RT Journal Article
SR Electronic
T1 The Development of a Biological Indicator for Validating Ultraviolet Radiation Sterilization of Polyethylene Bottles
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 191
OP 197
VO 37
IS 5
A1 Robert L. Abshire
A1 Barry A. Schlech
A1 Helen Dunton
YR 1983
UL http://journal.pda.org/content/37/5/191.abstract
AB A biological indicator (BI) model, referred to as a Spore-Tainer, was devised to challenge and determine the sterilization efficacies of ultraviolet (UV) systems which are used at Alcon facilities to sterilize empty, translucent (natural) polyethylene bottles. The microbial bioburden in these containers is extremely low. Spores of Bacillus pumilus served as an excellent BI for UV sterilization based on their extreme resistance to UV, reproducible resistance characteristics and ease of handling. UV lamps in a static type sterilizer delivered a minimal UV dose of 360,000 ergs/mm2 in 30 min. Ninety percent of a 106 spore population of B. pumilus was consistently destroyed within 2 min (i.e., D-value) with no survivors being recovered following a 10-min exposure in this system. The conveyor system generated a minimal UV dose of 252,000 ergs/mm2 in 30 min to plastic bottles, yielding a D-value of nearly 4 min. Surviving spores were not recovered from a 106 population after being exposed in this sterilizer for 21 min.