RT Journal Article
SR Electronic
T1 Permeation Risks with Peracetic Acid and Hydrogen Peroxide Sterilizing Agent Inside Ambulatory Pumps
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 200
OP 205
VO 59
IS 3
A1 Celine, Bourguignon
A1 Amandine, Grain
A1 Joel, Schlatter
A1 Norbert, Vermerie
YR 2005
UL http://journal.pda.org/content/59/3/200.abstract
AB The sterilizing agent commonly used to sterilize materials for an isolator is a peracetic acid (PA) and hydrogen peroxide (HP) mixture. The permeation of this agent through ambulatory pumps should reveal a potential toxic risk for the patient and a stability modification of the drug by a pH change. Six wrapped and six unwrapped ambulatory pumps from each laboratory were introduced in the transfer chamber for the sterilizing process over 2 h 45 min. The presence of PA and HP were determined by using analytical strips. If the analytical strips of HP were positive, the level of HP was determined by using a specific spectrometric kit. No acid permeation was found in all wrapped pumps. Acid permeation was found in two samples of Ultraflow® unwrapped series and in one unwrapped sample of Easypump® series by the analytical strips. In other unwrapped samples, no acid permeation was detected. In four unwrapped ambulatory pumps (Accufuser®, Infusor®, Ultraflow®, and Easypump®), the analytical strips of HP were positive in the range of 0.5 to 25 mg/L, varying by laboratory. In only one sample (Surefuser®), no detection of HP was found. The quantitative dosage of HP by spectrophotometry confirmed the permeation risk inside all pumps except the Surefuser®. Our investigation shows that the permeation risk inside ambulatory pumps is real when pumps are unwrapped and exposed at high levels to PA and HP mixture. The results of our study recommend retaining the wrapping for the peracetic acid sterilization of the ambulatory pumps.