RT Journal Article
SR Electronic
T1 A Procedure for Validating the Sterility of Individual Gamma Radiation Sterilized Production Batches
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 33
OP 36
VO 41
IS 1
A1 Genova, Thomas F.
A1 Hollis, Robert A.
A1 Crowell, Curtis A.
A1 Schady, Kathleen M.
YR 1987
UL http://journal.pda.org/content/41/1/33.abstract
AB A method is described (Batch Release method) which allows the user to validate the sterility of individual batches of gamma radiation-sterilized medical devices. The method has been validated using a wide variety of products ranging from sutures to complex mechanical devices. It has been used in instances where product is available in limited quantities, or is prohibitively expensive. The method is a corollary to the AAMI Guidelines for Radiation Sterilization method Bl. It has been modified to accept a reduced sample size (20 instead of 130 samples) without a concomitant loss of accuracy or sensitivity.