PT  - JOURNAL ARTICLE
AU  - Pflug, Irving J.
AU  - Odlaug, Theron E.
TI  - Biological Indicators in the Pharmaceutical and the Medical Device Industry
DP  - 1986 Sep 01
TA  - PDA Journal of Pharmaceutical Science and Technology
PG  - 242--248
VI  - 40
IP  - 5
4099  - http://journal.pda.org/content/40/5/242.short
4100  - http://journal.pda.org/content/40/5/242.full
SO  - PDA J Pharm Sci Technol1986 Sep 01; 40
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.