RT Journal Article
SR Electronic
T1 Biological Indicators in the Pharmaceutical and the Medical Device Industry
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 242
OP 248
VO 40
IS 5
A1 Pflug, Irving J.
A1 Odlaug, Theron E.
YR 1986
UL http://journal.pda.org/content/40/5/242.abstract
AB In the first part of this article Bis are closely examined regarding their constituents, attributes, and problems. The idea is developed that Bis are accurate measuring units when properly used but cannot be used as standards, that sterilization processes are desired to kill microorganisms, therefore, they must be validated in a way to demonstrate microbial kill, the role played by Bis. In the second part the use of Bis in the specific sterilization processes of wet-heat or steam, dry-heat, ethylene oxide, and radiation sterilization is discussed. Recommendations are made regarding the use of Bis in these processes.