Evaluation of substrates for 90 degrees peel adhesion--a collaborative study. I. Medical tapes.
As part of a method development for peel testing, an interlaboratory comparison among Food and Drug Administration-Center for Drug Evaluation and Research, Food and Drug Administration-Center for Devices and Radiological Health and Southwest Research Institute was conducted using medical tapes. The aim was to determine which readily available substrate [stainless steel (SS), high density polyethylene (HDPE) or Vitro-Skin(R)] would best distinguish among various medical tapes. Five medical tapes (3M 1523, 3M 1525L, 3M 1776, Mepiform(R) and Mediderm(R) 3505) were evaluated on four different substrates (SS, HDPE, Vitro-Skin, and human cadaver skin) using the following peel parameters: approximately 3 min dwell time, 90 degrees peel angle, and 300 mm/min peel rate. No substrate mimics cadaver skin for all five tapes. SS had the best ability to distinguish among the medical tapes. Overall, for quality control purposes (yielding good discrimination and precision), SS would be the optimal substrate.
Wokovich
Anna M
AM
Center for Drug Evaluation and Research, Food and Drug Administration, St. Louis, Missouri, USA. anna.wokovich@fda.hhs.gov
Brown
Stanley A
SA
McMaster
Fraser J
FJ
Doub
William H
WH
Cai
Bing
B
Sadrieh
Nakissa
N
Chen
Mei Ling
ML
Machado
Stella
S
Shen
Meiyu
M
Buhse
Lucinda F
LF
D006801:Humans; D008422:Materials Testing / Q000379:methods*; D008954:Models, Biological; D020959:Polyethylene; D012867:Skin; D017768:Skin, Artificial; D013193:Stainless Steel; D053832:Surgical Tape / Q000592:standards*
D013193:Stainless Steel; D020959:Polyethylene