). 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 0.3μg · 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.